Description
Hydrocortisone and pramoxine combination topical is used to help relieve redness, itching, swelling, or other discomfort caused by 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.
Before Using
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
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone and pramoxine topical in children. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone and pramoxine topical foam in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment for patients using this medicine.
No information is available on the relationship of age to the effects of hydrocortisone and pramoxine topical cream and lotion in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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. May make these conditions worse.
- Infection of the skin at or near the place of application—The chance of side effects may be increased.
Proper Use
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.
- For topical dosage forms (cream, foam, and lotion):
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.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.
If your or your child's symptoms do not improve, or if they become worse, check with your doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal or pituitary gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have 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, or unusual tiredness or weakness, or vomiting.
This medicine may cause serious skin reactions, which may occur if you cover the treated skin area or use the medicine for a long time. Check with 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, swelling of the skin.
Check with 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, talk with your doctor.
Side Effects
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 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 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 the 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 (eg, 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.
DRG-20526892
