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Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension

NAFDAC Reg. No. B4-5549 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension
NAFDAC number
B4-5549
Active ingredient
Brinzolamide; Timolol (Timolol Maleate)
Strength
1%; 0.5%
Form
Suspension/Drops
Pack size
1 x 5 mL (in LDPE bottle)
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
24 Jun 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
23 Jun 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension is on the NAFDAC register with an active registration (B4-5549). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension is used for

From the official U.S. FDA label for brinzolamide, the active ingredient registered with NAFDAC.

What it is used for

AZOPT is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. AZOPT is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. ( 1 )

Possible side effects

Most common adverse reactions (incidence 5% to 10%) are blurred vision and bitter, sour, or unusual taste. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Do not use if

AZOPT is contraindicated in patients who are hypersensitive to any component of this product. Hypersensitivity to any component of this product. ( 4 )

Warnings

• Sulfonamide hypersensitivity reactions. ( 5.1 ) • Corneal edema may occur in patients with low endothelial cell counts. ( 5.2 ) 5.1 Sulfonamide Hypersensitivity Reactions AZOPT is a sulfonamide and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of AZOPT. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. In reproductive toxicity studies, brinzolamide administered orally to rats induced fetal toxicity at 375 times the recommended human ophthalmic dose (RHOD) based on mg/kg. In rabbits, no fetal toxicity was observed following oral administration (see Data) . …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension

What is in Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension?

Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension contains Brinzolamide; Timolol (Timolol Maleate) (1%; 0.5%), as suspension/drops, according to its NAFDAC registration record.

Is Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension registered with NAFDAC?

Yes. Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension is listed on the NAFDAC register under registration number B4-5549, and its registration is active as of 6 November 2026.

Has Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension in our automatically synced alert list.

How can I check that my pack of Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension is genuine?

Run a free authenticity scan with the NAFDAC number B4-5549, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Azarga 10 mg/mL + 5 mg/mL Eye Drops, Suspension used for?

AZOPT is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. AZOPT is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. ( 1 ) (Summarised from the official U.S. FDA label for brinzolamide. Always follow your doctor or pharmacist.)

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Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.