Country: United States
Language: English
Source: NLM (National Library of Medicine)
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)
Biocon Pharma Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Dorzolamide hydrochloride ophthalmic solution, USP 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)]. Risk Summary 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 backgrou
Dorzolamide Hydrochloride Ophthalmic Solution, USP is a slightly opalescent, colorless to nearly colorless, slightly viscous solution. Dorzolamide Hydrochloride Ophthalmic Solution, USP 2% is supplied in a natural, LDPE plastic ophthalmic bottle with a natural nozzle and an orange, tamper-evident cap. NDC 70377-081-11, 10 mL, in an 10 mL capacity bottle. Storage Store dorzolamide hydrochloride ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. After opening, dorzolamide hydrochloride ophthalmic solution can be used until the expiration date on the bottle. KEEP OUT OF THE REACH OF CHILDREN. TEAR AND DISCARD RING BEFORE USE. Do not use if tear-off ring is broken or missing.
Abbreviated New Drug Application
DORZOLAMIDE HYDROCHLORIDE - DORZOLAMIDE SOLUTION/ DROPS BIOCON PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP. DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2% FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL: 1994 INDICATIONS AND USAGE Dorzolamide hydrochloride ophthalmic solution, USP is a carbonic anhydrase inhibitor indicated for 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 Ophthalmic solution containing dorzolamide 2% (20 mg/mL). (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 • Sulfonamide Hypersensitivity (5.1) • Bacterial Keratitis (5.2) • Corneal Endothelium (5.3) • Allergic Reactions (5.4) • Acute Angle-Closure Glaucoma (5.5) 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 BIOCON PHARMA INC, AT 1-866-924-6266 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG Read the complete document