LATISSE Eyes drops, solution (2020)
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Allergan, Inc.
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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1. 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.
2. 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 ...
3. Dosage Forms and Strengths
Ophthalmic solution containing bimatoprost 0.3 mg/mL.
4. Contraindications
LATISSE is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients <em>[see Adverse Reactions (6.2)]</em>.
5. Warnings and Precautions
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 ...
6. Adverse Reactions
The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure <em>[see Warnings and Precautions (5.1)]</em> Iris Pigmentation <em>[see Warnings and Precautions ...
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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of LATISSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
8.1. Pregnancy
Risk Summary There are no adequate and well-controlled studies of LATISSE (bimatoprost ophthalmic solution) 0.03% administration in pregnant women. There is no increase in the risk of major birth defects ...
8.2. Lactation
Risk Summary It is not known whether topical ocular treatment with LATISSE 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost ...
8.4. Pediatric Use
Use of LATISSE was evaluated in a sixteen week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who ...
8.5. Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
11. Description
LATISSE (bimatoprost ophthalmic solution) 0.03% is a synthetic prostaglandin analog. Its chemical name is (<em>Z</em>)7[(1<em>R</em>,2<em>R</em>,3<em>R</em>,5<em>S</em>)-3,5-Dihydroxy-2-[(1<em>E</em>,3 ...
12.1. 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 ...
12.3. Pharmacokinetics
Absorption 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 ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses up to 2 mg/kg/day and 1 mg/kg/day, respectively (192 and 291 times the human ...
14. Clinical Studies
LATISSE solution was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months ...
16.1. How Supplied
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 sterile, disposable ...
16.2. Storage and Handling
Store at 2º to 25ºC (36º to 77ºF).
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Nightly Application Inform patients that LATISSE (bimatoprost ophthalmic solution) should be applied every night using ...