Peitel 0.25%

Peitel 0.25% is a relatively new topical corticosteroid drug. It is similar in potency to hydrocortisone. It is used in the treatment of inflammatory skin diseases, such as atopic dermatitis. It has a favorable benefit-risk ratio, with an inflammatory action similar to that of a medium potency corticosteroid, but with a low potential to cause skin atrophy. The anti-inflammation action of corticosteroids is associated with the inhibition of the interleukin 1-alpha cytokine within keratinocytes. IL-1a is also found in fibroblasts, where it is responsible for proliferation, collagenase induction and IL-6 synthesis, which are related to skin thickness.

Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.

Peitel 0.25% is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Peitel 0.25% topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Peitel 0.25% topical may also be used for purposes not listed in this medication guide.

Apply a thin film of Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently.

Peitel 0.25% (Peitel 0.25% emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% should not be used with occlusive dressings unless directed by the physician. Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

How supplied

Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% is supplied in 15 g (NDC 0066-0507-15) and 60 g (NDC 0066-0507-60) tubes. Store between 41 and 77°F (5 and 25°C).

Dermik Laboratories., a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised October 2010

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What is the most important information I should know about Peitel 0.25%?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told 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 Peitel 0.25% topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Use Peitel 0.25% ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a thin film of medicine to the affected area. Gently rub the medicine in until it is evenly distributed.
• Wash your hands after applying Peitel 0.25% ointment, unless your hands are part of the treated area.
• Do not bandage or wrap the affected area, unless directed otherwise by your doctor.
• If you miss a dose of Peitel 0.25% ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Peitel 0.25% ointment.

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What other drugs will affect Peitel 0.25%?

No Information Provided.

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What are the possible side effects of Peitel 0.25%?

In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of Peitel 0.25% (Peitel 0.25% emollient cream) 0.1% was approximately 4%. Reported reactions included mild signs of skin atrophy in 1% of treated patients, as well as the following reactions which were reported in less than 1% of patients: pruritis, edema, paresthesia, urticaria, burning, allergic contact dermatitis and rash.

In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of Peitel 0.25% (Peitel 0.25% emollient cream) 0.1 % was limited. Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and 2 patients (2/59, 3%) developed thinness. Three patients (3/59, 5 %) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.