SOOLANTRA- ivermectin cream

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Galderma Laboratories, L.P.

INN (Medzinárodný Name):

IVERMECTIN

Zloženie:

IVERMECTIN 10 mg in 1 g

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea. None. Risk Summary The available data on the use of ivermectin, including SOOLANTRA 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 rabbits. In a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies ha

Prehľad produktov:

SOOLANTRA (ivermectin) cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following sizes: 30 gram NDC 0299-3823-30 45 gram NDC 0299-3823-45 60 gram NDC 0299-3823-60 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

SOOLANTRA- IVERMECTIN CREAM
GALDERMA LABORATORIES, L.P.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOOLANTRA CREAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOOLANTRA CREAM.
SOOLANTRA (IVERMECTIN) CREAM, 1%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
SOOLANTRA 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% (3)
CONTRAINDICATIONS
None. (4)
ADVERSE REACTIONS
In controlled clinical trials with SOOLANTRA cream the most common
adverse reactions (incidence ≤ 1 %)
included skin burning sensation and skin irritation. (6.1) (5)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GALDERMA LABORATORIES,
L.P. AT 1-866-
735-4137 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH. _(5)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2022
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
SOOLANTRA 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 cheek) that is affected.
Spread as a thin layer,
avoiding the eyes and lips.
SOOL