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

Benzalkonium chloride 0.10 mg, sodium hydrogen phosphate 8.10 mg, disodium phosphate dodecahydrate 29.30 mg, sodium hydroxide until the pH of the solution is 6.5-7.0, water for injection to 1.0 ml.

For a dosage of 5 mg / ml:

Active substance

Timolol maleate 6.84 mg (eq. timolol 5.0 mg).

Excipients

Benzalkonium chloride 0.10 mg, sodium hydrophosphate 6,10 mg, disodium phosphate dodecahydrate 30,50 mg, sodium hydroxide until The pH of the solution is 6.5-7.0, the water for injections up to 1.0 ml.

Description:

A clear, colorless solution.

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 beta-adrenergic blocker. It does not possess internal sympathomimetic and membrane-stabilizing activity.

When topical application in the form of eye drops timolol 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:

When topical application of timolol maleate quickly penetrates through the cornea. After instillation of eye drops, the maximum concentration of timolol in the aqueous humor 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 young children, the concentration of timolol, as an active substance, significantly exceeds its maximum concentration (C_max) in the blood plasma of adults.

Indications:

-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 closed-angle glaucoma (in combination with miotics);

-conditioned glaucoma (with ineffectiveness of other agents).

Contraindications:

-Bronchial asthma or other severe chronic obstructive airway disease;

- sinus bradycardia;

-atrioventricular blockade of II-III degree;

-decompensated heart failure;

-dystrophic processes in the cornea;

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

-Allergic reactions to the components of the drug.

Carefully:

In patients with pulmonary insufficiency, severe cerebrovascular insufficiency, heart failure in the stage of compensation, arterial hypotension, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, Reynaud's syndrome,

pheochromocytoma, atrophic rhinitis, and also with the simultaneous administration of other beta-blockers and psychoactive drugs that increase the release of epinephrine.

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy, breast-feeding is not, however it is established that timolol passes the placental barrier and enters the breast milk. For the prescription of the attending physician Oftan® Timolol can be used during pregnancy and during lactation, unless the expected therapeutic effect for the mother justifies the potential risk to the fetus and the baby.

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

Dosing and Administration:

At the beginning of treatment, 1-2 drops of Oftan® Timolol 2.5 mg / ml or 5.0 mg / ml in the affected eye 2 times a day.

If intraocular pressure with normal use is normalized, you should lower the dose to the 1-st drop 1 time a day in the morning.

Treatment of Ophthalmic ® 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 on the instructions of the attending physician.

Side effects:

Local reactions:

Blurred vision, irritation and congestion hyperemia, burning and itching of the eyes, lacrimation, corneal epithelial edema,spot superficial keratopathy, corneal hypostasis, dry eye syndrome, blepharitis, conjunctivitis and keratitis. With prolonged use, it is possible to develop ptosis and occasionally diplopia. When carrying out fistulizing (penetrating) antiglaucomatous operations, it is possible to develop a detachment of the choroid in the postoperative period.

Systemic reactions:

The cardiovascular system: bradycardia, bradyarrhythmia, lowering blood pressure, collapse, cardiac blockade, transient disorders of cerebral circulation, exacerbation of chronic heart failure.

Respiratory system: shortness of breath, bronchospasm, pulmonary insufficiency.

central nervous system: headache, dizziness, weakness, confusion, hallucinations, insomnia, morbidity, anxiety, mood changes. Allergic reactions: generalized or local rash, itching.

Skin covers: alopecia, psoriasis-like rashes and exacerbation of psoriasis. Genitourinary system: Peyronie's disease

Other Systemic Reactions: paresthesia, nasal congestion, myasthenia gravis, decreased potency, nausea, diarrhea, chest pain, ringing in the ears.

In case of side effects, you should, as soon as possible, contact your doctor.

Overdose:

It is possible to develop systemic effects characteristic of beta-adrenoblockers: dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea and vomiting. Treatment: immediately flush eyes with water or saline solution,

symptomatic therapy.

Interaction:

The simultaneous use of Offan Timolol with eye drops containing adrenaline can cause pupil dilatation.

A specific action of the drug is a decrease in intraocular pressure, which can be enhanced by simultaneous use of eye drops containing epinephrine and pilocarpine.

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

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

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

Simultaneous use with insulin or oral antidiabetics 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 under general anesthesia.

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

Special instructions:

Visual impairment, dizziness and fatigue can occasionally be observed with the use of eye drops Ofthan® Timolol. During the treatment period it is necessary to observe

caution when driving vehicles and during work with complex equipment, requiring increased concentration of attention, speed of psychomotor reactions and good vision (within 0.5 h after instillation into the eye), as the drug can lower blood pressure, cause fatigue and dizziness. Control of efficacy is recommended to be carried out 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.

In the application it is necessary to monitor the function of tear production, the state of the cornea and to estimate the magnitude of the visual fields at least once every 6 months.

Oftan® Timolol contains preservative benzalkonium chloride, which can cause eye irritation, can be absorbed by soft contact lenses, causing a change in their color and adversely affecting the eye tissue. Contact lenses should be removed before using the drug and, if necessary, to dress them again not earlier than 15 minutes after instillation.

When transferring patients to treatment with timolol may be needed. correction of refractive changes caused by previously used miotics.

Oftan® Timolol, like other beta-blockers, can hide the possible symptoms of low blood sugar in patients with diabetes mellitus.

In case of the upcoming surgery under general anesthesia, it is necessary to cancel the drug 48 hours before the surgery, as it increases the effect of muscle relaxants and general anesthetics.

Form release / dosage:

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

Packaging:

5 ml in a polyethylene bottle, sealed with a plastic stopper, a dropper with a screw cap. Vial with instructions for use in a cardboard box.

Storage conditions:Store at temperatures between 15 and 25 degrees. FROM.

In a place inaccessible to children.

Shelf life:

3 years.

After opening the bottle - 1 month.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015280 / 01

Date of registration:15.12.2008 / 15.08.2016

Expiration Date:Unlimited

The owner of the registration certificate: Santen, AO Santen, AO Finland

Manufacturer: & nbsp

SANTEN, OY Finland

Representation: & nbspSANTEN AS SANTEN AS Finland

Information update date: & nbsp20.06.2017

Illustrated instructions

Instructions

Ofthan® Timolol (Oftan® Timolol)