Soolantra Cream

Name: Soolantra Cream

Dosage Forms and Strengths

Cream, 1%.
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.

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.

Soolantra Cream Description

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 H2B1a and H2B1b, respectively; and the ratio (calculated by area percentage) of component H2B1a/(H2B1a + H2B1b) is not less than 90.0%. The respective empirical formulas of H2B1a and H2B1b are C48H74O14 and C47H72O14 with molecular weights of 875.10 and 861.07 respectively.

The structural formulas are:

Component H2B1a: R = C2H5, Component H2B1b: R = CH3.

Soolantra Cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Patients using Soolantra Cream should receive the following instruction:

Keep out of reach of children.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Made in Canada.

P52476-0

(web3)