Wednesday, 28 September 2016

Virazole




In the US, Virazole (ribavirin systemic) is a member of the following drug classes: inhaled anti-infectives, purine nucleosides and is used to treat Respiratory Syncytial Virus.

US matches:

  • Virazole Solution

  • Virazole

UK matches:

  • Virazole 6 g Aerosol

Ingredient matches for Virazole



Ribavirin

Ribavirin is reported as an ingredient of Virazole in the following countries:


  • Bahrain

  • Belgium

  • Brazil

  • Canada

  • Costa Rica

  • El Salvador

  • Georgia

  • Germany

  • Guatemala

  • Honduras

  • Jordan

  • Kuwait

  • Lebanon

  • Luxembourg

  • Netherlands

  • Nicaragua

  • Qatar

  • Russian Federation

  • Saudi Arabia

  • Singapore

  • Spain

  • Sudan

  • Sweden

  • Taiwan

  • United Arab Emirates

  • United Kingdom

  • United States

  • Yemen

International Drug Name Search

Virlix




Virlix may be available in the countries listed below.


Ingredient matches for Virlix



Cetirizine

Cetirizine is reported as an ingredient of Virlix in the following countries:


  • Luxembourg

  • Tunisia

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


  • France

  • Mexico

  • Philippines

  • Poland

  • Spain

International Drug Name Search

Aciclobene ratiopharm




Aciclobene ratiopharm may be available in the countries listed below.


Ingredient matches for Aciclobene ratiopharm



Acyclovir

Aciclovir is reported as an ingredient of Aciclobene ratiopharm in the following countries:


  • Austria

International Drug Name Search

Oxaliplatine Medac




Oxaliplatine Medac may be available in the countries listed below.


Ingredient matches for Oxaliplatine Medac



Oxaliplatin

Oxaliplatin is reported as an ingredient of Oxaliplatine Medac in the following countries:


  • Belgium

  • France

  • Netherlands

International Drug Name Search

Glotac




Glotac may be available in the countries listed below.


Ingredient matches for Glotac



Ranitidine

Ranitidine is reported as an ingredient of Glotac in the following countries:


  • Oman

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


  • Bahrain

International Drug Name Search

Fe Caps Controlled-Release Capsules


Pronunciation: FER-us SUL-fate
Generic Name: Ferrous Sulfate
Brand Name: Examples include Fe Caps and Slow Fe

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years old. Keep this product out of the reach of children. In case of an accidental overdose, call a doctor or poison control center right away.





Fe Caps Controlled-Release Capsules are used for:

Preventing or treating low levels of iron in the blood. It may also be used for other conditions as determined by your doctor.


Fe Caps Controlled-Release Capsules are an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.


Do NOT use Fe Caps Controlled-Release Capsules if:


  • you are allergic to any ingredient in Fe Caps Controlled-Release Capsules

  • you have high levels of iron in your blood

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



Before using Fe Caps Controlled-Release Capsules:


Some medical conditions may interact with Fe Caps Controlled-Release Capsules. 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 inflammation of the intestines, Crohn disease, digestive problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)

  • if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Fe Caps Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Fe Caps Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fe Caps Controlled-Release Capsules 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 Fe Caps Controlled-Release Capsules:


Use Fe Caps Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Fe Caps Controlled-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Swallow Fe Caps Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • Take Fe Caps Controlled-Release Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Fe Caps Controlled-Release Capsules.

  • If you are also taking an antacid, a bisphosphonate (eg, alendronate), a cephalosporin (eg, cephalexin), methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, minocycline) along with Fe Caps Controlled-Release Capsules, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Fe Caps Controlled-Release Capsules and your other medicines.

  • Certain foods and drinks may decrease the amount of Fe Caps Controlled-Release Capsules that works in your body. Ask your doctor or pharmacist how you should take Fe Caps Controlled-Release Capsules if you consume whole grain breads or cereal, dairy products, coffee, or tea.

  • If you miss a dose of Fe Caps Controlled-Release Capsules, 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 Fe Caps Controlled-Release Capsules.



Important safety information:


  • Do not take large doses of vitamins while you use Fe Caps Controlled-Release Capsules unless your doctor tells you to.

  • Do NOT take more than the recommended dose or take for longer than 6 months without checking with your doctor.

  • Fe Caps Controlled-Release Capsules has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.

  • Lab tests, including complete blood cell counts and blood iron levels, may be performed while you use Fe Caps Controlled-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Fe Caps Controlled-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fe Caps Controlled-Release Capsules while you are pregnant. Fe Caps Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Fe Caps Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Fe Caps Controlled-Release Capsules:


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:



Constipation; darkened or green stools; diarrhea; nausea; stomach upset.



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); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.



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: Fe Caps 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 difficulty breathing; loss of consciousness; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.


Proper storage of Fe Caps Controlled-Release Capsules:

Store Fe Caps Controlled-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fe Caps Controlled-Release Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Fe Caps Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Fe Caps Controlled-Release Capsules are 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 Fe Caps Controlled-Release Capsules. 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 Fe Caps resources


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


Compare Fe Caps with other medications


  • Anemia Associated with Chronic Renal Failure
  • Iron Deficiency Anemia
  • Vitamin/Mineral Supplementation and Deficiency
  • Vitamin/Mineral Supplementation during Pregnancy/Lactation

Carbimazol Henning




Carbimazol Henning may be available in the countries listed below.


Ingredient matches for Carbimazol Henning



Carbimazole

Carbimazole is reported as an ingredient of Carbimazol Henning in the following countries:


  • Germany

International Drug Name Search

Velamox




Velamox may be available in the countries listed below.


Ingredient matches for Velamox



Amoxicillin

Amoxicillin is reported as an ingredient of Velamox in the following countries:


  • Peru

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


  • Italy

International Drug Name Search

Tuesday, 27 September 2016

Solurrinol




Solurrinol may be available in the countries listed below.


Ingredient matches for Solurrinol



Potassium Chloride

Potassium Chloride is reported as an ingredient of Solurrinol in the following countries:


  • Spain

Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Solurrinol in the following countries:


  • Spain

International Drug Name Search

Vagothyl




Vagothyl may be available in the countries listed below.


Ingredient matches for Vagothyl



Policresulen

Policresulen is reported as an ingredient of Vagothyl in the following countries:


  • Czech Republic

  • Georgia

  • Hungary

  • Latvia

  • Lithuania

  • Poland

  • Russian Federation

International Drug Name Search

Gastroenteritis Medications


Definition of Gastroenteritis:

An acute inflammation of the lining of the stomach and intestines, characterised by anorexia, nausea, diarrhoea, abdominal pain and weakness, which has various causes, including food poisoning due to infection with such organisms as Escherichia coli, Staphylococcus aureus and Salmonella species, consumption of irritating food or drink or psychological factors such as anger, stress and fear.


Synonym: enterogastritis.

More...

Drugs associated with Gastroenteritis

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

See sub-topics

Topics under Gastroenteritis

  • Infectious Gastroenteritis (74 drugs in 8 topics)

Learn more about Gastroenteritis





Drug List:

Vals Cardio




Vals Cardio may be available in the countries listed below.


Ingredient matches for Vals Cardio



Valsartan

Valsartan is reported as an ingredient of Vals Cardio in the following countries:


  • Spain

International Drug Name Search

Beta-Histina Bluepharma




Beta-Histina Bluepharma may be available in the countries listed below.


Ingredient matches for Beta-Histina Bluepharma



Betahistine

Betahistine is reported as an ingredient of Beta-Histina Bluepharma in the following countries:


  • Portugal

International Drug Name Search

Erythrocin Stearate



Generic Name: erythromycin (Oral route, Parenteral route)

e-rith-roe-MYE-sin

Commonly used brand name(s)

In the U.S.


  • E.E.S. 200

  • E.E.S. 400

  • E.E.S. Granules

  • Eryped

  • Eryped 200

  • Eryped 400

  • Erythrocin

  • Erythrocin Stearate

  • Ilosone

In Canada


  • E.E.S. 100

  • Ees 200

  • Novo-Rythro Estolate Suspension

  • Novo-Rythro Ethyl Succinate Suspension

  • Novo-Rythro Stearate

Available Dosage Forms:


  • Suspension

  • Powder for Suspension

  • Tablet

  • Tablet, Chewable

  • Capsule

Uses For Erythrocin Stearate


Erythromycins are used to treat many kinds of infections. Erythromycins are also used to prevent "strep" infections in patients with a history of rheumatic heart disease who may be allergic to penicillin.


These medicines may also be used to treat Legionnaires' disease and for other problems as determined by your doctor. They will not work for colds, flu, or other virus infections.


Erythromycins are available only with your doctor's prescription.


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


  • Acne

  • Actinomycosis

  • Anthrax

  • Chancroid

  • Gastroparesis

  • Lyme disease

  • Lymphogranuloma venereum

  • Relapsing fever

Before Using Erythrocin Stearate


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.


Geriatric


This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older adults may be at increased risk of hearing loss, especially if they are taking high doses of erythromycin and/or have kidney or liver disease.


Pregnancy


Erythromycin estolate has caused side effects involving the liver in some pregnant women. However, none of the erythromycins has been shown to cause birth defects or other problems in human babies.


Breast Feeding


Erythromycins pass into the breast milk. However, erythromycins have not been shown to cause problems in nursing babies.


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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Heart disease—High doses of erythromycin may increase the chance of side effects in patients with a history of an irregular heartbeat.

  • Liver disease—Erythromycins, especially erythromycin estolate, may increase the chance of side effects involving the liver.

  • Loss of hearing—High doses of erythromycins may, on rare occasion, cause hearing loss, especially if you have kidney or liver disease.

Proper Use of erythromycin

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


Generally, erythromycins are best taken with a full glass (8 ounces) of water on an empty stomach (at least 1 hour before or 2 hours after meals). If stomach upset occurs, these medicines may be taken with food. If you have questions about the erythromycin medicine you are taking, check with your health care professional.


For patients taking the oral liquid form of this medicine:


  • This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid

  • Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

For patients taking the chewable tablet form of this medicine:


  • Tablets must be chewed or crushed before they are swallowed.

For patients taking the delayed-release capsule form (with enteric-coated pellets) or the delayed-release tablet form of this medicine:


  • Swallow capsules or tablets whole. Do not break or crush. If you are not sure about which type of capsule or tablet you are taking, check with your pharmacist.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a "strep" infection, you should keep taking this medicine for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.


This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.


Dosing


The dose medicines in this class 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 these medicines. 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 erythromycin base

  • For oral dosage forms (capsules, tablets):
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



  • For erythromycin estolate

  • For oral dosage forms (capsules, oral suspension, tablets):
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



  • For erythromycin ethylsuccinate

  • For oral dosage forms (oral suspension, tablets):
    • For treatment of infections:
      • Adults and teenagers—400 to 800 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1.6 grams two hours before your dental appointment or surgery, then 800 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



  • For erythromycin gluceptate

  • For injection dosage forms:
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.

      • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.



  • For erythromycin lactobionate

  • For injection dosage forms:
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.

      • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.



  • For erythromycin stearate

  • For oral dosage forms (oral suspension, tablets):
    • For treatment of infections:
      • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.

      • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day; or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.


    • For prevention of heart infections:
      • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.

      • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.



Missed Dose


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


Storage


Keep out of the reach of children.


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


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Erythrocin Stearate


If your symptoms do not improve within a few days, or if they become worse, check with your doctor.


Erythrocin Stearate 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
  • Fever

  • nausea

  • skin rash, redness, or itching

  • stomach pain (severe)

  • unusual tiredness or weakness

  • vomiting

  • yellow eyes or skin–with erythromycin estolate (rare with other erythromycins)

Less common - with erythromycin injection only
  • Pain, swelling, or redness at place of injection

Rare
  • Fainting (repeated)

  • irregular or slow heartbeat

  • loss of hearing (temporary)

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
  • Abdominal or stomach cramping and discomfort

  • diarrhea

  • nausea or vomiting

Less common
  • Sore mouth or tongue

  • vaginal itching and discharge

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.



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 Erythrocin Stearate resources


  • Erythrocin Stearate Use in Pregnancy & Breastfeeding
  • Drug Images
  • Erythrocin Stearate Drug Interactions
  • Erythrocin Stearate Support Group
  • 13 Reviews for Erythrocin Stearate - Add your own review/rating


Compare Erythrocin Stearate with other medications


  • Bacterial Endocarditis Prevention
  • Bartonellosis
  • Bowel Preparation
  • Bronchitis
  • Bullous Pemphigoid
  • Campylobacter Gastroenteritis
  • Chancroid
  • Chlamydia Infection
  • Dental Abscess
  • Legionella Pneumonia
  • Lyme Disease
  • Lymphogranuloma Venereum
  • Mycoplasma Pneumonia
  • Nongonococcal Urethritis
  • Ocular Rosacea
  • Otitis Media
  • Pemphigoid
  • Pertussis
  • Pharyngitis
  • Pneumonia
  • Rheumatic Fever Prophylaxis
  • Skin Infection
  • Strep Throat
  • Syphilis, Early
  • Upper Respiratory Tract Infection

Tromax




Tromax may be available in the countries listed below.


Ingredient matches for Tromax



Diclofenac

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


  • Ethiopia

International Drug Name Search

Vérapamil Sandoz




Vérapamil Sandoz may be available in the countries listed below.


Ingredient matches for Vérapamil Sandoz



Verapamil

Verapamil hydrochloride (a derivative of Verapamil) is reported as an ingredient of Vérapamil Sandoz in the following countries:


  • France

International Drug Name Search

Dometa




Dometa may be available in the countries listed below.


Ingredient matches for Dometa



Domperidone

Domperidone is reported as an ingredient of Dometa in the following countries:


  • Indonesia

International Drug Name Search

Verocod




Verocod may be available in the countries listed below.


Ingredient matches for Verocod



Butamirate

Butamirate citrate (a derivative of Butamirate) is reported as an ingredient of Verocod in the following countries:


  • Greece

International Drug Name Search

Polovital C




Polovital C may be available in the countries listed below.


Ingredient matches for Polovital C



Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Polovital C in the following countries:


  • Poland

International Drug Name Search

Afusidique




Afusidique may be available in the countries listed below.


Ingredient matches for Afusidique



Fusidic Acid

Fusidic Acid is reported as an ingredient of Afusidique in the following countries:


  • Tunisia

International Drug Name Search

Biorganic Beta-Carotene Gisand




Biorganic Beta-Carotene Gisand may be available in the countries listed below.


Ingredient matches for Biorganic Beta-Carotene Gisand



Betacarotene

Betacarotene is reported as an ingredient of Biorganic Beta-Carotene Gisand in the following countries:


  • Switzerland

International Drug Name Search

Triaz Foaming Cloth



benzoyl peroxide foaming cloth

Dosage Form: cloth
TRIAZ®

(benzoyl peroxide) 3%, 6%, & 9%

Foaming Cloths

Rx Only



Triaz Foaming Cloth Description


TRIAZ (benzoyl peroxide) 3%, 6%, and 9% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:



TRIAZ 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cleanser-based formulation consisting of: purified water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer 1342 NF, sodium hydroxide NF, glycolic acid, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP.


TRIAZ 9% Foaming Cloths contains benzoyl peroxide 9% as the active ingredient in a cleanser-based formulation consisting of: puried water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer copolymer type B NF, glycolic acid, sodium hydroxide NF, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP.



Triaz Foaming Cloth - Clinical Pharmacology



The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.



Indications and Usage for Triaz Foaming Cloth


TRIAZ 3%, 6%, and 9% Foaming Cloths are indicated for the topical treatment of acne vulgaris.



Contraindications


These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.



Warnings


When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of reach of children.



Precautions



General


For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.



Information for Patients


Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in children have not been established.



Adverse Reactions


Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.



Overdosage


If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.



Triaz Foaming Cloth Dosage and Administration


Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.



How is Triaz Foaming Cloth Supplied




















SIZENDC NUMBER
TRIAZ 3% Foaming Cloths3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-224-60
TRIAZ 6% Foaming Cloths3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-225-60
TRIAZ 9% Foaming Cloths3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-226-60

Store at 15°–25°C (59°–77°F).



U.S. Patent 5,648,389 and Patents Pending


Manufactured for:

Medicis, The Dermatology Company, Scottsdale, AZ 85256

by: Tapemark, West St. Paul, MN 55118

Made in U.S.A.


Prescribing information as of July 2009


www.Triaz.com


15100077



PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (3%)


NDC 99207-224-60


TRIAZ®

(benzoyl peroxide)


3%

Foaming Cloths


60

Cloths

Net wt.

3.2 g each




PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (6%)


NDC 99207-225-60


TRIAZ®

(benzoyl peroxide)


6%

Foaming Cloths


60

Cloths

Net wt.

3.2 g each




PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (9%)


NDC 99207-226-60


TRIAZ®

(benzoyl peroxide)


9%

Foaming Cloths


60

Cloths

Net wt.

3.2 g each










TRIAZ 
benzoyl peroxide  cloth










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-224
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide)benzoyl peroxide30 mg  in 1 g
































Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
sodium lauryl sulfoacetate 
disodium laureth sulfosuccinate 
sodium hydroxide 
glycolic acid 
hypromelloses 
zinc lactate 
sodium pyrrolidone carboxylate 
glycerin 
docusate sodium 
hyaluronate sodium 
silicon dioxide 
dimethicone 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-224-0330 POUCH In 1 CARTONcontains a POUCH
13.2 g In 1 POUCHThis package is contained within the CARTON (99207-224-03)
299207-224-6060 POUCH In 1 CARTONcontains a POUCH (99207-224-01)
299207-224-013.2 g In 1 POUCHThis package is contained within the CARTON (99207-224-60)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/27/200903/04/2011







TRIAZ 
benzoyl peroxide  cloth










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-225
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide)benzoyl peroxide60 mg  in 1 g
































Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
sodium lauryl sulfoacetate 
disodium laureth sulfosuccinate 
sodium hydroxide 
glycolic acid 
hypromelloses 
zinc lactate 
sodium pyrrolidone carboxylate 
glycerin 
docusate sodium 
hyaluronate sodium 
silicon dioxide 
dimethicone 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-225-0330 POUCH In 1 CARTONcontains a POUCH
13.2 g In 1 POUCHThis package is contained within the CARTON (99207-225-03)
299207-225-6060 POUCH In 1 CARTONcontains a POUCH (99207-225-01)
299207-225-013.2 g In 1 POUCHThis package is contained within the CARTON (99207-225-60)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/15/200903/04/2011







TRIAZ 
benzoyl peroxide  cloth










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-226
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide)benzoyl peroxide90 mg  in 1 g
































Inactive Ingredients
Ingredient NameStrength
water 
cetyl alcohol 
sodium lauryl sulfoacetate 
disodium laureth sulfosuccinate 
glycolic acid 
sodium hydroxide 
hypromelloses 
zinc lactate 
sodium pyrrolidone carboxylate 
glycerin 
docusate sodium 
hyaluronate sodium 
silicon dioxide 
dimethicone 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-226-0330 POUCH In 1 CARTONcontains a POUCH
13.2 g In 1 POUCHThis package is contained within the CARTON (99207-226-03)
299207-226-6060 POUCH In 1 CARTONcontains a POUCH (99207-226-01)
299207-226-013.2 g In 1 POUCHThis package is contained within the CARTON (99207-226-60)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/01/201003/04/2011


Labeler - Medicis Pharmaceutical Corp. (182837492)









Establishment
NameAddressID/FEIOperations
Tapemark006154595MANUFACTURE









Establishment
NameAddressID/FEIOperations
Contract Pharmaceutical Limited248761249MANUFACTURE
Revised: 03/2011Medicis Pharmaceutical Corp.

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Levulan


Generic Name: Aminolevulinic Acid Hydrochloride
Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: L01XD04
VA Class: DE350
Chemical Name: 5-Aminolevulinic acid hydrochloride
Molecular Formula: C5H9NO3•HCl
CAS Number: 5451-09-2

Introduction

Photosensitizer; hydrochloride salt of 5-aminolevulinic acid, an endogenous precursor of protoporphyrin IX.1 2


Uses for Levulan


Nonhyperkeratotic Actinic Keratoses of Face or Scalp


Treatment of minimally to moderately thick (nonhyperkeratotic) actinic keratoses of the face or scalp, in conjunction with blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator (BLU-U).a


Levulan Dosage and Administration


General



  • Topical solution should be applied only by qualified medical personnel.a




  • Apply topically to individual actinic keratosis lesions on either scalp or face, but not both simultaneously.a Do not apply in or around eyes or mucous membranes or to perilesional skin.a



Administration


Topical Administration


Preparation of the Applicator

With the applicator cap pointing up, sequentially break the 2 glass ampuls within the plastic applicator by applying finger pressure to appropriate position on the bottom ampul (vehicle solution), then the top ampul (powdered drug).a


With applicator cap pointed away from face, shake applicator gently for at least 3 minutes to completely dissolve the drug in the vehicle.a Do not press on end cap while shaking.a


Topical Application

Apply topically; use within 2 hours because of the instability of the activated product.a If application of the solution is not completed within 2 hours of activation, discard applicator and use a new one.1 a


Clean and dry lesions prior to application of solution.a


Gently dab target lesions directly with wet applicator tip, uniformly wetting lesion surface, including the edges, without excess running or dripping.a


Allow application to dry and then reapply one time in the same manner.a 7


Illumination of Treated Lesions

14–18 hours after application, gently rinse target lesions with water, pat dry, and photoactivate with blue light illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator.a


Patients and medical personnel should use blue light-blocking protective eyewear during BLU-U illumination.a


Solution is not intended for use with any device other than the BLU-U Blue Light Photodynamic Illuminator.a


Dosage


Adults


Actinic Keratoses

Topical

Apply solution to lesions as directed (See Topical Application under Dosage and Administration); allow to dry and reapply once.a 7 14–18 hours later, expose affected areas to BLU-U illumination for 1000 seconds [16 minutes, 40 seconds].a


After 8 weeks, apply solution a second time to lesions that have not completely resolved.a


Cautions for Levulan


Contraindications



  • Known cutaneous photosensitivity at wavelengths of 400–450 nm.a




  • Known porphyria or known allergies to porphyrins.a




  • Known sensitivity to aminolevulinic acid or any ingredient in the formulation.a



Warnings/Precautions


Warnings


Topical Application Only

Solution contains alcohol; for topical use only.a Do not apply in or around the eyes or to mucous membranes.a May cause excessive irritation if applied under occlusion.a


General Precautions


Application by Health Professional

Only qualified medical personnel should apply solution; application to perilesional area of face or scalp may result in photosensitivity.a


Photosensitivity Reactions

Sites will be photosensitive after topical application of solution; stinging and/or burning sensation, erythema, and/or edema of lesions may occur with exposure to bright light.a


Avoid exposure of treated sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, lights at close proximity) prior to blue light photoactivation.a


Protect treated lesions from sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and keep lesions dry.a Sunscreens will not protect against photosensitivity reactions caused by visible light.a


Reduce exposure to light if stinging and/or burning occurs.a


Dermatologic Reactions

Following photoactivation with blue light, reddening, swelling, and scaling of treated actinic keratoses and surrounding skin may occur.a


Lesion changes usually resolve completely within 4 weeks after treatment.a


Delay in Receiving Blue Light Treatment

Patients should contact clinician if they cannot return for blue light treatment 14–18 hours after application of solution.a


Patients should continue to avoid exposure of photosensitized lesions to sunlight or prolonged or intense light for ≥40 hours after solution application.a


Specific Populations


Pregnancy

Category C.a


Lactation

Not known whether aminolevulinic acid is distributed into milk; use caution.a


Common Adverse Effects


Transient local stinging and/or burning, itching, erythema, edema, scaling/crusting,a itching,1 hypopigmentation/hyperpigmentaion,a erosion,a skin disorder (unspecified),a wheal/flare,a vesiculation.a a


Interactions for Levulan


No formal drug interaction studies performed.a No drug-specific interactions noted during controlled clinical trials.a


Other Known Photosensitizing Agents


Potential pharmacologic interaction (increased photosensitivity reaction) with other known photosensitizing agents (e.g., griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, tetracyclines).a


Levulan Pharmacokinetics


Absorption


Bioavailability


50-60% after a 128-mg oral dose of aminolevulinic acid hydrochloride (equivalent to 100 mg of aminolevulinic acid).a


Distribution


Time to Peak Fluorescence


Peak fluorescence intensity for protoporphyrin IX (metabolite of aminolevulinic acid) reached at approximately 11 or 12 hours in actinic keratoses or perilesional skin, respectively.a


Elimination


Half-life


0.83 or 0.7 hours with a 128-mg aminolevulinic acid hydrochloride IV or oral dose, respectively.a


Mean fluorescence half-life of 30 or 28 hours in lesions or perilesional skin, respectively.a


Stability


Storage


Topical


Solution

20–25°C; excursions permitted to 15–30°C.a Discard reconstituted solution 2 hours after mixing.a


ActionsActions



  • Metabolism of aminolevulinic acid is first step in synthesis of heme,2 which is formed when iron (under action of ferrochelatase) is incorporated into protoporphyrin IX.2




  • Synthesis of endogenous aminolevulinic acid (ALA) tightly controlled by feedback inhibition of ALA synthetase, presumably by intracellular heme levels.a 2




  • Following topical application of aminolevulinic acid, it is converted into protoporphyrin IX (a photosensitizer), which accumulates in skin due to limited capacity of ferrochelatase to convert protoporphyrin IX into heme.a 2 6




  • When exposed to light of appropriate wavelength and energy, accumulated protoporphyrin IX produces a photodynamic reaction.a 3 5 6




  • Tissue-specific phototoxic effects result from generation of cytotoxic singlet oxygen atoms, which form superoxide and hydroxyl radicals.1 2 3 4 5 6



Advice to Patients



  • Aminolevulinic acid hydrochloride topical solution is not meant for application by patient.a Only qualified health professionals should apply drug.a




  • Importance of advising patient to keep lesions dry and out of bright light following application of the topical solution.a




  • Importance of informing patient of possible transient stinging and/or burning at treated lesion sites if exposed to bright light following topical solution application;a patient should reduce exposure to light if this occurs.a Importance of patient wearing light-protective clothing, such as a wide-brimmed hat or similar head covering of light-opaque material, before going into sunlight following topical solution application.a Importance of informing patient that sunscreens will not protect against photosensitivity reactions caused by visible light.a Importance of patient limiting exposure to bright indoor light following topical solution application.a




  • Importance of informing patient that transient tingling, stinging, prickling, and/or burning may occur at target lesion sites during period of blue light photoactivation.a




  • Importance of patient informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.a




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.













Aminolevulinic Acid Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



For solution



354 mg (for preparation of a 20% solution)



Levulan Kerastick (1.5 mL alcohol 48% v/v and isopropyl alcohol diluent)



DUSA



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. DUSA Pharmaceuticals, Inc. Levulan (aminolevulinic acid hydrochloride) topical solution prescribing information. Wilmington, MA; 1999 Dec.



2. Peng Q, Warloe T, Berg K et al. 5-Aminolevulinic acid-based photodynamic therapy. Cancer. 1997; 79:2282-2308. [IDIS 388777] [PubMed 9191516]



3. Stender IM, Wulf HC. Photodynamic therapy with 5-aminolevulinic acid in the treatment of actinic cheilitis. Br J Dermatol. 1996; 135:454-6. [IDIS 373292] [PubMed 8949443]



4. Jeffes EW, McCullough JL, Weinstein GD et al. Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. Arch Dermatol. 1997; 133:727-32. [IDIS 388720] [PubMed 9197826]



5. Fritsch C, Goerz G, Ruzicka T. Photodynamic therapy in dermatology. Arch Dermatol. 1998; 134:207-14. [PubMed 9487213]



6. Fritsch C, Lang K, Neuse W et al. Photodynamic diagnosis and therapy in dermatology. Skin Pharmacol Appl Skin Physiol. 1998; 11:358-73. [PubMed 10343206]



7. Manufacturer’s comments (personal observations).



a. DUSA Pharmaceuticals, Inc. Levulan (aminolevulinic acid hydrochloride) topical solution prescribing information. Wilmington, MA; revision F. Undated.



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tetracycline (class) Oral, Parenteral



Class Name: tetracycline (CLASS) (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Adoxa

  • Adoxa CK

  • Adoxa Pak

  • Adoxa TT

  • Brodspec

  • Cleeravue-M

  • Declomycin

  • Doryx

  • Dynacin

  • Minocin

  • Myrac

  • Periostat

  • Sumycin

  • Tetracon

  • Vibramycin Calcium

In Canada


  • Novo-Tetra Suspension

Available Dosage Forms:


  • Tablet

  • Powder for Suspension

  • Capsule

  • Capsule, Extended Release

  • Tablet, Delayed Release

  • Capsule, Delayed Release

  • Syrup

  • Tablet, Extended Release

  • Suspension

Uses For This Medicine


Tetracyclines are used to treat infections and to help control acne. Demeclocycline, doxycycline, and minocycline also may be used for other problems as determined by your doctor. Tetracyclines will not work for colds, flu, or other virus infections.


Tetracyclines are available only with your doctor's prescription.


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


  • Gonococcal arthritis

  • Leprosy (for minocycline)

  • Lyme disease (for doxycycline and tetracycline)

  • Malaria treatment (for doxycycline and tetracycline)

  • Nocardiosis (a type of bacterial infection) (for doxycycline and minocycline)

  • Ocular rosacea (a type of eye infection) (for doxycycline and tetracycline)

  • Pneumothorax (a pocket of air in the space surrounding the lungs) (for doxycycline and tetracycline)

  • Rheumatoid arthritis (for minocycline)

  • Shigellosis (a type of intestinal infection) (for doxycycline and tetracycline)

  • Syndrome of inappropriate antidiuretic hormone (SIADH) (for demeclocycline)

For patients taking this medicine for SIADH:


  • Some doctors may prescribe demeclocycline for certain patients who retain (keep) more body water than usual. Although demeclocycline works like a diuretic (water pill) in these patients, it will not work that way in other patients who may need a diuretic.

Before Using This Medicine


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Tetracyclines may cause permanent discoloration of teeth and slow down the growth of bones. These medicines should not be given to children 8 years of age and younger unless directed by the child's doctor.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tetracyclines in the elderly with use in other age groups.


Pregnancy


Use is not recommended during the last half of pregnancy. If tetracyclines are taken during that time, they may cause the unborn infant's teeth to become discolored and may slow down the growth of the infant's teeth and bones. In addition, liver problems may occur in pregnant women, especially those receiving high doses by injection into a vein.


Breast Feeding


Use is not recommended since tetracyclines pass into breast milk. They may cause the nursing baby's teeth to become discolored and may slow down the growth of the baby's teeth and bones. They may also increase the sensitivity of nursing babies' skin to sunlight and cause fungus infections of the mouth and vagina. In addition, minocycline may cause dizziness, light-headedness, or unsteadiness in nursing babies.


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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Acitretin

Using medicines in this class 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.


  • Atazanavir

  • Digoxin

  • Isotretinoin

  • Methotrexate

  • Tretinoin

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Diabetes insipidus (water diabetes)—Demeclocycline may make the condition worse.

  • Kidney disease (does not apply to doxycycline or minocycline)—Patients with kidney disease may have an increased chance of side effects.

  • Liver disease—Patients with liver disease may have an increased chance of side effects if they use doxycycline or minocycline.

Proper Use of This Medicine


Do not give tetracyclines to infants or children 8 years of age and younger unless directed by your doctor. Tetracyclines may cause permanently discolored teeth and other problems in patients in these age groups.


Tetracyclines should be taken with a full glass (8 ounces) of water to prevent irritation of the esophagus (tube between the throat and stomach) or stomach. In addition, most tetracyclines (except doxycycline and minocycline) are best taken on an empty stomach (either 1 hour before or 2 hours after meals). However, if this medicine upsets your stomach, your doctor may want you to take it with food.


Do not take milk, milk formulas, or other dairy products within 1 to 2 hours of the time you take tetracyclines (except doxycycline and minocycline) by mouth. They may keep this medicine from working properly.


If this medicine has changed color or tastes or looks different, has become outdated (old), or has been stored incorrectly (too warm or too damp area or place), do not use it. To do so may cause serious side effects. Throw away the medicine. If you have any questions about this, check with your health care professional.


For patients taking the oral liquid form of this medicine:


  • Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

  • Do not use after the expiration date on the label since the medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

For patients taking doxycycline or minocycline:


  • These medicines may be taken with food or milk if they upset your stomach.

  • Swallow the capsule (with enteric-coated pellets) form of doxycycline whole. Do not break or crush it.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.


This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.


Dosing


The dose medicines in this class 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 these medicines. 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 demeclocycline

  • For oral dosage form (tablets):
    • For bacterial or protozoal infections:
      • Adults and teenagers—150 milligrams (mg) every six hours; or 300 mg every twelve hours. Gonorrhea is treated with 600 mg on the first day, then 300 mg every twelve hours for four days.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 1.65 to 3.3 mg per kilogram (kg) (0.8 to 1.5 mg per pound) of body weight every six hours; or 3.3 to 6.6 mg per kg (1.5 to 3 mg per pound) of body weight every twelve hours.

      • Infants and children 8 years of age and younger—Tetracyclines usually are not used in young children because tetracyclines can permanently stain teeth.



  • For doxycycline

  • For oral dosage forms (capsules, suspension, and tablets):
    • For bacterial or protozoal infections:
      • Adults and children older than 8 years of age who weigh more than 45 kilograms (kg) (99 pounds)—100 milligrams (mg) every twelve hours the first day, then 100 mg once a day or 50 to 100 mg every twelve hours.

      • Children older than 8 years of age who weigh 45 kg (99 pounds) or less—Dose is based on body weight. The usual dose is 2.2 mg per kg (1 mg per pound) of body weight two times a day on the first day, then 2.2 to 4.4 mg per kg (1 to 2 mg per pound) of body weight once a day or 1.1 to 2.2 mg per kg (0.5 to 1 mg per pound) of body weight twice a day.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.


    • For the prevention of malaria:
      • Adults and teenagers—100 mg once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for four weeks after you leave the malarious area.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 2 mg per kg (0.9 mg per pound) of body weight once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for four weeks after you leave the malarious area.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



  • For injection dosage form:
    • For bacterial or protozoal infections:
      • Adults and children older than 8 years of age who weigh more than 45 kg of body weight (99 pounds)—200 mg injected slowly into a vein once a day; or 100 mg injected slowly into a vein every twelve hours the first day, then 100 to 200 mg injected slowly into a vein once a day or 50 to 100 mg injected slowly into a vein every twelve hours.

      • Children older than 8 years of age who weigh 45 kg of body weight (99 pounds) or less—Dose is based on body weight. The usual dose is 4.4 mg per kg (2 mg per pound) of body weight injected slowly into a vein once a day; or 2.2 mg per kg (1 mg per pound) of body weight injected slowly into a vein every twelve hours the first day, then 2.2 to 4.4 mg per kg (1 to 2 mg per pound) of body weight once a day, or 1.1 to 2.2 per kg (0.5 to 1 mg per pound) of body weight every twelve hours.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



  • For minocycline

  • For oral dosage forms (capsules and suspension):
    • For bacterial or protozoal infections:
      • Adults and teenagers—200 milligrams (mg) at first, then 100 mg every twelve hours; or 100 to 200 mg at first, then 50 mg every six hours.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 4 mg per kilogram (kg) (1.8 mg per pound) of body weight at first, then 2 mg per kg (0.9 mg per pound) of body weight every twelve hours.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



  • For injection dosage form:
    • For bacterial or protozoal infections:
      • Adults and teenagers—200 mg at first, then 100 mg every twelve hours, injected slowly into a vein.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 4 mg per kg (1.8 mg per pound) of body weight at first, then 2 mg per kg (0.9 mg per pound) of body weight every twelve hours, injected slowly into a vein.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



  • For oxytetracycline

  • For oral dosage form (capsules):
    • For bacterial or protozoal infections:
      • Adults and teenagers—250 to 500 milligrams (mg) every six hours.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 6.25 to 12.5 mg per kilogram (kg) (2.8 to 5.7 mg per pound) of body weight every six hours.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



  • For injection dosage form:
    • For bacterial or protozoal infections:
      • Adults and teenagers—100 mg every eight hours; or 150 mg every twelve hours; or 250 mg once a day, injected into a muscle.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 5 to 8.3 mg per kg (2.3 to 3.8 mg per pound) of body weight every eight hours; or 7.5 to 12.5 mg per kg (3.4 to 5.7 mg per pound) of body weight every twelve hours, injected into a muscle.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



  • For tetracycline

  • For oral dosage forms (capsules and suspension):
    • For bacterial or protozoal infections:
      • Adults and teenagers—250 to 500 milligrams (mg) every six hours; or 500 mg to 1 gram every twelve hours. Gonorrhea is treated with 1.5 grams as the first dose, then 500 mg every six hours for four days.

      • Children older than 8 years of age—Dose is based on body weight. The usual dose is 6.25 to 12.5 mg per kilogram (kg) (2.8 to 5.7 mg per pound) of body weight every six hours; or 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every twelve hours.

      • Infants and children 8 years of age and younger—Tetracyclines are usually not used in young children because tetracyclines can permanently stain teeth.



Missed Dose


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


Storage


Keep out of the reach of children.


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


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using This Medicine


If your symptoms do not improve within a few days (or a few weeks or months for acne patients), or if they become worse, check with your doctor.


Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking tetracyclines. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking tetracyclines. If you have any questions about this, check with your health care professional.


Before having surgery (including dental surgery) with a general anesthetic, tell the medical doctor or dentist in charge that you are taking a tetracycline. This does not apply to doxycycline, however.


Tetracyclines may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:


  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

  • Wear protective clothing, including a hat. Also, wear sunglasses.

  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.

  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.

  • Do not use a sunlamp or tanning bed or booth.

You may still be more sensitive to sunlight or sunlamps for 2 weeks to several months or more after stopping this medicine. If you have a severe reaction, check with your doctor.


For patients taking minocycline:


  • Minocycline may also cause some people to become dizzy, lightheaded, or unsteady. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Side Effects of This Medicine


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:


For all tetracyclinesMore common
  • Increased sensitivity of skin to sunlight (rare with minocycline)

Rare
  • Abdominal pain

  • bulging fontanel (soft spot on head) of infants

  • headache

  • loss of appetite

  • nausea and vomiting

  • visual changes

  • yellowing skin

For demeclocycline onlyLess common
  • Greatly increased frequency of urination or amount of urine

  • increased thirst

  • unusual tiredness or weakness

For minocycline onlyLess common
  • Pigmentation (darker color or discoloration) of skin and mucous membranes

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:


For all tetracyclinesMore common
  • Cramps or burning of the stomach

  • diarrhea

Less common
  • Itching of the rectal or genital (sex organ) areas

  • sore mouth or tongue

For minocycline onlyMore common
  • Dizziness, light-headedness, or unsteadiness

In some patients tetracyclines may cause the tongue to become darkened or discolored. This effect is only temporary and will go away when you stop taking this medicine.


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.



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