Country: United States
Language: English
Source: NLM (National Library of Medicine)
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)
Prasco Laboratories
TOPICAL
PRESCRIPTION DRUG
Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. None. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Ivermectin cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Note: The animal multiples of human exposure calculations were based on AUC comparisons. The maximum topical human dose (MTHD) of Ivermectin cream is 1 g applied once daily. Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1.5, 4, and 12 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 6–17) to pregnant female rats. Maternal death occurred at 12 mg/kg/day (1909X MTHD). Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909X MTHD) group. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 4 mg/kg/day (708X MTHD). Oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were admin
Ivermectin cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following size: 45 gram NDC 66993-948-48 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 Authorized Generic
IVERMECTIN- IVERMECTIN CREAM PRASCO LABORATORIES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IVERMECTIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IVERMECTIN. IVERMECTIN CREAM, 1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Ivermectin 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%, supplied in tubes of 45 g. (3) CONTRAINDICATIONS None. (4) ADVERSE REACTIONS In controlled clinical trials with Ivermectin the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRASCO LABORATORIES AT 1-866-525-0688 OR FDA AT 1- 800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 8/2019 FULL PRESCRIBING INFORMATION: CONTENTS* SPL PRODUCT DATA ELEMENTS SECTION 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 8.3 Nursing Mothers 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 Ivermectin 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 a Read the complete document