Latisse (LATISSE)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBimatoprostBimatoprost
Similar drugsTo uncover
  • BIMOPTIC ROMFARM
    drops d / eye 
    K.O. Ромфарм Компани С.Р.Л.     Romania
  • Latisse
    drops locally 
    Allergen, Inc.     USA
    • Dosage form: & nbspdrops for topical application
    Composition:

    Active substance: bimatoprost - 0.3 mg / ml;

    Excipients: benzalkonium chloride, sodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid, sodium hydroxide, water.

    Description:

    Transparent, almost colorless solution.

    Pharmacotherapeutic group:Hypothyroidism treatment
    ATX: & nbsp

    S.01.E.E.03   Bimatoprost

    Pharmacodynamics:

    Bimatoprost is a structural analogue of prostaglandin. The exact mechanism of action is unknown, but it is assumed that the growth of eyelashes is due to an increase in the number of eyelashes, as well as an increase in the duration of the growth phase of the hair follicle or eyelash growth phase.

    Pharmacokinetics:

    When instillation of bimatoprost in the drug form, drops for topical application 0.03% It is shown that the maximum concentration of the drug in the blood plasma is reached within 10 minutes after application, and within 1.5 hours is reduced to the lower limit of detection (0.025 ng / ml). Mean values ​​of maximum concentration (CmOh) in the blood plasma and the area under the curve "concentration-time" (AUC) on days 7 and 14 of the application of bimatoprost were approximately the same (0.08 ng / ml and 0.09 ng * h / ml, respectively). No significant systemic cumulation was observed.

    Bimatoprost is moderately distributed in the body tissues with the volume of distribution in the equilibrium state - 0.67 l / kg. In the blood plasma bimatoprost is mainly in the protein-bound state. In the systemic blood stream, only 12% of the bimatoprost is in free form.

    Bimatoprost reaches the systemic blood flow mainly in an unchanged state. Then there is oxidation, ethylation and glucuronidation with the formation of a number of metabolites.

    With intravenous administration of bimatoprost in a dose of 3.12 mg / kg 6 healthy volunteers CmOh drug in the blood plasma was 12.2 ng / ml. The half-life (T1/2) was about 45 minutes. The total clearance of bimatoprost is 1.5 l / h / kg. Up to 67% the active substance is excreted by the kidneys, and 25% - through the gastro-intestinal tract.

    Indications:

    Treatment of hypothyroidism of eyelashes (insufficient growth of eyelashes).

    Contraindications:

    Hypersensitivity to the components of the drug, age to 18 years, pregnancy, lactation.

    Carefully:

    Afakia, pseudofakia, damage to the posterior capsule of the lens, as well as in the presence of risk factors for edema of the macula, prolonged course of diabetes mellitus, high cholesterol, nephropathy, hypertension, especially with high diastolic pressure, in patients with uveitis due to possible progression of this disease.

    Pregnancy and lactation:

    In animal studies with oral bimatoprost treatment in a dose that was 33-97 times higher than recommended for topical use, miscarriages were observed. When applied at a dose 41 times higher than therapeutic, there was a reduction in gestation, an increase in the frequency of fetal death, a decrease in the body weight of newborns. Controlled studies of Latisse in pregnant women in the drug form of a drop for topical application of 0.03% were not performed.

    In animal studies, the penetration of bimatoprost into breast milk was confirmed. When prescribing the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:The drug is used 1 time at night.The face should be previously cleaned of make-up and remove contact lenses.
    One drop of the drug of Latisse is applied to the sterile applicator applied in the kit and evenly applied to the skin of the upper eyelid along the line of growth of the eyelashes, using a brush along the edge of the upper eyelid.

    The upper eyelid in the area of ​​eyelash growth should be slightly moistened, but without leakage of the drug beyond the line of eyelash growth. To avoid excessive moistening of the eyelid, it is necessary to remove excess drug.

    The applicator must be discarded after a single use. The procedure for applying the drug to the upper eyelid is repeated with the other eye using another sterile applicator.

    Do not use the applicators again!

    To apply the drug to Latisse, you can not use any other applicator (other than sterile applicators included in the kit) or a brush.

    Do not apply the drug to the lower eyelid. Avoid contact of the dropper with any surfaces to avoid infection.

    Side effects:

    General information on adverse reactions during the use of the drug was obtained during a multicentre,randomized, double-blind, placebo-controlled study in parallel groups involving 278 adult patients who received therapy with the study drug for 4 months.

    Itching of the eye, hyperemia of the conjunctiva, hyperpigmentation of the eyelid skin, eye irritation, dry eye syndrome, reddening of the eyelids. The listed undesirable reactions were observed in less than 4% of cases.

    The frequency of occurrence of adverse events from post-registration data can not be determined due to the lack of information about the size of the population in which the development of each of the undesirable phenomena was noted, as well as the spontaneous nature of reports of adverse events in this period. In addition, during the post-marketing period, the following adverse reactions were received: eyelid burning sensation, conjunctival puffiness, eyelid irritation, eyelid edema, itchy eyelid skin, hyperpigmentation of the iris, hypersensitivity reactions (local allergic reactions), lacrimation, madarose and trichorexis (temporary lash several pieces to whole sites and temporary fragility of eyelashes, respectively),changes in the skin of the eyelid and periorbital area, including the deepening of the fold of the eyelid, spotted rash or erythematous rashes, skin discoloration (periorbital), blurred vision.

    Overdose:

    Information on cases of overdose of the drug Latisse is absent.

    In case of an accidental overdose, therapy should be symptomatic.

    Interaction:

    If the preparation in the form of eye drops, containing bimatoprost, is used in patients with glaucoma or high intraocular pressure, the degree of decrease in intraocular pressure may be less pronounced with the simultaneous use of the drug Latisse.

    Cases of incompatibility are unknown.

    Special instructions:

    The effect of treatment develops gradually, in most patients up to 2 months. Patients should be warned that the effect of the drug is unstable, and a gradual return to baseline after the discontinuation of use of the drug Latisse is expected. In addition, there may be differences in the length of the eyelashes, their thickness, color intensity, total number of eyelashes or uneven growth, and / or a change in the direction of growth of the eyelashes.

    If the patient forgot to apply the drug to Latisse, it is applied at the usual time the next day.

    Effect on intraocular pressure (IOP)

    Bimatoprost reduces intraocular pressure (IOP) when it is instillated directly into the conjunctival cavity of patients with elevated IOP. In clinical studies, the use of the drug Latisse was accompanied by a decrease in IOP both in patients with high IOP, and with its normal values, but did not reach clinically significant values. With the joint use of the drug Latisse and analogues of prostaglandin (including bimatoprost in the form of eye drops), used to reduce IOP in patients with intraocular hypertension, it is possible to reduce the hypotensive effect. In case the patient receives treatment with analogues of prostaglandins, consultation of the attending physician and monitoring of intraocular pressure are necessary in the appointment of additional therapy with the drug Latisse.

    Risk groups

    Care should be taken when using the drug in patients with acute inflammatory diseases of the inner shells of the eyeball, for example,because the use of the drug may exacerbate the course of inflammatory phenomena, patients with aphakia, pseudoafacies with rupture of the posterior capsular lens or patients with risk factors for development of macular edema.

    Iris pigmentation

    Perhaps increased pigmentation of the iris, especially with a dark pigment, this effect can be irreversible. Strengthening the pigmentation of the iris was observed during instillation of eye drops. The change in pigmentation is associated, first of all, with an increase in melanin content, as well as an increase in the number of melanocytes.

    The duration of the pigmentation enhancement effect is unknown. The change in the color of the iris against the background of treatment can go unnoticed from a few months to several years. There is no information on the clinical significance of the increase in iris pigmentation in the long term. As a rule, when applying the drug, brown pigmentation around the pupil spreads concentrically to the periphery of the iris, as a result of which the entire iris or individual sectors become more brown.The use of the drug has no effect on the accumulation of pigment on the iris of the eye (nevi and freckles). A significant increase in iris pigmentation is not an indication for the discontinuation of the drug Latisse.

    Skin pigmentation eyelids

    It was reported that bimatoprost causes darkening of the skin of the eyelids and the periorbital area.

    It is assumed that the pigmentation may increase during the entire time of application of the drug Latisse, but in most patients it is reversible and gradually disappears when the drug is withdrawn.

    Hair growth outside the treatment zone

    It is possible to grow hair on those areas of the skin, on which the drug was accidentally applied. It is important to apply the drug Latisse only to the skin of the edge of the upper eyelid along the line of eyelash growth, using the attached sterile applicator; Do not let Latissa get on your face.

    Prevention of microbial contamination of the drug Latisse and applicators

    To reduce the risk of eye infection, it is recommended to use the drug Latisse strictly according to the instructions, the tip of the dropper bottle and the applicator brush should not touch any surfaces, nor should you touch them with your fingers.It is necessary to use the attached sterile applicator only once, after use, the applicator is discarded, since re-use of the applicator increases the probability of bacterial contamination of the preparation and its subsequent infection. The result of using an infected drug or an applicator may be infectious inflammation. Cases of bacterial keratitis have been reported with the use of multi-dose vials of ophthalmic agents for topical use.

    Use when wearing contact lenses

    The drug Latisse contains benzalkonium chloride, which can be adsorbed by soft contact lenses, cause eye irritation and discoloration of soft contact lenses. Contact lenses should be removed before the drug is used, and re-installed no earlier than 15 minutes.

    In case of any symptoms from the side of the eye (eye injury, infection complication, etc.), with a sudden decrease in visual acuity, if it is necessary to conduct a planned ophthalmologic operation, and if undesirable reactions occur, you should consult an ophthalmologist to solve the problem about the possibilityfurther treatment with the drug Latisse.

    The shelf life of the drug after the first opening of the bottle is 28 days.

    Effect on the ability to drive transp. cf. and fur:

    No adverse effects are expected.

    Form release / dosage:Drops for topical application, 0.03%.
    Packaging:

    To 3.0 ml of the drug in a dropper bottle of white low-density polyethylene with a capacity of 5 ml with a screw-on polystyrene cap, which is sealed with a white polyvinyl chloride film. One bottle-dropper along with the instruction for use is placed in an individual cardboard box.

    10 applicators for single use are placed in polyethylene blisters with perforations (5 x 2) and sealed with paper-film. 6 blisters are placed in an individual cardboard box.

    1 bottle-dropper complete with 60 applicators for single use, packaged properly, placed in a cardboard holder with side "windows" (for visualization of marking of cardboard packs).

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008174/10
    Date of registration:17.08.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Allergen, Inc.Allergen, Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspAllergen of CIS SARL. LtdAllergen of CIS SARL. LtdRussia
    Information update date: & nbsp11.03.2018
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