IVERMECTIN cream

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Viona Pharmaceuticals Inc

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. None. There are no adequate and well-controlled studies in pregnant women. Ivermectin cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Note: The animal multiples of human exposure calculations were based on AUC comparisons. The maximum topical human dose (MTHD) of ivermectin cream is 1 g applied once daily. Risk Summary The available data on the use of ivermectin, including ivermectin 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 rabbi

Ürün özeti:

Ivermectin cream, 1% is a white to pale yellow homogeneous cream, supplied in a laminated tube with a child-resistant cap in the following sizes: 30 gram NDC 72578-120-06 45 gram NDC 72578-120-08 60 gram NDC 72578-120-02 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

IVERMECTIN- IVERMECTIN CREAM
VIONA PHARMACEUTICALS INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IVERMECTIN CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IVERMECTIN CREAM.
IVERMECTIN CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Ivermectin 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%, supplied in tubes of 30 g, 45 g and 60 g. (3)
CONTRAINDICATIONS
None. (4)
ADVERSE REACTIONS
In controlled clinical trials with ivermectin the most common adverse
reactions (incidence ≤ 1 %) included
skin burning sensation and skin irritation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VIONA PHARMACEUTICALS
INC. AT 1-888-
304-5011 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION, FDA-APPROVED PATIENT
LABELING AND FDA-
APPROVED PATIENT LABELING.
REVISED: 12/2022
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
Ivermectin 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 chee