SKLICE 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:

Sanofi Pasteur, Inc

INN (nume internaţional):

IVERMECTIN

Compoziție:

IVERMECTIN 0.585 g in 117 g

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

SKLICE- IVERMECTIN LOTION
SANOFI PASTEUR, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SKLICE LOTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR SKLICE LOTION.
SKLICE (IVERMECTIN) LOTION, 0.5%FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
SKLICE 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 SKLICE 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 SANOFI PASTEUR, INC. AT
1-800-835-3592 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: 2/2012
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 Trial Experience
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 Pharmacokineti