Universal reference book for medicines
Name of the drug: OKUMED В® (OCUMED)

Active ingredient: timolol

Type: anti-glaucoma preparation - beta-blocker

Manufacturer: PROMED EXPORTS (India)
Composition, form of production and packaging
Eye drops 0.25%
in the form of a clear, colorless solution.

1 ml

timolol (in the form of maleate) 2.5 mg

Excipients: benzalkonium chloride (0.1 mg / ml), sodium hydrogen phosphate, sodium dihydrogen phosphate, water d / u.

5 ml - bottles of dark glass (1) complete with a dropper - packs of cardboard.

5 ml - a vial of a dropper plastic (1) - packs cardboard.

10 ml - a vial of a dropper plastic (1) - packs cardboard.

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

1 ml

timolol (in the form of maleate) 5 mg

Excipients: benzalkonium chloride (0.1 mg / ml), sodium hydrogen phosphate, sodium dihydrogen phosphate, water d / u.

5 ml - bottles of dark glass (1) complete with a dropper - packs of cardboard.

5 ml - a vial of a dropper plastic (1) - packs cardboard.

10 ml - a vial of a dropper plastic (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Non-selective beta-blocker for topical application in ophthalmology.
Has no internal sympathomimetic and membrane-stabilizing activity.
The drug 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 in the conjunctival sac.
The maximum decrease in intraocular pressure develops after 1-2 hours and persists for 24 hours.
PHARMACOKINETICS

Suction

With topical application timolol quickly penetrates through the cornea.

After instillation of eye drops C max timolol in the aqueous humor of the anterior chamber of the eye is achieved in 1-2 hours.

In a small amount enters the systemic bloodstream by absorption through the vessels of the conjunctiva, the nasal mucosa and the lacrimal tract.

Excretion

Metabolites of timolol are excreted mainly by the kidneys.

Pharmacokinetics in special clinical cases

In newborns and young children, C max in blood plasma significantly exceeds that in adults.

INDICATIONS

- increased intraocular pressure (ophthalmic hypertension);

- open-angle glaucoma;

- secondary glaucoma;

- to reduce intraocular pressure in closed-angle glaucoma (as an additional agent in combination with miotics);

- congenital glaucoma (with insufficient other therapeutic measures).

DOSING MODE

Adults and children over 10 years instilled 1 drop (eye drops 0.25%) in the conjunctival sac of the affected eye 2 times / day, with insufficient efficiency - 1 drop (eye drops 0.5%) 2 times / day.
With the normalization of intraocular pressure, the maintenance dose is 1 drop (eye drops 0.25%) 1 time / day.
Children under 10 years are prescribed 1 drop (eye drops 0.25%) 2 times / day.

The drug is intended for long-term use.

The patient should be warned that only a doctor can change the dose or temporarily cancel the drug.

SIDE EFFECT

From the side of the organ of vision: irritation and hyperemia of the conjunctiva, skin of the eyelids, burning and itching in the eyes, lacrimation or reduction of teardrop, photophobia, corneal epithelial edema, spot surface keratopathy, corneal hypopsy, diplopia, ptosis, dry eyes, short-term visual acuity, blepharitis , conjunctivitis, keratitis.
When performing surgical interventions for glaucoma, it is possible to develop a detachment of the choroid of the eye in the postoperative period.
From the cardiovascular system: chest pain, heart failure, bradycardia, bradyarrhythmia, lowering blood pressure, collapse, AV-blockade, cardiac arrest, transient cerebral circulation disorders.

On the part of the respiratory system: rhinitis, dyspnea, bronchospasm, pulmonary insufficiency.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, weakness, depression, paresthesia, myasthenia gravis, drowsiness, hallucinations, ringing in the ears, slowing the speed of the psychomotor reaction.

From the digestive system: nausea, vomiting, diarrhea.

Allergic reactions: urticaria, eczema.

Other: nosebleeds, decreased potency, alopecia.

CONTRAINDICATIONS

- bronchial asthma or other severe chronic obstructive airway disease;

- sinus bradycardia;

- AV blockade II and III degree;

- acute heart failure;

- severe chronic heart failure (NYHA III and IV functional class);

- cardiogenic shock;

- Allergic reactions with generalized skin rashes;

- Atrophic rhinitis;

- Dystrophic diseases of the cornea;

- the period of the newborn;

- Hypersensitivity to the components of the drug.

With caution appoint the drug to patients with pulmonary insufficiency, emphysema, severe cerebrovascular insufficiency, heart failure (I and II functional class according to the NYHA classification), sinoatrial blockade, arterial hypertension, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, Reye syndrome, with simultaneous appointment other beta-blockers, as well as children.

PREGNANCY AND LACTATION

Sufficient experience in the use of the drug during pregnancy and lactation (breastfeeding), no, so the appointment of the drug is only possible in cases where the intended use of therapy for the mother exceeds the potential risk to the fetus or child.

It has been established that timolol penetrates the placental barrier and is excreted in breast milk.

During treatment should stop breastfeeding.

SPECIAL INSTRUCTIONS

The patient should be warned about the need for regular measurement of intraocular pressure and examination of the cornea, as well as the need to stop using the drug and consult a doctor if side effects occur.

When wearing soft contact lenses, Ocumed eye drops should not be used.
the preservative included in their composition can be deposited in soft contact lenses and have an adverse effect on the eye tissue.
Rigid contact lenses should be removed before instillation of the drug and set them again after 15 minutes.

When transferring patients to Ocumed treatment, correction of refraction may be necessary (after the disappearance of the effects of previously used myotics).

Okumed must be discontinued 48 hours before surgery with general anesthesia.

Okumed should not be used simultaneously with antipsychotic (antipsychotics) and anxiolytic (tranquilizers) drugs.

During the use of the drug is not recommended to drink alcohol (perhaps a sharp decrease in blood pressure).

Use in Pediatrics

Sufficient experience in the use of the drug in children is not, therefore, the prescription of the drug is possible only in cases when the intended use of therapy exceeds the potential risk of side effects.

Impact on the ability to drive vehicles and manage mechanisms

Immediately after application of the drug, it is possible to reduce the clarity of vision and slow the psychomotor reactions, which can reduce the ability to engage in potentially dangerous activities that require increased attention (especially with simultaneous use of alcohol).

OVERDOSE

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

Treatment: Immediately flush eyes with water or saline solution.
Conduct symptomatic therapy.
DRUG INTERACTION

The combined use of Ocumed with eye drops containing epinephrine can cause a dilated pupil.

Decrease in intraocular pressure is intensified with simultaneous application of eye drops containing epinephrine and pilocarpine.
Bury in the eyes of two beta-blockers should not be.
Decrease in blood pressure and slowing of the heart rhythm can be strengthened by the joint application of the drug with blockers of slow calcium channels, reserpine and other beta-blockers.

Simultaneous use with insulin or oral antidiabetics can lead to hypoglycemia.

Timolol strengthens the action of peripheral muscle relaxants (it is necessary to cancel the drug 48 hours before the planned surgical intervention with the use of general anesthesia).

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 В° C;
Do not freeze. Shelf life - 2 years.
After opening, the vial should be used within 45 days.

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