Prolatan 2.5 ml 0.005% eye drops

The instruction
for medical use



of Prolatan Torgovoye medicine a name
Prolatan

Mezhdunarodnoye the unlicensed


name Latanoprost Lekarstvennaya
the Drop form eye 0.005% 2.5 ml

Structure
of 1 ml of drug contains
active agent - latanoprost 0.05 mg,
excipients: a benzalkoniya chloride, sodium chloride, sodium hydrophosphate anhydrous, dihydrophosphate sodium monohydrate, water for injections.

Description
Transparent colourless solution.

Pharmacotherapeutic group
Drugs for treatment of diseases of eyes. Protivoglaukomny drugs and miotik. Analogs of prostaglandins. Latanoprost.
The ATX S01EE01 code

the Pharmacological

Pharmacokinetics of Latanoprost properties, being a pro-dosage form, it is soaked up through a cornea where there is its hydrolysis to biologically active acid. Concentration in watery moisture reaches a maximum approximately in two hours after topical administration.
Latanoprost is exposed to hydrolysis in a cornea under the influence of esterases with formation of biologically active acid. The latanoprost acid coming to a system blood stream is metabolized, generally in a liver by beta oxidation of fatty acids with formation of 1,2-dinor- and 1,2,3,4-tetraholes-metabolites. The volume of distribution is 0.16 ± 0.02 l/kg. Acid of the latanoprost is defined in watery moisture within the first 4 hours, and in plasma - only within the first hour after topical administration. Acid of the latanoprost is quickly removed from plasma (T1/2=17 min.). The system clearance is about 7 ml/min. After beta oxidation in a liver the metabolites are removed, generally by kidneys: after topical administration with urine about 88% of the entered dose are removed.

Prolatan's pharmacodynamics - F2α prostaglandin analog, is selection agonist of receptors of FP and reduces the intraocular pressure (VGD) due to increase in outflow of watery moisture, mainly, in the uveoskleralny way and also through trabecular network.
It is established what latanoprost has no significant effect on products of watery moisture and on a blood-ocular barrier.
At use in therapeutic doses latanoprost does not render significant pharmacological effect on cardiovascular and respiratory systems.

Indications
- decrease in the increased intraocular pressure at patients with an open angle glaucoma and with the raised intraocular tension.

A route of administration and doses
Adult (including elderly patients)
On one drop in the affected eye once a day.
The optimum effect is reached at Prolatan's use in the evening.
Frequency of use of Prolatan should not exceed once a day as it is established that at more frequent use the efficiency of drug decreases.
If one dose was passed, then further it is necessary to continue treatment, entering the following dose as usual.

Side effects
Very often (≥1/10):
- strengthening of pigmentation of an iris, insignificant hyperaemia of a conjunctiva, irritation of eyes (burning, an itching, pricking, feeling of a foreign body), a thickening and lengthening of eyelashes, increase in their quantity, pigmentation
is frequent (≥1/100, & lt, 1/10):
- the tranzitorny dot epithelial erosion of a cornea in most cases proceeding asymptomatically, blepharitis, painful feelings in eyes
Infrequently (≥1/1000, & lt, 1/100):
- swell a century, xerophthalmus, a keratitis, indistinct sight, conjunctivitis
- skin rash
Seldom (≥1/10.0000, & lt, 1/1000):
- the iritis/uveitis, macular swelled (including cystous macular hypostasis), swelled also cornea erosion, periorbital swelled, disturbance of the direction of growth of eyelashes that can be followed by irritant action on eyes, distikhiaz (an additional number of eyelashes behind normally growing eyelashes)
- asthma, deterioration in a course of bronchial asthma, bad asthmatic attacks and short wind
- rash, darkening of an eyelid skin
is Very rare (& lt, 1/10.000):
- deterioration in a course of stenocardia at patients with the existing disease
- a stethalgia
Is unknown (cannot be estimated from the available data)
- dizziness, a headache
- a cardiopalmus
- myalgia, an arthralgia
- a herpetic keratitis

of the Contraindication
- hypersensitivity to a latanoprost or other components of drug
- children's and teenage age up to 18 years.

Medicinal interactions
Prolatan is effective both as monotherapy, and in a combination with other drugs reducing intraocular pressure, for example, beta blockers (Timololum). Prolatan has additive effect at its use in a combination from adrenomimetika (dipivalit adrenaline), oral inhibitors of a karboangidraza (acetazoleamide) and, at least, partially additive action when assigning in a combination with cholinomimetics (pilocarpine). When assigning combination therapy it is necessary to enter different eye drops with an interval not less than five minutes.
Use of two and more prostaglandins, analogs of prostaglandin is not recommended because of possible increase in intraocular pressure.
Prolatan is incompatible with the eye drops containing tiomersat as it conducts to precipitation.

Special instructions
Prolatan contains a benzalkoniya chloride which can be absorbed by contact lenses. Before burying eye drops the contact lenses should be taken out, and it is possible to insert them only in 15 minutes after burying.
Prolatan can strengthen pigmentation of an iris which is followed by gradual change of color of eyes due to increase in content of melanin in iris stroma melanocytes. Usually brown pigmentation which is located around a pupil extends concentrically to the periphery, and all iris or its part can gain more rich brown color. Discolorations of an iris develop in most cases slowly and can remain clinically imperceptible. Discoloration in one or two eyes comes to light mainly at patients from the iris mixed by coloring which contains brown color as the main. During clinical trials the accumulation of a pigment in trabecular network or in any other department of an anterior chamber of an eye is not revealed.
Despite strengthening of pigmentation of an iris, at patients the decrease in intraocular pressure was observed. Thus, treatment by Prolatan can be continued at patients at whom pigmentation of an iris amplifies. These patients have to undergo regular inspections or (depending on a clinical situation) treatment can be stopped.
Strengthening of pigmentation of an iris usually meets in the first year of treatment. Seldom it occurs within the second or third year of treatment and was not observed after the fourth year of treatment.
Extent of pigmentation of an iris decreases over time. After drug withdrawal the further increase in quantity of a brown pigment was not observed, however already developed discoloration can become constants.
At Prolatan's use the darkening of an eyelid skin which can be reversible was observed.
Prolatan can gradually cause darkening, a thickening and lengthening of eyelashes, increase in their quantity and disturbance of the direction of their growth. These changes are reversible after the treatment termination.
Macular hypostasis including cystous met generally at patients with an aphakia, a psevdofakiya, damage of the back capsule of a crystalline lens or at patients with the known risk factors of developing macular hypostasis, at these patients Prolatan has to be applied with care.
There are limited data on use of the drug Prolatan in neovascular and congenital glaucoma. Therefore, Prolatan is recommended to apply at these states with care.
There is a limited experience of use of drug for patients with asthma. It was reported about some cases of exacerbation of asthma and short wind. Therefore patients with asthma need to use drug with care.
Prolatan has to be applied with care at patients with a herpetic keratitis in the anamnesis, it is necessary to avoid use of drug in cases of the keratitis caused by Herpes simplex, and at patients with a recurrent herpetic keratitis in the anamnesis (especially connected with analogs of prostaglandins).
Pregnancy and the period of a lactation
Safety of use Prolatana at pregnancy was not studied. However its introduction represents potential risk for course of pregnancy, a fruit and the newborn. Therefore Prolatan should not be applied at pregnancy.
Prolatana active agent and its metabolites can get into maternal milk therefore Prolatan nursing mothers should not apply or breastfeeding has to be stopped.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Burying eye drops can cause a tranzitorny feeling of 'a veil before eyes' within several minutes that needs to be considered during the driving and work with moving mechanisms.

Overdose
Symptoms: irritation of a mucous membrane of eyes, hyperaemia of a conjunctiva or episclera.
Treatment: to immediately wash eyes with water or 0.9% chloride sodium solution, symptomatic therapy.

The form of release and packing
of the Drop
spill eye 0.005% On 2.5 ml of drug in plastic bottles with the screwing-up cap of turquoise color with control of the first opening. On 1 bottle with the instruction for medical use in the state and Russian languages place in a pack cardboard.


To Store storage conditions in the place protected from light at a temperature from 2 to 8 °C.
To store the opened bottle no more than 4 weeks at a temperature not above 25 °C. To store out of children's reach!


2 years
not to apply a period of storage after the expiry date specified on packing.

Prescription status
According to the prescription


of Proizvoditel SENTISS FARM Pvt. Ltd.
212/D-1, Greene Park, New Delhi, India
At the plant: Villidzh Khera Nikhla, Tekhsil Nalagarkh, Region of Solan, Himachal Pradesh 174,101, India

Name and country of the owner of the registration certificate
of SENTISS FARMA of Pvt. Ltd., India

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Republic of Kazakhstan, 050000, Almaty, Bogenbay St. of the Batyr 132, office 309
Ph./fax: +7 (7272) 96-45-99
Email:
To Develop sentiss_kz@land.ru