Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)
Galderma Laboratories, L.P.
IVERMECTIN
IVERMECTIN 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea. None. Risk Summary The available data on the use of ivermectin, including SOOLANTRA cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively. These orally administered doses were maternally toxic to pregnant rats and rabbits. In a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies ha
SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following sizes: 30 gram NDC 0299-3823-30 45 gram NDC 0299-3823-45 60 gram NDC 0299-3823-60 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
New Drug Application
SOOLANTRA- IVERMECTIN CREAM GALDERMA LABORATORIES, L.P. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SOOLANTRA CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOOLANTRA CREAM. SOOLANTRA (IVERMECTIN) CREAM, 1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea. (1) DOSAGE AND ADMINISTRATION Apply to the affected areas once daily. (2) Not for oral, ophthalmic or intravaginal use. (2) DOSAGE FORMS AND STRENGTHS Cream, 1% (3) CONTRAINDICATIONS None. (4) ADVERSE REACTIONS In controlled clinical trials with SOOLANTRA cream the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation. (6.1) (5) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GALDERMA LABORATORIES, L.P. AT 1-866- 735-4137 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH. _(5) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 10/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY ® 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * FULL PRESCRIBING INFORMATION 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. SOOL Прочетете целия документ