BRINZOLAMIDE suspension/ drops

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

BRINZOLAMIDE (UNII: 9451Z89515) (BRINZOLAMIDE - UNII:9451Z89515)

থেকে পাওয়া:

Sandoz Inc

প্রশাসন রুট:

OPHTHALMIC

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Brinzolamide ophthalmic suspension 1% 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 1% is contraindicated in patients who are hypersensitive to any component of this product. 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). The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4%, and of miscarriage is 15% to 20%, of clinically recognized pregnancies. Data Animal Data Embryo-fetal studies were conduct

পণ্য সারাংশ:

Brinzolamide ophthalmic suspension 1% is supplied in plastic dispensers with a controlled dispensing-tip as follows: 10 mL NDC 0781-6014-70 15 mL NDC 0781-6014-85 Storage and Handling Store brinzolamide ophthalmic suspension 1% at 4°C to 30°C (39°F to 86°F). Shake well before use. After opening, brinzolamide ophthalmic suspension 1% can be used until the expiration date on the bottle.

অনুমোদন অবস্থা:

New Drug Application Authorized Generic

পণ্য বৈশিষ্ট্য

BRINZOLAMIDE- BRINZOLAMIDE SUSPENSION/ DROPS
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRINZOLAMIDE
OPHTHALMIC SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BRINZOLAMIDE OPHTHALMIC SUSPENSION.
BRINZOLAMIDE OPHTHALMIC SUSPENSION 1%, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor
indicated for in the treatment of
elevated intraocular pressure (IOP) in patients with ocular
hypertension or open-angle glaucoma. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
•
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 SANDOZ INC., AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
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)
Ophthalmic suspension containing brinzolamide 10 mg/mL (1%). (3)
Hypersensitivity to any component of this product. (4)
Sulfonamide hypersensitivity reactions. (5.1)
Corneal edema may occur in patients with low endothelial cell counts.
(5.2)
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)
5.1 Sulfonamide Hypersensitivity Reactions
5.2 Corneal Endothelium
5.3 Severe Renal Impairment
5.4 Acute