IVERMECTIN

Ivermectin cream, 1% is a white to pale yellow homogeneous cream. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. 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 A 1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a , generally referred to as 22,23-dihydroavermectin B 1a and B 1b or H 2 B 1a and H 2 B 1b , respectively; and the ratio (calculated by area percentage) of component H 2 B 1a /(H 2 B 1a + H 2 B 1b )) is not less than 90.0 %. The respective empirical formulas of H 2 B 1a and H 2 B 1b are C 48 H 74 O 14 and C 47 H 72 O 14 with molecular weights of 875.10 and 861.07 respectively. The structural formulas are: Component H 2 B 1a : R = C 2 H 5 , Component H 2 B 1b : R = CH 3 . Ivermectin cream contains the following inactive ingredients: carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, cocodiethanolamide, dimethicone, dimethyl isosorbide, edetate disodium, glycerin, isopropyl palmitate, methyl paraben, propyl paraben, purified water, sodium hydroxide, sodium lauryl sulfate, and stearyl alcohol. Image

Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. ( 1 )

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. Ivermectin cream is not for oral, ophthalmic or intravaginal use. Apply to the affected areas once daily. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )

None. None. ( 4 )

In controlled clinical trials with ivermectin the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily. A total of 1,555 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 ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local adverse reactions: contact dermatitis and allergic dermatitis.

In vitro studies have shown that ivermectin cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.