LMX 5 Topical

Generic Name: lidocaine and prilocaine (Gingival route)

LYE-doe-kane, PRIL-oh-kane

Commonly used brand name(s)

In the U.S.

• Oraqix

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Anesthetic, Amino Amide Combination

Chemical Class: Amino Amide

Uses For LMX 5

Lidocaine and prilocaine periodontal (gingival) gel is used on the gums to cause numbness or loss of feeling during dental procedures. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the gum.

This medicine is available only with your dentist's prescription.

Before Using LMX 5

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 have not been performed on the relationship of age to the effects of lidocaine and prilocaine periodontal gel in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and prilocaine periodontal gel in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine periodontal gel.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency, history of or


• Heart disease or


• Heart rhythm problems—May cause side effects to become worse.

• Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of lidocaine

This section provides information on the proper use of a number of products that contain lidocaine. It may not be specific to LMX 5. Please read with care.

A dentist or other trained health professional will give you this medicine in an office or clinic setting. The medicine is applied to the gums using a special dispenser.

Precautions While Using LMX 5

It is very important that your dentist check you closely for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your dentist right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive this medicine.

During the time that the gum feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you have normal feeling in the area. Avoid foods or liquids that are very hot or very cold. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.

LMX 5 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

• Gum numbness that continues


• gum swelling or irritation


• nausea

Rare

• Itching


• hoarseness or trouble with swallowing


• rash


• shortness of breath


• swelling of the eyelids, face, lips, or tongue


• tightness in the chest


• trouble with breathing


• wheezing

Incidence not known

• Blue or blue-purple color of lips, fingernails, mouth, or skin


• blurred or double vision


• convulsions


• dark urine


• dizziness or drowsiness


• fainting


• feeling hot, cold, or numb


• headache


• irregular or fast heartbeat


• muscle twitching or trembling


• nausea or vomiting


• ringing or buzzing in the ears


• shortness of breath or troubled breathing


• unusual excitement, nervousness, or restlessness


• unusual tiredness or weakness

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

• Bad or bitter taste


• headache


• mouth pain or soreness


• mouth ulcers


• tiredness

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: LMX 5 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 LMX 5 Topical resources

• LMX 5 Topical Side Effects (in more detail)
• LMX 5 Topical Use in Pregnancy & Breastfeeding
• LMX 5 Topical Support Group
• 2 Reviews for LMX 5 Topical - Add your own review/rating

Compare LMX 5 Topical with other medications

• Anesthesia

Josamycin Propinonate

Josamycin Propinonate may be available in the countries listed below.

Ingredient matches for Josamycin Propinonate

Josamycin

Josamycin Propinonate (BANM, JAN) is also known as Josamycin (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

alglucerase

Generic Name: alglucerase (al GLOO ser ase)

Brand Names: Ceredase

What is alglucerase?

Alglucerase is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people with Type I Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Alglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, alglucerase is not a cure for this condition.

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

What is the most important information I should know about alglucerase?

Alglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, alglucerase is not a cure for this condition. Some people receiving an alglucerase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel itchy, dizzy, light-headed, or have hives, stomach cramps, pain or tightness in your chest, trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive alglucerase even after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.

What should I discuss with my health care provider before taking alglucerase?

Before using alglucerase, tell your doctor if you are allergic to any drugs, or if you have a hormone-related cancer such as prostate cancer. You may need a dose adjustment or special tests to safely take alglucerase.

Alglucerase is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Alglucerase may 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 is alglucerase given?

Alglucerase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 2 hours to complete.

Alglucerase is sometimes given 3 times per week at first. Your dosage may be changed to once per week, once every 2 weeks, or once every 4 weks. Follow your doctor's instructions.

Your doctor may also prescribe other medications to help prevent an allergic reaction to alglucerase. Take all of your medications as directed.

You may be shown how to use this medicine at home. Do not inject alglucerase yourself if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

If you store this medication at home, keep it in the refrigerator and do not allow it to freeze.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your alglucerase injection or forget to use it at home.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an alglucerase overdose are not known.

What should I avoid while taking alglucerase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using alglucerase.

Alglucerase side effects

Some people receiving an alglucerase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel itchy, dizzy, light-headed, or have hives, stomach cramps, pain or tightness in your chest, trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive alglucerase after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.

Call your doctor at once if you have any of these serious side effects:

• 
  

  mouth sores;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin;

  
  


• 
  

  easy bruising or bleeding;

  
  


• 
  

  extreme weakness or tired feeling;

  
  


• 
  

  swollen belly, stomach discomfort; or

  
  


• 
  

  pale skin.

  
  

Some of these may be symptoms of your condition and not actual side effects of alglucerase.

Less serious side effects may include:

• 
  

  hot flashes;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  headache;

  
  


• 
  

  back pain;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  changes in your sense of smell;

  
  


• 
  

  nausea, diarrhea, upset stomach;

  
  


• 
  

  fever or chills; or

  
  


• 
  

  any burning, itching, or swelling around the IV needle when the medicine is injected.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alglucerase?

There may be other drugs that can interact with alglucerase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More alglucerase resources

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

• alglucerase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Alglucerase Professional Patient Advice (Wolters Kluwer)


• Alglucerase Monograph (AHFS DI)


• Alglucerase MedFacts Consumer Leaflet (Wolters Kluwer)


• Ceredase Prescribing Information (FDA)

Compare alglucerase with other medications

• Gaucher Disease

Where can I get more information?

• Your pharmacist can provide more information about alglucerase.

See also: alglucerase side effects (in more detail)

Tanabid SR

Generic Name: brompheniramine and phenylephrine (BROM fen IR a meen and FEN il EFF rin)

Brand Names: Alacol, Alenaze-D, Alenaze-D NR, B-Vex D, BPM PE, Brom Tann PE, Bromfed, Bromfed-PD Capsules, BroveX ADT, BroveX PEB, Brovex-D, Children's Cold & Allergy, Dimaphen Elixir, Dimetapp Cold & Allergy, Entre-B, J-Tan D, J-Tan D SR, Phenyl 15/12mg, Phenyl 7.5/6mg, RespaHist II, Rhinabid, Rhinabid PD, Seradex-LA, Tanabid SR, V-Hist, VazoBid, VaZol-D, Vazotab, Zotex-PE

What is Tanabid SR (brompheniramine and phenylephrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine and phenylephrine is used to treat nasal congestion, sneezing, itching, watery eyes, and runny nose caused by allergies, hay fever, and the common cold.

Brompheniramine and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tanabid SR (brompheniramine and phenylephrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You should not use this medication if you are allergic to brompheniramine or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use brompheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist about taking brompheniramine and phenylephrine if you have heart disease or high blood pressure, diabetes, a thyroid disorder, glaucoma, kidney disease, an enlarged prostate, or problems with urination.

What should I discuss with my healthcare provider before taking Tanabid SR (brompheniramine and phenylephrine)?

You should not use this medication if you are allergic to brompheniramine or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use brompheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and phenylephrine if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  glaucoma;

  
  


• 
  

  kidney disease;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

FDA pregnancy category C. It is not known whether brompheniramine and phenylephrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Brompheniramine and phenylephrine 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 Tanabid SR (brompheniramine and phenylephrine)?

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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take the medicine with a full glass of water. Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Shake the oral suspension (liquid) well just before you measure a dose. Do not take brompheniramine and phenylephrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Store at room temperature away from moisture and heat.

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 feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Tanabid SR (brompheniramine and phenylephrine)?

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

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Drinking alcohol can increase certain side effects of brompheniramine and phenylephrine. Ask a doctor or pharmacist before using any other cold, cough, allergy, or pain medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Tanabid SR (brompheniramine and phenylephrine) 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 a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

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

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  mild stomach pain, constipation;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  warmth, redness, or tingly feeling under your skin.

  
  

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 Tanabid SR (brompheniramine and phenylephrine)?

Before using brompheniramine and phenylephrine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine and phenylephrine.

Tell your doctor about all other medications you are using, especially:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and other drugs may interact with brompheniramine and phenylephrine. 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 Tanabid SR resources

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

• Alenaze-D Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromfed MedFacts Consumer Leaflet (Wolters Kluwer)


• BroveX-D Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Entre-B Prescribing Information (FDA)


• J-Tan D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rhinabid Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tanabid SR with other medications

• Hay Fever
• Nasal Congestion
• Rhinitis

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine and phenylephrine.

See also: Tanabid SR side effects (in more detail)

Sodium Fluoride Drops

Sodium Fluoride Drops

Sodium Fluoride Drops Description

Each mL of Sodium Fluoride Drops contains 0.5 mg fluoride ion (F-) from 1.1 mg sodium fluoride (Naf). For use as a dental caries preventive in pediatric patients. Sugar-free Saccharin-free.

Active Ingredients: Sodium Fluoride 0.11% (w/v).

Other Ingredients: D&C red #33, FD&C yellow #6, glycerin, methylparaben, peach flavor, propylparaben, purified water.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Sodium Fluoride Drops - Clinical Pharmacology

Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization and by inhibiting the cariogenic microbial process.

Indications and Usage for Sodium Fluoride Drops

It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries. 1 Sodium Fluoride Drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F.

Contraindications

Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

Warnings

See “Contraindications” above.

Precautions

See “Overdosage” section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absored. Not for use in the eyes.

Adverse Reactions

Allergic rash and other idosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010

Overdosage

Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. (The total amount of sodium fluoride in a bottle of 50 mL Sodium Fluoride Drops (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes).

Sodium Fluoride Drops Dosage and Administration

Daily oral dose:

(in areas where the drinking water contains less than 0.3 ppm F)

6 months to age 3: one half dropperful (1/2 mL);

age 3-6, one dropperful (1 mL);

age 6-16, two dropperfuls (2 mL).

When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows:

6 months to age 3, fluoride supplementation not indicated;

age 3-6, one half dropperful (1/2 mL);

age 6-16, one dropperful (1mL).

* Conforms to new ADA and AAP guidelines for supplementation.*
DOSAGE SCHEDULE** WATER F CONTENT
AGE	0-0.3 PPM	0.3-0.6 PPM	> 0.6 PPM
6 months to 3 years	0.25 mg F = 1/2 mL = Half dropperful	0	0
3-6 years	0.5 mg F = 1 mL = One dropperful	0.25 mg F = 1/2 mL = Half dropperful	0
6-16 years	1 mg F = 2 mL = Two dropperfuls	0.5 mg F = 1 mL = One dropperful	0

How is Sodium Fluoride Drops Supplied

50 mL bottles (NDC 50383-656-50)

TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing.

*REFERENCES

1. Accepted Dental Therapeutics, Ed. 40. American Dental Association. Chicago, 1984. p.399-402.


2. Jakush, J., New Fluoride schedule adopted. ADA News. May 16, 1994, p. 12, 14.

Manufactured by:

HI-TECH PHARMACAL CO., INC.

AMITYVILLE, N.Y. 11701

MADE IN U.S.A.

Rev. 656:03 4/09

PRINCIPAL DISPLAY PANEL

NDC 50383-542-50

Poly-Vitamin Drops

WITH FLUORIDE

0.25 MG

MULTIVITAMIN AND FLUORIDE SUPPLEMENT DROPS

Rx Only

1 2/3 FL. OZ. (50 mL)

SODIUM FLUORIDE  sodium fluoride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-656 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength D&C RED NO. 33   FD&C YELLOW NO. 6   GLYCERIN   METHYLPARABEN   PROPYLPARABEN   WATER

Product Characteristics Color      Score      Shape Size Flavor PEACH Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-656-50 1  In 1 CARTON contains a BOTTLE 1 50 mL In 1 BOTTLE This package is contained within the CARTON (50383-656-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/1996	04/11/2012

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 01/2012Hi-Tech Pharmacal Co., Inc.

Duphalac 500ml

Duphalac

3.35g/5ml lactulose solution

Relieves Constipation

500ml

Duphalac

3.35g/5ml, Lactulose solution

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Duphalac carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.


• Ask your pharmacist if you need more information or advice.


• You should contact a doctor if your symptoms worsen or do not improve.


• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Duphalac is and what it is used for


• 2. Before you take Duphalac


• 3. How to take Duphalac


• 4. Possible side effects


• 5. How to store Duphalac


• 6. Further information

What Duphalac is and what it is used for

Duphalac contains a medicine called lactulose. This belongs to a group of medicines called laxatives.

Duphalac is used to treat constipation. It is also sometimes used to treat a liver problem called ‘hepatic encephalopathy’. This is also known as a ‘hepatic coma’.

Before you take Duphalac

Do not take Duphalac if:

• You are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (listed in Section 6).


• You have a rare problem called ‘galactosaemia’.


• You have a blockage caused by anything else but normal constipation

Do not take Duphalac if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Duphalac.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Duphalac is safe to take in normal doses during pregnancy and when breast-feeding.

Important information about some of the ingredients of Duphalac

Duphalac contains fructose, galactose and lactose (all are types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

How to take Duphalac

If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise follow the instructions below. If you do not understand the instructions, or you are not sure, ask your doctor or pharmacist.

Taking this medicine

• Take Duphalac from a spoon or measuring cup.


• You can mix it with fruit juice or water.


• Duphalac takes 2 to 3 days to start working.


• After this time you may be able to reduce the dose you take according to your needs.

Constipation

Adults: The usual starting dose is 15 ml twice a day.

Children 5 to 10 years: The usual starting dose is 10 ml twice a day.

Children under 5 years: The usual starting dose is 5 ml twice a day

Babies under 1 year: The usual starting dose is 2.5 ml twice a day.

Hepatic encephalophathy

Adults: The usual starting dose is 30 to 50ml three times a day.

If you take more Duphalac than you should

If you take more Duphalac than you should, talk to a doctor. You may have diarrhoea.

If you forget to take Duphalac

• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.


• Do not take a double dose to make up for a forgotten dose.

Duphalac 500ml Side Effects

Like all medicines, Duphalac can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:

• Increased wind and feeling bloated. This may happen during the first few days of treatment. These effects usually disappear after a few days.


• Diarrhoea. This may happen if you take high doses of Duphalac. If this happens, lower your dose.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Duphalac

Keep out of the reach and sight of children.

Do not use Duphalac after the expiry date on the bottle.

Do not store above 25°C. Do not refrigerate or freeze.

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 Duphalac contains

• The active substance is lactulose. Each 5ml of Duphalac contains 3.35g of lactulose.


• The other ingredients are water, lactose, galactose, epilactose, fructose, tagatose, hydrogen peroxide and sodium hydroxide.

What Duphalac looks like and contents of the pack

• Duphalac is a colourless or yellow liquid.


• Duphalac is available in plastic bottles containing 200ml, 300ml, 500ml and 1000ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Solvay Healthcare Limited

Southampton

SO18 3JD

The manufacturer is

Solvay Biologicals B.V.

8121 AA, OIst

The Netherlands

This leaflet was last approved in August 2009.

If you wish to receive this PIL in Braille, large font or audio format please contact 023 8046 7000.

Remember

This medicine is for you.

Please do not offer it to your family and friends, even if they have the same symptoms as you.

Duphalac

3.35g/5ml lactulose solution

Relieves Constipation

Duphalac contains a medicine called lactulose. Each 5ml of Duphalac contains 3.35g of lactulose.

500ml

Duphalac contains a medicine called lactulose.

Each 5ml of Duphalac contains 3.35g of lactulose. Duphalac contains fructose, galactose and lactose (all are types of sugar).

If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

Duphalac is a colourless or yellow liquid.

Duphalac is available in plastic bottles containing: 200ml, 300ml, 500ml, 1000ml.

Read the package leaflet before use.

Keep out of the reach and sight of children.

Do not use Duphalac after the expiry date on the bottle.

Do not store above 25°C.

Do not refrigerate or freeze.

This medicine is available without prescription.

Duphalac is used to treat constipation. It is also sometimes used to treat a liver problem called ‘hepatic encephalopathy’.

This is also known as a ‘hepatic coma’.

1068121

Solvay Healthcare

P

PL 00512/5001R

trade mark

PIP 0005-140

Batch number:

Expiry date:

Earex Ear Drops

1. Name Of The Medicinal Product

Earex Ear Drops

Boots Ear Wax Remover

2. Qualitative And Quantitative Composition

Almond oil	33.33%v/v
Arachis oil (peanut oil)	33.33%v/v
Rectified camphor oil	33.33%v/v

3. Pharmaceutical Form

Ear drops

4. Clinical Particulars

4.1 Therapeutic Indications

For the easy removal of ear wax.

4.2 Posology And Method Of Administration

Adults, children and the elderly:

1. Incline the head to one side.

2. Insert four drops with the applicator supplied.

3. Insert a piece of cotton wool.

4. Repeat night and morning for up to four days until wax is cleared.

Route of administration: Installation into the ear.

4.3 Contraindications

Do not use if the ear is inflamed or infected. Do not use where the eardrum is not whole.

4.4 Special Warnings And Precautions For Use

Never use force or instruments in the ear. Violent nose blowing should always be avoided. Wisdom or any decayed teeth should be examined in all cases of ear trouble.

Earex Ear Drops contain Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Earex Ear Drops.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Unlikely with this dosage form. Gastric lavage may be used in cases of accidental ingestion.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Not applicable.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months unopened.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Carton containing an amber glass bottle containing 10ml of product with a polypropylene/HDPE tamper evident closure, an acrylonitrile butadiene rubber (A7975C) teat and integral polypropylene dropper containing 10ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Pharmalab Ltd

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

8. Marketing Authorisation Number(S)

PL 12048/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

30/3/92 / 19/12/97

10. Date Of Revision Of The Text

16/05/2011

Sanomigran Elixir 0.25 mg / 5 ml

SANOMIGRAN Elixir

(pizotifen)

What you need to know about Sanomigran Elixir

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information.

Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Sanomigran Elixir is and what it’s used for


• 2. Things to consider before you start to take Sanomigran Elixir


• 3. How to take Sanomigran Elixir


• 4. Possible side effects


• 5. How to store Sanomigran Elixir


• 6. Further information

What Sanomigran Elixir is and what it’s used for

Sanomigran Elixir is a syrup containing 0.25 mg of the active ingredient, pizotifen, in each 5 ml.

Sanomigran Elixir is a migraine treatment. It may help to stop the effects of substances in your body called “serotonin”, “histamine” and “tryptamine” which are involved in causing some kinds of headache, including migraine.

Sanomigran Elixir has been prescribed for you by your doctor to help your migraine type headaches. If it is taken regularly it can help to prevent headaches or reduce the pain of cluster headaches, common and classical migraine. Sanomigran Elixir can stop some migraine attacks starting and help make other attacks less severe. It will not stop migraine attacks once they have started.

Things to consider before you start to take Sanomigran Elixir

Some people MUST NOT take Sanomigran Elixir. Talk to your doctor if:

• you think you may be allergic to pizotifen or to any of the other ingredients of the elixir. (These are listed at the end of the leaflet.)



• you are breast-feeding.

Sanomigran Elixir should not be given to children aged under 2.

You should also ask yourself these questions before taking Sanomigran Elixir:

• Do you have glaucoma (raised in your eyes)?


• Do you ever have problems passing urine?


• Do you have kidney problems, especially kidney failure? (The medical term for this is renal failure.)


• Do you have liver problems?


• Do you have epilepsy?


• Are you pregnant?


• Do you have an intolerance to some sugars such as fructose? (The elixir contains maltitol (hydrogenated glucose syrup).)


• Are you an alcoholic?

If the answer to any of these questions is YES, tell your doctor or pharmacist because Sanomigran Elixir might not be the right medicine for you.

Are you taking other medicines?

• Remind your doctor if you are taking drugs called alpha- or beta-blockers because Sanomigran Elixir may affect the way they work.



• Anything that makes you sleepy may make you even sleepier if you are taking Sanomigran Elixir as well. This includes sleeping pills, sedatives and antihistamines such as cold and hayfever medicines. It also includes alcohol. It is best not to drink alcohol while you are taking Sanomigran Elixir.

Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Will there be any problems with driving or using machinery?

Some people may feel drowsy and/or dizzy while they are taking Sanomigran Elixir. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until such problems clear.

Sanomigran Elixir contains ethanol (alcohol). 5 ml of the elixir contains nearly 0.1 g of ethanol. The usual daily dose of 30 ml (1.5 mg pizotifen), will contain nearly 0.6 g of ethanol. This is less than a glass of wine or a pint of beer, but will affect your blood alcohol levels so you should take care not to go over the limit if you are driving.

Other special warnings

• Sanomigran Elixir contains small amounts of the preservatives methyl and propyl hydroxybenzoate. These can sometimes cause allergic reactions which might appear some time after first taking the elixir.

How to take Sanomigran Elixir

The doctor will decide what dose of Sanomigran Elixir you should take. Always take the medicine exactly as your doctor has told you to. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how much to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking Sanomigran Elixir for as long as you have been told unless you have any problems. In that case, check with your doctor.

With Sanomigran Elixir, you do not wait for a migraine and then treat the pain. You take it regularly to stop your migraines even beginning or to make them less severe.

Adults

• The usual dose for adults is 1.5 mg of pizotifen each day. This is six 5ml spoonfuls.


• You may have been told to take your medicine once a day, or you may have it split into three smaller doses.


• Do not take more than 3 mg (twelve 5ml spoonfuls) in a single dose. Do not take more than 4.5 mg (eighteen 5ml spoonfuls) in a day.

Children (aged over 2 years)

• Children can take up to 1.5 mg of pizotifen each day. This is six 5ml spoonfuls.


• This is usually best given in two or three smaller doses.


• Do not give them more than 1 mg in a single dose. This is four 5ml spoonfuls.

Sanomigran Elixir should not be given to children under 2 years of age.

Taking Sanomigran Elixir

• Have a drink with your elixir if this helps you to swallow.



• If you take Sanomigran Elixir once a day, take it in the evening a few hours before you go to bed as any drowsiness will help you to sleep.



• If you take your elixir in two or three doses, spread them evenly through the day.

Carry on taking your Sanomigran Elixir even when you feel well. Your headaches may come back if you stop taking it. Do not stop taking it suddenly, or you may experience withdrawal symptoms, such as feeling anxious, shaking, insomnia, feeling sick and blackouts. Talk to your doctor if you want to stop taking the medicine.

What if you forget to take a dose?

If you forget to take your medicine, do not worry. If you normally take Sanomigran Elixir several times a day you should take the last dose you missed as soon as you remember. Do not take it if there is less than 4 hours before your next dose, but go back to your regular dosing schedule. Do not double doses or take more than your maximum daily dose.

If you normally take Sanomigran Elixir once a day take the dose as soon as you remember. Take your next dose as usual. Do not take more than your maximum daily dose.

Tell your doctor if you keep forgetting to take your medicine.

What if you take too much?

All medicines can be risky if you take too much. If you take too much Sanomigran Elixir at one go, tell your doctor or hospital casualty department as soon as possible. Take your medicine pack with you so that people can see what you have taken.

Possible side effects

Sanomigran Elixir is suitable for most people, but, like all medicines, it can sometimes cause side effects.

Some side effects can be serious

Stop taking the medicine and tell your doctor immediately if you notice any of the following rare symptoms:

• Symptoms of allergy such as a rash, itching or hives on the skin or swelling of the face.

The side effects listed below have also been reported:

More than 1 in 10 people have experienced:

Increase in appetite and weight gain. An increase in appetite may lead to an increase in bodyweight. If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than processed high calorie foods. Your doctor can give you advice about diet as some kinds of foods are known to trigger migraine.

Up to 1 in 10 people have experienced:

Drowsiness, tiredness, dizziness, dry mouth, nausea. Feeling drowsy is not usually a problem as you can take the medicine in the evening. The effect of making you drowsy will help you to sleep. You are less likely to feel drowsy after a few weeks, as you get used to the medicine.

Up to 1 in 100 people have experienced:

Constipation.

Up to 1 in 1,000 people have experienced:

Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not there), sleep disturbances, insomnia, anxiety, tingling or numbness of the hands or feet, muscle or joint pain.

Very rarely (less than 1 in 10,000) people have experienced:

Seizures (fits). Tell your doctor immediately if you have a fit.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Sanomigran Elixir

Keep all medicines out of the reach and sight of children.

Do not take the elixir after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Sanomigran Elixir, please take any which is left back to your pharmacist to be destroyed. Only keep it if the doctor tells you to. Do not throw it away with your normal household water or waste. This will help to protect the environment.

Further information

Sanomigran Elixir is a clear, colourless liquid with a pleasant fruity flavour containing 0.25 mg of the active ingredient pizotifen (as 0.365 mg of pizotifen hydrogen malate) in each 5 ml of syrup. It comes in a bottle containing 300 ml.

The syrup also contains the inactive ingredients citric acid anhydrous, methyl and propyl hydroxybenzoate, raspberry flavour, maraschino flavour, disodium phosphate anhydrous, ethanol 96% w/v, maltitol liquid and purified water. It does not contain tartrazine.

The product licence holder is

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

England

Sanomigran Elixir is made by

Famar France

Site Industriel d’Orleans

Avenue du Champ de Mars

F-45072 Orleans

France

This leaflet was revised in November 2007.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

SANOMIGRAN is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited

Managing Migraine

Migraine affects about one person in ten. Migraine attacks can affect people’s lives and work, sometimes several times a week. Most migraine sufferers get several attacks in a year, sometimes with other tension headaches in between attacks.

Migraine attacks usually last for a few hours but they can go on for several days. Some migraine sufferers can tell when an attack is beginning. They may feel unusually tired or energetic, crave certain foods, or see strange lights, lines or blank spots. Different people have different experiences and this is known as an “aura”. Later, they have a severe throbbing headache, usually on one or both sides of the head. Many people also feel very sick and dislike bright lights and noise during an attack.

We do not know exactly why some people have migraine. Migraine may run in families. This means that there may be a genetic factor. Women sometimes get migraine during or before their periods. We do know many things trigger migraine. These can include certain foods (e.g. cheese, chocolate, and red wine), certain medicines, overwork, worry, bright sunlight, sleeping too much or too little, missing meals. Try to work out which things trigger your migraines. Then you may be able to avoid them.

For more information contact:

Migraine Action Association

Unit 6, Oakley Hay Lodge Business Park

Great Folds Road

Great Oakley

Northants

NN18 9AS

Tel:01536 461333

The Migraine Trust

55 – 56 Russell Square

London

WC1B 4HP

Tel:0207 436 1336

Iso-Acetazone

Generic Name: isometheptene, dichloralphenazone, and acetaminophen (Oral route)

eye-soe-meth-EP-teen MUE-kate, dye-klor-al-FEN-a-zone, a-seet-a-MIN-oh-fen

Commonly used brand name(s)

In the U.S.

• Amidrine


• Diacetazone


• Duradrin


• Epidrin


• Iso-Acetazone


• Midrin


• Migquin


• Migratine


• Migrazone


• Migrin-A


• Nodolor


• Va-Zone

Available Dosage Forms:

• Capsule

Therapeutic Class: Acetaminophen Combination

Pharmacologic Class: Isometheptene

Uses For Iso-Acetazone

Isometheptene, dichloralphenazone, and acetaminophen combination is used to treat certain kinds of headaches, such as “tension” headaches and migraine headaches. This combination is not used regularly (for example, every day) to prevent headaches. It should be taken only after headache pain begins, or after a warning sign that a migraine is coming appears. Isometheptene helps to relieve throbbing headaches, but it is not an ordinary pain reliever. Dichloralphenazone helps you to relax, and acetaminophen relieves pain.

This medicine is available only with your doctor's prescription.

Before Using Iso-Acetazone

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

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

Many medicines have not been tested 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 use of this combination medicine in the elderly with use in other age groups.

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 this medicine, 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 this medicine 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.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine 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.

• Bromocriptine


• Fospropofol

Using this medicine 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.

• Acenocoumarol


• Carbamazepine


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

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:

• Alcohol abuse or


• Heart attack (recent) or


• Heart or blood vessel disease or


• Kidney disease or


• Liver disease or


• Stroke (recent) or


• Virus infection of the liver (viral hepatitis)—The chance of side effects may be increased

• Glaucoma, not well controlled, or


• High blood pressure (hypertension), not well controlled—The isometheptene in this combination medicine may make these conditions worse

Proper Use of isometheptene, dichloralphenazone, and acetaminophen

This section provides information on the proper use of a number of products that contain isometheptene, dichloralphenazone, and acetaminophen. It may not be specific to Iso-Acetazone. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often than directed, and do not take it every day for several days in a row. If the amount you are to take does not relieve your headache, check with your doctor. If a headache medicine is used too often, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse. Also, taking too much acetaminophen can cause liver damage.

This medicine works best if you:

• Take it as soon as the headache begins. If you get warning signals of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring.


• Lie down in a quiet, dark room until you are feeling better.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve, than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, 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 “tension” headaches:
  
  • Adults: 1 or 2 capsules every 4 hours, as needed. Not more than 8 capsules a day.
  
  
  • Children: Dose must be determined by the doctor.
  
  


• For migraine headaches:
  
  • Adults: 2 capsules for the first dose, then 1 capsule every hour, as needed. Not more than 5 capsules in 12 hours.
  
  
  • Children: Dose must be determined by the doctor.
  
  

Precautions While Using Iso-Acetazone

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better relief by increasing the dose.


• If you are having headaches more often than you did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. Taking other medicines that contain acetaminophen together with this medicine may lead to an overdose. If you have any questions about this, check with your health care professional.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with this medicine. 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; antiemetics (medicines that prevent or relieve nausea or vomiting), and anesthetics. If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are drowsy or dizzy or are not alert.

Do not drink alcoholic beverages while taking this medicine. To do so may increase the chance of liver damage caused by acetaminophen, especially if you drink large amounts of alcoholic beverages regularly. Also, because drinking alcoholic beverages may make your headaches worse or cause new headaches to occur, people who often get headaches should probably avoid alcohol.

Iso-Acetazone 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

• Unusual tiredness or weakness

Rare

• Black, tarry stools


• blood in urine or stools


• pinpoint red spots on skin


• skin rash, hives, or itching


• sore throat and fever


• unusual bleeding or bruising


• yellow eyes or skin

Symptoms of dependence on this medicine

• Headaches, more severe and/or more frequent than before

Symptoms of acetaminophen overdose

• Diarrhea


• increased sweating


• loss of appetite


• nausea or vomiting


• pain, tenderness, and/or swelling in the upper abdominal (stomach) area


• stomach cramps or pain

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

• Drowsiness

Rare

• Dizziness


• fast or irregular heartbeat

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: Iso-Acetazone side effects (in more detail)

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More Iso-Acetazone resources

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

• Duradrin Concise Consumer Information (Cerner Multum)


• Duradrin MedFacts Consumer Leaflet (Wolters Kluwer)

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The following drugs and medications are in some way related to, or used in the treatment of Microscopic polyangiitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

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