IVERMECTIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. None. Pregnancy Category C. 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. Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1.5 mg/kg/day, 4 mg/kg/day, and 12 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 6 to 17) to pregnant female rats. Maternal death occurred at 12 mg/kg/day (1909X MTHD). Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909X MTHD) group. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 4 mg/kg/day (708X MTHD). Oral doses of 0.5 mg/kg/day, 1.5 mg/kg/day, 2.5

Product summary:

Ivermectin cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following size: 45 gram – NDC: 63629-8754-1 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]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IVERMECTIN- IVERMECTIN CREAM
BRYANT RANCH PREPACK
----------
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, 1%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Ivermectin cream, 1% 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 45 g. (3)
CONTRAINDICATIONS
None. (4)
ADVERSE REACTIONS
In controlled clinical trials with ivermectin cream the most common
adverse reactions (incidence less than
or equal to 1 %) included skin burning sensation and skin irritation.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA PHARMACEUTICALS
USA, INC. AT 1-
866-832-8537 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2023
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
8.3 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 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, 1% 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