Universal reference book for medicines
Product name: OFTAN ® TIMOLOL (OFTAN ® TIMOLOL)

Active ingredient: timolol

Type: anti-glaucoma preparation - beta-blocker

Manufacturer: SANTEN (Finland)
Composition, form of production and packaging
Eye drops
in the form of a clear, colorless solution.

1 ml

timolol maleate 3.42 mg,

which corresponds to the content of timolol 2.5 mg

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

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

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, sodium hydrophosphate, sodium hydrogen phosphate dodecahydrate, sodium hydroxide, water d / and.

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antiglaukomny drug, non-selective beta-blocker.
Has no internal sympathomimetic and membrane-stabilizing activity. With 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 min after instillation into the conjunctival cavity.
The maximum decrease in intraocular pressure occurs after 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 small children, the concentration of timolol.
as an active substance, significantly exceeds its maximum concentration (C max ) in adult blood plasma.
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);

- congenital glaucoma (with ineffectiveness of other means).

DOSING MODE

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

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

Treatment of Ophthalmic ® Timolol is carried out, as a rule, 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 EFFECT

Local Reactions

From the side of the organ of vision: blurred vision, irritation and congestion of the conjunctiva, burning and itching of the eyes, lacrimation, corneal epithelial edema, punctate keratopathy, corneal hyperstasia, dry eye syndrome, blepharitis, conjunctivitis and keratitis.
With prolonged use, it is possible to develop ptosis and rarely diplopia. When performing fistulizing (penetrating) antiglaucoma operations, it is possible to develop a detachment of the choroid in the postoperative period.
Systemic reactions

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

From the side of the digestive system: nausea, diarrhea.

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

From the central nervous system and peripheral nervous system: headache, dizziness, weakness, confusion, hallucinations, insomnia, morbidity, anxiety, mood changes, paresthesia.

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

On the part of the genitourinary system: Peyronie's disease, a decrease in potency.

Allergic reactions: generalized or local rash, itching.

Other: myasthenia gravis, ringing in the ears.

CONTRAINDICATIONS

- bronchial asthma or other severe chronic obstructive airway disease;

- sinus bradycardia;

- AV blockade II and III degree;

Decompensated heart failure;

- dystrophic processes in the cornea;

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

- Hypersensitivity to the components of the drug.

Caution should be given to the drug with pulmonary insufficiency, severe cerebrovascular insufficiency, heart failure in the stage of compensation, arterial hypotension, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia, Reynaud's syndrome, pheochromocytoma, atrophic rhinitis, and concomitant administration of other beta adrenoblockers and psychoactive drugs that enhance the secretion of epinephrine.

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.
For the prescription of the attending physician, Offan ® Timolol can be used during pregnancy and during breastfeeding in cases where the expected curative 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, newborns should be closely monitored for several days after birth and during the entire treatment period of nursing mothers with Ophthalm ® Timolol.

APPLICATION FOR CHILDREN

In connection with the lack of data on the effectiveness and safety of the drug in children and adolescents in ozraste to 18 years is contraindicated.

SPECIAL INSTRUCTIONS

It is recommended to control the effectiveness of the drug approximately 3-4 weeks after the start of therapy (not earlier than in 1-2 weeks).
With prolonged use of timolol, the effect may be weakened.
When applying, it is necessary to monitor the function of tearing, the condition of the cornea and to assess the magnitude of the visual fields at least once every 6 months.

Oftan® Timolol contains a preservative of benzalkonium chloride, which can cause eye irritation, can be absorbed by soft contact lenses, causing a change in their color, and have an adverse effect on eye tissue.
Contact lenses should be removed before using the drug and, if necessary, set them again not earlier than 15 minutes after instillation.
When translating patients for treatment with timolol, correction of refractive changes caused by previously used miotics may be required.

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

In the case of an upcoming surgical intervention under general anesthesia, it is necessary to cancel the drug 48 hours prior to surgery, because
Timolol enhances the action of muscle relaxants and general anesthetics.
Do not bury two different beta-blockers in the same eye.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, care must be taken when driving vehicles and during work with complex equipment, requiring increased concentration of attention, rapidity of psychomotor reactions and good vision (within 30 minutes after instillation into the eye), since
the drug can reduce blood pressure, cause fatigue and dizziness.
OVERDOSE

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

Treatment: immediately rinse the eyes with water or saline, and perform symptomatic therapy.

DRUG INTERACTION

The combined use of Ophthalm ® Timolol with eye drops containing adrenaline may cause pupil dilatation.

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

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

Inhibitors of the CYP2D6 isoenzyme, 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 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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of 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 is 1 month.

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