BIMATOPROST solution/ drops

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BIMATOPROST (UNII: QXS94885MZ) (BIMATOPROST - UNII:QXS94885MZ)

可用日期:

LUPIN LIMITED

INN（国际名称）:

BIMATOPROST

组成:

BIMATOPROST 0.3 mg in 1 mL

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. None Teratogenic effects:   In embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure based on blood AUC levels. At doses at least 41 times the maximum intended human exposure based on blood AUC levels, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced. There are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. Because animal reproductive studies are not always predictive of human response. Bimatoprost ophthalmic solution, 0.03% should be administered during pregnancy only if the potential benefit justifies the

產品總結:

Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low density polyethylene bottle which is closed with white low density polyethylene nozzle and then with turquoise colored high density polyethylene cap in the following sizes: 2.5 mL fill in a 5 mL container           -           NDC 68180-429-01 5 mL fill in a 10 mL container            -           NDC 68180-429-02 7.5 mL fill in a 10 mL container         -           NDC 68180-429-03 Storage: Bimatoprost ophthalmic solution, 0.03% should be stored at 2 to 25°C (36 to 77°F).

授权状态:

Abbreviated New Drug Application

产品特点

BIMATOPROST- BIMATOPROST SOLUTION/ DROPS
LUPIN LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BIMATOPROST OPHTHALMIC SOLUTION, 0.03%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BIMATOPROST OPHTHALMIC SOLUTION, 0.03%.
BIMATOPROST OPHTHALMIC SOLUTION, 0.03%
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions, Intraocular Inflammation (5.3) 09/2014
INDICATIONS AND USAGE
Bimatoprost ophthalmic solution, 0.03% is a prostaglandin analog
indicated for the reduction of elevated intraocular
pressure in patients with open angle glaucoma or ocular hypertension.
(1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 0.3 mg/mL bimatoprost. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Pigme ntation.
Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes
can occur. Iris pigmentation is likely to be permanent.
(5.1)
Eyelash Changes.
Gradual change to eyelashes including increased length, thickness and
number of lashes. Usually reversible. (5.2)
ADVERSE REACTIONS
Most common adverse reaction is conjunctival hyperemia (45%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Use in pediatric patients below the age of 16 years is not recommended
because of potential safety concerns related to
increased pigmentation following long-term chronic use. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Bacterial Keratitis
5.6 Use with Contact Lenses
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6