Combipres5 ml

This eye drop is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Drugs for miotics and glaucoma

Brimonidine is more selective for the α-2 adrenoreceptor. It is thought that Brimonidine Tartrate lowers IOP by enhancing uveoscleral outflow and reducing aqueous humour formation. Timolol is a beta1 and β-2 non-selective adrenergic receptor blocking agent. Timolol lowers IOP by reducing aqueous humour formation. The precise mechanism of action is not clearly established, predominant action may be related to reduced aqueous formation. However, in some studies a slight increase in outflow facility was also observed.

The recommended dose is one drop of this eye drops in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, other eye drops should be instilled at least 5 minutes apart.

Instill 1 drop in the affected eye(s) twice daily.

Specific drug interaction studies have not been conducted.

Contraindicated in patients with hypersensitivity to any component of this product. Also contraindicated in bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure and cardiogenic shock.

The most common side effects are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus and ocular burning or stinging.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.Timolol has been detected in human milk following oral and ophthalmic drug administration. It is not known whether brimonidine passes into human breast milk. However, it has been shown to pass into the milk of nursing animals. Because of the potential for serious adverse reactions from this combination in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.

No clinical data are available on overdose with this eye drops.

Store at a cool & dry place, protect from light. Do not use longer than 30 days after the first opening of the bottle. Keep out of the reach of children.

Safety and effectiveness in children below the age of 2 years have not been established.

Drugs for miotics and glaucoma

This eye drops is comprised of two components: Brimonidine Tartrate & Timolol Maleate. Brimonidine Tartrate is a selective alpha-2 adrenergic receptor agonist having a dual mechanism of action. It decreases aqueous humor production and increases nonpressure dependent uveoscleral outflow. Timolol Maleate is a β-adrenergic receptor antagonist that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. It lowers IOP by reducing aqueous humor production. Therefore the combination of both drugs gives a rapid onset of action, with peak ocular hypotensive effect seen within two hours of administration.

There are no adequate and well-controlled studies in pregnant women. Combipres should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk but it is not known whether Brimonidine Tartrate is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue taking into account the importance of the drug to the mother.

Use in children: Safety and effectiveness in children below the age of 2 years have not been established.Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.