ACTIONS & CLINICAL PHARMACOLOGY

Dorzolamide and Timolol Eye Drops is comprised of two components: Dorzolamide Hydrochloride and Timolol Maleate. Each of these two components decreases elevated intra-ocular pressure by reducing aqueous humour secreation. Dorzolamide and Timolol Eye Drops reduce intra-ocular pressure without the common side effects of miotics such as night blindness , accommodative spasm and pupillary constriction.

INDICATIONS:

Dorzolamide and Timolol Eye Drops is indicated in the treatment of elevated intra-ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.

CONTRAINDICATIONS

Dorzolamide and Timolol Eye Drops is contraindicated in patients with hypersensitivity to one or both active substances or to any of the excipients. Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease, sinus, bradycardia, second- or third- degree atrioventricular block, overt cardiac failure, cardiogenic shock.

WARNINGS

Like other topically applied ophthalmic agents Timolol is absorbed systemically. Due to beta-adrenergic component, Timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta- adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration to reduce the systemic absorption.

Corneal diseases: Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.

Contact lens use: Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

DRUG INTERACTIONS

Specific drug interaction studies have not been performed with Dorzolamide and Timolol Eye Drops.

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

PREGNANCY

Dorzolamide and Timolol Eye Drops should not be used during pregnancy

Nursing Mothers: Beta-blockers are excreted in breast milk. However, at therapeutic doses of Timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. It is not known whether Dorzolamide is excreted in human milk. In lactating rats receiving Dorzolamide, decreases in the body weight gain of offspring were observed.

Pediatric Use: Safety and efficacy in pediatic patients below the age of 2 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patents.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

No data are available in humans in regard to overdosage by accidental or deliberate ingestion of Dorzolamide and Timolol Eye Drops. The most common signs and symptoms to be expected with overdosage of Dorzolamide are electrolyte imbalance, development of an acidotic state, and possibly central nervous system effects. With topical application the following have been reported: nausea, dizziness, headache, fatigue, abnormal dreams, and dysphagia.

Treatment should be symptomatic and supportive.Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Studies have shown that Timolol does not dialyse readily.

DOSAGE AND ADMINISTRATION

The dose is one drop of Dorzolamide and Timolol Eye Drops in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic medicinal product is being used, the other agent should be administered at least ten minutes apart. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

SPECIAL INSTRUCTIONS

Patients should be advised to avoid contamination of the dispensing tip.

STORAGE

Store in a cool & dark place below 30°C.

PRESENTATION

Dorfort-T Eye Drops are available in 5ml sterile plastic bottles.