DORZOLAMIDE HYDROCHLORIDE solution/ drops

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Alembic Pharmaceuticals Inc.

Stjórnsýsluleið:

OPHTHALMIC

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Dorzolamide hydrochloride ophthalmic solution 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) ]. 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 o

Vörulýsing:

Dorzolamide hydrochloride ophthalmic solution, USP 2% is supplied in sterile white low density polyethylene round screw neck bottle with high density polyethylene orange screw cap. 10 mL in a 10 mL bottle NDC 62332-519-10 Storage: Store Dorzolamide hydrochloride ophthalmic solution, USP at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature].Excursions permitted to 15° - 30° C (59° - 86° F). Protect from light.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DORZOLAMIDE HYDROCHLORIDE - DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS
ALEMBIC PHARMACEUTICALS 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
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Dorzolamide hydrochloride ophthalmic solution 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 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
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 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 ALEMBIC PHARMACEUTICALS
INC. AT 1-866-
210-9797 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Potential additive effect of o