Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)
Teva Pharmaceuticals USA, Inc.
DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE 20 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Dorzolamide Hydrochloride Ophthalmic Solution, 2% is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution, 2% is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.1)]. Teratogenic Effects Pregnancy Category C Developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. These malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. No treatment-related malformations were seen at 1 mg/kg/day. These doses represent estimated plasma Cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. There are no adequate and well-controlled studies in pregnant women. Dorzolamide hydrochloride op
Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% is a clear, colorless solution that is essentially free of visible particles. It is supplied as 10 mL of solution, in 10 mL LDPE white sterile bottles with LDPE natural sterile droppers and HDPE TE orange sterile caps. NDC 0093-7618 -43 10 mL of solution in 10 mL bottle Storage Store Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.
Abbreviated New Drug Application
DORZOLAMIDE HYDROCHLORIDE- DORZOLAMIDE HYDROCHLORIDE SOLUTION TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, 2% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, 2%. DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, 2% INITIAL U.S. APPROVAL: 1994 INDICATIONS AND USAGE Dorzolamide Hydrochloride Ophthalmic Solution, 2% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1) DOSAGE AND ADMINISTRATION The dose is one drop of dorzolamide hydrochloride ophthalmic solution, 2% in the affected eye(s) three times daily. Dorzolamide hydrochloride ophthalmic solution, 2% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. (2) DOSAGE FORMS AND STRENGTHS Solution containing 20 mg/mL dorzolamide. (3) CONTRAINDICATIONS Dorzolamide hydrochloride ophthalmic solution, 2% is contraindicated in patients who are hypersensitive to any component of this product. (4, 5.1) WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS The most frequently reported adverse reactions associated with dorzolamide hydrochloride ophthalmic solution, 2% were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA, PHARMACOVIGILANCE AT 1-866-832-8537 OR DRUG.SAFETY@TEVAPHARM.COM; OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 8/2016 FULL PRESCRI Прочитать полный документ