Xalatan drops Ch. 0.005% 2.5ml vial, cap.

$14.67

Xalatan drops Ch. 0.005% 2.5ml vial, cap.

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SKU: 0706768457 Categories: , , Tags: ,

Description

Composition
Active substance:
1 ml of solution contains: latanoprost – 50 micrograms ;.
Excipients:
Sodium chloride, sodium dihydrogen phosphate (monohydrate), sodium phosphate (anhydrous), benzalkonium chloride, water for injection.
Description:
The clear, colorless solution.
Product form:
Eye drops of 0.005%; 2.5 ml of a solution (ocular drops) in dropper vial (low density polyethylene) with a screw cap and a safety cap unthreaded from the control of the first opening; 1 or 3 dropper bottle with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to latanoprost or other components of the formulation. Up to 1 year (effectiveness and safety have been established).
Carefully
Aphakia, psevdoafakiya with rupture posterior lens capsule, patients with risk factors for macular edema (in treatment of latanoprost described cases of macular edema, including cystoid); inflammatory, neovascular glaucoma (due to lack of enough experience with the drug); bronchial asthma; herpetic keratitis in history. Avoid using the drug Ksalatan® in patients with an active form of herpetic keratitis and recurrent herpetic keratitis, especially those related to prostaglandin analogs taking F2alfa. Ksalatan® should be used with caution in patients with risk factors for iritis / uveitis. There are limited data on the use of the drug Ksalatan® in patients undergoing surgery for cataracts. In this regard, in this group of patients Ksalatan® should be used with caution.
Dosage
0.05 mg / ml
Indications
Reduction of elevated intraocular pressure (IOP) in adults and children (over the age of 1 year) with open angle glaucoma or elevated intraocular.
Interaction with other drugs
With simultaneous instillation into the eyes of two prostaglandin analogues described paradoxical increase in IOP, so simultaneous use of two or more prostaglandins, their analogs or derivatives not recommended.
Pharmaceutical incompatible with eye drops containing thiomersal – precipitation.
Overdose
In addition to eye irritation, conjunctival hyperemia episclera or other undesirable changes in the body of an overdose of latanoprost not known. When receiving the random latanoprost inwardly to consider the following: One vial containing 2.5 ml of a solution containing 125 micrograms latanoprost. More than 90% of the drug is metabolized during the first pass through the liver. An intravenous infusion at a dose of 3 mcg / kg in healthy volunteers did not cause any symptoms but when administered dose 5,5-10 g / kg were observed nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In patients with bronchial asthma, moderate administering latanoprost in the eye in a dose of 7 times exceeding the therapeutic one, does not cause bronchospasm.
In the case of overdose symptomatic treatment.
pharmachologic effect
Pharmacological group:
Antiglaucoma agents – prostaglandin F2alfa synthetic analogue.
Pharmacodynamics:
Latanoprost – prostaglandin analogue F2alfa – a FP (Prostaglandin F) selective receptor agonist and lowers intraocular pressure (IOP) by increasing the outflow of aqueous humor mainly uveoscleral route, as well as through the trabecular meshwork. Lowering IOP begins after about 3 – 4 hours after drug administration, the maximum effect is observed after 8 – 12 hours, the effect persists for at least 24 hours.
Established that latanoprost has no significant effect on production of aqueous humor and blood aqueous barrier.
When used in therapeutic doses latanoprost has no significant pharmacological effects on the cardiovascular and respiratory systems.
Pharmacokinetics:
Suction
Latanoprost, as a prodrug is absorbed through the cornea where it is hydrolyzed to the biologically active acid. The concentration in the aqueous humor reached the maximum after about two hours after topical application.
Distribution
The volume of distribution is 0.16 +/- 0.02 L / kg. Latanoprost acid is determined in aqueous humor within the first 4 hours and plasma – only during the first hour after topical application.
Metabolism
Latanoprost, as a prodrug, is hydrolyzed in the cornea by the action of esterase with the formation of a biologically active acid. Latanoprost acid entering the systemic circulation, it is metabolized mainly in the liver by the beta-oxidation of fatty acids to form the 1,2-dinor- and 1,2,3,4-tetranor-metabolites.
breeding
latanoprost acid is rapidly eliminated from the plasma (t1 / 2 = 17 min). Systemic clearance is approximately 7 mL / min / kg. After the beta-oxidation in the liver metabolites are excreted mainly by the kidneys: after topical application with urine output approximately 88% of the administered dose. Children
latanoprost exposure is approximately 2-fold higher in children aged 3 to 12 years compared with older patients, and 6 times higher in children aged under 3 years. However, the safety profile of the drug is no different in children and adults. The time to reach maximum concentration of latanoprost acid in plasma was 5 minutes for all age groups. The half-life period of latanoprost acid in children is the same as in adults. The equilibrium concentration is no cumulation of latanoprost acid in blood plasma.
Pregnancy and breast-feeding
Adequate controlled studies have not been conducted in pregnant women. The drug should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
Latanoprost and its metabolites may be released into the breast milk, so the lactation the drug should be used with caution.
Conditions of supply of pharmacies
On prescription.
side effects
Registered the following adverse reactions related to the use of the drug: the part of the organ of vision: eye irritation (burning sensation, feeling of sand in the eyes, itching, stinging and foreign body sensation); blepharitis; conjunctival hyperemia; Pain in the eyes; increased pigmentation of the iris; transient point corneal epithelium erosion, swelling of the eyelids, periorbital edema, corneal edema and erosion; conjunctivitis; lengthening, thickening, increased number and increased pigmentation of eyelashes and vellus hair; iritis / uveitis; keratitis; macular edema, including cystoid; a change in direction of growth of eyelashes sometimes cause irritation of the eyes; growth of an additional row of eyelashes on the meibomian glands, changes in the periorbital region and in the area of ​​the eyelashes, resulting in the deepening of the upper lid sulcus; blurred vision, photophobia, dryness of the mucous membranes.
For the skin and subcutaneous tissue disorders: rash, darkening of the eyelid skin and local skin reaction on the eyelids, toxic epidermal necrolysis.
From the nervous system: dizziness, headache.
From the respiratory system: bronchospasm (including acute attacks or exacerbations in patients with a history of bronchial asthma), shortness of breath.
On the part of the musculoskeletal system and connective tissue disorders: pain in muscles / joints. General and local reactions: non-specific chest pain.
Infections and infestations: herpetic keratitis.
Also, there were cases of retinal artery embolism, retinal detachment and vitreous hemorrhage in patients with diabetic retinopathy.
Children
Ksalatan® safety profile of the drug in children is not different from the safety profile in adults. Compared with the adult population, children most frequently observed nasopharyngitis and fever.
special instructions
Ksalatan® drug should be used no more than once a day, as more frequent administration of latanoprost leads to weakening of the IOP-lowering effect. Omitting a single dose, the next dose should be administered at the usual time. Latanoprost can be used simultaneously with other classes of drugs for ophthalmic topical use to reduce intraocular pressure. If the patient simultaneously uses other eye drops, they should be applied at intervals of at least 5 minutes. The composition includes a preparation Ksalatan® benzalkonium chloride which can be absorbed by contact lenses. Before burying drops contact lenses must be removed and re-install them in 15 minutes.
Latanoprost may cause a gradual increase in the content of brown pigment in the iris. Change eye color due to increased melanin content in the stromal melanocytes of the iris and not an increase in the number of melanocytes themselves. Typically, the brown pigmentation appears around the pupil spreads concentrically to the periphery of the iris. The entire iris or parts become brown. In most cases, the color change is small and can not be established clinically. Increased pigmentation of the iris of one or both eyes is mainly observed in patients with a mixed color of the iris, comprising at the base of a brown color. The drug has no effect on nevi and lentigo iris; Pigment accumulation in the trabecular meshwork or not observed in the anterior chamber.
In determining the degree of pigmentation of the iris for more than 5 years did not reveal adverse effects increased pigmentation even when continued treatment with latanoprost. Patients degree of IOP reduction was similar regardless of the presence or absence of amplification of iris pigmentation. Therefore, treatment with latanoprost can be continued in case of increased pigmentation of the iris. Such patients should be regularly monitored and, depending on the clinical situation, treatment can be discontinued.
Increased pigmentation of the iris usually occurs within the first year after the start of treatment, rarely – during the second or third year. After the fourth year of treatment, this effect was not observed. the rate of progression of pigmentation decreases with time and stabilized after 5 years. In more remote terms the effects of increased iris pigmentation has not been studied. After cessation of treatment gain brown pigmentation of the iris is not mentioned, but the change in eye color may be irreversible.
In connection with the application of latanoprost described cases of skin darkening age, which may be reversible.
Latanoprost may cause a gradual change eyelashes and vellus hair, such as lengthening, thickening, increased pigmentation, increased density and change in the direction of growth of eyelashes. Eyelash changes are reversible and disappear after cessation of treatment. Patients who use the drops only in one eye, may develop heterochromia. The use of eye drops can cause a transient blurring of vision.
To drive or to use complex equipment during the use of the drug with caution.
Storage conditions
At +2 – + 8 ° C, protected from light.
After opening, the vial is stored at a temperature not higher than +25 C.
Keep out of the reach of children.
Dosing and Administration
In adults and children older than 1 year – one drop into the affected eye (s) once a day. Optimal effect is achieved when using the drug in the evening.
As with any use of eye drops, to reduce possible systemic effect of the drug immediately after instillation of each drop is recommended to press the lower sloznuyu point located at the inner corner of the eye on the lower eyelid. This must be done within 1 minute.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Pfizer

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