Ocumed® eye drops

Composition :

Each mL of 0.25% solution contains:

Active ingredient: Timolol maleate equivalent to timolol – 2.5 mg.

Excipients:

Benzalkonium chloride, sodium phosphate, sodium dihydrogen phosphate, water for injections.

Each ml of 0.5% solution contains:

Active ingredient: Timolol maleate equivalent to timolol – 5 mg.

Excipients: Benzalkonium chloride, sodium phosphate, sodium di hydrogen phosphate, water for injections.

Pharmacotherapeutic Group:

Antiglaucoma agents – beta-adrenergic blocker.

Indications:

  • increased intraocular pressure;
  • open-angle glaucoma;
  • secondary glaucoma;
  • as an additional remedy to reduce intraocular pressure in angle-closure glaucoma (in combination with myotics);
  • congenital glaucoma (when failure of other therapeutic measures).

Treatment with Ocumed ® is long-term. Break or change of dosage carried out only by order of a physician.

Dosage and Administration:

In adults and children over 10 years: 1 drop of 0.25% solution 2 times a day into the conjunctival sac, in case of lack of effectiveness – 1 drop of 0.5% solution 2 times a day. With the normalization of intraocular pressure maintenance dose -1 drop of 0.25% 1 times a day.

Children under 10 years old: 1 drop of 0.25% solution 2 times a day. Treatment with Ocumed ® is held usually for a long time. Break or change of dosage carried out only by order of a physician.

Contraindications:

For patients with individual hypersensitivity to the drug and a history of the following diseases:

  • asthma or other severe chronic obstructive airways disease;
  • sinusbradycardia;
  • atrioventricular block II or III level;
  • congestive heart failure;
  • severe chronic heart failure (III – IV functional class);
  • cardiogenic shock;
  • allergic reaction with generalized skin rash;
  • atrophic rhinitis;
  • degenerative disease of the cornea;
  • the neonatal period.

Warning and Precautions:

It is necessary to visit a physician regular for to corneal examination and intraocular pressure monitoring. If the patient wears soft contact lenses, then he should not use eye drops Ocumed® 0,25% and 0,5% as a preservative can be adsorbed by material of soft contact lenses and have an adverse effect on the eye tissues. It is necessary to remove hard contact lenses prior to instillation of the drug and to wear them again only after 15 minutes.

Immediately after instillation of the drug visual acuity may be reduce and mental reactions may become slower, which may reduce the ability to actively participate in road traffic, maintenance of machinery or to perform work without support. While the use of the drug simultaneously with alcohol this takes place with higher probability.

When transferring patients to the treatment with timolol correction after refraction effects caused by myotics used previously may be necessary.

In the case of the upcoming surgery with general anesthesia withdraw the drug for 48 hours before it.

Side Effect:

Topical reactions:
irritation and conjunctival hyperemia, eyelid skin, burning and itchy eyes, watery eyes or a decrease in lacrimation, photophobia, edema of the corneal epithelium, dot the surface keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes, short-term disturbance of visual acuity, blepharitis, conjunctivitis , keratitis. In carrying out antiglaucomatous operations may develop choroidal detachment in the postoperative period.

Systemic reactions:
Cardio-vascular system: congestive heart failure, bradycardia, bradyarrhythmia, lowering blood pressure, collapse, atrioventricular block, heart failure, transient ischemic attacks.

The respiratory system: shortness of breath, bronchospasm, pulmonary insufficiency. The central nervous system: headache, dizziness, myasthenia gravis, depression, paresthesia, drowsiness, hallucinations, tinnitus, slowing of psychomotor responses. On the part of the gastrointestinal tract: nausea, vomiting, diarrhea. Allergic reaction: hives, eczema.

Rhinitis, nasal bleeding, chest pain, decreased potency, alopecia. In the case of side effects, discontinue use of the drug as soon as possible contact your doctor.

Drug Interaction:

The simultaneous use of the drug Ocumed ® with eye drops containing epinephrine can cause dilatation of the pupil. The specific effect of the drug (reducing the intraocular pressure) increases, while the use of eye drops containing epinephrine and pilocarpine; instilling into the eyes of two beta-adrenergic blocker is not be allowed.

Lowering blood pressure and slowing heart rate may increase when combined with slow calcium channels blocker drugs, reserpine, and other beta-blockers. The simultaneous use of insulin or oral antidiabetic agents may lead to hypoglycemia. Simultaneous use with the antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers) is not allowed.

During the treatment it is not recommended intake of ethanol (a sharp decreasing in blood pressure is possible). Timolol increases the effect of peripheral muscle relaxants, and therefore requires removal of the drug for 48 hours before the planned surgery with general anesthesia.

Over Dosage:

The development of general resorptive effects typical to beta-blockers are possible: dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea and vomiting.

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

Packaging:

Eye drops 0.25% and 0.5%.

  • 5 and 10 ml plastic vial-dropper with a screw-on cap. Each vial-dropper along with instructions for use is placed into carton unit.
  • 5 ml vial of dark glass, closed with a rubber stopper, crimped with aluminum cap with a plastic cap relief. One glass bottle with a sterile dropper, packed in a plastic bag, is placed into carton unit along with instructions for use.

Shelf Life:

  • 3 years
  • Do not use after expiration date printed on the packaging
  • Shelf life after opening the vial is 45 days.