Oftan Timolol eye drops 0.5%, 5 ml

• Increased intraocular pressure (ocular hypertension)

• open-angle glaucoma, glaucoma in the aphakic eye and other types of secondary glaucoma, angle-closure glaucoma - as an additional means (in combination with miotics) to reduce intraocular pressure, congenital glaucoma (if other therapeutic measures are insufficient).

Conjunctival. 1-2 drops in a sore eye 2 times a day.

If intraocular pressure normalizes with regular use, the dosage should be limited to 1 drop a day, 1 drop in the morning.

Eye drops in the form of a clear, colorless solution.

1 ml

timolol maleate 6.84 mg,

which corresponds to the content of timolol 5 mg

Excipients: benzalkonium chloride - 0.1 mg, sodium dihydrogen phosphate dihydrate - 6.1 mg, disodium phosphate dodecahydrate - 30.5 mg, sodium hydroxide - until the pH of the solution reaches 6.5-7.0, water d / i - up to 1 ml.

• Increased individual sensitivity to timolol or benzalkonium chloride,

• a history of: bronchial asthma or other severe chronic obstructive airway diseases, sinus bradycardia, atrioventricular block II or III degree, severe heart failure.

Use with caution in patients with pulmonary insufficiency, severe cerebrovascular insufficiency, chronic heart failure, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, as well as with the simultaneous administration of other beta-blockers.

pharmachologic effect

Antiglaucoma drug, non-selective beta-blocker. It has no internal sympathomimetic and membrane stabilizing activity. When applied topically in the form of eye drops, timolol reduces both normal and increased intraocular pressure by reducing the formation of intraocular fluid. Does not affect pupil size and accommodation.

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

Pharmacokinetics

Suction

When applied topically, timolol maleate rapidly penetrates the cornea. After instillation of eye drops, Cmax of timolol in the aqueous humor of the eye is reached after 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, nasal mucosa and lacrimal tract.

Withdrawal

Excretion of timolol metabolites is carried out mainly by the kidneys.

Pharmacokinetics in special patient groups

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

Side effect

Local reactions

From the side of the organ of vision: blurred vision, irritation and hyperemia of the conjunctiva, burning and itching of the eyes, lacrimation, edema of the corneal epithelium, punctate superficial keratopathy, corneal hypersthesia, dry eye syndrome, blepharitis, conjunctivitis and keratitis. With prolonged use, it is possible to develop ptosis and rarely diplopia. When carrying out fistulizing (penetrating) antiglaucoma operations, it is possible to develop detachment of the choroid in the postoperative period.

Systemic reactions

From the side of the cardiovascular system: bradycardia, bradyarrhythmia, decreased blood pressure, collapse, heart block, transient cerebral circulation disorders, exacerbation of chronic heart failure.

From the respiratory system: nasal congestion, shortness of breath, bronchospasm, pulmonary insufficiency.

From the digestive system: nausea, diarrhea.

From the nervous system: headache, dizziness, weakness, confusion, hallucinations, insomnia, onyrodynia, anxiety, mood changes, paresthesia.

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

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

Allergic reactions: generalized or localized rash, itching.

Others: myasthenia gravis, chest pain, ringing in the ears.

In case of side effects, the patient should contact the attending physician as soon as possible.

Application during pregnancy and lactation

There is no sufficient experience in the use of the drug during pregnancy and lactation, but it has been established that timolol penetrates the placental barrier and is excreted in breast milk. As prescribed by the attending physician, OftanЃ Timolol can be used during pregnancy and during breastfeeding in cases where the intended benefit to the mother outweighs the potential risk to the fetus and child.

If the drug was used immediately before childbirth or during breastfeeding, newborns should be closely monitored for several days after birth and during the entire period of treatment of nursing mothers with OftanЃ Timolol.

Application in children

Due to the lack of data on efficacy and safety, the use of the drug in children and adolescents aged up to 18 years is contraindicated.

special instructions

It is recommended to monitor the effectiveness of the drug approximately 3-4 weeks after the start of therapy (not earlier than 1-2 weeks). With prolonged use of timolol, the effect may be weakened.

When applied, it is necessary to monitor the function of lacrimation, the condition of the cornea and evaluate the magnitude of the visual fields at least once every 6 months.

OftanЃ Timolol contains the preservative benzalkonium chloride, which can irritate the eyes, be absorbed by soft contact lenses, causing discoloration, and have an adverse effect on eye tissue. Contact lenses should be removed before using the drug and, if necessary, reinsert them no earlier than 15 minutes after instillation.

When transferring patients to treatment with timolol, it may be necessary to correct changes in refraction caused by previously used miotics.

OftanЃ Timolol, like other beta-blockers, can mask the possible symptoms of hypoglycemia in patients with diabetes mellitus.

In the event of an upcoming surgery under general anesthesia, the drug should be discontinued 48 hours before the operation, because timolol enhances the action of muscle relaxants and general anesthetics.

Two different beta-blockers should not be instilled into the same eye.

Influence on the ability to drive vehicles and mechanisms

During the treatment period, care must be taken when driving vehicles and during work with complex equipment, requiring increased concentration of attention, speed of psychomotor reactions and good vision (within 30 minutes 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: immediately rinse the eyes with water or saline, carry out symptomatic therapy.

Drug interactions

The combined use of the drug OftanЃ Timolol with eye drops containing adrenaline can cause pupil dilation.

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

Arterial hypotension and bradycardia may increase with the simultaneous use of OftanЃ Timolol with calcium antagonists, reserpine and systemic beta-blockers.

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

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

Timolol enhances the effect of muscle relaxants, therefore, it is necessary to discontinue the drug 48 hours before the planned surgical intervention under general anesthesia.

These data may also apply to drugs that were used shortly before.