Pramcort topical / rectal

You should not use this medicine if you are allergic to hydrocortisone or pramoxine, or to any other anesthetics or "numbing medicines."

To make sure hydrocortisone and pramoxine is safe for you, tell your doctor if you have:

• liver disease;

• diabetes;

• problems with your eyes;

• a stomach or intestinal disorder;

• a rectal sore or infection; or

• if you use any drugs that weaken the immune system, including steroids.

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

FDA pregnancy category C. It is not known whether hydrocortisone and pramoxine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hydrocortisone and pramoxine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medicine on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

Since hydrocortisone and pramoxine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you show signs of absorbing too much of the medicine through your skin, such as:

• blurred vision, eye pain, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• high blood sugar (increased thirst or urination, hunger, dry mouth, fruity breath odor,weight loss);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Stop using the medicine and call your doctor if you have rectal bleeding or severe irritation in any treated skin.

Common side effects may include:

• mild redness or swelling of treated skin;

• thinning of treated skin; or

• numbness on areas where the medicine is accidentally applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to hydrocortisone / pramoxine topical: external cream, external foam, external gel, external lotion, external ointment

Other dosage forms:

• rectal cream, rectal foam, rectal kit, rectal lotion

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Irritation where this drug is used.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Thinning of the skin.

Applies to hydrocortisone / pramoxine topical: rectal cream, rectal foam, rectal kit, rectal lotion, topical cream, topical foam, topical gel, topical lotion, topical ointment

Dermatologic

Dermatologic side effects including burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including allergic contact dermatitis have been reported.[Ref]

Some side effects of Pramcort may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.