Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)
Sandoz 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 is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.1)]. There are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. Dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). Dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). Dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). Growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). The background risk of maj
Dorzolamide hydrochloride ophthalmic solution is a slightly opalescent, nearly colorless, slightly viscous solution. Dorzolamide hydrochloride ophthalmic solution is supplied in a white LDPE plastic bottle, a natural dropper tip and an orange polypropylene cap as follows: NDC 61314-019-10 10 mL, in a 10 mL bottle Storage Store dorzolamide hydrochloride ophthalmic solution at 2° to 25°C (36° to 77°F). Protect from light. After opening, dorzolamide hydrochloride ophthalmic solution can be used until the expiration date on the bottle.
Abbreviated New Drug Application
DORZOLAMIDE HYDROCHLORIDE- DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION. DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION 2%, FOR OPHTHALMIC USE INITIAL U.S. APPROVAL: 1994 INDICATIONS AND USAGE Dorzolamide hydrochloride ophthalmic solution 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 in the affected eye(s) three times daily. Dorzolamide hydrochloride ophthalmic solution 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 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 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 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: 12/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND S Belgenin tamamını okuyun