Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low-density polyethylene round screw neck bottle and tips with high density polyethylene turquoise opaque screw cap accompanied by sterile, disposable applicators: 5 mL in a 5 mL bottle with 140 applicators NDC 46708-511-05 3 mL in a 5 mL bottle with 70 applicators NDC 46708-511-03 Storage: Store at 2° to 25°C (36° to 77°F).; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 5 mL - Alembic: B imatoprost ophthalmic solution 0.03% Topical - Carton label - 5mL - Alembic : Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 3 mL - Alembic : B imatoprost ophthalmic solution 0.03% Topical - Carton label - 3mL - Alembic : Bottle-label-5 mL Carton -Label-5 mL Bottle-Label-3 mL Container-Label-3mL
- 16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low-density polyethylene round screw neck bottle and tips with high density polyethylene turquoise opaque screw cap accompanied by sterile, disposable applicators: 5 mL in a 5 mL bottle with 140 applicators NDC 46708-511-05 3 mL in a 5 mL bottle with 70 applicators NDC 46708-511-03 Storage: Store at 2° to 25°C (36° to 77°F).
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 5 mL - Alembic: B imatoprost ophthalmic solution 0.03% Topical - Carton label - 5mL - Alembic : Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 3 mL - Alembic : B imatoprost ophthalmic solution 0.03% Topical - Carton label - 3mL - Alembic : Bottle-label-5 mL Carton -Label-5 mL Bottle-Label-3 mL Container-Label-3mL
Overview
Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[( 1R, 2R, 3R, 5S )-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-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 soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is 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; Preservative : benzalkonium chloride 0.05 mg/mL; Inactives : sodium chloride; sodium phosphate, dibasic; citric acid; 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 to7.8. bimatoprost-struc
Indications & Usage
Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Bimatoprost ophthalmic solution, for topical ophthalmic use is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
Dosage & Administration
Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of lash growth should feel lightly moist without runoff. Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator. Do not reuse applicators and do not use any other brush/applicator to apply bimatoprost ophthalmic solution 0.03%. Do not apply to the lower eyelash line [ see Warnings and Precautions (5.3, 5.4 ] and Patient Counseling Information (17)]. Additional applications of bimatoprost ophthalmic solution 0.03% will not increase the growth of eyelashes. Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level. Apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. Blot any excess solution beyond the eyelid margin. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.
Warnings & Precautions
Concurrent administration of Bimatoprost ophthalmic solution, for topical ophthalmic use and intraocular pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2, 5.3 ) 5.1 Effects on Intraocular Pressure Bimatoprost ophthalmic solution (LUMIGAN ® ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, bimatoprost ophthalmic solution 0.03% lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN ® , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect. In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution 0.03% may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN ® for IOP reduction should only use bimatoprost ophthalmic solution 0.03% after consulting with their physician and should be monitored for changes to their intraocular pressure. 5.2 Iris Pigmentation Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent [see Adverse Reactions (6.2] . The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with administration of bimatoprost ophthalmic solution 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. Treatment with bimatoprost ophthalmic solution 0.03% can be continued in patients who develop noticeably increased iris pigmentation. 5.3 Lid Pigmentation Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients. 5.4 Hair Growth Outside the Treatment Area There is the potential for hair growth to occur in areas where bimatoprost ophthalmic solution 0.03% comes in repeated contact with the skin surface. It is important to apply bimatoprost ophthalmic solution 0.03% only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess bimatoprost ophthalmic solution 0.03% from the eyelid margin to avoid it running onto the cheek or other skin areas. 5.5 Intraocular Inflammation Bimatoprost ophthalmic solution 0.03% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. 5.6 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution (LUMIGAN®) for elevated IOP. Bimatoprost ophthalmic solution 0.03% 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. 5.7 Contamination of bimatoprost ophthalmic solution 0.03% or Applicator The Bimatoprost ophthalmic solution 0.03% bottle must be kept intact during use. It is important to use bimatoprost ophthalmic solution 0.03% as instructed, by placing one drop on the single-use- per-eye applicator. The bottle tip should not be allowed to contact any other surface since it could become contaminated. The accompanying sterile applicators should only be used on one eye and then discarded since reuse of applicators increases the potential for contamination and infections. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products [see Patient Counseling Information (17)]. 5.8 Use with Contact Lenses Bimatoprost ophthalmic solution 0.03% contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
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
Adverse Reactions
The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure [see Warnings and Precautions (5.1)] Iris Pigmentation [see Warnings and Precautions (5.2)] Lid Pigmentation [see Warnings and Precautions (5.3)] Hair Growth Outside the Treatment Area [see Warnings and Precautions (5.4)] Intraocular Inflammation [see Warnings and Precautions (5.5)] Macular Edema [see Warnings and Precautions (5.6)] Hypersensitivity [see Contraindications (4)] Most common adverse reactions (incidence approximately 3% to 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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. The following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients. Additional adverse reactions seen in clinical trials experience include foreign body sensation, hair growth abnormal, and iris hyperpigmentation. Additional adverse reactions reported with bimatoprost ophthalmic solution (LUMIGAN ® ) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, eye pain, blepharitis, cataract, superficial punctate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, conjunctival edema, iritis, infections (primarily colds and upper respiratory tract infections), headaches, and asthenia. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of bimatoprost ophthalmic solution 0.03%. 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. The reactions include dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few lashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis, rash (including macular and erythematous), skin discoloration (periorbital), skin exfoliation of the eyelid and/or periorbital area, trichiasis, and vision blurred.
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