Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
BIMATOPROST (UNII: QXS94885MZ) (BIMATOPROST - UNII:QXS94885MZ)
LUPIN LIMITED
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. 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
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).
Abbreviated New Drug Application
BIMATOPROST- BIMATOPROST SOLUTION/ DROPS LUPIN LIMITED ---------- 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 Lugege kogu dokumenti