Hydrocortisone and pramoxine (Topical application)

Hydrocortisone and pramoxine combination topical is used to help reduce redness, itching, swelling, or other discomfort from skin conditions (corticosteroid-responsive dermatoses). This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

It is very important that your doctor check how you or your child are doing at regular visits to ensure that this medicine is working properly. Blood and urine tests are needed to look for unwanted effects.

If your or your child's symptoms do not improve, or if they get worse, contact your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having problems with your adrenal or pituitary glands. The risk is higher for children and patients who use large amounts for a long time. Talk to your doctor immediately if you or your child experience blurred vision, darkening of the skin, diarrhea, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause serious skin reactions, especially if you cover the treated skin area or use the medicine for a long time. Contact your doctor right away if you or your child have thinning of the skin with easy bruising, reddish purple lines on the arms, face, legs, trunk, or groin areas, acne or pimples, darkening or lightening of skin color, blistering, burning, crusting, dryness, flaking of the skin, or itching, scaling, severe redness, soreness, or swelling of the skin.

Contact your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin. Do not use cosmetics or other skin care products on the treated areas.

This medicine may delay growth in children. If you think your child is not growing properly while using this medicine, discuss this with your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits of taking it. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Studies done so far have not shown any specific problems that would limit the use of hydrocortisone and pramoxine topical in children. However, due to the potential toxicity of this medicine, it should be used cautiously. Children may absorb large amounts through the skin, which can lead to serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

Studies done so far have not shown any specific problems that would limit the use of hydrocortisone and pramoxine topical foam in elderly patients. However, older adults are more likely to have age-related liver, kidney, or heart issues, which may require caution and dose adjustments when using this medicine.

No information is available about the effects of hydrocortisone and pramoxine topical cream and lotion in elderly patients.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while other medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or take other precautions. Inform 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 around mealtime or with certain foods because interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Glucosuria (sugar in the urine) or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. This may worsen these conditions.

• Infection of the skin at or near the application site—This may increase the risk of side effects.

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

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Backache
• blistering, burning, crusting, dryness, or flaking of the skin
• blurred or changes in vision
• bulging soft spot on the head of an infant
• burning, itching, and pain in the hairy areas, pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• confusion
• facial hair growth in females
• fractures
• full or round face, neck, or trunk
• headache
• increased hair growth on the forehead, back, arms, and legs
• increased hunger or thirst
• increased pressure in the head
• increased urination
• irritability
• lightening of the normal skin color
• lightening of treated areas of dark skin
• loss of sexual desire or ability
• menstrual irregularities
• muscle wasting
• severe nausea or vomiting
• severe redness, soreness, or swelling of the skin
• softening of the skin
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)
• unusual tiredness or weakness

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:

Incidence not known

• Acne, pimples

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.

Pharmacologic Class: Hydrocortisone

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.

Shake the lotion well before using.

Shake the aerosol foam can for 5 to 10 seconds just before using. Hold the can upright and prime it by pressing the cap for a few times until foam appears. Disassemble the container and cap and rinse with warm water after use. Do not inhale the foam or use it near heat, open flame, or while smoking. Do not puncture, break, or burn the can.

To use the cream, foam, or lotion:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants.
• If your doctor ordered an occlusive dressing (eg, bandage) or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions.

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 other corticosteroid-responsive dermatoses:For topical dosage forms (cream, foam, and lotion): Adults—Apply to the affected area of the skin 3 to 4 times a day. Children—Use and dose must be determined by your doctor.

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

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.

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

Do not refrigerate the aerosol foam can.