Saturday 28 July 2012

hydrochlorothiazide and bisoprolol


Generic Name: hydrochlorothiazide and bisoprolol (HYE droe klor oh THYE a zide and bi SOE proe lol)

Brand Names: Ziac


What is hydrochlorothiazide and bisoprolol?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.


Bisoprolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).


The combination of hydrochlorothiazide and bisoprolol is used to treat high blood pressure (hypertension).


Hydrochlorothiazide and bisoprolol may also be used for purposes not listed in this medication guide.


What is the most important information I should know about hydrochlorothiazide and bisoprolol?


You should not use this medication if you have severe or uncontrolled heart failure, a heart condition called "sick sinus syndrome" or "AV block," slow heartbeats, an allergy to sulfa drugs, or if you are unable to urinate.

Before using this medication, tell your doctor if you have congestive heart failure, circulation problems, kidney or liver disease, cirrhosis, glaucoma, asthma, bronchospastic lung disease, a thyroid disorder, lupus, gout, diabetes, or a penicillin allergy.


If you are diabetic, check your blood sugar carefully. Using bisoprolol can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking hydrochlorothiazide and bisoprolol. Talk with your doctor before changing any doses.


Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and bisoprolol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.


Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

There are many other medicines that can interact with hydrochlorothiazide and bisoprolol. Tell your doctor about all the prescription and over-the-counter medications you use.


What should I discuss with my doctor before taking hydrochlorothiazide and bisoprolol?


You should not use this medication if you are allergic to hydrochlorothiazide or bisoprolol, or if you have:

  • severe or uncontrolled heart failure;




  • a heart condition called "sick sinus syndrome" or "AV block" (2nd or 3rd degree);




  • slow heartbeats;



  • if you are unable to urinate;


  • if you are allergic to sulfa drugs; or




  • if you are allergic to any beta-blocker medication, such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others.



To make sure you can safely take hydrochlorothiazide and bisoprolol, tell your doctor if you have any of these other conditions:



  • congestive heart failure;




  • blood circulation problems;



  • kidney disease;

  • liver disease (or cirrhosis);


  • glaucoma;




  • asthma, or bronchospastic lung disease;




  • a thyroid disorder;




  • lupus;




  • gout;




  • diabetes; or




  • a penicillin allergy.




FDA pregnancy category C. It is not known whether hydrochlorothiazide and bisoprolol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hydrochlorothiazide can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using hydrochlorothiazide and bisoprolol.

How should I take hydrochlorothiazide and bisoprolol?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Take the medicine with a meal or right after you eat.

Your doctor may occasionally change your dose to make sure you get the best results.


Do not stop using hydrochlorothiazide and bisoprolol suddenly, or you could have a serious or life-threatening heart problem. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Your blood pressure will need to be checked often. Your blood and urine may both be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.


If you are diabetic, check your blood sugar carefully. Using bisoprolol can make it harder for you to tell when you have low blood sugar. Your insulin or diabetic medication needs may change while you are taking hydrochlorothiazide and bisoprolol. Talk with your doctor before changing any doses.


Hydrochlorothiazide and bisoprolol can affect the results of certain thyroid tests. Tell any doctor who treats you that you are using this medication.


If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and bisoprolol. You may need to stop using the medicine for a short time. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store in a tightly closed container at room temperature, away from heat, moisture, and light.

See also: Hydrochlorothiazide and bisoprolol dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fast or slow heart rate, confusion, weakness, shallow breathing, swelling, increased urination, and feeling like you might pass out.


What should I avoid while taking hydrochlorothiazide and bisoprolol?


Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and bisoprolol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.


Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Hydrochlorothiazide and bisoprolol side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • eye pain, vision problems;




  • swelling, rapid weight gain, feeling short of breath, even with mild exertion;




  • fast, slow, or uneven heartbeat;




  • easy bruising or bleeding;




  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with speech or balance;




  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;




  • pain, swelling, warmth, or redness in one or both legs;




  • numbness or tingly feeling in your hands or feet;




  • feeling weak, drowsy, restless, or light-headed;




  • dry mouth, extreme thirst, confusion, increased urination, leg discomfort, muscle weakness or limp feeling, nausea and vomiting;




  • urinating less than usual or not at all;




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or




  • upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • diarrhea, constipation, upset stomach;




  • dizziness, spinning sensation;




  • cough, runny nose;




  • ringing in your ears; or




  • blurred vision.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Hydrochlorothiazide and bisoprolol Dosing Information


Usual Adult Dose for Hypertension:

Initial dose: 1 tablet of (bisoprolol-hydrochlorothiazide 2.5 mg/6.25 mg) once a day. Determine dosage by individual titration.
Maintenance dose: May increase up to a maximum dose of 2 tablets of (bisoprolol-hydrochlorothiazide 10 mg/6.25 mg) once a day.


What other drugs will affect hydrochlorothiazide and bisoprolol?


Tell your doctor if you regularly use any other medicines that make you light-headed (especially narcotic pain medication or barbiturates). They can add to the side effects of hydrochlorothiazide and bisoprolol.

Many drugs can interact with hydrochlorothiazide and bisoprolol. Below is just a partial list. Tell your doctor if you are using:



  • insulin or oral diabetes medication;




  • colestipol (Colestid) or cholestyramine (Prevalite, Questran);




  • steroids (prednisone and others);




  • lithium (Lithobid);




  • rifampin (Rifadin, Rifamate, Rimactane);




  • NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;




  • other heart or blood pressure medications such as clonidine (Catapres) or reserpine; or




  • a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), or verapamil (Calan, Covera, Isoptin, Verelan).



This list is not complete and other drugs may interact with hydrochlorothiazide and bisoprolol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More hydrochlorothiazide and bisoprolol resources


  • Hydrochlorothiazide and bisoprolol Side Effects (in more detail)
  • Hydrochlorothiazide and bisoprolol Dosage
  • Hydrochlorothiazide and bisoprolol Use in Pregnancy & Breastfeeding
  • Drug Images
  • Hydrochlorothiazide and bisoprolol Drug Interactions
  • Hydrochlorothiazide and bisoprolol Support Group
  • 11 Reviews for Hydrochlorothiazide and bisoprolol - Add your own review/rating


Compare hydrochlorothiazide and bisoprolol with other medications


  • High Blood Pressure


Where can I get more information?


  • Your pharmacist can provide more information about hydrochlorothiazide and bisoprolol.

See also: hydrochlorothiazide and bisoprolol side effects (in more detail)


Children's Ibuprofen Berry



Generic Name: ibuprofen (EYE bue PROE fen)

Brand Names: Advil, Advil Childrens, Advil Junior Strength, Advil Liquigel, Advil Migraine, Advil Pediatric, Children's Ibuprofen Berry, Genpril, IBU, Midol IB, Midol Maximum Strength Cramp Formula, Motrin Childrens, Motrin IB, Motrin Infant Drops, Motrin Junior Strength, Motrin Migraine Pain, Nuprin


What is Children's Ibuprofen Berry (ibuprofen)?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.


Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.


Ibuprofen may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Children's Ibuprofen Berry (ibuprofen)?


This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.


This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking ibuprofen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.


Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. Use only the smallest amount of ibuprofen needed to get relief from your pain, swelling, or fever.

What should I discuss with my healthcare provider before taking Children's Ibuprofen Berry (ibuprofen)?


Do not use ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).


This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking ibuprofen, especially in older adults.


You should not use this medication if you are allergic to ibuprofen, aspirin or other NSAIDs.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:



  • a history of heart attack, stroke, or blood clot;




  • heart disease, congestive heart failure, high blood pressure;




  • a history of stomach ulcers or bleeding;




  • asthma;




  • polyps in your nose;



  • liver or kidney disease;


  • systemic lupus erythematosus (SLE);




  • a bleeding or blood clotting disorder; or




  • if you smoke.




FDA pregnancy category D. Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using ibuprofen. It is not known whether ibuprofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

How should I take Children's Ibuprofen Berry (ibuprofen)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.


Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of ibuprofen needed to get relief from your pain, swelling, or fever. Take ibuprofen with food or milk to lessen stomach upset. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The ibuprofen chewable tablet must be chewed before you swallow it.


If you take ibuprofen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.


Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?


Since ibuprofen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Children's Ibuprofen Berry (ibuprofen)?


Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Ibuprofen and other NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much ibuprofen. Check the label to see if a medicine contains ibuprofen or similar NSAIDs (aspirin, naproxen, ketoprofen). Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Children's Ibuprofen Berry (ibuprofen) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking ibuprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;




  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;




  • swelling or rapid weight gain;




  • urinating less than usual or not at all;




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;




  • bruising, severe tingling, numbness, pain, muscle weakness; or




  • severe headache, neck stiffness, chills, increased sensitivity to light, and/or seizure (convulsions).



Less serious side effects may include:



  • upset stomach, mild heartburn, diarrhea, constipation;




  • bloating, gas;




  • dizziness, headache, nervousness;




  • skin itching or rash;




  • blurred vision; or




  • ringing in your ears.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Children's Ibuprofen Berry (ibuprofen)?


Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all other medicines you use, especially:



  • aspirin or other NSAIDs such as naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;




  • heart or blood pressure medicine such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;




  • lithium (Eskalith, Lithobid);




  • diuretics (water pills) such as furosemide (Lasix);




  • methotrexate (Rheumatrex, Trexall);




  • steroids (prednisone and others); or




  • a blood thinner such as warfarin (Coumadin, Jantoven).



This list is not complete and other drugs may interact with ibuprofen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Children's Ibuprofen Berry resources


  • Children's Ibuprofen Berry Side Effects (in more detail)
  • Children's Ibuprofen Berry Use in Pregnancy & Breastfeeding
  • Drug Images
  • Children's Ibuprofen Berry Drug Interactions
  • Children's Ibuprofen Berry Support Group
  • 51 Reviews for Children's Ibuprofen Berry - Add your own review/rating


  • Ibuprofen Prescribing Information (FDA)

  • Ibuprofen Professional Patient Advice (Wolters Kluwer)

  • Ibuprofen Monograph (AHFS DI)

  • Advil MedFacts Consumer Leaflet (Wolters Kluwer)

  • Advil Prescribing Information (FDA)

  • Advil Advanced Consumer (Micromedex) - Includes Dosage Information

  • Advil Consumer Overview

  • Advil Childrens Prescribing Information (FDA)

  • Advil Migraine Prescribing Information (FDA)

  • Caldolor Injection MedFacts Consumer Leaflet (Wolters Kluwer)

  • Caldolor Consumer Overview

  • Caldolor Advanced Consumer (Micromedex) - Includes Dosage Information

  • Caldolor Prescribing Information (FDA)

  • IBU MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ibutilide Fumarate Monograph (AHFS DI)

  • Motrin Prescribing Information (FDA)

  • Motrin Consumer Overview

  • Motrin IB Prescribing Information (FDA)

  • Motrin Junior Strength Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • NeoProfen Prescribing Information (FDA)



Compare Children's Ibuprofen Berry with other medications


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  • Dysautonomia
  • Fever
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  • Muscle Pain
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  • Rheumatoid Arthritis
  • Sciatica
  • Spondylolisthesis
  • Temporomandibular Joint Disorder


Where can I get more information?


  • Your pharmacist can provide more information about ibuprofen.

See also: Children's Ibuprofen Berry side effects (in more detail)


Chloramphenicol Injection





Dosage Form: injection, powder, lyophilized, for solution
Chloramphenicol Sodium Succinate 1 gm Injection, USP 1 gm Vial
Boxed Warning

WARNING

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS AND USAGE section. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.


Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.




Description


IMPORTANT CONSIDERATIONS IN PRESCRIBING INJECTABLE CHLORAMPHENICOL SODIUM SUCCINATE.

CHLORAMPHENICOL SODIUM SUCCINATE IS INTENDED FOR INTRAVENOUS USE ONLY. IT HAS BEEN

DEMONSTRATED TO BE INEFFECTIVE WHEN GIVEN INTRAMUSCULARLY.


1. Chloramphenicol sodium succinate for injection must be hydrolyzed to its microbiologically active form, and there is a lag in achieving adequate blood levels compared with the base given intravenously.


2. The oral form of chloramphenicol is readily absorbed and adequate blood levels are achieved and maintained on the recommended dosage.


3. Patients started on intravenous chloramphenicol sodium succinate for injection should be changed to the oral form as soon as practicable.


Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see INDICATIONS AND USAGE section). When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1g/10mL). Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium. The chemical name for chloramphenicol sodium succinate is D-threo-(-)-2, 2-Dichloro-N-[b- hydroxy-a-(hydroxymethyl)-pnitrophenethyl] acetamide a-(sodium succinate).

The empirical and structural formulas are:





Clinical Pharmacology


In vitro chloramphenicol exerts mainly a bacteriostatic effect on a wide range of gram-negative and gram-positive bacteria and is active in vitro against rickettsias, the lymphogranuloma-psittacosis group and Vibrio cholerae.  It is particularly active against Salmonella typhi and Hemophilus influenzae.  The mode of action is through interference or inhibition of protein synthesis in intact cells and in cell-free systems. 


Chloramphenicol administered orally is absorbed rapidly from the intestinal tract. In controlled studies in adult volunteers using the recommended dosage of 50 mg/kg/day, a dosage of 1 g every 6 hours for 8 doses was given. Using the microbiological assay method, the average peak serum level was 11.2 mcg/mL one hour after the first dose. A cumulative effect gave a peak rise to 18.4 mcg/mL after the fifth dose of 1 g. Mean serum levels ranged from 8 to 14 mcg/mL over the 48-hour period. Total urinary excretion of chloramphenicol in these studies ranged from a low of 68% to a high of 99% over a three-day period. From 8% to 12% of the antibiotic excreted is in the form of free chloramphenicol; the remainder consists of microbiologically inactive metabolites, principally the conjugate with glucuronic acid. Since the glucuronide is excreted rapidly, most chloramphenicol detected in the blood is in the microbiologically active free form. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free chloramphenicol is relatively high, amounting to several hundred mcg/mL in patients receiving divided doses of 50 mg/kg/day. Small amounts of active drug are found in bile and feces. Chloramphenicol diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid. Chloramphenicol enters cerebrospinal fluid even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood. Measurable levels are also detected in pleural and in ascitic fluids, saliva, milk, and in the aqueous and vitreous humors. Transport across the placental barrier occurs with somewhat lower concentration in cord blood of neonates than in maternal blood.



Indications and Usage


In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicolmust be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon

as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of chloramphenicol rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional concepts contained in the Warning Box above.


1. Acute infections caused by Salmonella typhi*

It is not recommended for the routine treatment of the typhoid carrier state.


2. Serious infections caused by susceptible strains in accordance with the concepts expressed above:

a) Salmonella species

b) H. influenzae, specially meningeal infections

c) Rickettsia

d) Lymphogranuloma-psittacosis group

e) Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infections

f) Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.


3. Cystic fibrosis regimens




*In treatment of typhoid fever some authorities recommend that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.



Contraindications


Chloramphenicol is contraindicated in individuals with a history of previous hypersensitivity and/or toxic reaction to it. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.



Precautions


Baseline blood studies should be followed by periodic blood studies approximately every two days during therapy. The drug should be discontinued upon appearance of reticulocytopenia, leukopenia, thrombocytopenia, anemia or any other blood study findings attributable to chloramphenicol. However, it should be noted that such studies do not exclude the possible later appearance of the irreversible type of bone marrow depression.


Repeated courses of chloramphenicol treatment should be avoided if at all possible. Treatment should not be continued longer than required to produce a cure with little or no risk or relapse of the disease.


Concurrent therapy with other drugs that may cause bone marrow depression should be avoided.


Excessive blood levels may result from administration of the recommended dose to patients with impaired liver or kidney function, including that due to immature metabolic processes in the infant.  The dosage should be adjusted accordingly, or preferably, the blood concentration should be determined at appropriate intervals.


There are no studies to establish the safety of this drug in pregnancy. 


Since chloramphenicol readily crosses the placental barrier, caution in use of the drug is particularly imporant during pregnancy at term or during labor because of the potential toxic effects on the fetus (gray syndrome).


Precaution should be used in therapy of premature and full-term infants to avoid "gray syndrome" toxicity (see ADVERSE REACTIONS).  Serum drug levels should be carefully followed during therapy of the newborn infant.


Precaution should be used in therapy during lactation because of the possibility of toxic effects on the nursing infant.


the use of this antibiotic, as with other antibiotics, may result in an overgrowth of non-susceptible organisms, including fungi.  If infections caused by non-susceptible organisms appear during therapy, appropriate measures should be taken. 



Adverse Reactions


1. Blood Dyscrasias

The most serious adverse effect of chloramphenicol is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastic or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed. A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of chloramphenicol.


An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias.


In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.


There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.


Paroxysmal nocturnal hemoglobinuria has been reported.


2. Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.


3. Neurotoxic Reactions

Headache, mild depression, mental confusion, and delirium have been described in patients receiving chloramphenicol. Optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.


4. Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.


5. "Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.” One case of gray syndrome has been reported in a neonate born to a mother having received chloramphenicol during labor. One case has been reported in a 3-month-old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:

a) In most cases therapy with chloramphenicol had been instituted within the first 48 hours of life.

b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.

c) The symptoms appeared in the following order:

    (1) abdominal distension with or without emesis;

    (2) progressive pallid cyanosis;

    (3) vasomotor collapse, frequently accompanied by irregular respiration;

    (4) death within a few hours of onset of these symptoms.

d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

e)Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).

f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.



Dosage and Administration


Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Administration of 50 mg/kg/day in divided doses will produce blood levels of the magnitude to which the majority of susceptible microorganisms will respond.


As soon as feasible an oral dosage form of another appropriate antibiotic should be substituted for intravenous chloramphenicol sodium succinate.


The following method of administration is recommended:

Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval. This is prepared by the addition of 10 mL of an aqueous diluent such as water for injection or 5% dextrose injection.


Adults

Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals. In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly. (See discussion under Newborn Infants.) Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques (information available on request).

Children

Dosage of 50 mg/kg/day divided into 4 doses at 6-hour intervals yields blood levels in the range effective against most susceptible organisms. Severe infections (eg, bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired liver or kidney function may retain excessive amounts of the drug.

Newborn Infants

(See section titled “Gray Syndrome” under ADVERSE REACTIONS.)

A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in blood and tissues adequate to control most infections for which the drug is indicated. Increased dosage in these individuals, demanded by severe infections, should be given only to maintain the blood concentration within a therapeutically effective range. After the first two weeks of life, full-term neonates ordinarily may receive up to a total of 50 mg/kg/day equally divided into 4 doses at 6-hour intervals. These dosage recommendations are extremely important because blood concentration in all premature and full-term neonates under two weeks of age differs from that of other infants neonates. This difference is due to variations in the maturity of the metabolic functions of the liver and the kidneys. When these functions are immature (or seriously impaired in adults), high concentrations of the drug are found which tend to increase with succeeding doses.

Infants and Children with Immature Metabolic Processes

In young infants and other pediatric patients in whom immature metabolic functions are suspected, a dose of 25 mg/kg/day will usually produce therapeutic concentrations of the drug in the blood. In this group particularly, the concentration of the drug in the blood should be carefully followed by microtechniques. (Information available on request.)



How Supplied


Chloromycetin Sodium Succinate for Injection, USP is freeze-dried in the vial. When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL).









Product No.
NDC No.

1115
63323-011-15
Available in packages of 10 vials.

Store between 20° and 25°C (68° and 77°F). [See USP Controlled room Temperature].


Preservative Free.


APP Pharmaceuticals, LLC

Schaumburg, IL 60173

Sample Outer Label










CHLORAMPHENICOL SODIUM SUCCINATE 
chloramphenicol sodium succinate  injection, powder, lyophilized, for solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)52584-011 (63323-011)
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloramphenicol Sodium Succinate (Chloramphenicol)Chloramphenicol Sodium Succinate133.27 mg  in 133.27 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
152584-011-151 VIAL In 1 BAGcontains a VIAL
1133.27 mg In 1 VIALThis package is contained within the BAG (52584-011-15)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06236509/01/2010


Labeler - General Injectables and Vaccines, Inc (108250663)
Revised: 09/2010General Injectables and Vaccines, Inc

More Chloramphenicol Injection resources


  • Chloramphenicol Injection Use in Pregnancy & Breastfeeding
  • Chloramphenicol Injection Drug Interactions
  • Chloramphenicol Injection Support Group
  • 0 Reviews for Chloramphenicol Injection - Add your own review/rating


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Wednesday 25 July 2012

Prednisolone Tablets EC 2.5mg, 5mg






Prednisolone 2.5mg and 5mg tablets



(enteric-coated)



  • Prednisolone is a steroid medicine, prescribed for many different conditions, including serious illnesses.


  • You need to take it regularly to get the maximum benefit.


  • Don’t stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually.


  • Prednisolone can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.


  • Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).


  • If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.


  • Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

  • The full name of this medicine is Prednisolone 2.5mg and 5mg Tablets (enteric-coated) but within the leaflet it will be referred to as Prednisolone tablets.


Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.



Index:



1 What Prednisolone tablets are and what they are used for

2 Before you take Prednisolone tablets

3 How to take Prednisolone tablets

4 Possible side effects

5 How to store Prednisolone tablets

6 Further information





What Prednisolone tablets are and what they are used for


Prednisolone belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Prednisolone) is an effective way to treat various illnesses involving inflammation in the body.


Prednisolone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.




Before you take Prednisolone tablets



Do not take Prednisolone tablets if you:


  • are allergic (hypersensitive) to prednisolone or any of the other ingredients in Prednisolone tablets (see section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. Certain ingredients can cause allergic reactions such as Ponceau 4R and sunset yellow (azo dyes) which can cause asthma (5mg tablets only)

  • have cold sores that affect the eyes

  • have an untreated infection.


Check with your doctor or pharmacist before taking Prednisolone tablets if you:


  • have been in contact with anyone who has chickenpox, shingles or measles. Contact your doctor immediately for advice

  • have or have a family history of diabetes or glaucoma

  • have brittle bones, high blood pressure, a recent heart attack, a stomach ulcer, an underactive thyroid gland or tuberculosis

  • have taken prednisolone tablets (or a similar medicine) before and had muscular problems (steroid myopathy)

  • have heart, kidney or liver disease

  • suffer or have suffered from any mental illness

  • are being treated with vaccines


  • have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Prednisolone tablets or any of your close family has had these illnesses


  • Mental problems while taking Prednisolone tablets:

    Mental health problems can happen while taking steroids like Prednisolone tablets (see also section 4 Possible Side Effects)
    • These illnesses can be serious
    • Usually they start within a few days or weeks of starting the medicine.
    • They are more likely to happen at high doses.
    • Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment.

Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:


  • antacids – do not take at the same time as the Prednisolone tablets

  • diuretics (‘water tablets’)

  • medicines to treat epilepsy such as carbamazepine, phenobarbital, phenytoin, primidone

  • medicines for diabetes including insulin

  • medicines to treat infections such as rifabutin, rifampicin, amphotericin, ketoconazole, tetracyclines

  • medicines used to treat cancer such as methotrexate, etoposide

  • anticoagulant drugs used to thin blood

  • oral contraceptives (the ‘pill’)

  • other non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin

  • mifepristone (used for abortion), ciclosporin, acetazolamide, beta-2-agonists, theophylline, carbenoxolone, aminoglutethimide or carbimazole.



Driving and using machines


If you do not have enough sleep you may be less alert and patients should make sure they are not affected before driving or operating machinery.




Pregnancy and breastfeeding


Ask your doctor or pharmacist for advice before taking this medicine.




Sugar intolerance


If you have been told by your doctor that you have an intolerance to some sugars, contact them before taking this medicine, as it contains lactose.



If you see another doctor or go into hospital, let them know what medicines you are taking.




How to take Prednisolone tablets



You will be supplied with a ‘Steroid Treatment Card’ which includes important details of your treatment. This card should be carried at all times.


Always take Prednisolone tablets exactly as your doctor has told you, especially if you are elderly. If you are not sure, check with your doctor or pharmacist.


Swallow the tablets whole, with a little water as a single dose in the morning after breakfast unless otherwise directed by the doctor. Do not chew or cut the tablets.



The usual doses are:


General conditions 5-60mg daily


Allergic and skin disorders 5-15mg daily


Blood disorders 15-60mg daily


Collagenosis 20-30mg daily


Rheumatoid arthritis 10-15mg daily


Doses will be decided for children aged 1-17 years and the elderly.


Once a dose is established, it may be changed to use the lowest effective dose depending on your response to the drug.


If you are diabetic, you may find that you need to take more medication to balance the effect of Prednisolone tablets. You should discuss this with your doctor.


Your doctor should check your progress at regular visits. Also, your progress may have to be checked after you have stopped using this medicine, since some of the effects may continue.




If you forget to take Prednisolone tablets


If you forget to take a dose, take one as soon as you remember and then your next dose at the usual time. Never take two doses at the same time.




If you take more Prednisolone tablets than you should


If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.




If you stop taking Prednisolone tablets


If you stop taking the tablets suddenly you may develop muscle or joint pain, conjunctivitis, fever, weight loss, painful itchy skin lumps or runny nose. Talk to your doctor before you stop taking the tablets and follow their advice.





Possible side effects


Like all medicines, Prednisolone tablets can cause side effects, particularly when you first start taking it although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.



Stop taking Prednisolone tablets and contact your doctor straight away if the following allergic reaction happens: puffy, swollen face, tongue or body, which may cause shortness of breath, shock and collapse.



Tell your doctor straight away if the following happens:


  • inflammation of the pancreas (very severe abdominal pains)

  • Steroids including Prednisolone tablets can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Prednisolone tablets:
    • feeling depressed, including thinking about suicide
    • feeling high (mania) or moods that go up and down
    • feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory
    • feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.


Tell your doctor if the following occur:



Infections - lowered resistance to infections, such as a cold, existing eye infections may become worse or symptoms of a previous infection such as tuberculosis (TB) may happen more easily. This is especially important regarding chickenpox or measles.



Stomach and intestines – increased appetite, indigestion, a feeling of being full or bloated, very sore throat and white areas inside your mouth (oral thrush), feeling sick, weight gain, stomach ulcers.



Heart – high blood pressure.



Nervous system – unusual tiredness or weakness, nervousness, worsening of schizophrenia, increased pressure in the skull (causing painful eyes, changes in vision or a bad headache, especially behind your eyes).



Skin – reddish purple lines, thin skin, unusual bruising, acne, wounds that will not heal.



Muscle or bones – muscle weakness or wasting, pain in back, hips, ribs, arms, shoulders or legs. Osteoporosis (may be easier to fracture your bones or to tear your tendons).



Hormones - filling or rounding out of the face, periods become irregular or stop altogether, unusual increase in hair growth on body or face. Growth in infancy, childhood and adolescence may be reduced.



Kidney - urinating at night, water and salt retention.



Blood - blood clots, changes in the balance of minerals in the blood (detected by a blood test).



Eyes – cataracts, increased pressure in the eye (glaucoma), thinning of the tissues of the eye, pressure on the nerve of the eye.



Withdrawal symptoms – muscle or joint pain, conjunctivitis, fever, weight loss, runny nose and painful, itchy skin lumps.




How to store Prednisolone tablets


Keep out of the reach and sight of children.


Store in a cool dry place.


Do not use Prednisolone tablets after the expiry date stated on the label, carton or bottle. The expiry date refers to the last day of that month.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What Prednisolone tablets contain


  • The active substance (the ingredient that makes the tablets work) is prednisolone. Each tablet contains either 2.5mg or 5mg of
    the active ingredient.

  • The tablet also contains lactose, maize starch, microcrystalline cellulose and magnesium stearate.

  • The tablet coating contains colloidal silicon dioxide, hydroxypropylmethylcellulose (E464), indigo carmine (E132 – 5mg tablets only), iron oxide (E172 – 2.5mg tablets only), macrogol, polyvinyl acetate phthalate, ponceau 4R (E124 – 5mg tablets only), poly (vinyl alcohol), sodium alginate (E401), sodium hydrogen carbonate (E500), stearic acid, sunset yellow (E110 – 5mg tablets only), talc, titanium dioxide (E171), triethyl citrate (E1505).



What Prednisolone tablets look like and contents of the pack


Prednisolone 5mg are circular, red, enteric/film-coated tablets and the 2.5mg tablets are circular, dark brown, enteric/film-coated tablets.


Pack sizes are 28, 30 and 100 tablets.




Marketing Authorisation Holder and Manufacturer



Actavis

Barnstaple

EX32 8NS

UK




Date of last revision: October 2009.




Actavis

Barnstaple

EX32 8NS

UK


50329488





Tuesday 24 July 2012

meprobamate


me-proe-BAM-ate


Commonly used brand name(s)

In the U.S.


  • Mb-Tab

  • Miltown

  • Trancot

Available Dosage Forms:


  • Tablet

  • Capsule, Extended Release

Therapeutic Class: Antianxiety


Chemical Class: Carbamate


Uses For meprobamate


Meprobamate is used to relieve nervousness or tension. meprobamate should not be used for nervousness or tension caused by the stress of everyday life.


Meprobamate is available only with your doctor's prescription.


Before Using meprobamate


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For meprobamate, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to meprobamate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Studies on meprobamate have been done only in adult patients, and there is no specific information comparing use of meprobamate in children with use in other age groups.


Geriatric


Elderly people may be especially sensitive to the effects of meprobamate. This may increase the chance of side effects during treatment.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking meprobamate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using meprobamate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adinazolam

  • Alfentanil

  • Alprazolam

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Bromazepam

  • Brotizolam

  • Butabarbital

  • Butalbital

  • Carisoprodol

  • Chloral Hydrate

  • Chlordiazepoxide

  • Chlorzoxazone

  • Clobazam

  • Clonazepam

  • Clorazepate

  • Codeine

  • Dantrolene

  • Diazepam

  • Estazolam

  • Ethchlorvynol

  • Fentanyl

  • Flunitrazepam

  • Flurazepam

  • Fospropofol

  • Halazepam

  • Hydrocodone

  • Hydromorphone

  • Ketazolam

  • Levorphanol

  • Lorazepam

  • Lormetazepam

  • Medazepam

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Midazolam

  • Morphine

  • Morphine Sulfate Liposome

  • Nitrazepam

  • Nordazepam

  • Oxazepam

  • Oxycodone

  • Oxymorphone

  • Pentobarbital

  • Phenobarbital

  • Prazepam

  • Primidone

  • Propoxyphene

  • Quazepam

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Temazepam

  • Thiopental

  • Triazolam

  • Zolpidem

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Other Medical Problems


The presence of other medical problems may affect the use of meprobamate. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse (or history of) or

  • Drug abuse or dependence (or history of)—Dependence on meprobamate may develop

  • Epilepsy—The risk of seizures may be increased

  • Kidney disease or

  • Liver disease—Higher blood levels of meprobamate may occur, increasing the chance of side effects

  • Porphyria—Meprobamate may make the condition worse

Proper Use of meprobamate


Take meprobamate only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.


Dosing


The dose of meprobamate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of meprobamate. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For regular (short-acting) tablets:
    • Adults and children 12 years of age and older: 400 milligrams three or four times a day, or 600 milligrams two times a day.

    • Children 6 to 12 years of age: 100 to 200 milligrams two or three times a day.

    • Children up to 6 years of age: Dose must be determined by the doctor.


  • For long-acting dosage forms (extended-release tablets):
    • Adults and children 12 years of age or older: 400 to 800 milligrams two times a day, in the morning and at bedtime.

    • Children 6 to 12 years of age: 200 milligrams two times a day, in the morning and at bedtime.

    • Children up to 6 years of age: Dose must be determined by the doctor.


Missed Dose


If you miss a dose of meprobamate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using meprobamate


If you will be taking meprobamate regularly for a long time:


  • Your doctor should check your progress at regular visits.

  • Check with your doctor at least every 4 months to make sure you need to continue taking meprobamate.

If you will be taking meprobamate in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.


meprobamate will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking meprobamate.


Before you have any medical tests, tell the medical doctor in charge that you are taking meprobamate. The results of some tests, such as the metyrapone test and the phentolamine test, may be affected by meprobamate.


If you think you or someone else may have taken an overdose of meprobamate, get emergency help at once. Taking an overdose of meprobamate or taking alcohol or other CNS depressants with meprobamate may lead to unconsciousness and possibly death. Some signs of an overdose are severe confusion, drowsiness, or weakness; shortness of breath or slow or troubled breathing; slurred speech; staggering; and slow heartbeat.


meprobamate may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to meprobamate before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .


Meprobamate may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


meprobamate Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Skin rash, hives, or itching

Rare
  • Confusion

  • fast, pounding, or irregular heartbeat

  • sore throat and fever

  • unusual bleeding or bruising

  • unusual excitement

  • wheezing, shortness of breath, or troubled breathing

Symptoms of overdose
  • Confusion (severe)

  • dizziness or lightheadedness (continuing)

  • drowsiness (severe)

  • shortness of breath or slow or troubled breathing

  • slow heartbeat

  • slurred speech

  • staggering

  • weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Clumsiness or unsteadiness

  • drowsiness

Less common
  • Blurred vision or change in near or distant vision

  • diarrhea

  • dizziness or lightheadedness

  • false sense of well-being

  • headache

  • nausea or vomiting

  • unusual tiredness or weakness

After you stop using meprobamate, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:


  • Clumsiness or unsteadiness

  • confusion

  • convulsions (seizures)

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • increased dreaming

  • muscle twitching

  • nausea or vomiting

  • nervousness or restlessness

  • nightmares

  • trembling

  • trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: meprobamate side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


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More meprobamate resources


  • Meprobamate Side Effects (in more detail)
  • Meprobamate Use in Pregnancy & Breastfeeding
  • Drug Images
  • Meprobamate Drug Interactions
  • Meprobamate Support Group
  • 2 Reviews for Meprobamate - Add your own review/rating


  • meprobamate Concise Consumer Information (Cerner Multum)

  • Meprobamate Prescribing Information (FDA)

  • Meprobamate Professional Patient Advice (Wolters Kluwer)

  • Meprobamate MedFacts Consumer Leaflet (Wolters Kluwer)

  • Meprobamate Monograph (AHFS DI)



Compare meprobamate with other medications


  • Anxiety

Licide Topical


Generic Name: pyrethrum extract and piperonyl butoxide (Topical route)


pye-REE-thrum EX-trackt, PIP-er-oh-nil byoo-TOX-ide


Commonly used brand name(s)

In the U.S.


  • A200 Maximum Strength

  • A200 Time-Tested Formula

  • Lice-X

  • Licide

  • Medi-Lice Maximum Strength

  • Pronto Maximum Strength

  • Pyrinex

  • Pyrinyl

  • Rid

  • Tisit

Available Dosage Forms:


  • Gel/Jelly

  • Liquid

  • Shampoo

  • Kit

  • Foam

Therapeutic Class: Pediculicide


Chemical Class: Pyrethrums


Uses For Licide


Medicine containing pyrethrins is used to treat head, body, and pubic lice infections. This medicine is absorbed by the lice and destroys them by acting on their nervous systems. It does not affect humans in this way. The piperonyl butoxide is included to make the pyrethrins more effective in killing the lice. This combination medicine is known as a pediculicide.


This medicine is available without a prescription.


Before Using Licide


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrethrins and piperonyl butoxide combination medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Inflammation of the skin (severe)—Use of pyrethrins and piperonyl butoxide combination may make the condition worse

Proper Use of pyrethrum extract and piperonyl butoxide

This section provides information on the proper use of a number of products that contain pyrethrum extract and piperonyl butoxide. It may not be specific to Licide. Please read with care.


Pyrethrins and piperonyl butoxide combination medicine usually comes with patient directions. Read them carefully before using this medicine.


Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label. To do so may increase the chance of absorption through the skin and the chance of side effects.


Keep pyrethrins and piperonyl butoxide combination medicine away from the mouth and do not inhale it. This medicine is harmful if swallowed or inhaled.


To lessen the chance of inhaling this medicine, apply it in a well-ventilated room (for example, one with free flowing air or with a fan turned on).


Keep this medicine away from the eyes and other mucous membranes, such as the inside of the nose, mouth, or vagina, because it may cause irritation. If you accidentally get some in your eyes, flush them thoroughly with water at once.


Do not apply this medicine to the eyelashes or eyebrows . If they become infected with lice, check with your doctor.


To use the gel or solution form of this medicine:


  • Apply enough medicine to thoroughly wet the dry hair and scalp or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.

  • Then, thoroughly wash the affected areas with warm water and soap or regular shampoo. Rinse thoroughly and dry with a clean towel.

To use the shampoo form of this medicine:


  • Apply enough medicine to thoroughly wet the dry hair and scalp or skin. Allow the medicine to remain on the affected areas for exactly 10 minutes.

  • Then use a small amount of water and work shampoo into the hair and scalp or skin until a lather forms. Rinse thoroughly and dry with a clean towel.

After rinsing and drying, use a nit removal comb (special fine-toothed comb, usually included with this medicine) to remove the dead lice and eggs (nits) from hair.


Immediately after using this medicine, wash your hands to remove any medicine that may be on them.


This medicine should be used again in 7 to 10 days after the first treatment in order to kill any newly hatched lice.


Lice can easily move from one person to another by close body contact. This can happen also by direct contact with such things as clothing, hats, scarves, bedding, towels, washcloths, hairbrushes and combs, or the hair of infected persons. Therefore, all members of your household should be examined for lice and receive treatment if they are found to be infected.


To use this medicine for pubic (crab) lice:


  • Your sexual partner may also need to be treated, since the infection may spread to persons in close contact. If your partner is not being treated or if you have any questions about this, check with your doctor.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For topical dosage forms (gel, solution shampoo, and topical solution):
    • For head, body, or pubic lice:
      • Adults and children—Use one time, then repeat one time in seven to ten days.



Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Licide


To prevent reinfection or spreading of the infection to other people, good health habits are also required. These include the following:


  • For head lice
    • Machine wash all clothing (including hats, scarves, and coats), bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.

    • Shampoo all wigs and hairpieces.

    • Wash all hairbrushes and combs in very hot soapy water (above 130 °F) for 5 to 10 minutes and do not share them with other people.

    • Clean the house or room by thoroughly vacuuming upholstered furniture, rugs, and floors.


  • For body lice
    • Machine wash all clothing, bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.

    • Clean the house or room by thoroughly vacuuming upholstered furniture, rugs, and floors.


  • For pubic lice
    • Machine wash all clothing (especially underwear), bedding, towels, and washcloths in very hot water and dry them by using the hot cycle of a dryer for at least 20 minutes. Clothing or bedding that cannot be washed should be dry-cleaned or sealed in a plastic bag for 2 weeks.

    • Scrub toilet seats frequently.


Licide Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Skin irritation not present before use of this medicine

  • skin rash or infection

  • sneezing (sudden attacks of)

  • stuffy or runny nose

  • wheezing or difficulty in breathing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Licide Topical side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Licide Topical resources


  • Licide Topical Side Effects (in more detail)
  • Licide Topical Use in Pregnancy & Breastfeeding
  • Licide Topical Support Group
  • 0 Reviews for Licide Topical - Add your own review/rating


Compare Licide Topical with other medications


  • Head Lice
  • Lice

Friday 20 July 2012

Sandoglobulin


Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)


i-MUNE GLOB-ue-lin


Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .


Subcutaneous route(Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. Gammagard(R) does not contain sucrose .



Commonly used brand name(s)

In the U.S.


  • Baygam

  • Carimune

  • Gamimune N

  • Gammagard

  • Gammar-P

  • Hizentra

  • Iveegam EN

  • Octagam

  • Panglobulin NF

  • Polygam S/D

  • Sandoglobulin

  • Vivaglobin

Available Dosage Forms:


  • Solution

  • Powder for Solution

Therapeutic Class: Immune Serum


Uses For Sandoglobulin


Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).


This medicine is to be administered only by or under the supervision of your doctor.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:


  • Chronic parvovirus B19 infection (treatment).

  • Dermatomyositis (treatment).

  • Guillain-BarrĂ© syndrome (treatment).

  • Hyperimmunoglobulinemia E syndrome (treatment).

  • Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).

  • Lambert-Eaton myasthenic syndrome (treatment).

  • Multifocal motor neuropathy (treatment).

  • Relapsing-remitting multiple sclerosis (treatment).

Before Using Sandoglobulin


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia, history of or

  • Bleeding problems, history of or

  • Hyponatremia (low sodium in the blood) or

  • Kidney problems—Use with caution. May make these conditions worse.

  • Atherosclerosis (hardening of the arteries), history of or

  • Blood clotting problems, history of or

  • Diabetes or

  • Heart attack or stroke, recent or

  • Heart or blood vessel disease or

  • Hyperproteinemia (high protein in the blood) or

  • Hyperviscosity (thick blood), known or suspected or

  • Hypovolemia (low blood volume or major loss of body fluids) or

  • IgA (immunoglobulin A) deficiency with antibodies against IgA or

  • Paraproteinemia (paraproteins in the blood) or

  • Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

Proper Use of immune globulin

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Sandoglobulin. Please read with care.


A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.


This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.


While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.


The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.


Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.


If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.


Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.


To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:


  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.

  • Wash your hands with soap and water before and after using this medicine.

  • If you have been told to wear gloves when preparing your infusion, put the gloves on.

  • Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.

  • If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.

  • Follow your doctor's instructions on how to prepare the correct amount of medicine.

  • Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg, or hip). Clean the injection site with a fresh alcohol wipe, and let it dry.

  • With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.

  • Put sterile gauze and tape over the injection site to keep the needle from coming out.

  • Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.

  • Follow your doctor's instructions on how to use the infusion pump.

  • Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.

  • It usually takes about 60 minutes for each infusion.

  • When all of the medicine has been infused, turn off the pump.

  • Take the gauze off and remove the needle and tube from your skin.

  • Clean and store the infusion pump.

  • Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose


This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.


Storage


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.


Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.


Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.


You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.


Precautions While Using Sandoglobulin


It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.


Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).


This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.


This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.


This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.


Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).


This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.


Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving this medicine. These may be symptoms of a serious lung problem.


This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .


Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.


Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.


Sandoglobulin Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


More common
  • Chills

  • cough

  • difficulty with breathing

  • fast, pounding, or irregular heartbeat or pulse

  • fever

  • noisy breathing

  • shortness of breath

  • tightness in the chest

  • troubled breathing

  • unusual tiredness or weakness

Less common
  • Bluish coloring of the lips or nailbeds

  • burning sensation in the head

  • faintness or lightheadedness

Rare
  • Difficulty with swallowing

  • hives or welts

  • itching, especially of the feet or hands

  • reddening of the skin, especially around the ears

  • swelling of the eyes, face, or inside of the nose

Incidence not known
  • Back, leg, or stomach pains

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • bloody, black, or tarry stools

  • blurred vision

  • change in consciousness

  • chest pain or discomfort

  • cold, clammy, or pale skin

  • confusion

  • convulsions

  • coughing that sometimes produces a pink frothy sputum

  • dark urine

  • decrease in urine amount

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fever with or without chills

  • headache that is severe and occurs suddenly

  • increased sweating

  • light-colored stools

  • loss of appetite

  • loss of bladder control

  • loss of consciousness

  • low blood pressure or pulse

  • muscle spasm or jerking of all extremities

  • nausea or vomiting

  • nosebleeds

  • painful or difficult urination

  • pains in the chest, groin, or legs, especially calves of the legs

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • shakiness in the legs, arms, hands, or feet

  • shivering

  • skin blisters

  • slurred speech that occurs suddenly

  • slow breathing

  • sores, ulcers, or white spots in the mouth or on the lips

  • sudden loss of consciousness

  • sudden loss of coordination

  • sudden vision changes

  • sudden, severe weakness or numbness in the arm or leg

  • sweating

  • swelling in the legs and ankles

  • tightness in the chest

  • trembling or shaking of the hands or feet

  • unusual bleeding or bruising

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Diarrhea

  • dizziness

  • headache

  • joint pain

  • muscle pain

  • redness, swelling, itching, or pain at the injection site

  • skin rash

Less common
  • Hip pain

  • leg cramps

Incidence not known
  • Feeling of warmth

  • redness of the face, neck, arms, and occasionally, upper chest

  • stomach pain

  • swollen glands

  • tiredness

  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Sandoglobulin side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Sandoglobulin resources


  • Sandoglobulin Side Effects (in more detail)
  • Sandoglobulin Use in Pregnancy & Breastfeeding
  • Sandoglobulin Drug Interactions
  • Sandoglobulin Support Group
  • 0 Reviews for Sandoglobulin - Add your own review/rating


  • Carimune Prescribing Information (FDA)

  • Flebogamma MedFacts Consumer Leaflet (Wolters Kluwer)

  • Flebogamma Prescribing Information (FDA)

  • Gammaplex Prescribing Information (FDA)

  • Gammar-P I.V. Consumer Overview

  • Gammar-P I.V.

  • Gamunex MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gamunex Consumer Overview

  • Octagam Prescribing Information (FDA)

  • Octagam Consumer Overview

  • Privigen Prescribing Information (FDA)

  • Privigen Consumer Overview



Compare Sandoglobulin with other medications


  • Autoimmune Neutropenia
  • Bone Marrow Transplantation
  • Chronic Lymphocytic Leukemia
  • Evan's Syndrome
  • HIV Infection
  • Idiopathic Thrombocytopenic Purpura
  • Kawasaki Disease
  • Polymyositis/Dermatomyositis
  • Primary Immunodeficiency Syndrome