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Hypotrichosis AgentOther Miotics-Antiglaucoma Preparations, Plain
Topical ophthalmic agent; synthetic prostamide used to lower IOP in patients with open-angle glaucoma or ocular hypertension; also approved for hypotrichosis.
Bimatoprost/Latissee/Lumigan Ophthalmic Sol: 0.01%, 0.03%
Instill 1 drop to the affected eye(s) once daily in the evening. More frequent administration may decrease the IOP-lowering effect.
Apply 1 drop to each eye at night using the supplied applicator; apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. Do not apply to lower lashes. Additional applications will not further increase the growth of eyelashes. Upon discontinuation, eyelash growth is expected to return to its pre-treatment level.
Apply 1 drop to each eye at night using the supplied applicator; apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. Do not apply to lower lashes. Bimatoprost has been studied in children and adolescents 5—17 years who were post-chemotherapy or had alopecia areata and in adolescents 15—17 years with hypotrichosis not associated with a medical condition. Upon discontinuation, eyelash growth is expected to return to its pre-treatment level.
1 drop/day instilled in each affected eye or applied to each upper eyelid.
1 drop/day applied to each upper eyelid.
Children >= 5 years: 1 drop/day applied to each upper eyelid.Children < 5 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustment in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustment in renal impairment are not available; it appears that no dosage adjustments are needed.
Instruct patient on proper use of bimatoprost (see Patient Information).Wash hands before and after use.Contact lenses should be removed prior to ocular application and may be reinserted 15 minutes following drug administration. Lumigan contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.Lumigan administration:Lumigan (bimatoprost ophthalmic solution) is for ophthalmic use only.Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and gently close the eyes for 1—2 minutes. Do not blink.To avoid contamination, do not touch the tip of the dropper to the eye, fingertips, or other surface.The solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.Latisse administration:Prior to using, ensure the patient's face is clean and makeup removed.The disposable sterile applicator is the only applicator that should be used. Each applicator should be used for 1 eye only; dispose of the applicator after each use.After applying 1 drop of solution to the applicator, apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of eyelash growth should feel lightly moist without runoff. Blot excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth.Do not apply to the lower eyelash line.
Latissee:- Store between 36 to 77 degrees FLumigan:- Store between 36 to 77 degrees F
Bimatoprost is contraindicated in patients with hypersensitivity to bimatoprost.
Bimatoprost should not be used in patients with closed-angle glaucoma, or inflammatory or neovascular glaucoma.
Bimatoprost should be used with caution in patients with active intraocular inflammation (e.g., iritis, uveitis). Prostaglandin analogs have been reported to cause intraocular inflammation and use in patients with active intraocular inflammation may exacerbate the condition. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. Inadvertent contamination of the bimatoprost containers may increase the risk of infection in ocular surgery patients, or in patients who develop an ocular infection or ocular trauma, including corneal abrasion. If there is any damage to the ocular epithelial surface, bimatoprost should be used with caution. Bimatoprost should be used with caution in patients with aphakia, pseudophakic patients with a torn posterior lens capsule, and patients with known risk factors for macular edema. Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost.
Contact lenses should be removed prior to administration of bimatoprost and may be reinserted after 15 minutes. Bimatoprost ophthalmic solution contains the preservative benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses.
Bimatoprost may gradually change eye color, increasing the amount of brown pigment in the iris. This change may be permanent. Patients should be informed of the possibility of iridal discoloration. Some patients may also develop photophobia and may be more sensitive to sunlight (UV) exposure.
The use of bimatoprost for the reduction of intraocular pressure in neonates, infants, children, and adolescents < 16 years is not recommended because of potential safety concerns related to increased pigmentation after long-term chronic use. Safety and efficacy of bimatoprost for hypotrichosis has not been established for neonates, infants, and children < 5 years of age. The use of bimatoprost for hypotrichosis has been studied in children and adolescents 5—17 years who were post-chemotherapy or had alopecia areata and in adolescents 15—17 years with hypotrichosis not associated with a medical condition.
There are no adequate and well-controlled studies of bimatoprost ophthalmic solution in pregnant women; however, there is no increase in the risk of major birth defects or miscarriages based on postmarketing data. After repeated ophthalmic administration of bimatoprost, the drug does not significantly accumulate systemically. According to the manufacturer, bimatoprost should not be administered during pregnancy unless the potential benefit justifies the potential risk to the fetus.
It is not known whether bimatoprost is excreted in breast milk. Because the drug's half-life is short, systemic concentrations after ophthalmic administration are very low, and protein binding is > 80%, clinically significant amounts of the drug are not expected to be bioavailable to a nursing infant via breast-milk. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. According to the manufacturer, caution should be exercised when it is administered to a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
keratitis / Delayed / 0-10.0visual impairment / Early / 0-10.0ocular hemorrhage / Delayed / Incidence not knownmacular edema / Delayed / Incidence not known
blepharitis / Early / 0-10.0cataracts / Delayed / 0-10.0blurred vision / Early / 0-10.0erythema / Early / 1.0-4.0photophobia / Early / 1.0-3.0conjunctivitis / Delayed / 1.0-3.0iritis / Delayed / 0-1.0conjunctival hyperemia / Early / 15.0ocular inflammation / Early / Incidence not knownhypertension / Early / Incidence not knowndyspnea / Early / Incidence not known
ocular irritation / Rapid / 0-10.0foreign body sensation / Rapid / 0-10.0xerophthalmia / Early / 0-10.0ocular pain / Early / 0-10.0skin hyperpigmentation / Delayed / 1.0-10.0hirsutism / Delayed / 1.0-5.0asthenia / Delayed / 1.0-5.0headache / Early / 1.0-5.0ocular discharge / Delayed / 1.0-3.0iridal discoloration / Delayed / 1.0-3.0hypertrichosis / Delayed / 1.0ocular pruritus / Rapid / 15.0lacrimation / Early / Incidence not knownnausea / Early / Incidence not knowndizziness / Early / Incidence not knowninfection / Delayed / Incidence not knownmaculopapular rash / Early / Incidence not known
There are no drug interactions associated with Bimatoprost products.
•reduction of intraocular pressure (IOP): Bimatoprost selectively mimics endogenous prostamides to produce ocular hypotension. IOP is thought to be reduced by increased aqueous humor outflow through both trabecular network and uveoscleral routes. In vitro biological assays suggest that bimatoprost and related prostamides may also activate novel receptors, which have not yet been identified.•promotion of eyelash growth: The mechanism for promotion of eyelash growth is not known; however, an increase in the percent of hairs and an increase in the duration of the hair growth (anagen) phase is postulated.
Bimatoprost ophthalmic solution is administered topically to the eye. There is no significant systemic drug accumulation with repeated dosing. Bimatoprost is metabolized via oxidation, n-deethylation, and glucuronidation.
The elimination half-life following an intravenous dose is approximately 45 minutes with 67% of the administered dose excreted in the urine and 25% recovered in the feces.
Ophthalmic RouteFollowing ocular administration, bimatoprost is absorbed primarily through the sclera. Peak blood concentrations are achieved within 10 minutes and are undetectable within 90 minutes. Reduction of IOP begins approximately 4 hours after the first dose, with the maximum effect occurring in about 8—12 hours.