SOOLANTRA- Ivermectin cream
Galderma Laboratories, L.P.
1 INDICATIONS AND USAGE
SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.
2 DOSAGE AND ADMINISTRATION
Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. SOOLANTRA cream is not for oral, ophthalmic, or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS
Each gram of SOOLANTRA cream contains 10 mg of ivermectin in a white to pale yellow cream base. SOOLANTRA cream is supplied in tubes of 30 g, 45 g and 60 g.
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 2047 subjects with inflammatory lesions of rosacea received SOOLANTRA cream once daily. A total of 1555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year. Adverse reactions, reported in ≤ 1% of subjects treated with SOOLANTRA cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
7 DRUG INTERACTIONS
In vitro studies have shown that SOOLANTRA cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow hydrophilic cream. Each gram of SOOLANTRA cream contains 10 mg of ivermectin. It is intended for topical use.
Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones.
Ivermectin is a mixture containing not less than 95.0% and not more than 102.0% of 5-O-demethyl-22,23-dihydroavermectin A1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A1a , generally referred to as 22,23-dihydroavermectin B1a and B1b or H2 B1a and H2 B1b , respectively; and the ratio (calculated by area percentage) of component H2 B1a /(H2 B1a + H2 B1b ) is not less than 90.0%. The respective empirical formulas of H2 B1a and H2 B1b are C48 H74 O14 and C47 H72 O14 with molecular weights of 875.10 and 861.07 respectively.
Instructions for Use
SOOLANTRA (soo lan" trah) (ivermectin) cream, 1%
Important: SOOLANTRA� cream is for use on the face only. Do not use SOOLANTRA cream in your eyes, mouth or vagina.