Drug Catalog - Product Detail
PIMECROLIMUS 1% CREAM 100GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-2944-87 | ACTAVIS PHARMA | 100 | 1% | CREAM |
PACKAGE FILES
Generic Name
PIMECROLIMUS
Substance Name
PIMECROLIMUS
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA209345
Description
11 DESCRIPTION Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 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 molecular formula C 43 H 68 CINO 11 and the molecular weight of 810.47. The structural formula is: Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water. The Structural formula of 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 molecular formula C43H68CINO11 and the molecular weight of 810.47.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Pimecrolimus cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams. 30 gram tube………………………………………………………………NDC 0591-2944-30 60 gram tube………………………………………………………………NDC 0591-2944-60 100 gram tube……………………………………………………………..NDC 0591-2944-87 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.
Indications & Usage
1 INDICATIONS AND USAGE Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus c ream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ]. Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant indicated as s e c o n d -l i n e th e r a p y for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of pimecrolimus cream, 1% to the affected skin twice daily. The patient should stop using pimecrolimus cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur. If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis. Continuous long-term use of pimecrolimus cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis [see Warnings and Precautions (5.1) ]. The safety of pimecrolimus cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of pimecrolimus cream, 1% with occlusive dressings. Apply a thin layer of pimecrolimus cream, 1% to the affected skin twice daily. ( 2 ) If signs and symptoms persist beyond 6 weeks, patients should be re-examined. ( 2 ) Continuous long-term use of pimecrolimus cream, 1% should be avoided. ( 2 ) Avoid use with occlusive dressings. ( 2 )