Azobrin Ophthalmic Suspension is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions, with a subsequent reduction in sodium and fluid transport. This results in a decrease in intraocular pressure (IOP).
Shake well before use.
Insert one drop in the affected eye(s) three times daily.
It may be used concomitantly with other topical ophthalmic products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.
Pediatric Use:One drop in the affected eye(s) two times daily in pediatric patients (aged 4 weeks to 5 years).
Geriatric Use:No overall differences in safety or effectiveness have been observed between elderly and younger patients.
In patients treated with oral carbonic anhydrase inhibitors, rare instances of drug interactions have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving Azobrin.
Azobrin is contraindicated in patients who are hypersensitive to any component of this product.
The most frequently reported adverse events associated with Azobrin include:
Common (5-10%): Blurred vision, bitter, sour, or unusual taste.
Less Common (<1%): Blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, and ocular pruritus.
Rare: Allergic reactions, alopecia, chest pain, conjunctivitis, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, lid margin crusting or sticky sensation, nausea, pharyngitis, excessive tearing, and urticaria.
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Azobrin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It should be used during lactation only if the potential benefit outweighs the potential risk to the baby.
Azobrin is a sulfonamide and, although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions attributed to sulfonamides may occur with topical administration of Azobrin.
Serious Reactions: Fatalities, though rare, have occurred due to severe reactions to sulfonamides, including:
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Fulminant hepatic necrosis
Agranulocytosis
Aplastic anemia
Other blood dyscrasias
Hypersensitivity Risk: Sensitization may occur when a sulfonamide is re-administered, regardless of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of Azobrin immediately.
Renal Impairment: Since Azobrin and its metabolite are excreted primarily by the kidneys, it is not recommended for patients with renal impairment.
Hepatic Impairment: Azobrin has not been studied in patients with hepatic impairment and should be used with caution in such patients.
Although no human overdose data are available, potential effects include:
Electrolyte imbalance
Development of acidosis
Possible nervous system effects
In case of overdose, serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Store at room temperature and protect from light.
Do not touch the dropper tip to any surface.
The contents should not be used more than four weeks after first opening.
Protect from freezing.
