Timolol-DIA - instructions for use, dose, side effects, contraindications

Active substance: timolol maleate 0.34 mg (in terms of timolol base 0.25 mg) Excipients: benzalkonium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, purified water.

Timolol-DIA 0.5%

Active substance: timolol maleate 0.68 mg (in terms of timolol base 0.5 mg) Excipients: benzalkonium chloride, sodium hydrogen phosphate, sodium

dihydrogenphosphate dihydrate, purified water.

Description:

Transparent, colorless or slightly yellowish liquid.

Pharmacotherapeutic group:Antiglaucoma means β-blocker.

ATX: & nbsp

S.01.E.D. Beta-blockers

S.01.E.D.01 Timolol

Pharmacodynamics:

Non-selective blocker of beta receptors, does not have an internal

sympathomimetic activity. With topical application lowers the intraocular pressure, by reducing the formation of watery moisture and a slight increase in its outflow. The effect manifests itself 20 minutes after instillation, the maximum effect is achieved in 1-2 hours; the duration of action is 24 hours.

Pharmacokinetics:

Timolol maleate quickly penetrates through the cornea into the tissues of the eye. In an insignificant amount enters the systemic bloodstream by absorption through the conjunctiva, the mucous membranes of the nose and the lacrimal tract. Excretion of metabolites by the kidneys. In newborns and small children, the concentration of the active substance is significantly higher than its maximum concentration in adult plasma.

Indications:

Open angle glaucoma, secondary glaucoma (uveal, aphakic, posttraumatic), acute ophthalmotonus, closed-angle glaucoma (in combination with miotics).

Contraindications:

Bronchial asthma, sinus bradycardia, AV blockade of the FH stage, acute and chronic heart failure, cardiogenic shock, dystrophic diseases of the cornea, rhinitis, hypersensitivity to the drug.

Carefully:

chronic obstructive pulmonary disease of the severe course, sinoatrial blockade, arterial hypotension, childhood, especially the newborn period (in connection with benzalkonium chloride as a preservative), cerebrovascular insufficiency, chronic pulmonary insufficiency, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis,simultaneous administration of other beta-blockers.

Pregnancy and lactation:

In pregnancy, the drug is used if the expected benefit to the mother exceeds the potential risk to the fetus. During the use of the drug, breastfeeding should be discontinued.

Dosing and Administration:

Newborns and children under 10 years of instilled by 1 drop of Timolol-DIA 0.25% 2 times a day. Adults and children over 10 years of age are instilled in the conjunctival sac by 1 drop of Timolol-DIA 0.25% 2 times a day, with insufficient effectiveness - 1 drop of Timolol-DIA 0.5% 2 times a day. With the normalization of intraocular pressure, a maintenance dose of 1 drop of Timolol-DIA 0.25% once a day.

Treatment with the drug is usually carried out for a long time and should be accompanied by monitoring of intraocular pressure.

Side effects:

Local reactions: hyperemia of the skin of the eyelids, burning and itching in the eyes, conjunctival hyperemia, lacrimation or a decrease in teardrop, photophobia, corneal epithelial edema, short-term visual acuity; blepharitis, conjunctivitis, with prolonged use, it is possible to develop a surface point keratopathy (decrease the transparency of the cornea) and decrease the sensitivity of the cornea, it is possible ptosis, rarely - diplopia.

Systemic reactions: paresthesia, rhinitis, nasal congestion, epistaxis, lowering of blood pressure, bradycardia, bradyarrhythmia, AV blockade, heart failure, extremely rarely cardiac arrest; decreased myocardial contractility, chest pain, dizziness, headache, drowsiness, hallucinations, muscle weakness, impaired sexual function, decreased potency, transient cerebral circulation, collapse, depression; shortness of breath, bronchospasm, pulmonary insufficiency; nausea, vomiting, diarrhea, allergic reactions (including urticaria), ringing in the ears, slowing the speed of psychomotor reactions.

Overdose:

Overdose

When topical application in the recommended dose, the symptoms of an overdose were not noted. At casual intake it is possible development of following signs: a nausea, vomiting, a giddiness, a headache, depression of arterial pressure, a bronchospasm, a bradycardia. In case of symptoms of overdose, treatment is symptomatic. Isoprenaline can be administered intravenously to eliminate severe bradycardia or bronchospasm, dobutamine for the treatment of arterial hypotension.

Interaction:

Epinephrine, pilocarpine, systemic beta-blockers increase the effect. When used with reserpine - it is possible to develop severe bradycardia or hypotension (this combination requires careful medical supervision); with calcium channel blockers or cardiac glycosides - there may be a violation of AV conduction, acute left ventricular failure or arterial hypotension. Strengthens the effect of muscle relaxants (timolol should be discontinued 48 hours before the proposed general anesthesia using peripheral muscle relaxants). It can not be used simultaneously with antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers). During treatment it is not recommended to take ethanol (possibly a sharp drop in blood pressure). With caution appoint simultaneously with antihypertensive drugs, other beta-blockers, insulin or oral hypoglycemic drugs, glucocorticosteroids, psychoactive drugs (LS).

Special instructions:

The control of the effectiveness should be carried out approximately 3 * 4 weeks after the start of therapy. During the treatment period, at least once every 6 months, the function of lacrimation, the integrity of the cornea, and the field of vision should be monitored.During the treatment period, care must be taken when driving vehicles and practicing other potentially hazardous activities that require increased concentration of attention, speed of psychomotor reactions and good vision (within 0.5 hours after instillation into the eye).

Contact lenses should be removed before instillation and put on not earlier than 15 minutes after it. Do not wear soft contact lenses during the treatment period.

Do not bother with 2 beta-blockers at the same time.

With prolonged use of timolol, the effect may be weakened.

When transferring patients to treatment with timolol, correction of refraction may be necessary.

Before the forthcoming surgery with the use of general anesthesia, the drug should be discontinued within 48 hours.

Form release / dosage:

For 5 or 10 ml of Timolol-DIA drops eye 0.25% or 0.5% in glass bottles, corked with rubber stoppers and rolled with aluminum caps, or 5 or 10 ml each in polyethylene or polypropylene bottles, sealed with droppers and screw caps.

1 glass vial complete with a lid-dropper or without it, together with instructions for use ina cardboard bundle or in a contour acheive box placed in a thermo-sealable bag.

1 bottle of polymer, together with instructions for use in a cardboard bundle or in a contour box packaging, placed in a heat-seal bag.

50 bottles of glass or polymer, intended for hospital, together with 10 instructions for use in a cardboard box.

Packaging:

1 bottle of glass, complete with a lid-dropper or without it, together with instructions for use in a cardboard bundle or in a contoured package packed in a heat-sealable bag.

1 bottle of polymer, together with instructions for use in a cardboard bundle or in a contour box packaging, placed in a heat-seal bag.

50 bottles of glass or polymer, intended for hospital, together with 10 instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

: 3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N000522 / 01

Date of registration:24.12.2007

The owner of the registration certificate:DIAPHARM Institute of Molecular Diagnostics, ZAO DIAPHARM Institute of Molecular Diagnostics, ZAO Russia

Manufacturer: & nbsp

DIAPHARM Institute of Molecular Diagnostics, ZAO Russia

Information update date: & nbsp31.08.2015

Illustrated instructions

Instructions

Timolol-DIA (Timolol-DIA)