Pandel
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How should I use Pandel (hydrocortisone topical)?
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.
Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.
Apply a small amount to the affected area and rub it gently into the skin.
Avoid using this medicine on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.
Do not cover the treated skin area unless your doctor tells you to.
If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.
Call your doctor if your symptoms do not improve, or if they get worse while using hydrocortisone topical.
Store at room temperature away from moisture and heat.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.
An overdose of hydrocortisone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
Indications and Usage for Pandel
Pandel® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.
Dosage Forms and Strengths
Cream, 0.1%. Each gram of Pandel contains 1 mg of hydrocortisone probutate in a cream base.
Warnings and Precautions
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects
Pandel can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with Pandel twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown [see Clinical Pharmacology (12.2)].
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].
Allergic Contact Dermatitis
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. If irritation develops, discontinue Pandel and institute appropriate therapy.
Use in specific populations
Pregnancy
Risk Summary
There is no clinical information on Pandel use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, hydrocortisone probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively) [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
Effects on embryo-fetal development were evaluated in rats and rabbits following subcutaneous administration of hydrocortisone probutate during the period of organogenesis. Hydrocortisone probutate was teratogenic in rats when given during the period of organogenesis at subcutaneous doses equal to or greater than 1 mg/kg/day (12 times the human average topical dose of Pandel assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Abnormalities included delayed ossification of the caudal vertebrae and other skeletal variations, cleft palate, umbilical hernia, edema, and exencephalia.
In rabbits, hydrocortisone probutate given by the subcutaneous route was teratogenic at doses equal to or greater than 0.1 mg/kg/day (2 times the human average topical dose of Pandel assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Fetal weight and survival were affected. Delayed ossification and increased incidences of malformations (skeletal abnormalities and cleft palate) were also noted.
No adverse effects were seen in rats following subcutaneous administration of up to 1 mg/kg/day of hydrocortisone probutate during the perinatal and postnatal period (12 times the human average topical dose of Pandel assuming 3% absorption and an application of 30 g/day on a 70 kg individual).
Lactation
Risk Summary
There is no information on the presence of hydrocortisone probutate in breast milk, or on its effects on the breastfed infant or on milk production. It is not known whether topical administration of Pandel could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Pandel and any potential adverse effects on the breastfed infant from Pandel or from the underlying maternal condition.
Clinical Considerations
To minimize potential exposure to the breastfed infant via breast milk, use Pandel on the smallest area of skin and for the shortest duration possible while breastfeeding.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Patient Counseling Information
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).
Inform patients and/or caregivers of the following:
1. Discontinue therapy when control is achieved unless directed otherwise by the physician. 2. If no improvement is seen within two weeks, contact the physician. 3. Avoid contact with the eyes. 4. Do not use with occlusive dressing unless directed by the physician. 5. Report any signs or symptoms of local or systemic adverse reactions to the physician. 6. Do not treat diaper dermatitis. Do not apply Pandel in the diaper area as diapers or plastic pants may constitute occlusive dressings. 7. Do not use on the face, underarms, or groin areas unless directed by the physician. 8. Advise a woman to use Pandel on the smallest area of skin and for the shortest duration possible while breastfeeding.Manufactured by:
PharmaDerm®
A division of Fougera
PHARMACEUTICALS INC.
Melville, New York 11747 www.pharmaderm.com
| PATIENT INFORMATION Pandel® (pan-del) (hydrocortisone probutate) cream |
| Important: Pandel is for use on skin only (topical). Avoid using Pandel near or around your eyes. |
| What is Pandel? Pandel is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in people 18 years of age or older. It is not known if Pandel is safe and effective in children. |
| Before using Pandel tell your healthcare provider about all of your medical conditions, including if you: • have adrenal gland problems • have liver problems • have diabetes • have thinning skin (atrophy) at the site to be treated. • are pregnant or plan to become pregnant. It is not known if Pandel will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Pandel can pass into your breast milk and harm your baby. o If you breastfeed during treatment with Pandel, clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of Pandel with your baby’s skin. o You should use Pandel on the smallest area of skin and for the shortest time possible while breastfeeding.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
| How should I use Pandel? • Use Pandel exactly as your healthcare provider tells you to use it. • Apply a thin film to the affected skin area. Gently rub Pandel into your skin until it disappears. • Tell your healthcare provider if your symptoms do not improve after 2 weeks of treatment. • Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. • Do not apply Pandel in the diaper area or use with plastic pants. • Do not use Pandel on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to. • Wash your hands after applying Pandel, unless your hands are being treated. |
| What are possible side effects with Pandel? Pandel may cause serious side effects, including: • Pandel can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Pandel for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Pandel. • Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skinreactions such as pain, tenderness, swelling, or healing problems. The most common side effects of Pandel include burning and stinging and moderate tingling or prickling feeling. These are not all the possible side effects with Pandel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| How should I store Pandel? • Store Pandel between 68°F to 77°F (20°C to 25°C). Keep Pandel and all medicines out of the reach of children. |
| General information about the safe and effective use of Pandel. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Pandel for a condition for which it was not prescribed. Do not give Pandel to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Pandel that is written for health professionals. |
| What are the ingredients in Pandel? Active ingredient: hydrocortisone probutate Inactive ingredients: propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water. Manufactured by:PharmaDerm® A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 For more information, go to www.pharmaderm.com or call 1-800-645-9833. |
Package/label principal display panel
PharmaDerm®
NDC 10337-153-80
Pandel®
(hydrocortisone probutate) Cream, 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx only
80 g
Principal display panel - container
PharmaDerm®
NDC 10337-153-80
Pandel
(hydrocortisone probutate) Cream, 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx only
80 g
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| Labeler - PharmaDerm a division of Fougera Pharmaceuticals Inc. (043838424) |
For the Consumer
Applies to hydrocortisone topical: topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick
Other dosage forms:
- topical application cream, topical application lotion, topical application ointment, topical application solution
- topical application cream
- topical application cream, topical application ointment
Along with its needed effects, hydrocortisone topical (the active ingredient contained in Pandel) 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 while taking hydrocortisone topical:
Incidence not known- Blistering, burning, crusting, dryness, or flaking of the skin
- irritation
- itching, scaling, severe redness, soreness, or swelling of the skin
- redness and scaling around the mouth
- thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
- thinning, weakness, or wasting away of the skin
Some side effects of hydrocortisone topical 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 or pimples
- burning and itching of the skin with pinhead-sized red blisters
- burning, itching, and pain in hairy areas, or pus at the root of the hair
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of treated areas of dark skin
- reddish purple lines on the arms, face, legs, trunk, or groin
- softening of the skin