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Instructions

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Instruction for use: Oftan Timolol

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Active substance Timolol

ATX Code S01ED01 Timolol

Pharmacotherapeutic group:

Beta-blockers

Ophthalmic agents

The nosological classification (ICD-10)

H40.0 Suspected glaucoma

Marked rise in intraocular pressure, Hypertension eyes, ocular hypertension, Measurement of intraocular pressure, ophthalmohypertension, Elevated IOP, Elevated intraocular pressure, Elevated intraocular pressure in infectious diseases of the eye, Povyshennore intraocular pressure, Increased ophthalmotonus, Spontaneous blockade angle opposite eye, Narrow chamber angle, Iatrogenic, blockade angle opposite eye

H40.1 Primary open-angle glaucoma

open-angle glaucoma, Open-angle glaucoma, Primary glaucoma, pseudoexfoliation glaucoma, Elevated IOP

H40.2 Primary angle-closure glaucoma

closure Glaucoma, Glaucoma with a narrow angle of anterior chamber, Angle-closure glaucoma, Acute angle-closure glaucoma, An acute attack of angle-closure glaucoma, Elevated intraocular pressure angle-closure glaucoma, Chronic angle-closure glaucoma

H40.3 Glaucoma secondary posttraumatic

Post-traumatic secondary glaucoma, Glaucoma after cataract operated

H40.4 Glaucoma secondary to inflammatory diseases of the eye

Glaucoma uveal, Uveal secondary glaucoma

Q15.0 Congenital glaucoma

Structure and Composition

Eye drops 1 ml

Timolol maleate (equivalent to Timolol) 2.5 or 5.0 mg

Excipients: benzalkonium chloride - 0.1 mg; sodium dihydrogen phosphate aqueous 2; sodium phosphate dibasic 12 water; sodium hydroxide; water for injections

in plastic vials looks to 5 ml; in a cardboard box 1 bottle.

The drug forms

The clear, colorless solution.

Characteristic

Nonselective beta-adrenoceptor blocker.

pharmachologic effect

antiglaucoma.

When applied topically as eyedrops reduce both normal and elevated intraocular pressure by decreasing the formation of intraocular fluid.

pharmacodynamics

The maximum decrease in intraocular pressure occurs within 1-2 hours and lasts for 24 hours. No effect on pupil size and accommodation.

Pharmacokinetics

When applied topically to quickly penetrate through the cornea. The action is manifested through 20 minutes after instillation into conjunctival cavity, the Cmax in the aqueous humor of the eye is achieved in 1-2 hours. The small amount reaches the systemic circulation by absorption through the vessels of the conjunctiva, nasal mucosa and lacrimal tract. Excretion of the metabolites is carried out mainly by the kidneys. In infants and young children the concentration of the active substance substantially exceeds its plasma Cmax in adults.

Indications

Elevated intraocular pressure (ocular hypertension), open-angle glaucoma, glaucoma eye afakicheskom to other types of secondary glaucoma, angle-closure glaucoma - as an additional means (in combination with miotikami) to reduce intraocular pressure, congenital glaucoma (with other therapeutic measures failure).

Contraindications

Increased sensitivity to individual timolol or benzalkonium chloride, a history of: asthma or other severe chronic obstructive airways disease, sinus bradycardia, atrioventricular block II or III degree severe heart failure.

Use with caution in patients with pulmonary insufficiency, severe cerebrovascular insufficiency, congestive heart failure, diabetes, hypoglycemia, thyrotoxicosis, myasthenia gravis, and while the appointment of other beta-blockers.

Pregnancy and breast-feeding

Sufficient experience of use of the drug during pregnancy, breastfeeding, and children do not have, however, shown that timolol passes the placental barrier and enters the breast milk. It can be used for the treatment of children, pregnant and lactating mothers prescribed by a doctor, if the expected benefits exceed the risk of possible side effects.

If the drug is used just before birth or during breastfeeding, the newborn should be closely monitored for several days after birth and during the entire treatment period, nursing mothers medication.

Side effects

Local irritation and conjunctival hyperemia, burning and itchy eyes, watery eyes, superficial punctate keratopathy, corneal hypoesthesia, dry eyes.

Since the cardiovascular system: bradycardia, bradyarrhythmia, decreased blood pressure, collapse, AV block, transient ischemic attacks.

From the respiratory system: dyspnea, bronchospasm, pulmonary insufficiency.

From the nervous system: headache, dizziness, weakness.

Allergic reactions: urticaria.

In case of side effects, stop using the product and how to contact your doctor as soon as possible (ophthalmologist).

Interaction

Sharing with eye drops containing adrenaline may cause mydriasis.

The specific effect of the drug - reduction of intraocular pressure - is enhanced by the simultaneous use of eye drops containing pilocarpine and epinephrine. Bury's eyes two beta-blockers should not be.

Lowering blood pressure and slowing heart rate may increase in the combined use of the drug with calcium antagonists, reserpine or systemic beta-blockers.

Concomitant use with insulin or oral antidiabetic agents may lead to hypoglycemia.

Timolol increases the effects of muscle relaxants, therefore requires removal of the drug for 48 hours before planned surgery with general anesthesia.

These data may relate to drugs that have been applied shortly before.

Dosing and Administration

Kongungualno. 1-2 a drop in patient eye two times a day.

If the intraocular pressure is normal with regular use, the dosage should be limited to 1 times daily 1 drop in the morning.

Overdose

Perhaps the development of obscherezorbtivnyh effects typical of beta-blockers: dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting.

Treatment: Immediately rinse eyes with water or saline solution, symptomatic therapy.

Precautionary measures

In the case of the upcoming surgery with general anesthesia is necessary to stop the drug for 48 hours.

If the patient wears soft contact lenses should not be used drug as a preservative may be deposited in soft contact lenses and have an adverse effect on the eye tissue.

Hard contact lenses prior to instillation of the drug to be removed and re-set after 15 minutes.

special instructions

You must see your doctor regularly to measure intraocular pressure and corneal examination.

When transferring patients to treatment with timolol may need refractive error correction after effects caused by previously used miotikami.

Storage conditions

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf-life

3 years. After opening the bottle - 1 month.

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

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