Triple Care EPC Topical

In the U.S.

• Aloe Vesta 2-N-1 Antifungal
• Aloe Vesta Antifungal
• Baza Antifungal
• Carrington Antifungal
• Derma Gran AF
• DiabetAid Antifungal Foot Bath
• Fungoid
• Lotrimin AF
• Micatin
• Micro-Guard
• Mitrazol
• Monistat 1
• Monistat Derm
• Neosporin AF
• QC Miconazole Nitrate
• Secura Antifungal
• Soothe & Cool Inzo Antifungal
• Tetterine
• Therasoft Antifungal
• Triple Care Antifungal
• Triple Care EPC
• Zeasorb-AF

Available Dosage Forms:

• Lotion
• Tablet, Effervescent
• Cream
• Ointment
• Powder
• Kit
• Tincture
• Gel/Jelly
• Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

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

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 miconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 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.

• Warfarin

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.

This section provides information on the proper use of a number of products that contain miconazole. It may not be specific to Triple Care EPC. Please read with care.

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

• Shake well before using.
• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.
• Do not inhale the powder.
• Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

• Shake well before using.
• From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.
• Do not inhale the vapors from the spray.
• Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

• If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 aerosol powder, aerosol solution, cream , and powder dosage forms:
  • For fungus infections:
    • Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.
• For cream and lotion dosage forms:
  • For sun fungus:
    • Adults and children—Apply to the affected area(s) of the skin once a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

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:

• Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of 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.