Zolopt BR Ophthalmic Solution
Indications
This is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Pharmacology
Brinzolamide is a carbonic anhydrase inhibitor which reduce intraocular pressure (IOP) by decreasing aqueous humor secretion in the ciliary processes of the eye.
Brimonidine Tartrate is an alpha 2 adrenergic receptor agonist which reduces IOP by decreasing aqueous humor production and increasing uveoscleral outflow.
Dosage And Administration
Instill one drop in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Shake well before use.
Interaction
In patients treated with this drop rare instances to drug interactions have occurred with high-dose salicylate therapy, CNS Depressants, Antihypertensives/ Cardiac Glycosides, Tricyclic Antidepressants, Monoamine Oxidase Inhibitors. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide + Brimonidine Tartrate .
Contraindications
It is contraindicated in patients who are hypersensitivity to Brinzolamide, Brimonidine Tartrate, or to any ingredient in the formulation and Neonates and Infants (under the age of 2 years).
Side Effects
The most commonly reported side effects include blurred vision, eye irritation, bad taste and dry mouth.
Pregnancy And Lactation
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide and Brimonidine Tartrate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Brinzolamide or Brimonidine Tartrate are excreted in human milk. Caution should be exercised while giving this ophthalmic suspension to a nursing mother.
Precautions And Warnings
Shake well before use. For ophthalmic use only. Contact lenses should be removed during instillation of Brinzolamide and Brimonidine Tartrate ophthalmic suspension, but may be reinserted 15 minutes after instillation.
Overdose Effects
Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of Brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of Brimonidine Tartrate in adults; the only adverse event reported to date has been hypotension. Symptoms of Brimonidine Tartrate overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
Therapeutic Class
Drugs for miotics and glaucoma
Use in special populations
Use in children: Safety & effectiveness in children below the age of 2 years have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
Storage Conditions
Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use & do not freeze.