Overview
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-[(1 E ,3 S )-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 .
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. 12.3 Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.
Indications
- 1 INDICATIONS AND USAGE 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 a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. ( 1 )
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Contraindications
- 4 CONTRAINDICATIONS Bimatoprost ophthalmic solution 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2) ]. Hypersensitivity.
Side Effects
- 6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Pigmentation [see Warnings and Precautions (5.1) ] • Eyelash Changes [see Warnings and Precautions (5.2) ] • Intraocular Inflammation [see Warnings and Precautions (5.3) ] • Macular Edema [see Warnings and Precautions (5.4) ] • Hypersensitivity [see Contraindications (4) ] Most common adverse reaction (45%) is conjunctival hyperemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.