Arutimol - instructions for use, dose, side effects, contraindications

Benzalkonium chloride solution (50%) corresponds to benzalkonium chloride, povidone K 30, sodium dihydrogen phosphate dihydrate, sodium monohydrogenphosphate dodecahydrate, disodium edetate dihydrate, water for injection.

5 mg / ml:

Active substance:

Timolol maleate - 6.83 mg (corresponds to timolol 5.0 mg).

Excipients:

Description:

Transparent solution, colorless or with a yellowish tint, odorless.

Pharmacotherapeutic group:Antiglaucoma means β-blocker

ATX: & nbsp

S.01.E.D. Beta-blockers

S.01.E.D.01 Timolol

Pharmacodynamics:

Timolol is a non-selective blocker for beta-1 and beta-2 adrenergic receptors. Has no internal sympathomimetic and membrane-stabilizing activity.

With topical application in the form of eye drops reduces both normal and increased intraocular pressure by reducing the formation of intraocular fluid. Does not affect the size of the pupil and accommodation.The effect of the drug manifests itself 20 minutes after instillation into the conjunctival cavity. The maximum decrease in intraocular pressure occurs in 1-2 hours and persists for 24 hours.

Pharmacokinetics:

With topical application timolol quickly penetrates through the cornea. After instillation of eye drops, the maximum concentration of timolol in the aqueous humor of the anterior chamber of the eye is achieved after 1 -2 hours.

80% of timolol, used in the form of eye drops, enters the systemic bloodstream by absorption through the vessels of the conjunctiva, the nasal mucosa and the lacrimal tract. The excretion of timolol metabolites is mainly carried out by the kidneys.

In newborns and small children, the concentration of timolol, as an active substance, significantly exceeds its maximum concentration (Cmax) in adult blood plasma.

Indications:

- Increased intraocular pressure (ocular hypertension);

- open-angle glaucoma;

- aphakic glaucoma and other types of secondary glaucoma;

- as an additional means to reduce intraocular pressure in closed-angle glaucoma (in combination with miotics);

- congenital glaucoma (with insufficient other therapeutic measures).

Contraindications:

- Bronchial asthma or other severe chronic obstructive airway disease;

- sinus bradycardia;

- cardiogenic shock;

- atrioventricular blockade of II-III degree;

- heart failure;

- dystrophic processes in the cornea;

- Severe atrophic rhinitis;

- allergic reactions to the components of the drug

- pregnancy and lactation period

- children under 18 years of age

Carefully:

In patients with pulmonary insufficiency, severe cerebrovascular insufficiency, chronic heart failure, diabetes mellitus, hypoglycaemia, thyrotoxicosis, myasthenia, Reynaud's syndrome, pheochromocytoma, and simultaneous administration of other beta-blockers. In patients with diabetes mellitus, who take insulin or oral hypoglycemic agents, timolol can lead to hypoglycemia.

Dosing and Administration:

At the beginning of the therapy, drop 1 drop of the drug Arutimol 2.5 mg / ml or 5 mg / ml into the conjunctival sac 2 times a day.

With the normalization of intraocular pressure, the maintenance dose is 1 drop 2.5 mg / ml once a day.

Treatment with arutimol 2.5 mg / mL or 5 mg / mL is usually carried out for a long time. Interruption or change in dosage is carried out only according to the prescription of the attending physician.

Side effects:

Local Reactions: irritation and hyperemia of the conjunctiva, skin of the eyelids, burning and itching in the eyes, lacrimation, photophobia, edema of the corneal epithelium, spot surface keratopathy, corneal hyposis, diplopia, ptosis. When performing fistulizing antiglaucomatous operations, it is possible to develop a detachment of the choroid in the postoperative period.

Systemic reactions:

From the side of the cardiovascular system: heart failure, aetiology, bradyarrhythmia, lowering of arterial pressure, collapse, atrioventricular blockade, cardiac arrest, heart palpitations, hypoperfusion of the brain, transient disorders of cerebral circulation.

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

From the central nervous system: headache, dizziness, weakness, depression, paresthesia.

From the gastrointestinal tract: nausea, diarrhea.

Allergic reactions: urticaria, eczema.

Genitourinary system: violation of sexual functions.

Skin covers: alopecia.

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

Overdose:

Possible development of systemic effects characteristic of beta-blockers: dizziness, headache, arrhythmia, bradycardia, lowering blood pressure, heart failure, bronchospasm, nausea and vomiting.

Treatment: immediately flush eyes with water or 0.9% solution of sodium chloride, symptomatic therapy.

Interaction:

The simultaneous use of timolol with eye drops containing epinephrine, can cause a dilated pupil.

Specific action of the drug - decrease in intraocular pressure is enhanced with simultaneous use of eye drops containing epinephrine and pilocarpine; Bury in the eyes of two beta-blockers should not be. Reduction of blood pressure and slowing of the heart rhythm can be potentiated when the drug is combined with calcium antagonists, reserpine and beta-blockers.

Simultaneous use with insulin or oral hypoglycemic agents can lead to hypoglycemia.

Timolol strengthens the action of muscle relaxants, so it is necessary to cancel the drug 48 hours before the planned surgical intervention with the use of general anesthesia.

These data can also refer to medicines that were applied shortly before.

Special instructions:

It is necessary to visit the doctor regularly to measure intraocular pressure and examine the cornea.

If the patient wears soft contact lenses, Arutimol Eye Drops 2.5 mg / ml and 5 mg / ml should not be used, since it contains a preservative that can be adsorbed by soft contact lenses and adversely affect the eye tissue.

Immediately after instillation, a short-term decrease in vision clarity is possible.

Strict contact lenses should be removed before instillation of the preparation and they should be worn again only 15 minutes after instillation.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention,rapidity of psychomotor reactions and good vision (within 30 minutes after instillation into the eye), since the drug can help reduce blood pressure, the appearance of a feeling of fatigue and dizziness. In an even greater degree, this occurs when the drug interacts with alcohol.

When transferring patients to treatment with eye drops Arutimol 2.5 mg / ml and 5 mg / ml, correction of refraction after effects caused by previously used miotic may be necessary.

In the case of an upcoming surgical intervention with general anesthesia, it is necessary to cancel the drug within 48 hours.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention, rapidity of psychomotor reactions and good vision (within 30 minutes after instillation into the eye), since the drug can help reduce blood pressure, feelings of fatigue and dizziness.

Form release / dosage:

Eye drops 2.5 mg / ml and 5 mg / ml.

Packaging:

5 ml per bottle of low density polyethylene, sealed with a screw cap with an opening needle made of polypropylene. A label is attached to the vial. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

List B.

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. 6 weeks from the moment the vial is opened.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014623 / 01

Date of registration:22.04.2009 / 15.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

CHAUVIN ANKERPHARM, GmbH Germany

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp14.09.2017

Illustrated instructions

Instructions

Arutimol (Arutimol)