Drug Catalog - Product Detail
BIMATOPROST OPTHALMIC SOLUTION 0.03% SOL 0.0003 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0429-02 | LUPIN PHARMACEUTICALS | 5 | 0.03% | SOLUTION |
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Description
11 DESCRIPTION Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is ( Z )-7-[(1 R ,2 R ,3 R ,5 S )-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5- N -ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C 25 H 37 NO 4 . Its chemical structure is: Bimatoprost is a powder, which is freely soluble in alcohol. Bimatoprost ophthalmic solution, 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution, 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL; disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.9 to 7.6. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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).
Indications & Usage
1 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 ) Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION One drop in the affected eye(s) once daily in the evening. ( 2 ) The recommended dosage is one drop in the affected eye(s) once daily in the evening. Bimatoprost ophthalmic solution, 0.03% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours. Bimatoprost ophthalmic solution, 0.03% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.