DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION- dorzolamide hydrochloride solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Micro Labs Limited

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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)]. 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 clinic

Produktu pārskats:

Dorzolamide hydrochloride ophthalmic solution, USP 2% is supplied in an LDPE white opaque cylindrical shape, screw type neck dispenser bottle closed with a LDPE white opaque cone shaped open nozzle and an HDPE orange color cone shaped cap as follows. NDC 42571-141-26, 10 mL in a 10 mL capacity bottle. Storage Store dorzolamide hydrochloride ophthalmic solution at 15 to 30°C (59 to 86°F). Protect from light.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION - DORZOLAMIDE
HYDROCHLORIDE SOLUTION/ DROPS
MICRO LABS LIMITED
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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 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
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
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 MICRO LABS USA, INC. AT
1-855-839-8195
OR FDA AT 1-800-332-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potential a