Instruction for use: Timolol-POS

Active substance Timolol

ATX Code S01ED01 Timolol

Pharmacotherapeutic group:

Beta-blockers

Ophthalmic tools

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

H40.5 Glaucoma secondary to other eye diseases

The secondary open-angle glaucoma, Glaucoma afakicheskaya, Secondary glaucoma

Q15.0 Congenital glaucoma

Structure and Composition

Eye drops 0.25% [without preservative] 1 ml

timolol maleate 3.42 mg

(Corresponds to 2.5 mg of timolol)

Excipients: sodium dihydrogen phosphate dihydrate; Sodium phosphate dodecahydrate; water for injections

multidose vial in a plastic dropper 10 ml; In the paper cartons 1 Dropper bottle.

Drops eye 0.5% [without preservative] 1 ml

timolol maleate 6.84 mg

(Corresponds to 5.0 mg of timolol)

Excipients: sodium dihydrogen phosphate dihydrate; Sodium phosphate dodecahydrate; water for injections

The drug forms

The clear, colorless solution.

pharmachologic effect

antiglaucoma.

pharmacodynamics

Nonselective beta-adrenoceptor blocker without sympathomimetic activity. When applied topically, it lowers intraocular pressure by reducing aqueous humor formation and a slight increase in its outflow. Effect is 20 minutes after instillation, the maximum effect - in 1-2 hours; duration - 24 hours.

Pharmacokinetics

Timolol maleate is rapidly penetrates the cornea of the eye tissue. The small amount reaches the systemic circulation by absorption through the conjunctiva, the mucous membranes of the nose and the lachrymal tract. Excretion of metabolites - the kidneys. In infants and young children the concentration of active substance in plasma significantly exceeds its maximum concentration in plasma adults.

Indications

Primary open-angle glaucoma;

secondary glaucoma (uveal, afakicheskaya, posttraumatic);

congenital glaucoma (with the ineffectiveness of other therapeutic measures);

a sharp rise in intraocular pressure;

primary angle-closure glaucoma (in combination with miotikami).

Contraindications

COPD including bronchial asthma;

sinus bradycardia (slow heartbeat);

AV blockade II and III level;

acute and chronic heart failure II and III level;

cardiogenic shock;

degenerative diseases of the cornea;

severe vasomotor rhinitis;

hypersensitivity to the drug.

Precautions:

sinoatrial block;

hypotension;

children's age, particularly the neonatal period;

cerebrovascular insufficiency;

diabetes;

hypoglycemia;

hyperthyroidism;

myasthenia gravis;

co-administration of other beta-blockers.

Pregnancy and breast-feeding

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

Side effects

local reactions

Eye irritation, which manifests itself in the form of conjunctivitis, blepharitis, keratitis (hyperemia of the eyelid skin, burning and itching in the eyes, conjunctival hyperemia, tearing or decrease lacrimation, photophobia, edema of the corneal epithelium, a short break in visual acuity, prolonged use may develop superficial punctate keratopathy ( decrease the transparency of the cornea and corneal sensitivity reduction), ptosis, diplopia.

systemic reactions

Cardio-vascular system: decrease in blood pressure, bradycardia, bradyarrhythmia, AV block, heart failure, heart failure, decreased myocardial contractility, chest pain, transient ischemic attack, collapse.

The respiratory system: dyspnea, bronchospasm, pulmonary insufficiency.

CNS: dizziness, headache, drowsiness, hallucinations, slow the speed of psychomotor reactions.

Other side effects: allergic reactions (including hives), rhinitis, nasal congestion, nosebleeds, nausea, vomiting, diarrhea, paresthesia, muscle weakness, sexual dysfunction, depression.

Interaction

Epinephrine, pilocarpine, systemic beta-blockers increase the effect.

When applied with reserpine may develop bradycardia or hypotension (this combination requires careful medical supervision). When combined with CCBs or cardiac glycosides - may impair AV conduction, acute left ventricular failure or hypotension.

It enhances the action of neuromuscular blocking agents - timolol-POS® should be canceled 48 hours before the expected general anesthesia with the use of peripheral muscle relaxants.

You can not simultaneously be used with antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers).

During treatment is not recommended to take ethanol (perhaps a sharp decrease in blood pressure).

With caution in conjunction with antihypertensive drugs, other beta-blockers, insulin or oral hypoglycemic drugs, corticosteroids, psychoactive drugs.

Dosing and Administration

In the conjunctival sac.

Babies and children up to 10 years: instill 1 drop of 0.25% solution of 2 times a day.

Adults and children over 10 years: instilled into the conjunctival sac of one drop of 0.25% solution of 2 times a day, the lack of effectiveness - 1 drop of 0.5% solution of 2 times a day. If necessary, the dose may be decreased to 1 drop 1-2 times per day.

Instructions for use of the drug:

1. Before each instillation is necessary to remove the protective cap.

2. Before the first use of the drug to turn the bottle dropper vertically down and put pressure on its base (bottom) several times, until the tip of the dropper is not the first drop appears. Thereafter the vial is ready for use.

With instillation of the drug to retain a dropper bottle down quickly and forcefully pressing on his base (bottom). Thus, a mechanism is actuated only extracted a dropper and one drop of formulation. A special valve design of the system provides a dropper always the same size drops and extracted the same rate of its extraction even with a very strong pressure on the vial bottom.

3. Tilt your head back slightly, gently take your finger and lower eyelid to drip one drop into the conjunctival sac as described above. Slowly close your eyes. When backfilling should avoid contact with the surface of the dropper tip eyes and skin.

4. After the procedure immediately tightly put on a drip cap.

Overdose

When applied topically in the recommended dose overdose symptoms are not observed.

Symptoms (in case of accidental ingestion): nausea, vomiting, dizziness, headache, decreased blood pressure, bronchospasm, bradycardia.

Treatment: symptomatic. Isoprenaline can be administered in / in to correct severe bradycardia or bronchospasm, dobutamine - for the treatment of arterial hypotension.

special instructions

Efficiency control should be about 3-4 weeks after initiation of therapy. During treatment at least 1 time in 6 mec should monitor the function of tearing, the integrity of the cornea, the field of view. During the period of treatment must be careful when driving and other activities potentially hazardous activities that require high concentration and psychomotor speed reactions and good vision (for 0.5 hours after instillation of the eye).

Contact lenses should be removed prior to instillation and put on no earlier than 15 minutes after it.

With prolonged use of Timolol-POS® [without preservative] possible weakening effect.

Before the upcoming surgery with general anesthesia followed by 48 hours to cancel the drug.

The original design of bottle-dropper, working on the principle of airless pump does not allow outside air to penetrate into the bottle and thus provides sterile eye drops without preservatives in their structure.

The use of timolol-POS® [without preservative] avoids the undesirable effects of preservative to the external eye tissue, conjunctiva and cornea, and eliminates the risk of allergic reactions to the preservative.

After opening the bottle, and the first instillation of timolol eye drops-POS® [without preservative] the drug can be used for 12 weeks. To this end it should be noted on the vial and / or cardboard pack date of first use of the drug. On the bottle label and the carton pack, a special graph to fill the patient - "the first application date."

After use, the contents of the vial should buy a new vial; used bottle is not suitable for re-use and recycling shall be (used bottle should be discarded in the trash).

release Form

Eye drops (without preservative) 0.25%, 0.5%. In 10 mL multidose vials-droppers plastic. The vial is placed in a cardboard box.

Conditions of supply of pharmacies

On prescription.

Storage conditions

The temperature is not above 25 ° C.

Keep out of the reach of children.

Shelf-life

3 years. After opening -12 weeks.

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