Bimatan drops Ch. 0.03% 2.5ml vial 1 piece

$12.63

Bimatan drops Ch. 0.03% 2.5ml vial 1 piece

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Description

Composition
Active substance:
1 ml contains: 0.3 mg of bimatoprost.
Excipients:
Benzalkonium chloride 0.05 mg Sodium chloride 8.30 mg citric acid monohydrate 0.14 mg disodium hydrogen phosphate heptahydrate 2.68 mg Sodium hydroxide to pH 7.3 hydrochloric acid to pH 7.3 Water for injection to 1 ml.
Description:
The clear, colorless solution.
Product form:
Eye drops 0.03%.
2.5 mL in a polyethylene bottle with a cork-screw cap and the dropper turquoise color with the first control opening. One vial with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to bimatoprost or to other components of the drug, the age of 18 years.
Carefully.
Caution must be exercised when using the drug therapy in patients with known risk factors for macular edema (e.g., aphakic patients, patients with pseudophakic and posterior lens capsule rupture).
Use with caution in patients with severe eye infections in history (eg, herpes simplex virus) or iritis / uveitis.
No experience with bimatoprost in patients with concomitant impairment of respiratory function, which requires careful observance of these patients. In clinical studies in patients with impaired function of external respiration was not observed any significant adverse effects on the respiratory system.
Not examined the effects of bimatoprost on patients with heart block is heavier than the first degree, or patients with uncontrolled congestive heart failure. It was noted a limited number of cases, bradycardia or hypotension when applying bimatoprost. Bimatoprost should be used with caution in patients predisposed to low heart rate or low blood pressure.
Not examined the effects of bimatoprost on patients with inflammatory diseases of the eye, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Dosage
0.3 mg / ml
Indications
The reduction of elevated intraocular pressure in ocular hypertension and open-angle glaucoma in adults (as monotherapy or in combination with beta-blockers).
Interaction with other drugs
Special studies of interaction with other drugs has not been conducted. Interactions are not expected in the human body, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng / ml) of the drug after topical application in ophthalmology.
In clinical studies, bimatoprost was used in conjunction with several different beta-blockers for topical use in ophthalmology, but no interactions were observed.
Concomitant use of bimatoprost and other antiglaucoma drugs, in addition to ophthalmic beta-blockers has not been evaluated in studies of efficacy and safety of combination therapy.
There was a decrease of antihypertensive effect of bimatoprost by combining it with other prostaglandin analogues in the treatment of ocular hypertension or glaucoma.
Overdose
There were no cases of overdose when applied topically. In the case of treatment of an overdose should be symptomatic and supportive.
pharmachologic effect
Pharmacological group:
Antiglaucoma agents – prostaglandin F2-alpha analog synthesis.
Pharmacodynamics:
Bimatoprost reduces intraocular pressure in humans by increasing the outflow of aqueous humor through the trabecular meshwork and increasing uveoscleral outflow. Reducing the intraocular pressure begins after approximately 4 hours after the first administration and the maximum effect is achieved after about 8 – 12 hours. This effect lasts for at least 24 hours.
Bimatoprost is a potent ophthalmic hypotensive agent. This synthetic prostamid structurally related to prostaglandin F2 alpha (PGF2 alpha) which does not act through known prostaglandin receptors. Bimatoprost selectively mimics the effects of newly discovered biosynthesized substances prostamidov. However prostamida receptor structure has not been identified yet.
Only has limited information on the effectiveness of the drug in the treatment of pseudoexfoliation and pigmentary glaucoma, as well as on the experience of the application of bimatoprost in the treatment of angle-closure glaucoma in patients who had previously been held iridotomy.
According to data from clinical studies, no significant drug effect on heart rate and blood pressure.
Pediatric population.
There are no data on the efficacy and safety of bimatoprost in patients younger than 18 years.
Pharmacokinetics:
Suction.
Bimatoprost well penetrates into the cornea and sclera human in vitro. After instillation of the adult systemic exposure of bimatoprost is very low drug accumulation was observed. After administration of one drop of the drug in both eyes once a day for two weeks, the concentration in the blood peaked 10 minutes after dosing, and for 1.5 hours, this figure was below detection level (0,025 ng / ml). The mean values ​​Cmax and AUC 0-24 h were similar on the 7th and 14th day – 0.08 ng / ml and 0.09 ng · h / ml, respectively, indicating that the steady state concentration of bimatoprost It was reached during the first week of instillation.
Distribution.
Bimatoprost is moderately distributed in the tissues of the body, and the system equilibrium volume – 0.67 L / kg. In human blood bimatoprost it is mainly in the plasma. Bimatoprost Plasma protein binding is approximately 88%.
Metabolism.
Bimatoprost reaches the systemic circulation mainly unchanged. Then oxidation occurs, N-deethylation and glucuronidation to form several metabolites.
Withdrawal.
Bimatoprost is derived mainly through the kidneys. Up to 67% of an intravenous dose in healthy adult volunteers excreted in the urine, 25% of the dose excreted in the feces. The half-life after intravenous administration was approximately 45 minutes, total clearance from blood was 1.5 l / h / kg.
Pregnancy and breast-feeding
Pregnancy.
No data for clinical trials of bimatoprost pregnant women. According to studies on animal reproductive toxicity demonstrated when used in the high, toxic doses for the mother body.
We do not recommend the use of bimatoprost in the period of pregnancy in the absence of rigorous evidence.
During breastfeeding.
It is unknown whether bimatoprost is excreted into breast milk in humans. In animal studies showed that bimatoprost is released in breast milk. If necessary, the use of bimatoprost in the period of breastfeeding is necessary to take a decision to stop breastfeeding or discontinuing therapy of bimatoprost, taking into account the benefit of breast-feeding for the child and the need for drug therapy for the mother.
Fertility.
There is no information on the effect of bimatoprost on human fertility.
Conditions of supply of pharmacies
On prescription.
side effects
The following adverse events were observed in clinical trials and in the post-registration period.
The incidence was conducted in accordance with the following classification: very often (> 1/10); often (> 1/100 to
special instructions
Before you begin treatment, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation. Some of these changes may be permanent, and may lead to differences in appearance between the eyes when exposed to the treatment of only one eye. Changing iris pigmentation occurs slowly and may not be noticeable for several months or years. The most common change in iris color is permanent. Changing the color of the iris is more concerned with increased melanin content in melanocytes, rather than with the number of melanocytes. Long term effects of improving pigmentation of the iris unknown. In typical cases there is a distribution of brown pigment from the area around the pupil to iris root, resulting in all or part of the iris acquire a brown color. Application bimatoprost no effect on nevi and lentigo iris. Pigmentation of the periorbital tissue is reversible in some patients.
There are reports about the possibility of development of cystoid macular edema during therapy of bimatoprost, the frequency of occurrence of this adverse event – rare ((> 1 / 1,000 to
Bimatan® preservative comprises benzalkonium chloride which may be absorbed by soft contact lenses. They may also experience eye irritation and discoloration of soft contact lenses because of the presence of benzalkonium chloride. Contact lenses should be removed before installation, and again put them in 15 minutes after instillation.
Benzalkonium chloride is used in eye drops as a preservative, may cause the development of pitting keratopathy and / or toxic peptic keratopathy. Caution must be exercised when using the drug in patients with the syndrome of “dry” eyes at corneal damage in the case of simultaneous use of several kinds of eye drops containing benzalkonium chloride. It takes control of the cornea during long-term use of the drug in these patients.
It has been reported associated with the use of bottles of opportunities for the development of bacterial keratitis to reusable eye drops. Dropper bottle inadvertently contaminated by patients with body comorbidities view. The risk of bacterial keratitis was higher in patients with impaired corneal epithelial integrity. Patients should be warned about the need to avoid contact between the tip of the dropper-bottle with the surface of the eye and other surfaces to avoid damage to the organ of vision and bacterial contamination of the drug.
Effects on ability to drive and use machines.
Bimatan® has little effect on the ability to drive and use machines. As with the other eye drops, instillation occurs if after the temporary blurred vision, it is necessary to wait for recovery definition of visual perception before how to drive or operate machinery.
Storage conditions
Store at 2 to 25 ° C.
Keep out of the reach of children.
Dosing and Administration
1 drop in the affected eye (s), 1 per day in the evening. should not exceed the recommended dose, since more frequent instillations can reduce the hypotensive effect of the drug.
The use in the pediatric population.
Efficacy and safety of bimatoprost in patients aged 0 to 18 years has not been established.
Use in patients with renal or hepatic insufficiency.
Not studied application Bimatana® patients with hepatic failure secondary to severe, requiring care in compliance with the use by patients of these groups. Patients with a history information about any function of liver mild or increasing the level of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and / or bilirubin offline bimatoprost pathological effect on the functional state of the liver within 24 months of application.
In applying bimatoprost in combined therapy to be observed for at least 5 minute interval between instillation preparations bimatoprost and concomitant therapy.
In the case of the admission of the drug should take the medicine as soon as possible at the dosage instructions provided.
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

Sentis

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