IVERMECTIN lotion

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Ivermectin (UNII: 8883YP2R6D) (Ivermectin - UNII:8883YP2R6D)

Disponibil de la:

Taro Pharmaceuticals U.S.A., Inc.

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

IVERMECTIN- IVERMECTIN LOTION
TARO PHARMACEUTICALS U.S.A., INC.
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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