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:

FOSUN PHARMA USA INC

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

Product summary:

Dorzolamide Hydrochloride Ophthalmic Solution, USP 2 % is supplied in 10 mL ratchet modified screw neck white LDPE bottle with LDPE nozzle having white Opaque pump with a dip tube and Orange color ring modified HDPE screw cap as follows: NDC 72266-197-01 10 mL Fill in a 10 mL bottle 1 bottle in 1 carton Storage : Store at 15°C to 30°C (59°F to 86°F). Protect from light. After opening, Dorzolamide Hydrochloride Ophthalmic Solution 2 % can be used until the expiration date on the bottle.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE- DORZOLAMIDE HYDROCHLORIDE SOLUTION
FOSUN PHARMA 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 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION.
DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, 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,
USP in the affected eye(s) three
times daily. Dorzolamide Hydrochloride Ophthalmic Solution, USP 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 FOSUN PHARMA USA INC.
AT 1-866-611-
3762 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV