Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
BIMATOPROST (UNII: QXS94885MZ) (BIMATOPROST - UNII:QXS94885MZ)
Lupin Pharmaceuticals, Inc.
BIMATOPROST
BIMATOPROST 0.3 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2)] . Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [AUC] levels). These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended
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). After opening, Bimatoprost ophthalmic solution , 0.03% can be used until the expiration date stamped on the bottle.
Abbreviated New Drug Application
BIMATOPROST - BIMATOPROST SOLUTION/ DROPS LUPIN PHARMACEUTICALS, INC. ---------- 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 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 Ophthalmic solution containing 0.3 mg/mL of bimatoprost. (3) CONTRAINDICATIONS Hypersensitivity. (4) WARNINGS AND PRECAUTIONS Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. (5.1) (5) Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. (5.2) (5) ADVERSE REACTIONS Most common adverse reaction (45%) is conjunctival hyperemia. (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: 7/2022 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 Contact Lense Use 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.1 Clinical Trials Experience 6.2 Postmarke Läs hela dokumentet