BRINZOLAMIDE 10 mg/mL
brinzolamide · SUSPENSION/ DROPS · Bausch & Lomb Incorporated
BRINZOLAMIDE is a suspension/ drops containing brinzolamide at 10 mg/mL, taken ophthalmic. Manufactured by Bausch & Lomb Incorporated.
Key Facts
- Brand Name
- BRINZOLAMIDE
- Generic Name
- brinzolamide
- NDC Code (Product)
24208-464- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 10 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA204884
- Drug Class
- Carbonic Anhydrase Inhibitor [EPC]
- Marketing Start
- 03/31/2022
Recall History
Teva Pharmaceuticals USA
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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 )
Contraindications
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 )
Drug Interactions
7 DRUG INTERACTIONS There is a potential additive effect of the known systemic effects of carbonic anhydrase inhibition in patients receiving both oral and topical carbonic anhydrase inhibitors. ( 7.1 ) Rare instances of acid-base alterations have occurred with high-dose salicylate therapy. ( 7.2 ) 7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide ophthalmic suspension. The concomitant administration of brinzolamide ophthalmic suspension and oral carbonic anhydrase inhibitors is not recommended. 7.2 High-Dose Salicylate Therapy Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations. These alterations were not reported in the clinical trials with brinzolamide. However, in patients treated with oral carbonic anhydrase inhibitors, rare instances of acid-base alterations have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving brinzolamide ophthalmic suspension.
Adverse Reactions
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 Bausch & Lomb Incorporated at 1-800-553-5340 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, e…
Frequently Asked Questions
What is BRINZOLAMIDE used for?
BRINZOLAMIDE contains brinzolamide. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is BRINZOLAMIDE a controlled substance?
BRINZOLAMIDE is not classified as a controlled substance by the DEA.
What is the generic name for BRINZOLAMIDE?
The generic name for BRINZOLAMIDE is brinzolamide. There are 3 other brand versions of brinzolamide.
What is the NDC code for BRINZOLAMIDE 10 mg/mL?
The NDC (National Drug Code) for BRINZOLAMIDE 10 mg/mL is 24208-464, listed by Bausch & Lomb Incorporated.