Universal reference book for medicines
Product name: LATISSE (LATISSE)

Active substance: bimatoprost

Type: Analog prostaglandin.
The drug for the treatment of hypotrichosis
Manufacturer: ALLERGAN (United States) manufactured by ALLERGAN SALES (United States)
Composition, form of production and packaging
Drops
for topical application in the form of a transparent, almost colorless solution.

1 ml

Bimatoprost 0.3 mg

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

3 ml - bottle-droppers (1) - packs of cardboard (1) complete with applicators (60 pcs.) - cardboard holders.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

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 installing the bimatoprost in the drug form drops for topical application of 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 decreases to the lower limit of detection (0.025 ng / ml).
The mean values ​​of the maximum concentration (C max ) in the blood plasma and the area under the concentration-time curve (AUC) on the 7th and 14th day of the application of bimatoprost were approximately the same (0.08 ng / ml and 0.09 ng h / 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 found in the protein-related condition. 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 injection of bimatoprost in a dose of 3.12 mg / kg 6 healthy volunteers C max drug in blood plasma was 12.2 ng / ml.
The half-life (T 1/2 ) was about 45 minutes. The total clearance of bimatoprost is 1.5 l / h / kg. Up to 67% of the active substance is excreted by the kidneys, and 25% by the gastrointestinal tract.
INDICATIONS

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

DOSING MODE

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, by brushing 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 EFFECT

Itching of the eyes, hyperemia of the conjunctiva, hyperpigmentation of the eyelid skin, eye irritation, dry eye syndrome, reddening of the eyelids.
The listed side effects were observed in less than 4% of cases. Possible decrease in intraocular pressure.
CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- age up to 18 years;

- Pregnancy;

- the period of breastfeeding.

With care: aphakia, pseudophakia, 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 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.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution in nephropathy.

APPLICATION FOR CHILDREN

Contraindicated for children under 18 years.

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 Latissee 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.
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. With the concomitant use of the drug Latisse and prostaglandin analogs (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. It is recommended to control IOP.
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 the installation 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. A significant increase in iris pigmentation is not an indication for the discontinuation of the drug Latisse.
Skin pigmentation eyelids

It has been reported that bimatoprost causes darkening of the skin of the eyelid and 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.
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 on the part of the visual organ (eye trauma, infection complication, etc.), with a sudden decrease in visual acuity, if it is necessary to conduct a planned ophthalmic operation, and if side effects occur, you should consult an ophthalmologist to solve the problem the possibility of further treatment with the drug Latisse.

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

Impact on the ability to manage vehicles and mechanisms

No adverse effects are expected.

OVERDOSE

Information on cases of overdose of the drug Latisse is absent.
In case of an accidental overdose, therapy should be symptomatic.
DRUG INTERACTION

If the eye drops preparation 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.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

At a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life - 2 years.
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