IVERMECTIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis US LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. None. Risk Summary The available data on the use of ivermectin, including lvermectin 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 lvermectin 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 have a

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 0574-2107 -45 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].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

IVERMECTIN- IVERMECTIN CREAM
PADAGIS US LLC
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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 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 ivermectin cream the most common
adverse reactions (incidence ≤ 1 %)
included skin burning sensation and skin irritation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2023
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
8.4 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 cheek) that is affected.
Spread as a thin layer,
avoiding the eyes and lips.
Ivermectin cream is not for oral,