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Latisse (Bimatoprost) ophthalmic solution 0.03% prescribing information
Latisse (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)-3hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-Nethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4.
Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Latisse is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol / kg.
Contains Active Ingredient: bimatoprost 0.3 mg / ml;
Preservative: benzalkonium chloride 0.05 mg / ml;
Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; purified water. Sodium hydroxide and / or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8.
Mechanism of Action
Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.
After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean Cmax and AUC0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing. There was no significant systemic drug accumulation over time.
Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation. Bimatoprost then undergoes oxidation, N-deethylation, and glucuronidation to form a diverse variety of metabolites.
Following an intravenous dose of radiolabeled bimatoprost (3.12 .g/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes. The total blood clearance of bimatoprost was 1.5 L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the recommended human exposure based on blood AUC levels after topical corneal and/or conjunctival sac administration respectively) for 104 weeks.
Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.
Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day.
INDICATIONS AND USAGE
Latisse (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
DOSAGE AND ADMINISTRATION
Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of Latisse (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 Latisse.
Do not apply to the lower eyelash line.
Additional applications of Latisse will not increase the growth of eyelashes.
Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.
DOSAGE FORMS AND STRENGTHS
Bimatoprost ophthalmic solution 0.3 mg / ml.
Latisse is contraindicated in patients with hypersensitivity to bimatoprost or any other ingredient in this product.
WARNINGS AND PRECAUTIONS
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, Latisse 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 Latisse may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including Lumigan for IOP reduction should only use Latisse after consulting with their physician and should be monitored for changes to their intraocular pressure.
Increased iris pigmentation has occurred when the same formulation of bimatoprost ophthalmic solution (Lumigan) was instilled directly onto the eye. Although iridal pigmentation was not reported in clinical studies with Latisse, patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent.
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 Latisse solution can be continued in patients who develop noticeably increased iris pigmentation.
Patients who receive treatment with Latisse should be informed of the possibility of increased 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.
Hair Growth Outside the Treatment Area
There is the potential for hair growth to occur in areas where Latisse solution comes in repeated contact with the skin surface. It is important to apply Latisse 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 Latisse from the eyelid margin to avoid it running onto the cheek or other skin areas.
Latisse solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution (Lumigan) for elevated IOP. Latisse 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.
Contamination of Latisse or Applicators
The Latisse bottle must be kept intact during use. It is important to use Latisse solution 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.
Use with Contact Lenses
Latisse contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
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 events were eye pruritis, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients.
Adverse reactions reported with bimatoprost ophthalmic solution (Lumigan) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, blepharitis, cataract, superficial punctuate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, conjunctival edema, abnormal hair growth, iritis, infections (primarily colds and upper respiratory tract infections), headaches, asthenia.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C
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 after topical ophthalmic administration to the cornea or conjunctival sac).
At doses at least 41 times the maximum intended human exposure, 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, Latisse should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Latisse solution is excreted in human milk, although in animal studies, bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Latisse is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
Latisse (bimatoprost ophthalmic solution) 0.03% is supplied sterile in opaque white low density polyethylene dispenser bottles and tips with turquoise polystyrene caps accompanied by 60 sterile, disposable applicators:
3 mL in a 5 ml bottle
Latisse should be stored at 2° to 25°C (36° to 77°F).
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