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Azopt 10mg/5ml eye dr #1
Azopt 10mg/5ml eye dr #1

Azopt 10mg/5ml eye dr #1

Belgium

ალკონი

Azopt, ophthalmic drops 10 mg/mL, is a carbonic anhydrase inhibitor that works by reducing elevated intraocular pressure.

About Product

Azopt Ophthalmic Solution 10 mg/mL (5 mL vial)

Composition:

  • Active ingredient: Brinzolamide

  • Each milliliter of the solution contains 10 mg of brinzolamide

  • Excipients include: Benzalkonium chloride, mannitol (E 421), carbomer (974P), thiomersal, disodium edetate, sodium chloride, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and purified water.


Indications:

Azopt (10 mg/mL) is a carbonic anhydrase inhibitor used to lower elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma in the following situations:

  • As monotherapy in patients who are unresponsive to beta-blockers

  • In those for whom beta-blockers are contraindicated

  • As an adjunctive therapy to beta-blockers or prostaglandin analogs


Contraindications:

  • Known hypersensitivity to brinzolamide or any other component of the formulation

  • Hypersensitivity to sulfonamide derivatives

  • Severe renal impairment

  • Hyperchloremic acidosis


Dosage and Administration:

  • Adults: Instill one drop into the affected eye(s) twice daily. In some patients, a better effect may be achieved with three times daily dosing.

If a dose is missed, continue with the next dose as scheduled; do not exceed one drop per eye more than three times daily.

  • Children (0–17 years): The safety and efficacy of brinzolamide eye drops in this age group have not been established; use is not recommended.

  • Elderly patients: No differences in safety or effectiveness observed compared to younger adults; no dose adjustment required.

  • Liver and kidney impairment:

  • Not studied in patients with hepatic impairment, thus not recommended.

  • In severe renal impairment (creatinine clearance < 30 mL/min/1.73 m²), the drug is contraindicated.

  • No dose adjustment is necessary for moderate renal impairment (creatinine clearance 30–60 mL/min/1.73 m²).


Administration Instructions:

  • For ophthalmic use only. To avoid contamination of the contents, do not allow the dropper tip to touch the eyelids, surrounding areas, or any surfaces. Occluding the nasolacrimal duct or closing the eyelids may reduce systemic absorption and enhance local effect.

  • Shake well before use. After removing the cap, ensure clarity of the dropper tip before applying.

  • If using multiple ophthalmic products, wait at least 5 minutes between each. Apply ointments last.


Pregnancy and Lactation:

  • Pregnancy: There is limited or no clinical data on ophthalmic use of brinzolamide in pregnant women. Animal studies with systemic administration have shown reproductive toxicity at high doses. Thus, it is not recommended during pregnancy.

  • Breastfeeding: It is unknown whether brinzolamide or its metabolites are excreted in breast milk when used topically. This risk to the infant cannot be excluded. Systemic administration in animal studies did show minimal levels in milk. The decision to discontinue breastfeeding or therapy should consider the benefits to the nursing child and the mother’s need for treatment.

Fertility:

No studies have evaluated the effect of topical application on ocular fertility. Systemic administration in animals showed no impact on fertility.


Storage Conditions:

  • Store at 4–30 °C.

  • Keep out of reach of children.

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More Info
Brand
ალკონი
Country
Belgium
Generic
brinzolamide
Dose
10მგ/1მლ
Form
წვეთები თვალის
Packing
ფლაკონი
Quantity
1
Volume
5მლ
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(032) 2 71 07 07
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digitalsupport@gepha.com
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info@gepha.com
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JSC Gepha, ID 201991229
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24A Sulkhan Tsintsadze Street 0160, Tbilisi, Georgia
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