Okumed - instructions for use, dose, side effects, contraindications

With topical application in the form of eye drops 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:

With topical application timolol quickly penetrates through the cornea. After instillation of eye drops, the maximum concentration of timolol in the aqueous humor of the anterior chamber of the eye is achieved after 1-2 hours.

In a small amount falls into 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 maximum concentration significantly exceeds that in adults.

Indications:

- Increased intraocular pressure (ophthalmic hypertension);

- open-angle glaucoma;

- secondary glaucoma;

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

- congenital glaucoma (with insufficient other therapeutic measures).

Contraindications:

Increased individual sensitivity to the components of the drug, as well as patients who have a history of the following diseases:

- bronchial asthma or other severe chronic obstructive airway disease;

- sinus bradycardia, atrioventricular block II or III degree;

- acute heart failure;

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

- cardiogenic shock;

- Allergic reactions with generalized skin rashes;

- Atrophic rhinitis;

- Dystrophic diseases of the cornea;

- the period of the newborn.

Carefully:

Patients with pulmonary disease, emphysema, severe cerebrovascular insufficiency, congestive heart failure (functional class 1-11), sinoatrial blockade, hypotension, diabetes, hypoglycemia, hyperthyroidism, myasthenia, Raynaud's syndrome, pheochromocytoma, and with concomitant administration of other beta - adrenoblockers, children's age.

Pregnancy and lactation:

Sufficient experience of use of the drug during pregnancy, lactation and children do not have, however, found that timolol passes the placental barrier, and also enters breast milk.It is possible to use the drug Okumed ® for the treatment of children and pregnant women, if the expected therapeutic effect exceeds the risk of possible side effects. During the use of the drug, breastfeeding should be discontinued.

Dosing and Administration:

Adults and children over 10 years instilled into the conjunctival sac of one drop of 0.25% solution of 2 times a day, the lack of effectiveness - 1 drop of 0.5% solution of 2 times a day. With the normalization of intraocular pressure, the maintenance dose -1 drop 0.25% once a day.

Children under 10 years -1 drop 0.25% solution 2 times a day.

Treatment with Ocumed® is usually carried out for a long time. Interruption or change in dosage is carried out only according to the prescription of the attending physician.

Side effects:

Local reactions: irritation and redness of the conjunctiva, eyelid skin, burning and itchy eyes, watery eyes, or a decrease in lacrimation, photophobia, edema of the corneal epithelium, superficial punctate keratopathy, gipostezii cornea, diplopia, ptosis, dry eyes, a short break in visual acuity, blepharitis, conjunctivitis, keratitis. When conducting antiglaukomatoznyh operations may develop detachment of the choroid of the eye in the postoperative period.

Systemic reactions:

From the cardiovascular system: heart failure, bradycardia, bradyarrhythmia, lowering of arterial pressure, collapse, atrioventricular blockade, cardiac arrest, transient cerebral circulation disorders.

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

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

From the gastrointestinal tract: nausea, vomiting, diarrhea.

Allergic reactions: hives, eczema.

Rhinitis, nosebleeds, chest pain, decreased potency, alopecia.

In case of side effects, discontinue use of the drug and contact your doctor as soon as possible.

Overdose:

It is possible to develop general-resorptive effects, characteristic for beta-blockers: dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting.

Treatment: immediately flush eyes with water or 0.9% solution of sodium chloride, symptomatic therapy.

Interaction:

Co-administration of Ocumed® with eye drops containing epinephrine, can cause a dilated pupil.

Specific action of the drug - decrease in intraocular pressure is enhanced with simultaneous use of eye drops containing epinephrine and pilocarpine; Bury in the eyes of two beta-blockers should not be.

Reduction of 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.

It can not be used simultaneously with antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers).

During treatment it is not recommended to take ethanol (possibly a sharp drop in blood pressure).

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

Special instructions:

It is necessary to visit the doctor regularly to measure intraocular pressure and examine the cornea.

If the patient wears soft contact lenses, Ocumed® eye drops of 0.25% and 0.5% should not be used, since the preservative can be sorbed by soft contact lens material and adversely affect the eye tissue.

Strict contact lenses should be removed before instillation of the preparation and they should be worn again only after 15 minutes.

Immediately after instillation of the drug, it is possible to reduce the clarity of vision and slow mental reactions, which may reduce the ability to actively participate in street traffic, machine maintenance or work without support. In an even greater degree this is the case with the simultaneous use of the drug with alcohol.

When transferring patients to treatment with timolol, correction of refraction after effects caused by previously used miotics may be necessary.

In the case of an upcoming surgical intervention with general anesthesia, it is necessary to cancel the drug within 48 hours.

Effect on the ability to drive transp. cf. and fur:Immediately after instillation of the drug, it is possible to reduce the clarity of vision and the slowing of mental reactions,which can reduce the ability to actively participate in traffic, machine maintenance or work without support.

Form release / dosage:

Eye drops 0.25% and 0.5%.

Packaging:

For 5 and 10 ml in a plastic bottle-dropper with a screw cap. Each vial-dropper along with the instruction for use is placed in a cardboard box.

5 ml in a bottle of dark glass, closed with a rubber stopper, crimped aluminum cap with a safety plastic cap. One glass bottle with a sterile dropper packed in a plastic bag is placed in a cardboard box along with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C in a dark place. Do not freeze. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package. Shelf life after opening the bottle is 45 days.

Terms of leave from pharmacies:On prescription

Registration number:П N012980 / 01

Date of registration:20.12.2007 / 05.12.2013

Expiration Date:Unlimited

The owner of the registration certificate:Promed Exports Pvt. Ltd.Promed Exports Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspPROMED EXPORTS Pvt. Ltd. PROMED EXPORTS Pvt. Ltd. India

Information update date: & nbsp02.06.2017

Illustrated instructions

Instructions

Okumed® (Ocumed)