Epifoam

Before using hydrocortisone and pramoxine topical, talk to your doctor if you have

• chickenpox, herpes, or tuberculosis infection;

• diabetes;

• thinning of the skin; or

• infection near the site of use.

You may not be able to use hydrocortisone and pramoxine topical, or you may require a dosage adjustment or special monitoring during use.

Hydrocortisone and pramoxine topical is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use hydrocortisone and pramoxine topical without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Hydrocortisone and pramoxine passes into breast milk. It is unlikely that hydrocortisone and pramoxine topical will be harmful to a nursing baby, however do not use hydrocortisone and pramoxine topical without first talking to your doctor if you are breast-feeding a baby.

Apply the medication exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Hydrocortisone and pramoxine topical is intended for topical use on the skin or in the rectum. Do not take the medication by mouth. Do not get this medication if the eyes. Wash your hands before and after application of the medication.

Using the fingers or a tissue, apply a thin film of the cream, ointment, or lotion to the affected area and rub in gently.

To apply the foam externally, shake the container vigorously for 5 to 10 seconds before each use. Press down on the top several times until foam appears. Dispense the foam onto a tissue or cloth and gently rub into the affected area. The fingers should not be used to apply the foam. Rinse the container and cap after each use.

To apply the foam into the rectum using the rectal applicator:

• Hold the container upright and gently place the tip of the applicator onto the nose of the container cap.

• Pull the applicator plunger past the fill line on the applicator barrel.

• Hold the container and applicator at eye level. Place your index and middle fingers on the arms of the container cap and the thumb beneath container. Support the applicator with your other hand. Prime the container by pressing down firmly on the arms of the cap and then release. It usually requires 1 or 2 pumps for foam to appear. The first time you prime the pump a burst of air may come out of the container.

• To fill the applicator, press down firmly on cap flanges, hold for 1 to 2 seconds, and release. Wait 5 to 10 seconds to allow foam to expand in the applicator. Repeat until the foam reaches the fill line. It may take 3 or 4 pumps to reach the fill line. Remove the applicator from the container cap.

• Hold the applicator firmly. Place your index finger over the plunger. Gently insert the tip of the applicator into the anus. Once in place, push plunger to expel foam, then withdraw applicator. Apply to the anus only with the applicator provided with the foam.

• The applicator parts and container and cap should be pulled apart and rinsed with warm water after each use.

The foam is flammable, do not use near heat, flame, or while smoking.

Use care to avoid inhaling the vapors when using hydrocortisone and pramoxine topical foam.

Do not use plastic bandages or dressings that do not allow air to circulate to the area. The use of occlusive dressings can increase the amount of drug the body absorbs.

Contact your healthcare provider if your symptoms worsen or do not improve within 7 days. Do not use hydrocortisone and pramoxine topical for longer than 14 days without first talking to your doctor.

Store hydrocortisone and pramoxine topical at room temperature away from moisture and heat.

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply the next regularly scheduled dose. Do not use a double dose of this medication unless otherwise directed by your doctor.

No serious systemic side effects are expected from the use of hydrocortisone and pramoxine topical unless a large amount of the medication is used for a long period of time. If the drug is being absorbed into the system, you may experience blurred vision, halos around lights, an irregular heartbeat, insomnia, mood changes, weight gain, or fatigue. If you experience any unusual side effects, notify your doctor.

Less serious side effects are more likely to occur. You may experience some redness, burning, itching, or irritation at the application site. Continue to use hydrocortisone and pramoxine topical and talk to your doctor about any side effects you experience.

Long-term treatment with hydrocortisone and pramoxine topical may cause decreased wound healing, thinning of the skin, increased skin irritation, or skin infection.

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.

Do not use plastic bandages or dressings that do not allow air to circulate to the area. The use of occlusive dressings can increase the amount of drug the body absorbs.

Contact your healthcare provider if your symptoms worsen or do not improve within 7 days. Do not use hydrocortisone and pramoxine topical for longer than 14 days without first talking to your doctor.

The foam is flammable, do not use near heat, flame, or while smoking.

Use care to avoid inhaling the vapors when using hydrocortisone and pramoxine topical foam.

Do not use other topical medications on the affected area during treatment with hydrocortisone and pramoxine topical without first talking to your doctor.

Do not use other topical medications on the affected area during treatment with hydrocortisone and pramoxine topical without first talking to your doctor.

Drugs other than those listed here may also interact with hydrocortisone and pramoxine topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

An overdose of hydrocortisone and pramoxine topical is not likely to threaten life.

If the medication has been ingested, or if a large amount is used over a large area and side effects are being experienced, call an emergency room or a poison control center for advice.