DORZOLAMIDE HYDROCHLORIDE- dorzolamide solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Indoco Remedies Limited

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 14445-404-10, 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE - DORZOLAMIDE SOLUTION/ DROPS
INDOCO REMEDIES LIMITED
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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) (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) (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing dorzolamide 2% (20 mg/mL). (3) (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride ophthalmic solution is contraindicated in
patients who are hypersensitive to
any component of this product. (4, 5.1) (4)
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) (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 INDOCO REMEDIES LIMITED
AT +1-855-
642-2594 OR FDA AT 1-800-FDA-108