BRINZOLAMIDE suspension/ drops

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Bryant Ranch Prepack

Администрация маршрут:

OPHTHALMIC

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 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 conducted in pregnant rats administered 0, 2, 6, or 18 mg/kg/day brinzolamide by oral gavage on gestation days 6 to 17, to target the period of organogenesis. Decreased fetal body weight with reduced skeletal ossification were observed at 18 mg/kg/day (375 times the RHOD based on mg/kg). The no-observed-adverse-effect-level (NOAEL) for fetal toxicity was 6 mg/kg/day (125 times the RHOD). Decreased maternal weight gain was observed at 18 mg/kg/day. The NOAEL for maternal toxicity was 6 mg/kg/day (125 times the RHOD). Embryo-fetal studies were conducted in pregnant rabbits administered 0, 1, 3, or 6 mg/kg/day of brinzolamide by oral gavage on gestation days 6 to 18, to target the period of organogenesis. No treatment-related fetal effects were observed at any dose. The NOAEL for fetal toxicity was 6 mg/kg/day (125 times the RHOD based on mg/kg). Maternal weight loss during pregnancy was observed at 3 mg/kg/day (63 times the RHOD) and above. The NOAEL for maternal toxicity was 1 mg/kg/day (21 times the RHOD). A peri-/postnatal study was conducted in rats administered brinzolamide by oral gavage from gestation day 16 through lactation day 20. Decreased pup body weight was observed at 15 mg/kg/day (313 times the RHOD based on mg/kg). The NOAEL for developmental toxicity was 5 mg/kg/day (104 times the RHOD). Following oral administration of 14 C-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood. Risk Summary There are no data on the presence of brinzolamide in human milk, the effects on the breastfed infant, or the effects on milk production. Brinzolamide has been detected in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for brinzolamide ophthalmic suspension and any potential adverse effects on the breastfed child from brinzolamide ophthalmic suspension. A 3-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. Patients were not required to discontinue their IOP-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension. IOP-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated IOP was between 0 mmHg and 2 mmHg. Five out of 32 patients demonstrated an increase in corneal diameter of one millimeter. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Обзор продуктов:

Brinzolamide ophthalmic suspension, USP 1% is supplied in a plastic bottle with a controlled drip tip and an orange cap. 10 mL NDC 72162-2201-2 15 mL NDC 72162-2201-4 Storage and Handling Store brinzolamide ophthalmic suspension at 4°C to 30°C (39°F to 86°F). Shake well before use. After opening, brinzolamide ophthalmic suspension can be used until the expiration date on the bottle. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

BRINZOLAMIDE- BRINZOLAMIDE SUSPENSION/ DROPS
BRYANT RANCH PREPACK
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions,
Sulfonamide Hypersensitivity Reactions (5.1) 6/2023
INDICATIONS AND USAGE
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 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 PADAGIS AT 1-866-634-9120 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2023
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 1% (10 mg/mL). (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)