Oxistat

DRUG DESCRIPTION

OXISTAT (oxiconazole) Cream and Lotion formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only.

Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the empirical formula C18H13ON3Cl4•HNO3, a molecular weight of 492.15, and the following structural formula:

OXISTAT® (oxiconazole nitrate cream)  Structural Formula Illustration

Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water.

OXISTAT Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.

OXISTAT Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.

What are the possible side effects of oxiconazole topical (Oxistat)?

Serious side effects of oxiconazole topical use are not expected. Stop using oxiconazole and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Oxistat »

What are the precautions when taking oxiconazole (Oxistat)?

Before using oxiconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Oxistat »


Oxistat Consumer (continued)

SIDE EFFECTS: Burning, stinging, swelling, irritation, redness, pimple-like bumps, tenderness, or flaking of the treated skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, oozing, open sores.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using oxiconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Oxistat Patient Information Including Side Effects

Brand Names: Oxistat

Generic Name: oxiconazole topical (Pronunciation: ox ee CON a zole)

  • What is oxiconazole topical (Oxistat)?
  • What are the possible side effects of oxiconazole topical (Oxistat)?
  • What is the most important information I should know about oxiconazole topical (Oxistat)?
  • Who should not use oxiconazole topical (Oxistat)?
  • How should I use oxiconazole topical (Oxistat)?
  • What happens if I miss a dose (Oxistat)?
  • What happens if I overdose (Oxistat)?
  • What should I avoid while using oxiconazole topical (Oxistat)?
  • What other drugs will affect oxiconazole topical (Oxistat)?
  • Where can I get more information?

What is oxiconazole topical (Oxistat)?

Oxiconazole topical is an antifungal medication. Oxiconazole topical prevents fungus from growing on your skin.

Oxiconazole topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm.

Oxiconazole topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of oxiconazole topical (Oxistat)?

Serious side effects of oxiconazole topical use are not expected. Stop using oxiconazole and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oxiconazole topical (Oxistat)?

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

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