Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost Ophthalmic Solution, 0.01% is a sterile, clear colourless solution filled in 5 mL or 10 mL low density polyethylene white opaque bottles with low density polyethylene white opaque new nozzle and high density polyethylene turquoise cap. It is available as follows: 2.5 mL in 5 mL Containers (Filled to 1/2 Capacity): NDC 60219-2149-1 5 mL in 5 mL Containers: NDC 60219-2149-4 7.5 mL in 10 mL Containers (Filled to 3/4 Capacity): NDC 60219-2149-2 Storage: Store at 2° to 25°C (36° to 77°F). After opening, bimatoprost ophthalmic solution 0.01% can be used until the expiration date on the bottle.; PRINCIPAL DISPLAY PANEL NDC 60219-2149-1 Bimatoprost Ophthalmic Solution, 0.01% (2.5 mL) Rx only Amneal Pharmaceuticals LLC NDC 60219-2149-4 Bimatoprost Ophthalmic Solution, 0.01% (5 mL) Rx only Amneal Pharmaceuticals LLC NDC 60219-2149-2 Bimatoprost Ophthalmic Solution , 0.01% (7.5 mL) Rx only Amneal Pharmaceuticals LLC 001 002 003 004 005 006
- 16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost Ophthalmic Solution, 0.01% is a sterile, clear colourless solution filled in 5 mL or 10 mL low density polyethylene white opaque bottles with low density polyethylene white opaque new nozzle and high density polyethylene turquoise cap. It is available as follows: 2.5 mL in 5 mL Containers (Filled to 1/2 Capacity): NDC 60219-2149-1 5 mL in 5 mL Containers: NDC 60219-2149-4 7.5 mL in 10 mL Containers (Filled to 3/4 Capacity): NDC 60219-2149-2 Storage: Store at 2° to 25°C (36° to 77°F). After opening, bimatoprost ophthalmic solution 0.01% can be used until the expiration date on the bottle.
- PRINCIPAL DISPLAY PANEL NDC 60219-2149-1 Bimatoprost Ophthalmic Solution, 0.01% (2.5 mL) Rx only Amneal Pharmaceuticals LLC NDC 60219-2149-4 Bimatoprost Ophthalmic Solution, 0.01% (5 mL) Rx only Amneal Pharmaceuticals LLC NDC 60219-2149-2 Bimatoprost Ophthalmic Solution , 0.01% (7.5 mL) Rx only Amneal Pharmaceuticals LLC 001 002 003 004 005 006
Overview
Bimatoprost is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide and its molecular weight is 415.58 g/mol. Its molecular formula is C 25 H 37 NO 4 . Its chemical structure is: Bimatoprost is a white to an off-white powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.01% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg (260 mOsmol/kg to 330 mOsmol/kg). Each mL of Bimatoprost ophthalmic solution 0.01% contains: Active: Bimatoprost, 0.1 mg Preservative: Benzalkonium chloride, 0.15 mg Inactives: Citric acid monohydrate; sodium chloride; sodium phosphate dibasic heptahydrate; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8. 1
Indications & Usage
Bimatoprost ophthalmic solution 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. ( 1 )
Dosage & Administration
The recommended dosage is one drop in the affected eye(s) once daily in the evening. Bimatoprost ophthalmic solution 0.01% 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 hours to 12 hours. Bimatoprost ophthalmic solution 0.01% 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. One drop in the affected eye(s) once daily in the evening. ( 2 )
Warnings & Precautions
Pigmentation : 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 ) 5.1 Pigmentation Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with bimatoprost ophthalmic solution 0.01% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 5.2 Eyelash Changes Bimatoprost ophthalmic solution 0.01% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. 5.3 Intraocular Inflammation Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis). 5.4 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. Bimatoprost ophthalmic solution 0.01% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. 5.5 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 5.6 Contact Lens Use Bimatoprost ophthalmic solution 0.01% contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to instillation of bimatoprost ophthalmic solution 0.01% and may be reinserted 15 minutes following its administration.
Contraindications
Bimatoprost ophthalmic solution 0.01% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2) ] . Hypersensitivity. ( 4 )
Adverse Reactions
The following adverse reactions are described elsewhere in the labeling: Pigmentation including blepharal pigmentation and iris hyperpigmentation [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 (31%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug reactions (reported in 1% to 4% of patients) with bimatoprost ophthalmic solution 0.01% in this study included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred and visual acuity reduced. 6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of bimatoprost ophthalmic solution 0.01%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to bimatoprost ophthalmic solution 0.01% , or a combination of these factors include: asthma-like symptoms, dizziness, dry eye, dyspnea, eye discharge, eye edema, foreign body sensation, headache, hypersensitivity including signs and symptoms of eye allergy and allergic dermatitis, hypertension, lacrimation increased, periorbital and lid changes associated with periorbital fat atrophy leading to skin tightness, deepening of the eyelid sulcus, eyelid ptosis, enophthalmos and eyelid retraction; and photophobia.
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