BRINZOLAMIDE

Product Type: HUMAN PRESCRIPTION DRUG

Route: OPHTHALMIC

Dosage Form:

NDC: 72162-2201

Application: ANDA211914

Effective: 20231219

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

2 DOSAGE AND ADMINISTRATION The recommended dose is one drop of brinzolamide ophthalmic suspension in the affected eye(s) 3 times daily. Shake well before use. Brinzolamide ophthalmic suspension may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart. • Instill one drop in the affected eye(s) 3 times daily. ( 2 ) • If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart. ( 2 )

4 CONTRAINDICATIONS Brinzolamide ophthalmic suspension is contraindicated in patients who are hypersensitive to any component of this product. Hypersensitivity to any component of this product. ( 4 )

Not available.

6 ADVERSE REACTIONS 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 Padagis ® at 1-866-634-9120 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. In clinical studies of brinzolamide ophthalmic suspension, the most frequently reported adverse reactions reported in 5% to 10% of patients were blurred vision and bitter, sour, or unusual taste. Adverse reactions occurring in 1% to 5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus, and rhinitis. The following adverse reactions were reported at an incidence below 1%: allergic reactions, alopecia, chest pain, conjunctivitis, diarrhea, diplopia, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky sensation, nausea, pharyngitis, tearing, and urticaria. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of brinzolamide containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious skin and subcutaneous tissue reactions such as Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) may occur with the use of brinzolamide due to its sulfonamide component [see Warnings and Precautions ( 5.1 )] .