Texit

Texit may be available in the countries listed below.

Ingredient matches for Texit

Cefixime

Cefixime trihydrate (a derivative of Cefixime) is reported as an ingredient of Texit in the following countries:

• Bangladesh

International Drug Name Search

Asmo ID

Asmo ID may be available in the countries listed below.

Ingredient matches for Asmo ID

Indometacin

Indometacin is reported as an ingredient of Asmo ID in the following countries:

• Japan

International Drug Name Search

Vitamin B12 Sanum

Vitamin B12 Sanum may be available in the countries listed below.

Ingredient matches for Vitamin B12 Sanum

Cyanocobalamin

Cyanocobalamin is reported as an ingredient of Vitamin B12 Sanum in the following countries:

• Germany

International Drug Name Search

Inibrex

Inibrex may be available in the countries listed below.

Ingredient matches for Inibrex

Celecoxib

Celecoxib is reported as an ingredient of Inibrex in the following countries:

• Tunisia

International Drug Name Search

Voselmit

Voselmit may be available in the countries listed below.

Ingredient matches for Voselmit

Trimethobenzamide

Trimethobenzamide hydrochloride (a derivative of Trimethobenzamide) is reported as an ingredient of Voselmit in the following countries:

• Turkey

International Drug Name Search

Intaflam

Intaflam may be available in the countries listed below.

Ingredient matches for Intaflam

Ibuprofen

Ibuprofen is reported as an ingredient of Intaflam in the following countries:

• Peru

Paracetamol

Paracetamol is reported as an ingredient of Intaflam in the following countries:

• Peru

International Drug Name Search

Dabex

Dabex may be available in the countries listed below.

Ingredient matches for Dabex

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Dabex in the following countries:

• Mexico

International Drug Name Search

Ilostal

Ilostal may be available in the countries listed below.

Ingredient matches for Ilostal

Cilostazol

Cilostazol is reported as an ingredient of Ilostal in the following countries:

• Chile

International Drug Name Search

Omeprazol Abdrug

Omeprazol Abdrug may be available in the countries listed below.

Ingredient matches for Omeprazol Abdrug

Omeprazole

Omeprazole is reported as an ingredient of Omeprazol Abdrug in the following countries:

• Spain

International Drug Name Search

Intesul

Intesul may be available in the countries listed below.

Ingredient matches for Intesul

Mosapride

Mosapride citrate dihydrate (a derivative of Mosapride) is reported as an ingredient of Intesul in the following countries:

• Argentina

International Drug Name Search

Nistaken

Nistaken may be available in the countries listed below.

Ingredient matches for Nistaken

Propafenone

Propafenone hydrochloride (a derivative of Propafenone) is reported as an ingredient of Nistaken in the following countries:

• Mexico

International Drug Name Search

Lotoquis

Lotoquis may be available in the countries listed below.

Ingredient matches for Lotoquis

Phenytoin

Phenytoin is reported as an ingredient of Lotoquis in the following countries:

• Argentina

Phenytoin sodium salt (a derivative of Phenytoin) is reported as an ingredient of Lotoquis in the following countries:

• Argentina

International Drug Name Search

Pollyferm

Pollyferm may be available in the countries listed below.

Ingredient matches for Pollyferm

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Pollyferm in the following countries:

• Sweden

International Drug Name Search

Gem Bronchialpastillen mit Codein

Gem Bronchialpastillen mit Codein may be available in the countries listed below.

Ingredient matches for Gem Bronchialpastillen mit Codein

Codeine

Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Gem Bronchialpastillen mit Codein in the following countries:

• Switzerland

International Drug Name Search

Hexocil

Hexocil may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Hexocil

Hexetidine

Hexetidine is reported as an ingredient of Hexocil in the following countries:

• United Kingdom

International Drug Name Search

Potassium Glucaldrate

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0023835-15-6

Chemical Formula

C6-H16-Al-K-O11

Molecular Weight

330

Therapeutic Category

Antacid

Chemical Name

Aluminate(1-), diaqua[D-gluconato(2-)-O1,O2]dihydroxy-, potassium

Foreign Names

• Kalii Glucaldras (Latin)
• Kalium glucaldrat (German)
• Glucaldrate de potassium (French)
• Glucaldrato potasico (Spanish)

Generic Names

• Potassium Glucaldrate (OS: USAN)
• Kalii glucaldras (IS)
• Aloglutamol (IS)
• Tromethamol Glucaldrate (IS)

Brand Names

• Sabro
  Senosiain, Dominican Republic; Senosiain, Guatemala; Senosiain, Honduras; Senosiain, Mexico; Senosiain, Panama

International Drug Name Search

Glossary

IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Graneodin

Graneodin may be available in the countries listed below.

Ingredient matches for Graneodin

Chlorhexidine

Chlorhexidine dihydrochloride (a derivative of Chlorhexidine) is reported as an ingredient of Graneodin in the following countries:

• Chile

International Drug Name Search

Benzamycin Pak Topical

Generic Name: erythromycin and benzoyl peroxide (Topical route)

e-rith-roe-MYE-sin, BEN-zoe-il per-OX-ide

Commonly used brand name(s)

In the U.S.

• Benzamycin Pak

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Antiacne

Chemical Class: Macrolide

Uses For Benzamycin Pak

Erythromycin and benzoyl peroxide combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean (tiny openings on the skin).

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

Before Using Benzamycin Pak

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 erythromycin and benzoyl peroxide combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of erythromycin and benzoyl peroxide combination in geriatric patients.

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.

• Astemizole


• Bepridil


• Cisapride


• Dihydroergotamine


• Dronedarone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Methylergonovine


• Methysergide


• Pimozide


• Posaconazole


• Simvastatin


• Sparfloxacin


• Terfenadine


• Thioridazine


• Ziprasidone

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.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Apomorphine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Atorvastatin


• Azimilide


• Azithromycin


• Bretylium


• Cerivastatin


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clindamycin


• Clomipramine


• Colchicine


• Crizotinib


• Dasatinib


• Desipramine


• Dibenzepin


• Digoxin


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Encainide


• Enflurane


• Eplerenone


• Everolimus


• Fentanyl


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Lapatinib


• Levofloxacin


• Lidoflazine


• Lopinavir


• Lorcainide


• Lovastatin


• Lumefantrine


• Mefloquine


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Oxycodone


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirmenol


• Pitavastatin


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Risperidone


• Saquinavir


• Sematilide


• Sertindole


• Sertraline


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tadalafil


• Tedisamil


• Telavancin


• Telithromycin


• Tetrabenazine


• Theophylline


• Tolvaptan


• Toremifene


• Trazodone


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Troleandomycin


• Vandetanib


• Vasopressin


• Vemurafenib


• Verapamil


• Voriconazole


• Zolmitriptan


• Zotepine

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.

• Alfentanil


• Alprazolam


• Anisindione


• Bexarotene


• Budesonide


• Buspirone


• Carbamazepine


• Cilostazol


• Clozapine


• Cyclosporine


• Diazepam


• Dicumarol


• Fesoterodine


• Methylprednisolone


• Midazolam


• Phenprocoumon


• Roflumilast


• Salmeterol


• Sildenafil


• Sirolimus


• Tacrolimus


• Tolterodine


• Triazolam


• Trimetrexate


• Valproic Acid


• Zafirlukast

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Diarrhea, severe or


• Fungal infections—Use with caution. May make these conditions worse.

Proper Use of Benzamycin Pak

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

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


• Before applying this medicine, wash the affected area(s) with warm water and mild soap. Rinse well and gently pat dry.


• Apply a small amount of the medicine, using enough to cover the affected area(s) of the skin (e.g., forehead, chin, cheeks, chest, shoulders), and gently rub it in. You should apply the medicine to the whole area usually affected by acne, not just to the pimples themselves.

Benzamycin® Pak is available in one foil pouch that has two separated compartments. If you are using this brand, open the pouch and mix the contents in the palm of your hand thoroughly. Apply the product right away after mixing. Do not mix or apply the medicine near an open flame.

After washing or shaving, it is best to wait 30 minutes before applying the medicine. The alcohol in the mixed medicine may irritate freshly washed or shaved skin.

Avoid washing the acne-affected area(s) too often. This may dry your skin and make your acne worse. Washing with a mild, bland soap 2 or 3 times a day should be enough, unless you have oily skin. If you have any questions about this, check with your doctor.

Do not use this medicine after the expiration date on the label. The medicine may not work properly. Get a fresh supply from your pharmacist. Check with your pharmacist if you have any questions about this.

To help keep your acne under control, keep using this medicine for the full time of treatment. You may have to continue using this medicine every day for months or even longer in some cases.

Dosing

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

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

• For topical dosage form (gel):
  
  • For acne:
    
    • Adults, teenagers, and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin two times a day (morning and evening), or as directed by your doctor.
    
    
    • Children below 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Keep the Benzamycin® Pak in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the Benzamycin® topical gel in the refrigerator, away from heat and direct light. Do not freeze. Throw away any unused medicine after 3 months.

Precautions While Using Benzamycin Pak

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat.

If you develop severe swelling, shortness of breath, or any allergic reaction to this medicine, stop using the medicine and check with your doctor right away.

If your acne does not improve within 3 to 4 weeks, or if it becomes worse, check with your doctor. However, treatment of acne may take up to 8 to 12 weeks before you see full improvement.

If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to apply the second medicine at least 1 hour after you apply the first medicine. This may help keep your skin from becoming too irritated. Also, if the medicines are used too close together, they may not work properly.

Mild stinging or burning of the skin may be expected after this medicine is applied. These effects may last up to a few minutes or more. If irritation continues, check with your doctor. You may have to use the medicine less often. Follow your doctor's directions.

You may continue to use cosmetics (make-up) while you are using this medicine for acne. However, it is best to use only ``oil-free'' cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor.

Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include skin peeling agents.

Do not apply the medicine to your hair or to any colored fabric. This medicine may cause bleaching.

Benzamycin Pak 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

• Burning, blistering, crusting, itching, severe redness, or swelling of the skin


• dryness or peeling of the skin


• eye irritation


• feeling of warmth, mild stinging, or redness of the skin


• increased sensitivity of the skin to sunlight


• oiliness or tenderness of the skin


• painful irritation of the skin


• redness or other discoloration of the skin


• redness, swelling, or itching of the eyelid


• severe sunburn


• skin rash


• swelling of the eyes, face, and nose

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: Benzamycin Pak 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 Benzamycin Pak Topical resources

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

Compare Benzamycin Pak Topical with other medications

• Acne

Econazole Teva

Econazole Teva may be available in the countries listed below.

Ingredient matches for Econazole Teva

Econazole

Econazole nitrate (a derivative of Econazole) is reported as an ingredient of Econazole Teva in the following countries:

• France

International Drug Name Search

ISMIN AL

ISMIN AL may be available in the countries listed below.

Ingredient matches for ISMIN AL

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of ISMIN AL in the following countries:

• Czech Republic

International Drug Name Search

Vitamin E ratiopharm

Vitamin E ratiopharm may be available in the countries listed below.

Ingredient matches for Vitamin E ratiopharm

Tocopherol, α-

Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Vitamin E ratiopharm in the following countries:

• Austria

International Drug Name Search

Bronquisedan

Bronquisedan may be available in the countries listed below.

Ingredient matches for Bronquisedan

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bronquisedan in the following countries:

• Argentina

International Drug Name Search

Caniprevent

Caniprevent may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Caniprevent

Chlorothymol

Chlorothymol is reported as an ingredient of Caniprevent in the following countries:

• Germany

International Drug Name Search

Diazoxide Suspension

Pronunciation: dye-az-OX-ide
Generic Name: Diazoxide
Brand Name: Proglycem

Diazoxide Suspension is used for:

Treating low blood sugar.

Diazoxide Suspension is a glucose-elevating agent. It works by blocking the release of insulin from the pancreas, which helps to increase blood sugar.

Do NOT use Diazoxide Suspension if:

• you are allergic to any ingredient in Diazoxide Suspension or to other thiazides (eg, hydrochlorothiazide)


• you have functional low blood sugar

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

Before using Diazoxide Suspension:

Some medical conditions may interact with Diazoxide Suspension. 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 heart problems, kidney problems, low potassium levels in the blood, or high blood pressure


• if you have a history of aneurysm

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

• Hydantoins (eg, phenytoin), sulfonylureas (eg, glipizide), or thiazide-type diuretics (eg, hydrochlorothiazide) because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diazoxide Suspension 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 Diazoxide Suspension:

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

• Shake well before using.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Diazoxide Suspension works best if it is taken on a regular schedule.


• Continue to use Diazoxide Suspension even if you feel well. Do not miss any doses.


• If you miss a dose of Diazoxide Suspension, 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 how to use Diazoxide Suspension.

Important safety information:

• Follow the dietary plan as provided by your doctor.


• Using a kit, test your urine or blood sugar as instructed by your doctor.


• LAB TESTS, including blood glucose determinations, platelet counts, and serum urea nitrogen, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Diazoxide Suspension, discuss with your doctor the benefits and risks of using Diazoxide Suspension during pregnancy. Use Diazoxide Suspension with caution during labor and delivery. It is unknown if Diazoxide Suspension is excreted in breast milk. Do not breast-feed while taking Diazoxide Suspension.

Possible side effects of Diazoxide Suspension:

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:

Diarrhea; excessive hair growth; headache; loss of appetite; nausea; weakness.

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); excessive drowsiness; excessive hunger or thirst; fast or irregular heartbeat; frequent urination; fruity breath; sudden weight gain; sweating; swelling of the feet or ankles.

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: Diazoxide 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 continued loss of appetite; drowsiness; flushed, dry skin; fruit-like breath odor; increased urination; unusual thirst.

Proper storage of Diazoxide Suspension:

Store Diazoxide Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diazoxide Suspension out of the reach of children and away from pets.

General information:

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


• Diazoxide Suspension 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 Diazoxide Suspension. 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 Diazoxide resources

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

Compare Diazoxide with other medications

• Hypertensive Emergency
• Hypoglycemia

Supramycina

Supramycina may be available in the countries listed below.

Ingredient matches for Supramycina

Doxycycline

Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of Supramycina in the following countries:

• Costa Rica


• Dominican Republic


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama

International Drug Name Search

Trobicine

Trobicine may be available in the countries listed below.

Ingredient matches for Trobicine

Spectinomycin

Spectinomycin is reported as an ingredient of Trobicine in the following countries:

• Tunisia

Spectinomycin dihydrochloride (a derivative of Spectinomycin) is reported as an ingredient of Trobicine in the following countries:

• Benin


• Burkina Faso


• Cameroon


• Central African Republic


• Chad


• Congo


• Cote D'ivoire


• France


• Gabon


• Guinea


• Madagascar


• Mali


• Mauritania


• Mauritius


• Niger


• Senegal


• Togo


• Zaire

International Drug Name Search

Amiloride Hydrochloride

Ingredient matches for Amiloride Hydrochloride

Amiloride

Amiloride Hydrochloride (BANM, USAN) is known as Amiloride in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

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

Mebex

Mebex may be available in the countries listed below.

Ingredient matches for Mebex

Mebendazole

Mebendazole is reported as an ingredient of Mebex in the following countries:

• Ethiopia


• India

International Drug Name Search

Axo

Axo may be available in the countries listed below.

Ingredient matches for Axo

Atorvastatin

Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Axo in the following countries:

• Colombia


• Dominican Republic


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama

International Drug Name Search

Imoclone

Imoclone may be available in the countries listed below.

Ingredient matches for Imoclone

Eszopiclone

Zopiclone is reported as an ingredient of Imoclone in the following countries:

• Denmark

International Drug Name Search

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Definition of Polymyositis/Dermatomyositis: A connective tissue disease, which is characterized by inflammation and degeneration of the muscles.

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

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Rifampin Injection

Dosage Form: injection, powder, lyophilized, for solution
rifampin for injection, USP

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin for injection, USP and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Rifampin Injection Description

Rifampin for injection, USP is a lyophilized powder that contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH.

Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12.

The chemical name for rifampin is either:

3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin

or

5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22–heptamethyl-8-[N-(4-methyl-1- piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)- dione 21-acetate.

Its structural formula is:

Rifampin Injection - Clinical Pharmacology

Intravenous Administration

After intravenous administration of a 300 or 600 mg dose of rifampin infused over 30 minutes to healthy male volunteers (n=12), mean peak plasma concentrations were 9.0 ± 3.0 and 17.5 ± 5.0 mcg/mL, respectively. Total body clearances after the 300 and 600 mg IV doses were 0.19 ± 0.06 and 0.14 ± 0.03 L/hr/kg, respectively. Volumes of distribution at steady state were 0.66 ± 0.14 and 0.64 ± 0.11 L/kg for the 300 and 600 mg IV doses, respectively. After intravenous administration of 300 or 600 mg doses, rifampin plasma concentrations in these volunteers remained detectable for 8 and 12 hours, respectively (see Table).

Plasma Concentrations (mean ± standard deviation, mcg/mL)

Rifampin Dosage IV	30 min	1 hr	2 hr	4 hr	8 hr	12 hr
300 mg	8.9±2.9	4.9±1.3	4±1.3	2.5±1	1.1±0.6	<0.4
600 mg	17.4±5.1	11.7±2.8	9.4±2.3	6.4±1.7	3.5±1.4	1.2±0.6

Plasma concentrations after the 600 mg dose, which were disproportionately higher (up to 30% greater than expected) than those found after the 300 mg dose, indicated that the elimination of larger doses was not as rapid.

After repeated once-a-day infusions (3 hr duration) of 600 mg in patients (n=5) for 7 days, concentrations of IV rifampin decreased from 5.81 ± 3.38 mcg/mL 8 hours after the infusion on day 1 to 2.6 ± 1.88 mcg/mL 8 hours after the infusion on day 7.

Rifampin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid. Rifampin is about 80% protein bound. Most of the unbound fraction is not ionized and therefore diffuses freely into tissues.

Rifampin is rapidly eliminated in the bile and undergoes progressive enterohepatic circulation and deacetylation to the primary metabolite, 25-desacetyl-rifampin. This metabolite is microbiologically active. Less than 30% of the dose is excreted in the urine as rifampin or metabolites. Serum concentrations do not differ in patients with renal failure at a studied dose of 300 mg and consequently, no dosage adjustment is required.

Pediatrics

Intravenous Administration

In pediatric patients 0.25 to 12.8 years old (n=12), the mean peak serum concentration of rifampin at the end of a 30 minute infusion of approximately 300 mg/m2 was 25.9 ± 1.3 mcg/mL; individual peak concentrations 1 to 4 days after initiation of therapy ranged from 11.7 to 41.5 mcg/mL; individual peak concentrations 5 to 14 days after initiation of therapy were 13.6 to 37.4 mcg/mL. The individual serum half-life of rifampin changed from 1.04 to 3.81 hours early in therapy to 1.17 to 3.19 hours 5 to 14 days after therapy was initiated.

Mechanism of Action

Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible Mycobacterium tuberculosis organisms. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

Drug Resistance

Organisms resistant to rifampin are likely to be resistant to other rifamycins.

In the treatment of both tuberculosis and the meningococcal carrier state (see INDICATIONS AND USAGE), the small number of resistant cells present within large populations of susceptible cells can rapidly become predominant. In addition, resistance to rifampin has been determined to occur as single-step mutations of the DNA-dependent RNA polymerase. Since resistance can emerge rapidly, appropriate susceptibility tests should be performed in the event of persistent positive cultures.

Activity in vitro and in vivo

Rifampin has bactericidal activity in vitro against slow and intermittently growing M tuberculosis organisms.

Rifampin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

 

Aerobic Gram-Negative Microorganisms:

Neisseria meningitidis

 

"Other" Microorganisms:

Mycobacterium tuberculosis

The following in vitro data are available, but their clinical significance is unknown.

Rifampin exhibits in vitro activity against most strains of the following microorganisms; however, the safety and effectiveness of rifampin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.

 

Aerobic Gram-Positive Microorganisms:

Staphylococcus aureus (including Methicillin-Resistant S. aureus/MRSA)

Staphylococcus epidermidis

 

Aerobic Gram-Negative Microorganisms:

Haemophilus influenzae

 

"Other" Microorganisms:

Mycobacterium leprae

β-lactamase production should have no effect on rifampin activity.

Susceptibility Tests

Prior to initiation of therapy, appropriate specimens should be collected for identification of the infecting organism and in vitro susceptibility tests.

In vitro testing for Mycobacterium tuberculosis isolates:

Two standardized in vitro susceptibility methods are available for testing rifampin against M. tuberculosis organisms. The agar proportion method (CDC or NCCLS(1) M24-P) utilizes Middlebrook 7H10 medium impregnated with rifampin at a final concentration of 1.0 mcg/mL to determine drug resistance. After three weeks of incubation MIC99 values are calculated by comparing the quantity of organisms growing in the medium containing drug to the control cultures. Mycobacterial growth in the presence of drug, of at least 1% of the growth in the control culture, indicates resistance.

The radiometric broth method employs the BACTEC 460 machine to compare the growth index from untreated control cultures to cultures grown in the presence of 2 mcg/mL of rifampin. Strict adherence to the manufacturer's instructions for sample processing and data interpretation is required for this assay.

Susceptibility test results obtained by the two different methods can only be compared if the appropriate rifampin concentration is used for each test method as indicated above. Both procedures require the use of M. tuberculosis H37Rv ATCC 27294 as a control organism.

The clinical relevance of in vitro susceptibility test results for mycobacterial species other than M. tuberculosis using either the radiometric or the proportion method has not been determined.

In vitro testing for Neisseria meningitidis isolates:

Dilution Techniques

Quantitative methods that are used to determine minimum inhibitory concentrations provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure uses a standardized dilution method2,4 (broth, agar, or microdilution) or equivalent with rifampin powder. The MIC values obtained should be interpreted according to the following criteria for Neisseria meningitidis:

MIC (mcg/mL)	Interpretation
≤ 1	(S) Susceptible
2	(I) Intermediate
≥ 4	(R) Resistant

A report of "susceptible" indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the blood. A report of "intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where the maximum acceptable dose of drug can be used. This category also provides a buffer zone that prevents small-uncontrolled technical factors from causing major discrepancies in interpretation. A report of "resistant" indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected.

Measurement of MIC or minimum bactericidal concentrations (MBC) and achieved antimicrobial compound concentrations may be appropriate to guide therapy in some infections. (See CLINICAL PHARMACOLOGY section for further information on drug concentrations achieved in infected body sites and other pharmacokinetic properties of this antimicrobial drug product.)

Standardized susceptibility test procedures require the use of laboratory control microorganisms. The use of these microorganisms does not imply clinical efficacy (see INDICATIONS AND USAGE); they are used to control the technical aspects of the laboratory procedures. Standard rifampin powder should give the following MIC values:

Microorganism	MIC (mcg/mL)
Staphylococcus aureus	ATCC 29213	0.008 – 0.06
Enterococcus faecalis	ATCC 29212	1 – 4
Escherichia coli	ATCC 25922	8 – 32
Pseudomonas aeruginosa	ATCC 27853	32 – 64
Haemophilus influenzae	ATCC 49247	0.25 – 1

Diffusion Techniques

Quantitative methods that require measurement of zone diameters provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure3,4 that has been recommended for use with disks to test the susceptibility of microorganisms to rifampin uses the 5 mcg rifampin disk. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for rifampin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5 mcg rifampin disk should be interpreted according to the following criteria for Neisseria meningitidis:

Zone Diameter (mm)	Interpretation
≥ 20	(S) Susceptible
17–19	(I) Intermediate
≤ 16	(R) Resistant

Interpretation should be as stated above for results using dilution techniques.

As with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms. The use of these microorganisms does not imply clinical efficacy (see INDICATIONS AND USAGE); they are used to control the technical aspects of the laboratory procedures. The 5 mcg rifampin disk should provide the following zone diameters in these quality control strains:

Microorganism		Zone Diameter (mm)
S. aureus	ATCC 25923	26 – 34
E. coli	ATCC 25922	8 – 10
H. influenzae	ATCC 49247	22 – 30

Indications and Usage for Rifampin Injection

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.

Tuberculosis

Rifampin is indicated in the treatment of all forms of tuberculosis.

A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., RIFATER® manufactured by Sanofi Aventis) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

Following the initial phase, treatment should be continued with rifampin and isoniazid (e.g., RIFAMATE® manufactured by Sanofi Aventis) for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

Rifampin for injection is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth.

Meningococcal Carriers

Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS.)

Rifampin should not be used indiscriminately, and therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

Rifampin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (See WARNINGS.)

Rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity. (See PRECAUTIONS, Drug Interactions.) Rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance.

Warnings

Rifampin has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with liver disease and in patients taking rifampin with other hepatotoxic agents. Patients with impaired liver function should be given rifampin only in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function, especially SGPT/ALT and SGOT/AST should be carried out prior to therapy and then every 2 to 4 weeks during therapy. If signs of hepatocellular damage occur, rifampin should be withdrawn.

In some cases, hyperbilirubinemia resulting from competition between rifampin and bilirubin for excretory pathways of the liver at the cell level can occur in the early days of treatment. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather, the decision should be made after repeating the tests, noting trends in the levels, and considering them in conjunction with the patient's clinical condition.

Rifampin has enzyme-inducing properties, including induction of delta amino levulinic acid synthetase. Isolated reports have associated porphyria exacerbation with rifampin administration. The possibility of rapid emergence of resistant meningococci restricts the use of rifampin to short-term treatment of the asymptomatic carrier state. Rifampin is not to be used for the treatment of meningococcal disease.

Precautions

General

Rifampin should be used with caution in patients with a history of diabetes mellitus, as diabetes management may be more difficult.

Prescribing rifampin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

For the treatment of tuberculosis, rifampin is usually administered on a daily basis. Doses of rifampin greater than 600 mg given once or twice weekly have resulted in a higher incidence of adverse reactions, including the "flu syndrome" (fever, chills and malaise), hematopoietic reactions (leukopenia, thrombocytopenia, or acute hemolytic anemia), cutaneous, gastrointestinal, and hepatic reactions, shortness of breath, shock, anaphylaxis, and renal failure. Recent studies indicate that regimens using twice-weekly doses of rifampin 600 mg plus isoniazid 15 mg/kg are much better tolerated.

Rifampin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones, and vitamin D. Rifampin and isoniazid have been reported to alter vitamin D metabolism. In some cases, reduced levels of circulating 25-hydroxy vitamin D and 1,25-dihydroxy vitamin D have been accompanied by reduced serum calcium and phosphate, and elevated parathyroid hormone.

Rifampin for Injection

For intravenous infusion only. Must not be administered by intramuscular or subcutaneous route. Avoid extravasation during injection: local irritation and inflammation due to extravascular infiltration of the infusion have been observed. If these occur, the infusion should be discontinued and restarted at another site.

Information for Patients

Patients should be counseled that antibacterial drugs including rifampin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When rifampin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by rifampin or other antibacterial drugs in the future.

The patient should be told that rifampin may produce a reddish coloration of the urine, sweat, sputum, and tears, and the patient should be forewarned of this. Soft contact lenses may be permanently stained.

The patient should be advised that the reliability of oral or other systemic hormonal contraceptives may be affected; consideration should be given to using alternative contraceptive measures.

Patients should be instructed to notify their physicians promptly if they experience any of the following: fever, loss of appetite, malaise, nausea and vomiting, darkened urine, yellowish discoloration of the skin and eyes, and pain or swelling of the joints.

Compliance with the full course of therapy must be emphasized, and the importance of not missing any doses must be stressed.

Laboratory Tests

Adults treated for tuberculosis with rifampin should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count, and a platelet count (or estimate). Baseline tests are unnecessary in pediatric patients unless a complicating condition is known or clinically suspected.

Patients should be seen at least monthly during therapy and should be specifically questioned concerning symptoms associated with adverse reactions. All patients with abnormalities should have follow-up, including laboratory testing, if necessary. Routine laboratory monitoring for toxicity in people with normal baseline measurements is generally not necessary.

Drug Interactions

Healthy subjects who received rifampin 600 mg once daily concomitantly with saquinavir 1000 mg/ritonavir 100 mg twice daily (ritonavir-boosted saquinavir) developed severe hepatocellular toxicity. Therefore, concomitant use of these medications is contraindicated. (See CONTRAINDICATIONS.)

ENZYME INDUCTION

Rifampin is known to induce certain cytochrome P-450 enzymes. Administration of rifampin with drugs that undergo biotransformation through these metabolic pathways may accelerate elimination of coadministered drugs. To maintain optimum therapeutic blood levels, dosages of drugs metabolized by these enzymes may require adjustment when starting or stopping concomitantly administered rifampin.

Rifampin has been reported to accelerate the metabolism of the following drugs: anticonvulsants (e.g., phenytoin), antiarrhythmics (e.g., disopyramide, mexiletine, quinidine, tocainide), oral anticoagulants, antifungals (e.g., fluconazole, itraconazole, ketoconazole), barbiturates, betablockers, calcium channel blockers (e.g., diltiazem, nifedipine, verapamil), chloramphenicol, clarithromycin, corticosteroids, cyclosporine, cardiac glycoside preparations, clofibrate, oral or other systemic hormonal contraceptives, dapsone, diazepam, doxycycline, fluoroquinolones (e.g., ciprofloxacin), haloperidol, oral hypoglycemic agents (sulfonylureas), levothyroxine, methadone, narcotic analgesics, nortriptyline, progestins, quinine, tacrolimus, theophylline tricyclic antidepressants (e.g., amitriptyline, nortriptyline) and zidovudine. It may be necessary to adjust the dosages of these drugs if they are given concurrently with rifampin.

Patients using oral or other systemic hormonal contraceptives should be advised to change to nonhormonal methods of birth control during rifampin therapy.

Rifampin has been observed to increase the requirements for anticoagulant drugs of the coumarin type. In patients receiving anticoagulants and rifampin concurrently, it is recommended that the prothrombin time be performed daily or as frequently as necessary to establish and maintain the required dose of anticoagulant.

Other Interactions

When the two drugs were taken concomitantly, decreased concentrations of atovaquone and increased concentrations of rifampin were observed.

Concurrent use of ketoconazole and rifampin has resulted in decreased serum concentrations of both drugs. Concurrent use of rifampin and enalapril has resulted in decreased concentrations of enalaprilat, the active metabolite of enalapril. Dosage adjustments should be made if indicated by the patient's clinical condition.

Concomitant antacid administration may reduce the absorption of rifampin. Daily doses of rifampin should be given at least 1 hour before the ingestion of antacids.

Probenecid and cotrimoxazole have been reported to increase the blood level of rifampin.

When rifampin is given concomitantly with either halothane or isoniazid, the potential for hepatotoxicity is increased. The concomitant use of rifampin and halothane should be avoided. Patients receiving both rifampin and isoniazid should be monitored close for hepatotoxicity.

Plasma concentrations of sulfapyridine may be reduced following the concomitant administration of sulfasalazine and rifampin. This finding may be the result of alteration in the colonic bacteria responsible for the reduction of sulfasalazine to sulfapyridine and mesalamine.

Drug/Laboratory Interactions

Cross-reactivity and false-positive urine screening tests for opiates have been reported in patients receiving rifampin when using the KIMS (Kinetic Interaction of Microparticles in Solution) method (e.g., Abuscreen OnLine opiates assay; Roche Diagnostic Systems). Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish rifampin from opiates.

Therapeutic levels of rifampin have been shown to inhibit standard microbiological assays for serum folate and vitamin B12. Thus, alternate assay methods should be considered. Transient abnormalities in liver function tests (e.g., elevation in serum bilirubin, alkaline phosphatase, and serum transaminases) and reduced biliary excretion of contrast media used for visualization of the gallbladder have also been observed. Therefore, these tests should be performed before the morning dose of rifampin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. A few cases of accelerated growth of lung carcinoma have been reported in man, but a causal relationship with the drug has not been established. An increase in the incidence of hepatomas in female mice (of a strain known to be particularly susceptible to the spontaneous development of hepatomas) was observed when rifampin was administered in doses 2 to 10 times the average daily human dose for 60 weeks, followed by an observation period of 46 weeks. No evidence of carcinogenicity was found in male mice of the same strain, mice of a different strain, or rats under similar experimental conditions.

Rifampin has been reported to possess immunosuppressive potential in rabbits, mice, rats, guinea pigs, human lymphocytes in vitro, and humans. Antitumor activity in vitro has also been shown with rifampin.

There was no evidence of mutagenicity in bacteria, Drosophila melanogaster, or mice. An increase in chromatid breaks was noted when whole blood cell cultures were treated with rifampin. Increased frequency of chromosomal aberrations was observed in vitro in lymphocytes obtained from patients treated with combinations of rifampin, isoniazid, and pyrazinamide and combinations of streptomycin, rifampin, isoniazid, and pyrazinamide.

Pregnancy

Teratogenic Effects

Category C

Rifampin has been shown to be teratogenic in rodents given oral doses of rifampin 15 to 25 times the human dose. Although rifampin has been reported to cross the placental barrier and appear in cord blood, the effect of rifampin, alone or in combination with other antituberculosis drugs, on the human fetus is not known. Neonates of rifampin-treated mothers should be carefully observed for any evidence of adverse effects. Isolated cases of fetal malformations have been reported; however, there are no adequate and well-controlled studies in pregnant women. Rifampin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rifampin in oral doses of 150 to 250 mg/kg produced teratogenic effects in mice and rats. Malformations were primarily cleft palate in the mouse and spina bifida in the rat. The incidence of these anomalies was dose-dependent. When rifampin was given to pregnant rabbits in doses up to 20 times the usual daily human dose, imperfect osteogenesis and embryotoxicity were reported.

Pregnancy–Non-Teratogenic Effects

When administered during the last few weeks of pregnancy, rifampin can cause post-natal hemorrhages in the mother and infant for which treatment with vitamin K may be indicated.

Nursing Mothers

Because of the potential for tumorigenicity shown for rifampin in animal studies, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

See CLINICAL PHARMACOLOGY– Pediatrics; see also DOSAGE AND ADMINISTRATION.

Geriatric Use

Clinical studies of rifampin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution should therefore be observed in using rifampin in elderly patients. (See WARNINGS).

Adverse Reactions

Gastrointestinal

Heartburn, epigastric distress, anorexia, nausea, vomiting, jaundice, flatulence, cramps, and diarrhea have been noted in some patients. Although Clostridium difficile has been shown in vitro to be sensitive to rifampin, pseudomembranous colitis has been reported with the use of rifampin (and other broad spectrum antibiotics). Therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with antibiotic use.

Hepatic

Transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, BSP, alkaline phosphatase, serum transaminases) have been observed. Rarely, hepatitis or a shock-like syndrome with hepatic involvement and abnormal liver function tests has been reported.

Hematologic

Thrombocytopenia has occurred primarily with high dose intermittent therapy, but has also been noted after resumption of interrupted treatment. It rarely occurs during well supervised daily therapy. This effect is reversible if the drug is discontinued as soon as purpura occurs. Cerebral hemorrhage and fatalities have been reported when rifampin administration has been continued or resumed after the appearance of purpura.

Rare reports of disseminated intravascular coagulation have been observed.

Leukopenia, hemolytic anemia, and decreased hemoglobin have been observed.

Agranulocytosis has been reported very rarely.

Central Nervous System

Headache, fever, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, behavioral changes, muscular weakness pains in extremities, and generalized numbness have been observed.

Psychoses have been rarely reported.

Rare reports of disseminated intravascular coagulation have been observed.

Ocular

Visual disturbances have been observed.

Endocrine

Menstrual disturbances have been observed.

Rare reports of adrenal insufficiency in patients with compromised adrenal function have been observed.

Renal

Elevations in BUN and serum uric acid have been reported. Rarely, hemolysis, hemoglobinuria, hematuria, interstitial nephritis, acute tubular necrosis, renal insufficiency, and acute renal failure have been noted. These are generally considered to be hypersensitivity reactions. They usually occur during intermittent therapy or when treatment is resumed following intentional or accidental interruption of a daily dosage regimen, and are reversible when rifampin is discontinued and appropriate therapy instituted.

Dermatologic

Cutaneous reactions are mild and self-limiting and do not appear to be hypersensitivity reactions. Typically, they consist of flushing and itching with or without a rash. More serious cutaneous reactions which may be due to hypersensitivity occur but are uncommon.

Hypersensitivity Reactions

Occasionally, pruritus, urticaria, rash, pemphigoid reaction, erythema multiforme including Stevens-Johnson Syndrome, toxic epidermal necrolysis, vasculitis, eosinophilia, sore mouth, sore tongue, and conjunctivitis have been observed.

Anaphylaxis has been reported rarely.

Miscellaneous

Edema of the face and extremities has been reported. Other reactions reported to have occurred with intermittent dosage regimens include "flu syndrome" (such as episodes of fever, chills, headache, dizziness, and bone pain), shortness of breath, wheezing, decrease in blood pressure and shock. The "flu syndrome" may also appear if rifampin is taken irregularly by the patient or if daily administration is resumed after a drug free interval.

Overdosage

Signs and Symptoms

Nausea, vomiting, abdominal pain, pruritus, headache, and increasing lethargy will probably occur within a short time after ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces will occur, and its intensity is proportional to the amount ingested.

Liver enlargement, possibly with tenderness, can develop within a few hours after severe overdosage; bilirubin levels may increase and jaundice may develop rapidly. Hepatic involvement may be more marked in patients with prior impairment of hepatic function. Other physical findings remain essentially normal. A direct effect upon the hematopoietic system, electrolyte levels, or acid-base balance is unlikely.

Facial or periorbital edema has also been reported in pediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.

Acute Toxicity

The LD50 of rifampin is approximately 885 mg/kg in the mouse, 1720 mg/kg in the rat, and 2120 mg/kg in the rabbit.

The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 gm rifampin. Fatal acute overdoses in adults have been reported with doses ranging from 14 to 60 gm. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports. Nonfatal overdoses in pediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses has been reported.

Treatment

Intensive support measures should be instituted and individual symptoms treated as they arise. The airway should be secured and adequate respiratory exchange established. Since nausea and vomiting are likely to be present, gastric lavage within the first 2 to 3 hours after ingestion is probably preferable to induction of emesis. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting.

Active diuresis (with measured intake and output) will help promote excretion of the drug.

For severe cases, extracorporeal hemodialysis may be required. If this is not available, peritoneal dialysis can be used along with forced diuresis.

Rifampin Injection Dosage and Administration

Rifampin can be administered by IV infusion (see INDICATIONS AND USAGE).

See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.

Tuberculosis

Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, IV

Pediatric Patients: 10–20 mg/kg, not to exceed 600 mg/day, IV

Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., RIFATER® manufactured by Sanofi Aventis) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

Following the initial phase, treatment should be continued with rifampin and isoniazid (e.g., RIFAMATE® manufactured by Sanofi Aventis) for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

Preparation of Solution for IV Infusion

Reconstitute the lyophilized powder by transferring 10 mL of sterile water for injection to a vial containing 600 mg of rifampin for injection. Swirl vial gently to completely dissolve the antibiotic. The reconstituted solution contains 60 mg rifampin per mL and is stable at room temperature for 24 hours. Prior to administration, withdraw from the reconstituted solution a volume equivalent to the amount of rifampin calculated to be administered and add to 500 mL of infusion medium. Mix well and infuse at a rate allowing for complete infusion within 3 hours. Alternatively, the amount of rifampin calculated to be administered may be added to 100 mL of infusion medium and infused in 30 minutes.

Dilutions in dextrose 5% for injection (D5W) are stable at room temperature for up to 4 hours and should be prepared and used within this time. Precipitation of rifampin from the infusion solution may occur beyond this time. Dilutions in normal saline are stable at room temperature for up to 24 hours and should be prepared and used within this time. Other infusion solutions are not recommended.

Incompatibilities

Physical incompatibility (precipitate) was observed with undiluted (5 mg/mL) and diluted (1 mg/mL in normal saline) diltiazem hydrochloride and rifampin (6 mg/mL in normal saline) during simulated Y-site administration.

Meningococcal Carriers

Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days.

Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days.

Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.

How is Rifampin Injection Supplied

Rifampin for injection, USP is available in glass vials containing 600 mg rifampin (NDC 0069-0112-01).

Storage

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Avoid excessive heat (temperatures above 40°C or 104°F). Protect from light.

References

1. Clinical Laboratory Standards Institute, Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard CLSI Document M24-A, Vol. 23, No. 18, CLSI, Villanova, PA, 2003.


2. Clinical Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically -- Eighth Edition. Approved Standard CLSI Document M7- A8, Vol. 29, No. 2, CLSI, Villanova, PA, January 2009.


3. Clinical Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests -- Tenth Edition. Approved Standard CLSI Document M2-A10, Vol. 29, No. 1, CLSI, Villanova, PA, January 2009.


4. Clinical Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement, CLSI Document M100-S20, Vol. 30, No. 1, CLSI, Villanova, PA, January 2010.

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February 2011

PRINCIPAL DISPLAY PANEL - 600 mg Vial Carton

600 mg

NDC 0069-0112-01

Rx only

1 Vial

rifampin for

injection, USP

600 mg/vial

Sterile

For IV Infusion Only

Pfizer Injectables

RIFAMPIN  rifampin  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-0112 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rifampin (Rifampin) Rifampin 600 mg  in 10 mL

Inactive Ingredients Ingredient Name Strength Sodium Formaldehyde Sulfoxylate 10 mg  in 10 mL Sodium Hydroxide

Product Characteristics Color RED (Red-Brown) Score      Shape Size Flavor Imprint Code Contains

Packaging #