SKLICE- ivermectin lotion

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)

থেকে পাওয়া:

Arbor Pharmaceuticals

INN (International Name):

IVERMECTIN

রচনা:

IVERMECTIN 5 mg in 1 g

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

SKLICE® Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. SKLICE 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 SKLICE 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 reproduct

পণ্য সারাংশ:

SKLICE Lotion, 0.5% is supplied in a 4 oz (117g) laminate tube (NDC 24338-183-04). Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP controlled room temperature]. Do not freeze.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

SKLICE- IVERMECTIN LOTION
ARBOR PHARMACEUTICALS
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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 ARBOR PHARMACEUTICALS,
LLC AT 1-866-516-4950 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: 6/2017
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 Pharmacodynamics
12.3 Pharmacokin