DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION 2%, 10ML OPHTHALMIC SOLUTION 2%, 10ML

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

ALVOGEN INC.

INN (Internationale Bezeichnung):

DORZOLAMIDE HYDROCHLORIDE

Zusammensetzung:

DORZOLAMIDE 22.3 mg in 1 mL

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION 2%, 10ML OPHTHALMIC SOLUTION 2%, 10ML- DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC
SOLUTION 2%,
10ML SOLUTION
ALVOGEN 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: 2013
INDICATIONS AND USAGE
Dorzolamide hydrochloride 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
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 ALVOGEN AT
1-866-770-3024 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potential