Oftan-timolol eye drops 0.5% 5ml

Oftan-timolol drops hl. 0.5% 5ml

Release form, composition and packaging

Eye drops 0.25% in the form of a clear colorless solution.

Excipients: benzalkonium chloride, sodium hydrogen phosphate, sodium hydrogen phosphate dodecahydrate, sodium hydroxide, water d / i.

5 ml - polyethylene bottles (1) with droppers, droppers - cardboard packs.

Eye drops 0.5% in the form of a clear colorless solution.

Excipients: benzalkonium chloride, sodium hydrogen phosphate, sodium hydrogen phosphate dodecahydrate, sodium hydroxide, water d / i.

5 ml - polyethylene bottles (1) with droppers, droppers - cardboard packs.

Clinico-pharmacological group

Antiglaucoma drug - beta-blocker

Mechanism of action

Antiglaucoma drug, non-selective beta-blocker. Does not possess internal sympathomimetic and membrane stabilizing activity. When applied topically as eye drops, timolol reduces both normal and increased intraocular pressure by reducing the formation of intraocular fluid. No effect on pupil size and accommodation.

The effect of the drug is manifested 20 minutes after instillation into the conjunctival cavity. The maximum reduction in intraocular pressure occurs after 1-2 hours and persists for 24 hours.

Pharmacokinetics

With topical application of timolol maleate quickly penetrates the cornea. After instillation of eye drops, the maximum concentration of timolol in the aqueous humor of the eye is reached in 1-2 hours.

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

In newborns and young children, the concentration of timolol. as an active substance, significantly exceeds its maximum concentration (C_max) in the blood plasma of adults.

Indications for use of the drug

- Increased intraocular pressure (ophthalmic hypertension);

- open-angle glaucoma;

- glaucoma on the aphakic eye and other types of secondary glaucoma;

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

- congenital glaucoma (with the ineffectiveness of other means).

Dosage and administration

At the beginning of treatment, 1-2 drops are prescribed to the affected eye in the form of 0.25% eye drops or 0.5% eye drops 2 times / day.

If the intraocular pressure with normal use is normalized, the dose should be reduced to 1 drop 1 time per day in the morning.

Oftan treatment^® Timolol is usually carried out for a long time. A break in treatment or a change in the dosage of the drug is carried out only as prescribed by the attending physician.

Side effect

Local reactions

On the part of the organ of vision: blurred vision, irritation and hyperemia of the conjunctiva, burning and itching of the eyes, lacrimation, swelling of the corneal epithelium, punctate superficial keratopathy, corneal hypersthesia, dry eye syndrome, blepharitis, conjunctivitis and keratitis. With prolonged use may develop ptosis and rarely - diplopia. When conducting fistulizing (penetrating) antiglaucomatous operations, the development of choroidal detachment in the postoperative period is possible.

Systemic reactions

Cardiovascular: bradycardia, bradyarrhythmia, reduction of blood pressure, collapse, heart block, transient cerebral circulation, exacerbation of chronic heart failure, chest pain.

From the digestive system: nausea, diarrhea.

Respiratory: nasal congestion, dyspnea, bronchospasm, pulmonary insufficiency.

Nervous system: headache, dizziness, weakness, confusion, hallucinations, insomnia, onyrodynia, anxiety, mood changes, paresthesias.

From the skin: alopecia, psoriasis-like rashes and exacerbation of psoriasis.

From the genitourinary system: Peyronie's disease, reduced potency.

Allergic reactions: generalized or localized rash, pruritus.

Other: myasthenia, tinnitus.

Contraindications to the use of the drug

- bronchial asthma or other severe chronic obstructive respiratory diseases;

- sinus bradycardia;

- AV blockade II and III degree;

- decompensated heart failure;

- dystrophic processes in the cornea;

- children and adolescents up to 18 years (due to the lack of data on the efficacy and safety of use of the drug in children and adolescents);

- hypersensitivity to the drug.

WITH caution It should be prescribed the drug for pulmonary insufficiency, severe cerebrovascular insufficiency, congestive heart failure in the stage of compensation, hypotension, diabetes, hypoglycemia, hyperthyroidism, myasthenia, Raynaud's syndrome, pheochromocytoma, atrophic rhinitis, as well as with concomitant administration of other beta-blockers, and psychoactive drugs which increase the secretion of epinephrine.

Use of the drug during pregnancy and lactation

Sufficient experience in the use of the drug during pregnancy and lactation is not, however, it was found that timolol penetrates the placental barrier and is excreted in breast milk. As prescribed by the attending physician Oftan ^® Timolol can be used during pregnancy and during breastfeeding in cases where the expected therapeutic effect for the mother justifies the potential risk to the fetus and child.

If the drug was used immediately before birth or during breastfeeding, the newborn should be carefully monitored for several days after birth and during the entire period of treatment of nursing mothers with Oftan^® Timolol.

Special notes

Monitoring the effectiveness of the drug is recommended about 3-4 weeks after the start of therapy (no earlier than 1-2 weeks). With prolonged use of timolol, a weakening effect is possible.

When applied, it is necessary to monitor the tearing function, the state of the cornea, and to evaluate the size of the visual fields at least 1 time in 6 months.

Oftan^® Timolol contains preservative benzalkonium chloride, which can cause eye irritation, be absorbed by soft contact lenses, causing a change in their color, and adversely affect eye tissue. Contact lenses should be removed before using the drug and, if necessary, install them again no earlier than 15 minutes after instillation.

When transferring patients to treatment with timolol, correction of refractive changes caused by previously applied myotics may be required.

Oftan^® Timolol, like other beta-blockers, can mask the possible symptoms of hypoglycemia in diabetic patients.

In case of an upcoming surgery under general anesthesia, it is necessary to cancel the drug 48 hours before the operation, sincetimolol enhances the action of muscle relaxants and general anesthetics.

Do not bury two different beta-blockers in the same eye.

Influence on ability to drive motor transport and control mechanisms

During the period of treatment, care must be taken when driving vehicles and when working with complex equipment, requiring high concentration of attention, psychomotor speed and good vision (within 30 min after instillation into the eye), because The drug can lower blood pressure, cause fatigue and dizziness.

Overdose

Symptoms: possible development of systemic effects characteristic of beta-blockers (dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea and vomiting).

Treatment: rinse immediately with water or saline; symptomatic therapy is carried out.

Drug interaction

The combined use of the drug Oftan^® Timolol with adrenaline eye drops can cause pupil dilation.

With simultaneous use of eye drops containing epinephrine and pilocarpine, it is possible to increase the reduction in intraocular pressure.

Hypotension and bradycardia may increase with simultaneous use of Oftan^® Timolol with Calcium antagonists, reserpine and systemic beta-blockers.

Inhibitors of the isoenzyme CYP2D6, such as quinidine and cimetidine, can increase the concentration of timolol in the plasma.

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

Timolol enhances the action of muscle relaxants, therefore, it is necessary to remove the drug 48 hours before the planned surgery under general anesthesia. These data may also apply to drugs that were used shortly before.

Terms and conditions of storage

List B. The drug should be stored out of the reach of children at a temperature of 15 ° to 25 ° C. Shelf life - 3 years.

After opening the bottle, the shelf life of the drug - 1 month.