Drumoptol® Eye Drops contain Timolol Maleate chemically described as (S)-1-[(1,1- dimethylethyl) amino] -3-[[4-(4-morpholinyl)-1,2,2 – thiadiazo-3-yl) oxy]-2- propanol, (z)-butenedioate (1:1) salt a beta-adrenergic blocking agent. It is available as 0.5% solution, containing Timolol BP 5mg (Timolol Maleate 6.8mg) in 1ml ophthalmic solution.

ACTION

Timolol Maleate is a non-selective beta-blocking agent which does not have significant intrinsic sympathomimetic, direct myocardial, depressant or local anesthetic activity.

Drumoptol® reduces intraocular pressure (IOP) approximately 20 minutes after ocular instillation. The maximum effect usually occurs in one or two hours and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose.

INDICATIONS

Drumoptol® is known to be effective in lowering intraocular pressure and may be used in:

  • Patients with chronic open-angle glaucoma.
  • Patients with aphatic glaucoma.
  • Patients with elevated intraocular pressure who are at sufficient risk to require lowering of the ocular pressure.

CONTRAINDICATIONS

Drumoptol® is contraindicated in patients with history of bronchial asthma or severe chronic obstructive pulmonary disease, such as sinus bradycardia, second and third degree atrioventricular block and cardiogenic shock.

Drumoptol® is contraindicated in patients with known hypersensitivity to any of its components.

PRECAUTIONS

Monitor for signs of cardiac insufficiency in patients with a history of severe cardiac disease and in the elderly.

Severe respiratory and cardiac reactions may occur when administered to patients with asthma or cardiac failure.

Observe patients already receiving oral beta-blocker for potential additive effect on the intraocular pressure or on the known systemic effects of beta-blockers.

Use with caution in diabetic patients who are receiving insulin or oral hypoglycaemic agents since beta-blockers may risk the signs and symptoms of acute hypoglycaemia.

Use during pregnancy and lactation is strictly at the discretion of the doctor. Not recommended for use in children and newborn babies.

KEEP OUT OF REACH OF CHILDREN

DOSAGE AND ADMINISTRATION

Instill one drop of 0.5% solution in the affected eye(s) twice a day. The dosage may be changed to one drop once daily if the intraocular pressure is maintained at satisfactory levels after 4 weeks of treatment with Drumoptol®.

PRESENTATION

Drumoptol® Eye Drops is available in sterile lupolen bottle containing 5ml of the drops

STORAGE CONDITIONS

Store below 300C. Protect from light and moisture. Replace cap immediately after use.

Discard after 28 days of opening the bottle.