ELIDEL (30G CREAM)

769911274

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Pimecrolimus

$41.00

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Brand Generic Brand  
Product ID 8698856350305
Product Elidel 1%
Strength 1%
Pack Size 30g
Pharmaceutical Form Tube
Active Ingredients Pimecrolimus
Manufacturer Novartis
License Holder Meda Pharma
E.Q.US.Brand Name Elidel
Origin Germany
Active-Passive-Not Avaliable Active

DESCRIPTION

FOR DERMATOLOGIC USE ONLY, NOT FOR OPHTHALMIC USE

Elidel® (pimecrolimus) Cream 1% contains the compound pimecrolimus, the 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone.

The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.47. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water.

Each gram of Elidel Cream 1% contains 10 m g of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

INDICATIONS AND USAGE

Elidel® (pimecrolimus) Cream 1% is indicated for short-term and intermittent long-term therapy in the treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 2 years of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Apply a thin layer of Elidel ® (pimecrolimus) Cream 1% to the affected skin twice daily and rub in gently and completely. Elidel may be used on all skin surfaces, including the head, neck, and intertriginous areas.

Elidel should be used twice daily for as long as signs and symptoms persist. Treatment should be discontinued if resolution of disease occurs. If symptoms persist beyond 6 weeks, the patient should be re-evaluated.

The safety of Elidel Cream under occlusion, which m ay promote systemic exposure, has not been evaluated. Elidel Cream should not be used with occlusive dressings.

PRECAUTIONS

General

Elidel® (pimecrolimus) Cream 1% should not be applied to areas of active cutaneous viral infections.
Studies have not evaluated the safety and efficacy of Elidel Cream in the treatment of clinically infected atopic dermatitis. Before commencing treatment with Elidel Cream, clinical infections at treatment sites should be cleared.

While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi?s varicelliform eruption), treatment with Elidel Cream may be associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In the presence of these skin infections, the balance of risks and benefits associated with Elidel Cream use should be evaluated.

In clinical studies, 14 cases of lymphadenopathy (0.9%) were reported while using Elidel Cream. These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. Patients who receive Elidel Cream and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, discontinuation of Elidel Cream should be considered. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

In clinical studies, 15 cases of skin papilloma or warts (1%) were observed in patients using Elidel Cream. The youngest patient was age 2 and the oldest was age 12. In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of Elidel Cream should be considered until complete resolution of the warts is achieved.

The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Despite the absence of observed phototoxicity in humans (see ADVERSE REACTIONS), Elidel Cream shortened the time to skin tumor formation in an animal photo-carcinogenicity study (see Carcinogenesis, Mutagenesis, Impairment of Fertility). Therefore, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure.

The use of Elidel Cream in patients with Netherton?s Syndrome is not recommended due to the potential for increased systemic absorption of pimecrolimus. There are no data to support use of Elidel in immunocompromised patients. The use of Elidel Cream may cause local symptoms such as skin burning. Localized symptoms are most common during the first few days of Elidel Cream application and typically improve as the lesions of atopic dermatitis resolve. Most application site reactions lasted no more than 5 days, were mild to moderate in severity, and started within 1-5 days of treatment. (See ADVERSE REACTIONS.)

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