DORZOLAMIDE HYDROCHLORIDE- dorzolamide hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

DORZOLAMIDE HYDROCHLORIDE

Composition:

DORZOLAMIDE 20 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE- DORZOLAMIDE HYDROCHLORIDE SOLUTION
TEVA PHARMACEUTICALS USA, INC.
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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
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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 [e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2016
FULL PRESCRI