Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)
Viona Pharmaceuticals Inc
TOPICAL
PRESCRIPTION DRUG
Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. None. 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. Risk Summary The available data on the use of ivermectin, including ivermectin 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 rabbi
Ivermectin cream, 1% is a white to pale yellow homogeneous cream, supplied in a laminated tube with a child-resistant cap in the following sizes: 30 gram NDC 72578-120-06 45 gram NDC 72578-120-08 60 gram NDC 72578-120-02 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
IVERMECTIN- IVERMECTIN CREAM VIONA PHARMACEUTICALS INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IVERMECTIN CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IVERMECTIN CREAM. IVERMECTIN CREAM, 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 30 g, 45 g and 60 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. (6.1) 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. SEE 17 FOR PATIENT COUNSELING INFORMATION, FDA-APPROVED PATIENT LABELING AND FDA- APPROVED PATIENT LABELING. REVISED: 12/2022 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 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 chee Perskaitykite visą dokumentą