DORZOLAMIDE HYDROCHLORIDE solution/ drops

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

A-S Medication Solutions

INN (Internationale Bezeichnung):

DORZOLAMIDE HYDROCHLORIDE

Zusammensetzung:

DORZOLAMIDE 20 mg in 1 mL

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride 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 should be used during pre

Produktbesonderheiten:

Product: 50090-1246 NDC: 50090-1246-0 10 mL in a BOTTLE / 1 in a CARTON

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DORZOLAMIDE HYDROCHLORIDE- DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS
A-S MEDICATION SOLUTIONS
----------
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.
INITIAL U.S. APPROVAL: 1994
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) (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
Solution containing 20 mg/mL dorzolamide. (3) (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride is contraindicated in patients who are
hypersensitive to any component of this
product. (4, 5.1) (4)
WARNINGS AND PRECAUTIONS
1.
2.
3.
4.
5.
ADVERSE REACTIONS
The most frequently reported adverse reactions associated with
dorzolamide hydrochloride 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 HI-TECH PHARMACAL CO.,
INC. AT 1-800-
262-9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
1.
2.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Sulfonamide Hypersensitivity
Su