Inhavir

Inhavir may be available in the countries listed below.

Ingredient matches for Inhavir

Lamivudine

Lamivudine is reported as an ingredient of Inhavir in the following countries:

• Colombia


• Peru

International Drug Name Search

Compressed Gas N.O.S.

Dosage Form: gas
COMPRESSED GAS, N.O.S.

       

LifeGas®

COMPRESSED GAS, N.O.S.

UN1956

(Helium, Oxygen)

NON-FLAMMABLE GAS 2

_______	% HELIUM USP
_______	% OXYGEN USP MIXTURE (NOT FOR CALIBRATION PURPOSES)
Component concentrations in mol%.

_________________ PSI @ 70°F _________________ LITERS

Rx only

WARNING:

Administration of this mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Helium / Oxygen Mixtures, who is familiar with the indications, effects, dosages, methods, frequency, and duration of administration and with the hazards, contraindications, side effects, and precautions to be taken.

CAUTION:

HIGH PRESSURE GAS MIXTURE. MIXTURES CONTAINING LESS THAN 19.5% OXYGEN MAY CAUSE RAPID SUFFOCATION AND DEATH.

Keep away from heat, flame or sparks. Keep oil grease and other combustibles away. Oxygen reacts violently with oil or grease, which could cause fire and severe burns. (Body oil, hand lotion and items containing oil or grease). Transport, store and use with adequate ventilation. Do not strike arc or laser beam on cylinder. Use equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52˚C (125˚F). Always secure cylinder in upright position. Use in accordance with Material Safety Data Sheet for this product, available at Web Site: www.lindeus.com. Close valve after each use and when empty. Return cylinder with 25 PSIG pressure and cylinder cap secured, if applicable. Keep valve protection cap in place when not in use, if so equipped. Open valve slowly.

FIRST AID:

IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.

DO NOT REMOVE THIS LABEL.

Distributed by:

Linde

Linde Gas North America LLC

575 Mountain Ave.

Murray Hill, NJ 07974

CAS 7440-59-7

CAS 7782-44-7

LG062

L&SP 7474

COMPRESSED GAS, N.O.S.   helium, oxygen  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25373-012 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (Helium) Helium 79 L  in 100 L Oxygen (Oxygen) Oxygen 21 L  in 100 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 25373-012-01 300 L In 1 CYLINDER None 2 25373-012-02 500 L In 1 CYLINDER None 3 25373-012-03 2260 L In 1 CYLINDER None 4 25373-012-04 4000 L In 1 CYLINDER None 5 25373-012-05 4500 L In 1 CYLINDER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		06/24/1998

Labeler - Linde Gas North America LLC (805568339)

Establishment
Name	Address	ID/FEI	Operations
Linde Gas North America LLC		010263301	MANUFACTURE

Revised: 12/2011Linde Gas North America LLC

Zypram Cream

Pronunciation: hye-droe-KOR-ti-sone ASS-eh-tate/pra-MOX-een
Generic Name: Hydrocortisone Acetate/Pramoxine
Brand Name: Examples include Analpram-HC and Zypram

Zypram Cream is used for:

Treating inflammation and itching of the anal area due to certain skin conditions.

Zypram Cream is a combination topical corticosteroid and local anesthetic. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not exactly understood. It also decreases pain in the affected area.

Do NOT use Zypram Cream if:

• you are allergic to any ingredient in Zypram Cream


• you have a rectal obstruction, abscess, or perforation

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zypram Cream:

Some medical conditions may interact with Zypram Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin in the affected area


• if you have a parasitic, bacterial, fungal, or viral infection; diabetes; diarrhea; swelling of the esophagus; stomach or intestinal problems (eg, inflammation, blockage, ulcer, perforation, fistula, colostomy); inflammation of the lining of the abdomen; measles; tuberculosis (TB); a positive TB skin test; chickenpox; shingles; herpes infection of the eye; kidney problems; or you have received a recent vaccination


• if you have a history of congestive heart failure or heart attack


• if you have had recent intestinal surgery or procedure

Some MEDICINES MAY INTERACT with Zypram Cream. Because little, if any, of Zypram Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Zypram Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zypram Cream:

Use Zypram Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zypram Cream is for use around the rectal area only.


• Wash your hands immediately before and after using Zypram Cream.


• For use around the anus, apply a small amount of medicine to the affected area and rub in gently.


• If you miss a dose of Zypram Cream, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zypram Cream.

Important safety information:

• Avoid getting Zypram Cream in your eyes. If you get Zypram Cream in your eyes, immediately flush them with cool tap water.


• If your symptoms do not get better within 2 to 3 weeks or if they get worse, check with your doctor.


• Do not use Zypram Cream for other rectal conditions at a later time.


• Check with your doctor before having vaccinations while you are using Zypram Cream.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Zypram Cream.


• Caution is advised when using Zypram Cream in CHILDREN; they may be more sensitive to its effects.


• Serious side effects may occur if too much of Zypram Cream is absorbed through the skin. This may be more likely to occur if you use Zypram Cream over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Zypram Cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zypram Cream while you are pregnant. It is not known if Zypram Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Zypram Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zypram Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry skin; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; rectal pain, burning, cracking, itching, bleeding, peeling, or irritation not present before using Zypram Cream; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zypram side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face. Zypram Cream may be harmful if swallowed.

Proper storage of Zypram Cream:

Store Zypram Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zypram Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Zypram Cream, please talk with your doctor, pharmacist, or other health care provider.


• Zypram Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zypram Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zypram resources

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

Compare Zypram with other medications

• Hemorrhoids

Zolvit

Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)

Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone

What is Zolvit (acetaminophen and hydrocodone)?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zolvit (acetaminophen and hydrocodone)?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Zolvit (acetaminophen and hydrocodone)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or hydrocodone. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

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

• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  Addison's disease or other adrenal gland disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share acetaminophen and hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Zolvit (acetaminophen and hydrocodone)?

Take exactly as prescribed. Never take acetaminophen and hydrocodone in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Measure liquid medicine with a special dose-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.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and hydrocodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and hydrocodone.

Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

What happens if I miss a dose?

Since acetaminophen and hydrocodone 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 use 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. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

What should I avoid while taking Zolvit (acetaminophen and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Zolvit (acetaminophen and hydrocodone) 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  problems with urination; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  anxiety, dizziness, drowsiness;

  
  


• 
  

  mild nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  headache, mood changes;

  
  


• 
  

  blurred vision;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  dry mouth.

  
  

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 Zolvit (acetaminophen and hydrocodone)?

Do not take acetaminophen and hydrocodone with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

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

• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with acetaminophen and hydrocodone. 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 Zolvit resources

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

• Zolvit Prescribing Information (FDA)


• Anexsia Advanced Consumer (Micromedex) - Includes Dosage Information


• Co-gesic Prescribing Information (FDA)


• Dolacet MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycet Prescribing Information (FDA)


• Hycet Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Liquicet Prescribing Information (FDA)


• Lorcet Plus Prescribing Information (FDA)


• Lortab Prescribing Information (FDA)


• Lortab Consumer Overview


• Lortab MedFacts Consumer Leaflet (Wolters Kluwer)


• Maxidone Prescribing Information (FDA)


• Norco Consumer Overview


• Norco Prescribing Information (FDA)


• Vicodin Consumer Overview


• Vicodin Prescribing Information (FDA)


• Vicodin ES Prescribing Information (FDA)


• Vicodin HP Prescribing Information (FDA)


• Xodol Prescribing Information (FDA)


• Zydone Prescribing Information (FDA)

Compare Zolvit with other medications

• Back Pain
• Cough
• Pain
• Rheumatoid Arthritis

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and hydrocodone.

See also: Zolvit side effects (in more detail)

Prevpac Therapy Pack

Pronunciation: a-MOX-i-SIL-in/kla-RITH-roe-MYE-sin/lan-SOE-pra-zole
Generic Name: Amoxicillin/Clarithromycin/Lansoprazole
Brand Name: Prevpac

Prevpac Therapy Pack is used for:

Treating certain patients who have Helicobacter pylori infection and duodenal ulcer.

Prevpac Therapy Pack is a proton pump inhibitor (PPI), penicillin antibiotic, and macrolide antibiotic combination. It works by killing H. pylori bacteria and reducing stomach acid. This helps to heal the ulcer and prevent it from coming back.

Do NOT use Prevpac Therapy Pack if:

• you are allergic to any ingredient in Prevpac Therapy Pack, to any penicillin antibiotic (eg, ampicillin), or to any macrolide antibiotic (eg, erythromycin)


• you have severe kidney problems or infectious mononucleosis (mono)


• you have had liver problems or yellowing of the skin or eyes caused by previous use of clarithromycin


• you are taking alfuzosin, astemizole, atazanavir, cabazitaxel, cisapride, conivaptan, diltiazem, docetaxel, dofetilide, dronedarone, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), lovastatin, lurasidone, nilotinib, pimozide, propafenone, quinupristin/dalfopristin, ranolazine, romidepsin, salmeterol, silodosin, simvastatin, tamsulosin, terfenadine, tetrabenazine, ticagrelor, tolvaptan, or toremifene


• you have kidney or liver problems and you are also taking colchicine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prevpac Therapy Pack:

Some medical conditions may interact with Prevpac Therapy Pack. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have low blood potassium or magnesium levels, liver or kidney problems, blood problems (eg, porphyria), or myasthenia gravis


• if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Prevpac Therapy Pack. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Many prescription and nonprescription medicines (eg, used for allergies, anxiety, asthma or other breathing problems, blood thinning, cancer, decreased blood clot formation, diabetes, enlarged prostate, erectile dysfunction, gout, heart problems, high blood pressure, high cholesterol, high prolactin levels, HIV, immune system suppression, infections, inflammation, irregular heartbeat, malaria, mental or mood problems, migraines, nausea and vomiting, pain, parathyroid problems, pulmonary arterial hypertension [PAH], overactive bladder, seizures, sleep, stomach or bowel problems, Tourette syndrome, and other conditions), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Prevpac Therapy Pack, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prevpac Therapy Pack may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prevpac Therapy Pack:

Use Prevpac Therapy Pack as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Prevpac Therapy Pack by mouth before a meal in the morning and in the evening unless your doctor tells you differently.


• Swallow Prevpac Therapy Pack whole. Do not break, crush, or chew before swallowing.


• If you also take sucralfate, do not take it within 30 minutes after taking Prevpac Therapy Pack. Check with your doctor if you have questions.


• If you are also taking zidovudine, do not take it within 2 hours before or after you take the clarithromycin.


• To clear up your infection completely, take Prevpac Therapy Pack for the full course of treatment. Keep taking it even if you feel better in a few days.


• Continue to take Prevpac Therapy Pack even if you feel well. Do not miss any doses.


• If you miss a dose of Prevpac Therapy Pack, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of Prevpac Therapy Pack.

Important safety information:

• Prevpac Therapy Pack may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Prevpac Therapy Pack with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Prevpac Therapy Pack only works against bacteria; it does not treat viral infections (eg, the common cold).


• Lansoprazole, an ingredient in Prevpac Therapy Pack, may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Prevpac Therapy Pack in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.


• Prevpac Therapy Pack contains a PPI. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Prevpac Therapy Pack for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).


• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Prevpac Therapy Pack.


• Be sure to use Prevpac Therapy Pack for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Prevpac Therapy Pack may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Severe and sometimes fatal liver problems have been reported with clarithromycin. This has usually been reversible when the medicine is stopped. Discuss any questions or concerns with your doctor. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).


• Tell your doctor or dentist that you take Prevpac Therapy Pack before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Prevpac Therapy Pack may rarely affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• There have been reports of tooth discoloration with the use of clarithromycin. This has usually been reversible with a dental cleaning.


• There have been reports of hearing loss with use of clarithromycin, usually in elderly women. This has usually been reversible. Discuss any questions or concerns with your doctor.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Prevpac Therapy Pack. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Talk with your doctor before you receive any live vaccine (eg, typhoid) while you are taking Prevpac Therapy Pack.


• Prevpac Therapy Pack may interfere with certain lab tests, including certain urine glucose tests. Be sure your doctor and lab personnel know you are taking Prevpac Therapy Pack.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Prevpac Therapy Pack. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Prevpac Therapy Pack should be used with caution in Asian patients; the risk of side effects may be increased in these patients.


• Use Prevpac Therapy Pack with caution in the ELDERLY; they may be more sensitive to its effects, especially liver problems; kidney problems; and hip, wrist, and spine fractures.


• Prevpac Therapy Pack should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Clarithromycin has been shown to cause harm to the fetus. It is not recommended for use during pregnancy except when no other antibiotics can be used. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prevpac Therapy Pack while you are pregnant. Prevpac Therapy Pack is found in breast milk. Do not breast-feed while taking Prevpac Therapy Pack.

Possible side effects of Prevpac Therapy Pack:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in taste; diarrhea; dizziness; dry mouth; headache; indigestion; nausea; stomach discomfort.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; bone pain; confusion; decreased urination; fast or irregular heartbeat; hallucinations; loss of taste or sense of smell; mental or mood changes (eg, depression); muscle weakness; nightmares; pain, swelling, sores, or white patches in the mouth; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain or cramps; severe or persistent dizziness; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness); tremor; trouble sleeping; vaginal discharge, pain, or itching.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prevpac side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; nausea; stomach pain; vomiting.

Proper storage of Prevpac Therapy Pack:

Store Prevpac Therapy Pack at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Prevpac Therapy Pack out of the reach of children and away from pets.

General information:

• If you have any questions about Prevpac Therapy Pack, please talk with your doctor, pharmacist, or other health care provider.


• Prevpac Therapy Pack is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prevpac Therapy Pack. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Prevpac resources

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

Compare Prevpac with other medications

• Helicobacter Pylori Infection

fludrocortisone

floo-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Florinef Acetate

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Mineralocorticoid

Uses For fludrocortisone

Fludrocortisone is a corticosteroid (cortisone-like medicine). It belongs to the family of medicines called steroids. Your body naturally produces similar corticosteroids, which are necessary to maintain the balance of certain minerals and water for good health. If your body does not produce enough corticosteroids, your doctor may have prescribed fludrocortisone to help make up the difference.

Fludrocortisone may also be used to treat other medical conditions as determined by your doctor.

Fludrocortisone is available only with your doctor's prescription.

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, fludrocortisone is used in certain patients with the following medical conditions:

• Idiopathic orthostatic hypotension (a certain type of low blood pressure)


• Too much acid in the blood, caused by kidney disease

Before Using fludrocortisone

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 fludrocortisone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fludrocortisone 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

Fludrocortisone may slow or stop growth in children or growing adolescents when used for a long time. The natural production of corticosteroids by the body may also be decreased by the use of fludrocortisone. Before fludrocortisone is given to a child or adolescent, you and your child's doctor should talk about the good fludrocortisone will do as well as the risks of using it. Follow the doctor's directions very carefully to lessen the chance that these unwanted effects will occur.

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 or if they cause different side effects or problems in older people. There is no specific information comparing the use of fludrocortisone in the elderly with its use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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. When you are taking fludrocortisone, 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 fludrocortisone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using fludrocortisone 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.

• Bupropion

Using fludrocortisone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alatrofloxacin


• Balofloxacin


• Cinoxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Fosphenytoin


• Furosemide


• Gemifloxacin


• Grepafloxacin


• Itraconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Phenytoin


• Prulifloxacin


• Rifampin


• Rifapentine


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

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 fludrocortisone. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—Using fludrocortisone and also using aspirin may cause bleeding problems to become worse.

• Bone disease—Fludrocortisone may make bone disease worse because it causes more calcium to pass into the urine

• Edema (swelling of feet or lower legs) or


• Heart disease or


• High blood pressure or


• Kidney disease—Fludrocortisone causes the body to retain (keep) more salt and water. These conditions may be made worse by this extra body water

• Herpes infection of the eye—may cause a hole in the cornea of the eye.

• Liver disease or


• Abdominal surgery (fresh) or


• Diseases of the intestines or


• Myasthenia gravis or


• Tuberculosis or


• Ulcers in the stomach or intestines—Fludrocortisone suppresses the immune system. Infections with these conditions may be made worse by this suppression.

• Thyroid disease—The body may not get fludrocortisone out of the bloodstream at the usual rate, which may increase the effect of fludrocortisone or cause more side effects

Proper Use of fludrocortisone

Your doctor may want you to control the amount of sodium in your diet. When fludrocortisone is used to treat certain types of kidney diseases, too much sodium may cause high blood sodium, high blood pressure, and excess body water.

Take fludrocortisone only as directed by your doctor . Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of fludrocortisone 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 fludrocortisone. 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 oral dosage forms (tablets):
  
  • Adults
    
    • For adrenal gland deficiency: 50 to 200 micrograms a day.
    
    
    • For adrenogenital syndrome: 100 to 200 micrograms a day.
    
    
  
  
  • Children: For adrenal gland deficiency: 50 to 100 micrograms a day.
  
  

Missed Dose

If you miss a dose of fludrocortisone, 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 fludrocortisone

Your doctor should check your progress at regular visits to make sure fludrocortisone does not cause unwanted effects.

If you will be using fludrocortisone for a long time, your doctor may want you to carry a medical identification card stating that you are using fludrocortisone.

While you are taking fludrocortisone, be careful to limit the amount of alcohol you drink.

fludrocortisone 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 immediately if any of the following side effects occur:

Less common or rare

• Abdominal pain


• agitation or combativeness


• anxiety


• back or rib pain


• blindness


• bloating


• bloody or black, sticky stools


• blurred vision


• burning in stomach


• changes in skin color


• chest pain or tightness


• chills


• confusion


• constipation


• convulsions


• cough


• coughing up blood


• darkened urine


• decrease in height


• decreased range of motion


• decreased urine output


• decreased vision


• depression


• difficulty swallowing


• dry mouth


• expressed fear of impending death


• eye pain


• eyeballs bulge out of eye sockets


• fainting or lightheadedness when getting up from a lying or sitting position


• fast or slow heartbeat


• fever


• flushed dry skin


• fractures in arms or legs without any injury


• fractures in the neck or back


• fruit-like breath odor


• hallucinations


• headache


• heartburn


• hives


• increased fat deposits on face, neck, and trunk


• increased hunger


• increased thirst


• increased urination


• indigestion


• irregular breathing or shortness of breath


• irregular heartbeat


• joint pain


• lack or slowing of normal growth in children


• walking with a limp


• loss of appetite


• loss of consciousness


• muscle cramps or pain


• nausea or vomiting


• nervousness


• pain, tenderness, or swelling of foot or leg


• pains in stomach or side, possibly radiating to the back


• patients taking oral medicines or insulin for diabetes may need to increase the amount they take


• pounding in the ears


• problems with wound healing


• redness and itching of skin


• redness of eyes


• redness of face


• severe or continuing dizziness


• severe weakness of arms and legs


• skin rash


• sweating


• swelling of face, fingers, feet, or lower legs


• swelling of nasal passages, face, or eyelids


• swollen neck veins


• tearing of eyes


• unexplained weight loss


• unusual tiredness or weakness


• vision changes


• weight gain


• wheezing


• 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:

Less common or rare

• Acne, pimples


• bruising, large, flat, blue or purplish patches in the skin


• change in color of skin or nails


• increased sweating


• loss of muscle mass


• menstrual changes


• muscle weakness


• reddish purple lines on arms, face, legs, trunk, or groin


• sleeplessness, trouble sleeping, unable to sleep


• small, red, or purple spots on skin


• swelling of abdominal or stomach area, full or bloated feeling or pressure in the stomach


• thin, fragile skin


• unusual increase in hair growth

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: fludrocortisone 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 fludrocortisone resources

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

• fludrocortisone Concise Consumer Information (Cerner Multum)


• Fludrocortisone MedFacts Consumer Leaflet (Wolters Kluwer)


• Fludrocortisone Prescribing Information (FDA)


• Florinef Acetate Monograph (AHFS DI)

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• Addison's Disease
• Adrenogenital Syndrome
• Dysautonomia
• Postural Orthostatic Tachycardia Syndrome

Cyclophosphamide

Cyclophosphamide Tablets USP, 25 mg and 50 mg

Rx only

Cyclophosphamide Description

Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2P • H2O and a molecular weight of 279.1. The chemical name for Cyclophosphamide is 2H-1,3,2-Oxazaphosphorin-2-amine, N,N-bis(2-chloroethyl)tetrahydro-, 2-oxide, monohydrate, (±). Cyclophosphamide is soluble in water, saline, or ethanol and has the following structural formula:

Each tablet for oral administration contains Cyclophosphamide (anhydrous) 25 mg or 50 mg. In addition, each tablet contains the following inactive ingredients: acacia, FD&C Blue No. 1, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Cyclophosphamide - Clinical Pharmacology

Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells. The mechanism of action is thought to involve cross-linking of tumor cell DNA.

Cyclophosphamide is well absorbed after oral administration with a bioavailability greater than 75%. The unchanged drug has an elimination half-life of 3 to 12 hours. It is eliminated primarily in the form of metabolites, but from 5% to 25% of the dose is excreted in urine as unchanged drug. Several cytotoxic and noncytotoxic metabolites have been identified in urine and in plasma. Concentrations of metabolites reach a maximum in plasma 2 to 3 hours after an intravenous dose. Plasma protein binding of unchanged drug is low but some metabolites are bound to an extent greater than 60%. It has not been demonstrated that any single metabolite is responsible for either the therapeutic or toxic effects of Cyclophosphamide. Although elevated levels of metabolites of Cyclophosphamide have been observed in patients with renal failure, increased clinical toxicity in such patients has not been demonstrated.

Indications and Usage for Cyclophosphamide

Malignant Diseases

Cyclophosphamide Tablets USP, 25 mg and 50 mg, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. The following malignancies are often susceptible to Cyclophosphamide treatment:

1. Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma.


2. Multiple myeloma.


3. Leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia in children (Cyclophosphamide given during remission is effective in prolonging its duration).


4. Mycosis fungoides (advanced disease).


5. Neuroblastoma (disseminated disease).


6. Adenocarcinoma of the ovary.


7. Retinoblastoma.


8. Carcinoma of the breast.

Nonmalignant Disease

Biopsy Proven “Minimal Change” Nephrotic Syndrome in Children:

Cyclophosphamide Tablets USP, 25 mg and 50 mg are useful in carefully selected cases of biopsy proven “minimal change” nephrotic syndrome in children but should not be used as primary therapy. In children whose disease fails to respond adequately to appropriate adrenocorticosteroid therapy or in whom the adrenocorticosteroid therapy produces or threatens to produce intolerable side effects, Cyclophosphamide may induce a remission. Cyclophosphamide is not indicated for the nephrotic syndrome in adults or for any other renal disease.

Contraindications

Continued use of Cyclophosphamide is contraindicated in patients with severely depressed bone marrow function. Cyclophosphamide is contraindicated in patients who have demonstrated a previous hypersensitivity to it (see WARNINGS and PRECAUTIONS).

Warnings

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Second malignancies have developed in some patients treated with Cyclophosphamide used alone or in association with other antineoplastic drugs and/or modalities. Most frequently, they have been urinary bladder, myeloproliferative, or lymphoproliferative malignancies. Second malignancies most frequently were detected in patients treated for primary myeloproliferative or lymphoproliferative malignancies or nonmalignant disease in which immune processes are believed to be involved pathologically.

In some cases, the second malignancy developed several years after Cyclophosphamide treatment had been discontinued. In a single breast cancer trial utilizing two to four times the standard dose of Cyclophosphamide in conjunction with doxorubicin a small number of cases of secondary acute myeloid leukemia occurred within two years of treatment initiation. Urinary bladder malignancies generally have occurred in patients who previously had hemorrhagic cystitis. In patients treated with Cyclophosphamide-containing regimens for a variety of solid tumors, isolated case reports of secondary malignancies have been published. One case of carcinoma of the renal pelvis was reported in a patient receiving long-term Cyclophosphamide therapy for cerebral vasculitis. The possibility of Cyclophosphamide-induced malignancy should be considered in any benefit-to-risk assessment for use of the drug.

Cyclophosphamide can cause fetal harm when administered to a pregnant woman and such abnormalities have been reported following Cyclophosphamide therapy in pregnant women. Abnormalities were found in two infants and a six-month-old fetus born to women treated with Cyclophosphamide. Ectrodactylia was found in two of the three cases. Normal infants have also been born to women treated with Cyclophosphamide during pregnancy, including the first trimester. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. Development of sterility appears to depend on the dose of Cyclophosphamide, duration of therapy, and the state of gonadal function at the time of treatment. Cyclophosphamide-induced sterility may be irreversible in some patients.

Amenorrhea associated with decreased estrogen and increased gonadotropin secretion develops in a significant proportion of women treated with Cyclophosphamide. Affected patients generally resume regular menses within a few months after cessation of therapy. Girls treated with Cyclophosphamide during prepubescence generally develop secondary sexual characteristics normally and have regular menses. Ovarian fibrosis with apparently complete loss of germ cells after prolonged Cyclophosphamide treatment in late prepubescence has been reported. Girls treated with Cyclophosphamide during prepubescence subsequently have conceived.

Men treated with Cyclophosphamide may develop oligospermia or azoospermia associated with increased gonadotropin but normal testosterone secretion. Sexual potency and libido are unimpaired in these patients. Boys treated with Cyclophosphamide during prepubescence develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion. Some degree of testicular atrophy may occur. Cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. Men temporarily rendered sterile by Cyclophosphamide have subsequently fathered normal children.

Urinary System

Hemorrhagic cystitis may develop in patients treated with Cyclophosphamide. Rarely, this condition can be severe and even fatal. Fibrosis of the urinary bladder, sometimes extensive, also may develop with or without accompanying cystitis. Atypical urinary bladder epithelial cells may appear in the urine. These adverse effects appear to depend on the dose of Cyclophosphamide and the duration of therapy. Such bladder injury is thought to be due to Cyclophosphamide metabolites excreted in the urine. Forced fluid intake helps to assure an ample output of urine, necessitates frequent voiding, and reduces the time the drug remains in the bladder. This helps to prevent cystitis. Hematuria usually resolves in a few days after Cyclophosphamide treatment is stopped, but it may persist. Medical and/or surgical supportive treatment may be required, rarely, to treat protracted cases of severe hemorrhagic cystitis. It is usually necessary to discontinue Cyclophosphamide therapy in instances of severe hemorrhagic cystitis.

Cardiac Toxicity

Although a few instances of cardiac dysfunction have been reported following use of recommended doses of Cyclophosphamide, no causal relationship has been established. Acute cardiac toxicity has been reported with doses as low as 2.4 g/m2 to as high as 26 g/m2, usually as a portion of an intensive antineoplastic multi-drug regimen or in conjunction with transplantation procedures. In a few instances with high doses of Cyclophosphamide, severe, and sometimes fatal, congestive heart failure has occurred after the first Cyclophosphamide dose. Histopathologic examination has primarily shown hemorrhagic myocarditis. Hemopericardium has occurred secondary to hemorrhagic myocarditis and myocardial necrosis. Pericarditis has been reported independent of any hemopericardium.

No residual cardiac abnormalities, as evidenced by electrocardiogram or echocardiogram appear to be present in patients surviving episodes of apparent cardiac toxicity associated with high doses of Cyclophosphamide.

Cyclophosphamide has been reported to potentiate doxorubicin-induced cardiotoxicity.

Infections

Treatment with Cyclophosphamide may cause significant suppression of immune responses. Serious, sometimes fatal, infections may develop in severely immunosuppressed patients. Cyclophosphamide treatment may not be indicated, or should be interrupted, or the dose reduced, in patients who have or who develop viral, bacterial, fungal, protozoan, or helminthic infections.

Other

Anaphylactic reactions have been reported; death has also been reported in association with this event. Possible cross-sensitivity with other alkylating agents has been reported.

Precautions

General

Special attention to the possible development of toxicity should be exercised in patients being treated with Cyclophosphamide if any of the following conditions are present:

1. Leukopenia


2. Thrombocytopenia


3. Tumor cell infiltration of bone marrow


4. Previous X-ray therapy


5. Previous therapy with other cytotoxic agents


6. Impaired hepatic function


7. Impaired renal function

Laboratory Tests

During treatment, the patient’s hematologic profile (particularly neutrophils and platelets) should be monitored regularly to determine the degree of hematopoietic suppression. Urine should also be examined regularly for red cells which may precede hemorrhagic cystitis.

Drug Interactions

The rate of metabolism and the leukopenic activity of Cyclophosphamide reportedly are increased by chronic administration of high doses of phenobarbital.

The physician should be alert for possible combined drug actions, desirable or undesirable, involving Cyclophosphamide even though Cyclophosphamide has been used successfully concurrently with other drugs, including other cytotoxic drugs.

Cyclophosphamide treatment, which causes a marked and persistent inhibition of cholinesterase activity, potentiates the effect of succinylcholine chloride.

If a patient has been treated with Cyclophosphamide within 10 days of general anesthesia, the anesthesiologist should be alerted.

Adrenalectomy

Since Cyclophosphamide has been reported to be more toxic in adrenalectomized dogs, adjustment of the doses of both replacement steroids and Cyclophosphamide may be necessary for the adrenalectomized patient.

Wound Healing

Cyclophosphamide may interfere with normal wound healing.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

See WARNINGS: Carcinogenesis, Mutagenesis, and Impairment of Fertility.

Pregnancy

Pregnancy Category D:

See WARNINGS.

Nursing Mothers

Cyclophosphamide is excreted in breast milk. Because of the potential for serious adverse reactions and the potential for tumorigenicity shown for Cyclophosphamide in humans, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety profile of Cyclophosphamide in pediatric patients is similar to that of the adult population (see ADVERSE REACTIONS).

Geriatric Use

Insufficient data from clinical studies of cyclophospamide for malignant lymphoma, multiple myeloma, leukemia, mycosis fungoides, neuroblastoma, retinoblastoma, and breast carcinoma are available for patients 65 years of age and older to determine whether they respond differently than younger patients. In two clinical trials in which Cyclophosphamide was compared with paclitaxel, each in combination with cisplatin, for the treatment of advanced ovarian carcinoma, 154 (28%) of 552 patients who received Cyclophosphamide plus cisplatin were 65 years or older. Subset analyses (<65 versus >65 years) from these trials, published reports of clinical trials of Cyclophosphamide-containing regimens in breast cancer and non-Hodgkin’s lymphoma, and postmarketing experience suggest that elderly patients may be more susceptible to Cyclophosphamide toxicities. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range and adjusting as necessary based on patient response (see DOSAGE AND ADMINISTRATION: Treatment of Malignant Diseases).

Adverse Reactions

Information on adverse reactions associated with the use of Cyclophosphamide is arranged according to body system affected or type of reaction. The adverse reactions are listed in order of decreasing incidence. The most serious adverse reactions are described in the WARNINGS section.

Reproductive System

See WARNINGS: Carcinogenesis, Mutagenesis, and Impairment of Fertility.

Digestive System

Nausea and vomiting commonly occur with Cyclophosphamide therapy. Anorexia and, less frequently, abdominal discomfort or pain and diarrhea may occur. There are isolated reports of hemorrhagic colitis, oral mucosal ulceration and jaundice occurring during therapy. These adverse drug effects generally remit when Cyclophosphamide treatment is stopped.

Skin and Its Structures

Alopecia occurs commonly in patients treated with Cyclophosphamide. The hair can be expected to grow back after treatment with the drug or even during continued drug treatment, though it may be different in texture or color. Skin rash occurs occasionally in patients receiving the drug. Pigmentation of the skin and changes in nails can occur. Very rare reports of Stevens-Johnson syndrome and toxic epidermal necrolysis have been received during postmarketing surveillance; due to the nature of spontaneous adverse event reporting, a definitive causal relationship to Cyclophosphamide has not been established.

Hematopoietic System

Leukopenia occurs in patients treated with Cyclophosphamide, is related to the dose of drug, and can be used as a dosage guide. Leukopenia of less than 2000 cells/mm3 develops commonly in patients treated with an initial loading dose of the drug, and less frequently in patients maintained on smaller doses. The degree of neutropenia is particularly important because it correlates with a reduction in resistance to infections. Fever without documented infection has been reported in neutropenic patients.

Thrombocytopenia or anemia develop occasionally in patients treated with Cyclophosphamide. These hematologic effects usually can be reversed by reducing the drug dose or by interrupting treatment. Recovery from leukopenia usually begins in 7 to 10 days after cessation of therapy.

Urinary System

See WARNINGS: Urinary System for information on cystitis and urinary bladder fibrosis.

Hemorrhagic ureteritis and renal tubular necrosis have been reported to occur in patients treated with Cyclophosphamide. Such lesions usually resolve following cessation of therapy.

Infections

See WARNINGS: Infections for information on reduced host resistance to infections.

Carcinogenesis

See WARNINGS: Carcinogenesis, Mutagenesis, and Impairment of Fertility.

Respiratory System

Interstitial pneumonitis has been reported as part of the postmarketing experience. Interstitial pulmonary fibrosis has been reported in patients receiving high doses of Cyclophosphamide over a prolonged period.

Other

Anaphylactic reactions have been reported; death has also been reported in association with this event. Possible cross-sensitivity with other alkylating agents has been reported. SIADH (syndrome of inappropriate ADH secretion) has been reported with the use of Cyclophosphamide. Malaise and asthenia have been reported as part of the postmarketing experience.

Overdosage

No specific antidote for Cyclophosphamide is known. Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur.

Cyclophosphamide Dosage and Administration

Treatment of Malignant Diseases

Adults and Children:

Oral Cyclophosphamide dosing is usually in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.

Many other regimens of intravenous and oral Cyclophosphamide have been reported. Dosages must be adjusted in accord with evidence of antitumor activity and/or leukopenia. The total leukocyte count is a good, objective guide for regulating dosage. Transient decreases in the total white blood cell count to 2000 cells/mm3 (following short courses) or more persistent reduction to 3000 cells/mm3 (with continuing therapy) are tolerated without serious risk of infection if there is no marked granulocytopenia.

When Cyclophosphamide is included in combined cytotoxic regimens, it may be necessary to reduce the dose of Cyclophosphamide, as well as that of the other drugs.

Cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. Patients with compromised renal function may show some measurable changes in pharmacokinetic parameters of Cyclophosphamide metabolism, but there is no consistent evidence indicating a need for Cyclophosphamide dosage modification in patients with renal function impairment.

Treatment of Nonmalignant Diseases

Biopsy Proven “Minimal Change” Nephrotic Syndrome in Children:

An oral dose of 2.5 to 3 mg/kg daily for a period of 60 to 90 days is recommended. In males, the incidence of oligospermia and azoospermia increases if the duration of Cyclophosphamide treatment exceeds 60 days. Treatment beyond 90 days increases the probability of sterility. Adrenocorticosteroid therapy may be tapered and discontinued during the course of Cyclophosphamide therapy (see PRECAUTIONS: Laboratory Tests).

Preparation and Handling of Solutions

Extemporaneous liquid preparations of Cyclophosphamide for oral administration may be prepared by dissolving Cyclophosphamide for injection in Aromatic Elixir, N.F. Such preparations should be stored under refrigeration in glass containers and used within 14 days.

How is Cyclophosphamide Supplied

Cyclophosphamide Tablets USP

25 mg, light blue, round, unscored tablets

(Identified 54 639)

NDC 0054-4129-25: Bottle of 100 tablets.

50 mg, light blue, round, unscored tablets

(Identified 54 980)

NDC 0054-4130-25: Bottle of 100 tablets.

Storage

Storage at or below 25°C (77°F) is recommended; this product will withstand brief exposure to temperatures up to 30°C (86°F) but should be protected from temperatures above 30°C (86°F).

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing Cyclophosphamide tablets. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.

References

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.


2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.


3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA.1985; 253: 1590-1592.


4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.


5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust.1983;1:426-428.


6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from The Mount Sinai Medical Center. CA Cancer J Clin.1983;33:258-263.


7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm.1990;47:1033-1049.


8. Controlling occupational exposure to hazardous drugs. (OSHA Work-Practice Guidelines.) Am J Health- Syst Pharm.1996;53:1669-1685.

4047201//03

Revised September 2007

© RLI, 2007

Package Label - Cyclophosphamide Tablets USP

25 mg

NDC 0054-4129-25

Bottle of 100 tablets.

CYTOTOXIC AGENT

Rx Only

Roxane Laboratories, Inc.

50 mg 

NDC 0054-4130-25

Bottle of 100 tablets.

CYTOTOXIC AGENT

Rx Only

Roxane Laboratories, Inc.

Cyclophosphamide  Cyclophosphamide  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-4129 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cyclophosphamide (Cyclophosphamide) Cyclophosphamide 25 mg

Inactive Ingredients Ingredient Name Strength ACACIA   FD&C BLUE NO. 1   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color BLUE (Light) Score no score Shape ROUND Size 9mm Flavor Imprint Code 54;639 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0054-4129-25 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040032	08/17/1999

Cyclophosphamide  Cyclophosphamide  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-4130 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cyclophosphamide (Cyclophosphamide) Cyclophosphamide 50 mg

Inactive Ingredients Ingredient Name Strength ACACIA   FD&C BLUE NO. 1   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color BLUE (Light) Score no score Shape ROUND Size 11mm Flavor Imprint Code 54;980 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0054-4130-25 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040032	08/17/1999

Labeler - Roxane Laboratories, Inc (058839929)

Registrant - Roxane Laboratories, Inc (058839929)

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Roxane Inc		128407710	MANUFACTURE

Revised: 11/2009Roxane Laboratories, Inc

More Cyclophosphamide resources

• Cyclophosphamide Side Effects (in more detail)
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• cyclophosphamide oral/injection Concise Consumer Information (Cerner Multum)

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