MIRVASO- brimonidine tartrate gel

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)

可用日期:

Galderma Laboratories, L.P.

INN（国际名称）:

BRIMONIDINE TARTRATE

组成:

BRIMONIDINE TARTRATE 5 mg in 1 g

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. MIRVASO topical gel is contratindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticaria, and contact dermatitis [see Warnings and Precautions (5.6) and Adverse Reactions (6.1,6.2) ]. Pregnancy Category B. There are no adequate and well-controlled studies of MIRVASO topical gel in pregnant women. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. MIRVASO topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Brimonidine tartrate was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18. It is not

產品總結:

MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube or pump with a child resistant cap in the following sizes: 30 gram tube NDC 0299-5980-30 30 gram pump NDC 0299-5980-35 45 gram tube NDC 0299-5980-45 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].

授权状态:

New Drug Application

产品特点

MIRVASO - BRIMONIDINE TARTRATE GEL
GALDERMA LABORATORIES, L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRVASO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIRVASO.
MIRVASO (BRIMONIDINE) TOPICAL GEL
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Contraindications (4) 07/2016
Warnings and Precautions (5.4, 5.5, 5.6) 07/2016
INDICATIONS AND USAGE
MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic
agonist indicated for the topical
treatment of persistent (nontransient) facial erythema of rosacea in
adults 18 years of age or older.(1)
DOSAGE AND ADMINISTRATION
Apply a pea-sized amount once daily to each of the five areas of the
face (forehead, chin, nose, each
cheek) avoiding the eyes and lips. (2)
Hands should be washed immediately after applying MIRVASO topical gel.
(2)
For topical use only (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 0.33%; Each gram of gel contains 5 mg of brimonidine tartrate,
equivalent to 3.3 mg of brimonidine
free base. (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of MIRVASO topical gel (4)
WARNINGS AND PRECAUTIONS
Potentiation of Vascular Insufficiency (5.1)
Severe Cardiovascular Disease (5.2)
Serious Adverse Reactions Following Ingestion of MIRVASO topical gel
(5.3)
Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists (5.4)
Local Vasomotor Adverse Reactions (5.5)
Hypersensitivity (5.6)
ADVERSE REACTIONS
In controlled clinical trials with MIRVASO topical gel the most common
adverse reactions (incidence > 1%)
included erythema, flushing, skin burning sensation, and contact
dermatitis. (6)
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._
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATI