Thursday 31 December 2009

oxiconazole Topical


ox-i-KON-a-zole


Commonly used brand name(s)

In the U.S.


  • Oxistat

Available Dosage Forms:


  • Lotion

  • Cream

Therapeutic Class: Antifungal


Chemical Class: Imidazole


Uses For oxiconazole


Oxiconazole is used to treat infections caused by a fungus. It works by killing the fungus or preventing its growth.


Oxiconazole is applied to the skin to treat:


  • ringworm of the body (tinea corporis);

  • ringworm of the foot (tinea pedis; athlete's foot); and

  • ringworm of the groin (tinea cruris; jock itch).

  • ringworm of the trunk (tinea [pityriasis] versicolor)

Oxiconazole is available only with your doctor's prescription.


Before Using oxiconazole


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 oxiconazole, the following should be considered:


Allergies


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


Oxiconazole cream has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. However, ringworm rarely occurs in children below the age of 12.


Geriatric


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


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


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


Interactions with Food/Tobacco/Alcohol


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


Proper Use of oxiconazole


Apply enough oxiconazole to cover the affected and surrounding skin areas and rub in gently.


Keep oxiconazole away from the eyes, nose, mouth, and other mucous membranes. Also, do not use it in the vagina. Wash hands after application to affected areas.


To help clear up your infection completely, it is very important that you keep using oxiconazole for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using oxiconazole every day for several weeks or more. If you stop using oxiconazole too soon, your symptoms may return. Do not miss any doses .


Dosing


The dose of oxiconazole 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 oxiconazole. 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 cream or lotion dosage form:
    • For ringworm of the body or groin:
      • Adults and children—Use 1 or 2 times a day for at least 2 weeks.


    • For athlete's foot:
      • Adults and children—Use 1 or 2 times a day for at least 4 weeks.


    • For ringworm of the trunk:
      • Adults and children—Use once a day for at least 2 weeks.



Missed Dose


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


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using oxiconazole


If your skin problem does not improve within 2 to 4 weeks, or if it becomes worse, check with your doctor.


To help clear up your infection completely and to help make sure it does not return, good health habits are also required. The following measures will help reduce chafing and irritation and will also help keep the area cool and dry.


  • For patient using oxiconazole for ringworm of the groin:
    • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.

    • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder on the skin. It is best to use the powder between the times you use oxiconazole.


  • For patients using oxiconazole for ringworm of the foot:
    • Carefully dry the feet, especially between the toes, after bathing.

    • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if the feet sweat a lot.

    • Wear sandals or other well-ventilated shoes.

    • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder between the toes, on the feet, and in socks and shoes 1 or 2 times a day. It is best to use the powder between the times you use oxiconazole.


If you have any questions about these measures, check with your health care professional.


oxiconazole Side Effects


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


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


Less common
  • Burning

  • itching

Rare
  • Blistering, crusting, dryness, or flaking of skin

  • scaling

  • severe redness, soreness, or swelling of skin

  • burning, itching, and pain in hairy areas

  • pus at root of hair

  • skin irritation

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


Less common or rare
  • Pain

  • skin rash

  • tingling

  • stinging

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: oxiconazole 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.


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More oxiconazole Topical resources


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


  • oxiconazole topical Concise Consumer Information (Cerner Multum)

  • Oxistat Prescribing Information (FDA)

  • Oxistat Monograph (AHFS DI)

  • Oxistat Cream MedFacts Consumer Leaflet (Wolters Kluwer)



Compare oxiconazole Topical with other medications


  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor

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Thursday 17 December 2009

Calcipotriol Rafarm




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Wednesday 16 December 2009

Asasantin Retard




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Friday 11 December 2009

Ketolef




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Ketoconazole

Ketoconazole is reported as an ingredient of Ketolef in the following countries:


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Wednesday 9 December 2009

Hydrotalcit-CT




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Hydrotalcite

Hydrotalcite is reported as an ingredient of Hydrotalcit-CT in the following countries:


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Sunday 6 December 2009

Virulax Heumann




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Saturday 5 December 2009

CardiASK




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Friday 4 December 2009

Isosorbide Mononitrato EG




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Isosorbide Mononitrate

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Nokof




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Thursday 3 December 2009

Artrodar




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Diacerein

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Wednesday 2 December 2009

Frineg




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Friday 27 November 2009

Dapson ratiopharm




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Thursday 19 November 2009

Lincomycin & Buquinolate




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Tuesday 10 November 2009

Monoplus




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Saturday 7 November 2009

Pepimidol




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Zyrtec


Zyrtec is a brand name of cetirizine, approved by the FDA in the following formulation(s):


ZYRTEC (cetirizine hydrochloride - syrup; oral)



  • Manufacturer: MCNEIL CONSUMER

    Approval date: September 27, 1996

    Strength(s): 5MG/5ML [RLD][AA]

Has a generic version of Zyrtec been approved?


Yes. The following products are equivalent to Zyrtec:


cetirizine hydrochloride syrup; oral



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Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zyrtec. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Zyrtec.

See also...

  • Zyrtec Consumer Information (Drugs.com)
  • Zyrtec Consumer Information (Wolters Kluwer)
  • Zyrtec Chewable Tablets Consumer Information (Wolters Kluwer)
  • Zyrtec Syrup Consumer Information (Wolters Kluwer)
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  • ZyrTEC Liquid Gels Consumer Information (Cerner Multum)
  • Zyrtec Consumer Information (Cerner Multum)
  • Zyrtec AHFS DI Monographs (ASHP)
  • Cetirizine Consumer Information (Drugs.com)
  • Cetirizine Consumer Information (Wolters Kluwer)
  • Cetirizine Chewable Tablets Consumer Information (Wolters Kluwer)
  • Cetirizine Syrup Consumer Information (Wolters Kluwer)
  • Indoor/Outdoor Allergy Relief Consumer Information (Cerner Multum)
  • Cetirizine Consumer Information (Cerner Multum)
  • Cetirizine Hydrochloride AHFS DI Monographs (ASHP)

Thursday 5 November 2009

Tipuric




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Wednesday 4 November 2009

Lisipril-D




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Monday 26 October 2009

Aprapharm




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Saturday 24 October 2009

Bactrim



Generic Name: sulfamethoxazole/trimethoprim (Oral route)


sul-fa-meth-OX-a-zole, trye-METH-oh-prim


Commonly used brand name(s)

In the U.S.


  • Bactrim

  • Bactrim DS

  • Septra

  • Septra DS

  • Sulfatrim

  • Sulfatrim Pediatric

In Canada


  • Apo-Sulfatrim

  • Novo-Trimel

  • Nu-Cotrimox

  • Septa Pediatric

  • Septra Pediatric Suspension

Available Dosage Forms:


  • Tablet

  • Suspension

Therapeutic Class: Sulfonamide Combination


Pharmacologic Class: Folic Acid Antagonist


Chemical Class: Sulfonamide


Uses For Bactrim


Sulfamethoxazole and trimethoprim combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery). This medicine is also used to prevent or treat Pneumocystis carinii pneumonia (PCP), a very serious kind of pneumonia. This type of pneumonia occurs more commonly in patients whose immune systems are not working normally, such as cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).


Sulfamethoxazole and trimethoprim combination is an antibiotic. It works by eliminating the bacteria that cause many kinds of infections. This medicine will not work for colds, flu, or other virus infections.


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


Before Using Bactrim


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


Allergies


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


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in children and infants 2 months of age and older. Because of the toxicity of the combination of sulfamethoxazole and trimethoprim, use in infants younger than 2 months of age is not recommended.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfamethoxazole and trimethoprim combination in the elderly. However, elderly patients are more likely to have a folate deficiency, age-related kidney or liver problems, and may be more likely to experience unwanted side effects (e.g., severe skin rash, increased potassium in the body, or problems with blood clotting or the immune system). There may be a dose adjustment for elderly patients receiving sulfamethoxazole and trimethoprim combination.


Pregnancy








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

Breast Feeding


Sulfamethoxazole

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


Trimethoprim

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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.


  • Bepridil

  • Cisapride

  • Dofetilide

  • Levomethadyl

  • Mesoridazine

  • Pimozide

  • Terfenadine

  • Thioridazine

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

  • Acenocoumarol

  • Ajmaline

  • Amiodarone

  • Amisulpride

  • Amitriptyline

  • Amoxapine

  • Aprindine

  • Arsenic Trioxide

  • Astemizole

  • Azimilide

  • Bretylium

  • Chloral Hydrate

  • Chloroquine

  • Chlorpromazine

  • Clarithromycin

  • Desipramine

  • Dibenzepin

  • Disopyramide

  • Dolasetron

  • Doxepin

  • Droperidol

  • Eltrombopag

  • Enflurane

  • Erythromycin

  • Flecainide

  • Fluconazole

  • Fluoxetine

  • Foscarnet

  • Gemifloxacin

  • Halofantrine

  • Haloperidol

  • Halothane

  • Hydroquinidine

  • Ibutilide

  • Imipramine

  • Isoflurane

  • Isradipine

  • Lidoflazine

  • Lorcainide

  • Mefloquine

  • Methotrexate

  • Nortriptyline

  • Octreotide

  • Pentamidine

  • Pirmenol

  • Prajmaline

  • Probucol

  • Procainamide

  • Prochlorperazine

  • Propafenone

  • Pyrimethamine

  • Quetiapine

  • Quinidine

  • Risperidone

  • Sematilide

  • Sertindole

  • Sotalol

  • Spiramycin

  • Sultopride

  • Tedisamil

  • Telithromycin

  • Trifluoperazine

  • Trimipramine

  • Vasopressin

  • Warfarin

  • 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.


  • Acetohexamide

  • Anisindione

  • Chlorpropamide

  • Didanosine

  • Digoxin

  • Enalaprilat

  • Enalapril Maleate

  • Fosphenytoin

  • Glipizide

  • Glyburide

  • Phenytoin

  • Quinapril

  • Repaglinide

  • Rifabutin

  • Rosiglitazone

  • Tolazamide

  • Tolbutamide

Interactions with Food/Tobacco/Alcohol


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


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


  • Ethanol

Other Medical Problems


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


  • Alcohol abuse, history of or

  • Folate (vitamin B9) deficiency or

  • HIV or AIDS or

  • Kidney disease or

  • Liver disease or

  • Malabsorption syndrome (difficulty of absorbing food in the body) or

  • Malnutrition state (nutrition disorder)—Use with caution. May have an increased chance of serious side effects.

  • Anemia, megaloblastic (caused by not enough folic acid) or

  • Drug-induced thrombocytopenia (low platelets in the blood) after using this medicine or

  • Kidney disease, severe or

  • Liver disease, severe—Should not be used in patients with these conditions.

  • Asthma or

  • Diabetes or

  • Hyperkalemia (high potassium in the blood) or

  • Porphyria (enzyme problem) or

  • Severe allergies or

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

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (blood disorder) in patients with this condition.

  • Streptococcal infection (group A β-hemolytic)—Sulfonamides should not be used in patients with this condition.

Proper Use of trimethoprim and sulfamethoxazole

This section provides information on the proper use of a number of products that contain trimethoprim and sulfamethoxazole. It may not be specific to Bactrim. Please read with care.


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


Sulfamethoxazole and trimethoprim combination is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects. .


For patients taking the oral liquid, 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.


To help clear up your infection completely, keep using 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.


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 oral dosage forms (liquid or tablets):
    • For treatment of bacterial infections:
      • Adults and children weighing 40 kilograms (kg) or more—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours. Your doctor may adjust this dose if needed.

      • Children and infants 2 months of age and older, and weighing up to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 40 milligrams (mg) of sulfamethoxazole and 8 milligrams (mg) of trimethoprim per kilogram of body weight, given in two divided doses every 12 hours.

      • Infants younger than 2 months of age—Use is not recommended.


    • For chronic bronchitis:
      • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours. Your doctor may adjust this dose if needed.

      • Children and infants 2 months of age and older—Use and dose must be determined by your doctor.

      • Infants younger than 2 months of age—Use is not recommended.


    • For treatment of Pneumocystis carinii pneumonia (PCP):
      • Adults and children 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 75 to 100 milligrams (mg) of sulfamethoxazole and 15 to 20 milligrams (mg) of trimethoprim per kilogram of body weight each day, given in equally divided doses every 6 hours.

      • Infants younger than 2 months of age—Use is not recommended.


    • For prevention of Pneumocystis carinii pneumonia (PCP):
      • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim once a day. Your doctor may adjust this dose if needed.

      • Children and infants 2 months of age and older—Dose is based on body size and must be determined by your doctor. The dose is 750 mg of sulfamethoxazole and 150 mg of trimethoprim per square meter (m[2]) of body surface each day. This is given in equally divided doses two times a day for 3 days a week on consecutive days (e.g., Monday, Tuesday, Wednesday).

      • Infants younger than 2 months of age—Use is not recommended.


    • For traveler's diarrhea:
      • Adults—800 milligrams (mg) of sulfamethoxazole and 160 mg of trimethoprim every 12 hours. Your doctor may adjust this dose if needed.

      • Children and infants 2 months of age and older—Use and dose must be determined by your doctor.

      • Infants younger than 2 months of age—Use is not recommended.



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


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Bactrim


It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


Very rarely, this medicine has caused severe side effects. If you or your child start to have a skin rash, or if you think you are having a severe skin reaction, stop taking this medicine and call your doctor right away. Symptoms of a severe reaction may include a skin rash, skin color that is very pale or yellow, or skin with purple spots, along with a sore throat, fever, muscle pain, cough, and trouble with breathing.


This medicine, especially if you are receiving high doses or for a long period of time, may lower the number of platelets in your body, which are necessary for proper blood clotting. Because of this, you may bleed or get infections more easily. Talk with your doctor if you have concerns about this.


This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.


Check with your doctor right away if you or your child have abdominal or stomach cramps; bloating; watery and severe diarrhea, which may also be bloody; nausea or vomiting; or unusual tiredness or weakness. These may be symptoms of a serious intestinal infection.


This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; shortness of breath; or chest pain after you use the medicine.


Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.


Patients receiving anticonvulsant therapy (medicines to prevent seizures) may be at risk for a folate (vitamin B9) deficiency, which may increase the risk for side effects. Talk with your doctor if you have concerns about this.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Bactrim 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:


Rare
  • Abdominal or stomach pain

  • black, tarry stools

  • blistering, peeling, or loosening of the skin

  • changes in skin color

  • chest pain

  • chills

  • cough or hoarseness

  • dark urine

  • diarrhea

  • dizziness

  • fever with or without chills

  • general feeling of tiredness or weakness

  • headache

  • itching

  • joint or muscle pain

  • light-colored stools

  • loss of appetite

  • lower back or side pain

  • nausea

  • pain, tenderness, or swelling of the foot or leg

  • painful or difficult urination

  • pale skin

  • rash

  • red irritated eyes

  • red skin lesions, often with a purple center

  • shortness of breath

  • sore throat

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

  • swollen or painful glands

  • tightness in the chest

  • unpleasant breath odor

  • unusual bleeding or bruising

  • vomiting of blood

  • wheezing

  • yellow eyes or skin

Incidence not known
  • Abdominal or stomach tenderness

  • back, leg, or stomach pains

  • bleeding gums

  • blindness or vision changes

  • blisters, hives, or itching

  • bloating

  • blood in the urine or stools

  • bluish-colored lips, fingernails, or palms

  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

  • burning of the face or mouth

  • chest pain

  • cloudy urine

  • confusion

  • constipation

  • continuing ringing or buzzing or other unexplained noise in the ears

  • convulsions

  • cracks in the skin

  • decreased frequency or amount of urine

  • diarrhea, watery and severe, which may also be bloody

  • difficulty with breathing

  • difficulty with swallowing

  • fainting spells

  • general body swelling

  • general feeling of discomfort or illness

  • hair loss

  • hearing loss

  • hives

  • increased blood pressure

  • increased thirst

  • indigestion

  • irregular heartbeat

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

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • loss of heat from the body

  • muscle or joint pain

  • nosebleeds

  • not able to pass urine

  • numbness or tingling in the hands, feet, or lips

  • pain or burning while urinating

  • pinpoint red spots on the skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • raised red swellings on the skin, the buttocks, legs, or ankles

  • redness of the white part of the eyes

  • redness, swelling, or soreness of the tongue

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

  • soreness of the muscles

  • stiff neck or back

  • swelling of the face, hands, legs, and feet

  • unsteadiness, trembling, or other problems with muscle control or coordination

  • unusual weight loss

  • weakness in the hands or feet

  • weakness or heaviness of the legs

  • weight gain

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
  • Passing of gas

Incidence not known
  • Discouragement

  • feeling of constant movement of self or surroundings

  • feeling sad or empty

  • increased sensitivity of skin to sunlight

  • irritability

  • lack of feeling or emotion

  • loss of interest or pleasure

  • nervousness

  • redness or other discoloration of the skin

  • seeing, hearing, or feeling things that are not there

  • sensation of spinning

  • severe sunburn

  • sleeplessness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

  • uncaring

  • weight loss

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: Bactrim 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 Bactrim resources


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


  • Bactrim Prescribing Information (FDA)

  • Bactrim Consumer Overview

  • Bactrim MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bactrim DS Prescribing Information (FDA)

  • Cotrim Consumer Overview

  • Septra Consumer Overview

  • Septra Prescribing Information (FDA)

  • Sulfatrim Suspension MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Bactrim with other medications


  • Acne
  • Bacterial Infection
  • Bacterial Skin Infection
  • Bronchitis
  • Diverticulitis
  • Epiglottitis
  • Granuloma Inguinale
  • Infection Prophylaxis
  • Kidney Infections
  • Melioidosis
  • Meningitis
  • Nocardiosis
  • Otitis Media
  • Pneumocystis Pneumonia
  • Pneumocystis Pneumonia Prophylaxis
  • Pneumonia
  • Prevention of Bladder infection
  • Prostatitis
  • Shigellosis
  • Sinusitis
  • Toxoplasmosis
  • Toxoplasmosis, Prophylaxis
  • Traveler's Diarrhea
  • Upper Respiratory Tract Infection
  • Urinary Tract Infection

Thursday 22 October 2009

Capozide




In the US, Capozide (captopril/hydrochlorothiazide systemic) is a member of the drug class antihypertensive combinations and is used to treat Heart Failure and High Blood Pressure.

US matches:

  • Capozide

  • Capozide 25/15

  • Capozide 25/25

  • Capozide 50/15

  • Capozide 50/25

UK matches:

  • Capozide LS Tablets
  • Capozide Tablets (SPC)

Ingredient matches for Capozide



Captopril

Captopril is reported as an ingredient of Capozide in the following countries:


  • Austria

  • Bahrain

  • Denmark

  • Georgia

  • Luxembourg

  • Oman

  • Peru

  • South Africa

  • Switzerland

  • United Kingdom

  • United States

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Capozide in the following countries:


  • Austria

  • Bahrain

  • Denmark

  • Luxembourg

  • Oman

  • South Africa

  • Switzerland

  • United Kingdom

  • United States

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

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

Monday 19 October 2009

Neo Kaolana




Neo Kaolana may be available in the countries listed below.


Ingredient matches for Neo Kaolana



Kaolin

Kaolin is reported as an ingredient of Neo Kaolana in the following countries:


  • Indonesia

Pectin

Pectin is reported as an ingredient of Neo Kaolana in the following countries:


  • Indonesia

International Drug Name Search

Thursday 15 October 2009

Avalox




Avalox may be available in the countries listed below.


Ingredient matches for Avalox



Moxifloxacin

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


  • Bahrain

  • Brazil

  • Georgia

  • Germany

  • Ireland

  • Italy

  • Malta

  • Oman

  • Switzerland

International Drug Name Search

Wednesday 14 October 2009

Aviane




In the US, Aviane (ethinyl estradiol/levonorgestrel systemic) is a member of the drug class contraceptives and is used to treat Abnormal Uterine Bleeding, Birth Control, Endometriosis, Gonadotropin Inhibition, Ovarian Cysts and Polycystic Ovary Syndrome.

US matches:

  • Aviane

  • Aviane 28

Ingredient matches for Aviane



Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Aviane in the following countries:


  • Canada

  • United States

Levonorgestrel

Levonorgestrel is reported as an ingredient of Aviane in the following countries:


  • Canada

  • United States

International Drug Name Search

Tuesday 13 October 2009

Luteum




Luteum may be available in the countries listed below.


Ingredient matches for Luteum



Progesterone

Progesterone is reported as an ingredient of Luteum in the following countries:


  • Japan

International Drug Name Search

Articox




Articox may be available in the countries listed below.


Ingredient matches for Articox



Celecoxib

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


  • Peru

International Drug Name Search

Saturday 10 October 2009

Flupentixol Hydrochloride




Flupentixol Hydrochloride may be available in the countries listed below.


Ingredient matches for Flupentixol Hydrochloride



Flupentixol

Flupentixol Hydrochloride (BANM) is also known as Flupentixol (Rec.INN)

International Drug Name Search

Glossary

BANMBritish Approved Name (Modified)
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

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

Friday 9 October 2009

Ofloxacine PCH




Ofloxacine PCH may be available in the countries listed below.


Ingredient matches for Ofloxacine PCH



Ofloxacin

Ofloxacin is reported as an ingredient of Ofloxacine PCH in the following countries:


  • Netherlands

International Drug Name Search

Sunday 4 October 2009

Prandin




In the US, Prandin (repaglinide systemic) is a member of the drug class meglitinides and is used to treat Diabetes, Type 2.

US matches:

  • Prandin

UK matches:

  • Prandin 0.5 mg, 1 mg, 2 mg Tablets
  • Prandin 0.5mg, 1mg and 2 mg
  • Prandin 0.5mg, 1mg, 2mg Tablets (SPC)

Ingredient matches for Prandin



Repaglinide

Repaglinide is reported as an ingredient of Prandin in the following countries:


  • Luxembourg

  • Mexico

  • Spain

  • United Kingdom

  • United States

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

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

Tensilon




In the US, Tensilon (edrophonium systemic) is a member of the drug class cholinergic muscle stimulants and is used to treat Reversal of Nondepolarizing Muscle Relaxants.

US matches:

  • Tensilon

Ingredient matches for Tensilon



Edrophonium

Edrophonium Chloride is reported as an ingredient of Tensilon in the following countries:


  • United States

International Drug Name Search

Wednesday 23 September 2009

Atren




Atren may be available in the countries listed below.


Ingredient matches for Atren



Naproxen

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


  • Turkey

International Drug Name Search

Tuesday 15 September 2009

Adenoject




Adenoject may be available in the countries listed below.


Ingredient matches for Adenoject



Adenosine

Adenosine is reported as an ingredient of Adenoject in the following countries:


  • India

International Drug Name Search

Banminth plus




Banminth plus may be available in the countries listed below.


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

Ingredient matches for Banminth plus



Epsiprantel

Epsiprantel is reported as an ingredient of Banminth plus in the following countries:


  • Austria

  • Germany

  • Switzerland

Pyrantel

Pyrantel is reported as an ingredient of Banminth plus in the following countries:


  • Austria

  • Switzerland

Pyrantel embonate (a derivative of Pyrantel) is reported as an ingredient of Banminth plus in the following countries:


  • Germany

International Drug Name Search

Saturday 12 September 2009

Nu-Naprox




Nu-Naprox may be available in the countries listed below.


Ingredient matches for Nu-Naprox



Naproxen

Naproxen is reported as an ingredient of Nu-Naprox in the following countries:


  • Canada

International Drug Name Search

Thursday 10 September 2009

Anthelpor




Anthelpor may be available in the countries listed below.


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

Ingredient matches for Anthelpor



Levamisole

Levamisole is reported as an ingredient of Anthelpor in the following countries:


  • United Kingdom

International Drug Name Search

Wednesday 9 September 2009

Flagyl Vaginal




Flagyl Vaginal may be available in the countries listed below.


Ingredient matches for Flagyl Vaginal



Metronidazole

Metronidazole is reported as an ingredient of Flagyl Vaginal in the following countries:


  • Spain

International Drug Name Search

Monday 7 September 2009

Loben




Loben may be available in the countries listed below.


Ingredient matches for Loben



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Loben in the following countries:


  • Greece

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Loben in the following countries:


  • Greece

International Drug Name Search

Monday 24 August 2009

Ardinex




Ardinex may be available in the countries listed below.


Ingredient matches for Ardinex



Codeine

Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Ardinex in the following countries:


  • Finland

  • Poland

  • Sweden

Ibuprofen

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


  • Finland

  • Poland

  • Sweden

International Drug Name Search

Quinace




Quinace may be available in the countries listed below.


Ingredient matches for Quinace



Quinapril

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


  • South Africa

International Drug Name Search

Etacin




Etacin may be available in the countries listed below.


Ingredient matches for Etacin



Ciprofloxacin

Ciprofloxacin is reported as an ingredient of Etacin in the following countries:


  • Indonesia

Ciprofloxacin lactate (a derivative of Ciprofloxacin) is reported as an ingredient of Etacin in the following countries:


  • Indonesia

International Drug Name Search

Sunday 23 August 2009

Unasyn


Unasyn is a brand name of ampicillin/sulbactam, approved by the FDA in the following formulation(s):


UNASYN (ampicillin sodium; sulbactam sodium - injectable; injection)



  • Manufacturer: PFIZER

    Approval date: December 31, 1986

    Strength(s): EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [RLD][AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [RLD][AP]


  • Manufacturer: PFIZER

    Approval date: December 10, 1993

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [RLD][AP]

Has a generic version of Unasyn been approved?


Yes. The following products are equivalent to Unasyn:


AMPICILLIN AND SULBACTAM (ampicillin sodium; sulbactam sodium injectable; injection)



  • Manufacturer: ACS DOBFAR

    Approval date: December 22, 2009

    Strength(s): EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: ACS DOBFAR

    Approval date: December 23, 2009

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP]


  • Manufacturer: AUROBINDO PHARMA

    Approval date: September 20, 2010

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: BAXTER HLTHCARE

    Approval date: March 19, 2002

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: BIONICHE PHARMA

    Approval date: June 29, 2007

    Strength(s): EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: HANFORD GC

    Approval date: November 25, 2005

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP]


  • Manufacturer: HANFORD GC

    Approval date: November 30, 2005

    Strength(s): EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: HOSPIRA INC

    Approval date: December 21, 2011

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: INSTITUTO BIOCHIMICO

    Approval date: November 29, 2005

    Strength(s): EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]


  • Manufacturer: INSTITUTO BIOCHIMICO

    Approval date: November 27, 2006

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP]


  • Manufacturer: SANDOZ

    Approval date: July 25, 2006

    Strength(s): EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP], EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Unasyn. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Unasyn.

See also...

  • Unasyn Consumer Information (Wolters Kluwer)
  • Unasyn Consumer Information (Cerner Multum)
  • Unasyn Advanced Consumer Information (Micromedex)
  • Ampicillin/Sulbactam Consumer Information (Wolters Kluwer)
  • Ampicillin and sulbactam Consumer Information (Cerner Multum)
  • Ampicillin and sulbactam Injection Advanced Consumer Information (Micromedex)
  • Ampicillin Sodium and Sulbactam Sodium AHFS DI Monographs (ASHP)

Saturday 22 August 2009

Stamonevrol




Stamonevrol may be available in the countries listed below.


Ingredient matches for Stamonevrol



Sulpiride

Sulpiride is reported as an ingredient of Stamonevrol in the following countries:


  • Greece

International Drug Name Search

Famotidin Alkaloid




Famotidin Alkaloid may be available in the countries listed below.


Ingredient matches for Famotidin Alkaloid



Famotidine

Famotidine is reported as an ingredient of Famotidin Alkaloid in the following countries:


  • Bulgaria

  • Serbia

International Drug Name Search

Vilbinitan




Vilbinitan may be available in the countries listed below.


Ingredient matches for Vilbinitan



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Vilbinitan in the following countries:


  • Slovakia

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Vilbinitan in the following countries:


  • Slovakia

International Drug Name Search

Friday 21 August 2009

Minurin Singad Pharma




Minurin Singad Pharma may be available in the countries listed below.


Ingredient matches for Minurin Singad Pharma



Desmopressin

Desmopressin acetate (a derivative of Desmopressin) is reported as an ingredient of Minurin Singad Pharma in the following countries:


  • Denmark

International Drug Name Search

Wednesday 19 August 2009

Zolpidex GMP




Zolpidex GMP may be available in the countries listed below.


Ingredient matches for Zolpidex GMP



Zolpidem

Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Zolpidex GMP in the following countries:


  • Venezuela

International Drug Name Search

Tuesday 18 August 2009

Antispasmin




Antispasmin may be available in the countries listed below.


Ingredient matches for Antispasmin



Oxyphenonium Bromide

Oxyphenonium Bromide is reported as an ingredient of Antispasmin in the following countries:


  • Georgia

International Drug Name Search

Sunday 9 August 2009

Desoximetasone Ointment




Desoximetasone

Ointment USP, 0.25%

For topical use only. Not for oral, ophthalmic, or intravaginal use.


Rx only



Desoximetasone Ointment Description


Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.


Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum.


The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-.


Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.


The structural formula is:




Desoximetasone Ointment - Clinical Pharmacology


Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.


The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.



Pharmacokinetics


The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.


Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.


Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.


Pharmacokinetic studies in men with Desoximetasone Ointment USP, 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 µg/mL) in 1 subject and 0.004 and 0.006 µg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces. Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.



Indications and Usage for Desoximetasone Ointment


Desoximetasone Ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.



Contraindications


Desoximetasone Ointment USP, 0.25% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.



Warnings


Keep out of reach of children.



Precautions



General


Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.


Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.


Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.


Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.


Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.



Local Adverse Reactions with Topical Corticosteroids


Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.



Allergic Contact Dermatitis with Topical Corticosteroids


Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.



Concomitant Skin Infections


Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Desoximetasone Ointment USP, 0.25% should be discontinued until the infection has been adequately treated.



Information for the Patient


Patients using topical corticosteroids should receive the following information and instructions:


  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

  2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.

  3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.

  4. Patients should report any signs of local adverse reactions, especially under occlusive dressings.

  5. Other corticosteroid-containing products should not be used withDesoximetasone Ointment USP, 0.25% without first consulting with the physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.



Laboratory Tests


The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:


 


 

Urinary free cortisol test

ACTH stimulation test



Carcinogenesis, Mutagenesis, and Impairment of Fertility


Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.


Desoximetasone was nonmutagenic in the Ames test.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.


Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of Desoximetasone Ointment USP, 0.25%.


There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Desoximetasone Ointment USP, 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.



Nursing Mothers


It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.



Pediatric Use


Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.


Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.


Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. Safety and effectiveness of Desoximetasone Ointment USP, 0.25% in pediatric patients below the age of 10 have not been established.



Adverse Reactions


The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:


Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.


In controlled clinical studies the incidence of adverse reactions was low (0.3%) for Desoximetasone Ointment USP, 0.25% and included mild burning sensation at the site of application.



Overdosage


Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).



Desoximetasone Ointment Dosage and Administration


Apply a thin film of Desoximetasone Ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.



How is Desoximetasone Ointment Supplied


Desoximetasone Ointment USP, 0.25% is supplied in 15 gram (NDC 51672-1262-1), 60 gram (NDC 51672-1262-3) and 100 gram (NDC 51672-1262-7) tubes.



Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]



Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: November, 2010


PK-6353-1

85



PRINCIPAL DISPLAY PANEL - 100 g Tube Carton


NDC 51672-1262-7


100 g


Desoximetasone

Ointment USP, 0.25%


FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.


Rx only


Keep this and all medications out of the reach of children.


TARO










DESOXIMETASONE 
desoximetasone  ointment










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51672-1262
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Desoximetasone (Desoximetasone)Desoximetasone2.5 mg  in 1 g








Inactive Ingredients
Ingredient NameStrength
coconut oil 
petrolatum 


















Product Characteristics
ColorWHITE (translucent)Score    
ShapeSize
FlavorImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
151672-1262-11 TUBE In 1 CARTONcontains a TUBE
115 g In 1 TUBEThis package is contained within the CARTON (51672-1262-1)
251672-1262-31 TUBE In 1 CARTONcontains a TUBE
260 g In 1 TUBEThis package is contained within the CARTON (51672-1262-3)
351672-1262-71 TUBE In 1 CARTONcontains a TUBE
3100 g In 1 TUBEThis package is contained within the CARTON (51672-1262-7)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07428606/07/1996


Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)









Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE
Revised: 11/2010Taro Pharmaceuticals U.S.A., Inc.

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