Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
Ivermectin (UNII: 8883YP2R6D) (Ivermectin - UNII:8883YP2R6D)
Taro Pharmaceuticals U.S.A., Inc.
TOPICAL
PRESCRIPTION DRUG
Ivermectin Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. Ivermectin Lotion should be used in the context of an overall lice management program: - Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels. - Wash personal care items such as combs, brushes and hair clips in hot water. - A fine-tooth comb or special nit comb may be used to remove dead lice and nits. None. Risk Summary There are no studies with the use of Ivermectin Lotion in pregnant women. Epidemiologic studies with the use of oral ivermectin during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester (see Data) . However, systemic exposure from topical use of ivermectin is much lower than that from oral use [see Clinical Pharmacology (12.3)]. In animal
Ivermectin Lotion, 0.5% is supplied in a 4 oz (117 g) white laminate tube (NDC 51672-4211-8). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.
Abbreviated New Drug Application
IVERMECTIN- IVERMECTIN LOTION TARO PHARMACEUTICALS U.S.A., INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IVERMECTIN LOTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IVERMECTIN LOTION. IVERMECTIN LOTION, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Ivermectin Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older. (1) DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic or intravaginal use. (2) Apply Ivermectin Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. (2) After 10 minutes, rinse off with water. (2) For single use. Discard any unused portion. (2) DOSAGE FORMS AND STRENGTHS Lotion: 0.5% (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Accidental ingestion in pediatric patients may occur: Administer only under direct adult supervision. (5.1) ADVERSE REACTIONS Most common adverse reactions (incidence <1%) are conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS U.S.A., INC. AT 1-866-923-4914 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ USE IN SPECIFIC POPULATIONS Safety and effectiveness in pediatric patients below the age of 6 months have not been established. (8.4) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 12/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Indication 1.2 Adjunctive Measures 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Ingestion in Pediatric Patients 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 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 Pharmacodyn Belgenin tamamını okuyun