TRUSOPT- dorzolamide hydrochloride solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Merck Sharp & Dohme LLC

INN (Rahvusvaheline Nimetus):

DORZOLAMIDE HYDROCHLORIDE

Koostis:

DORZOLAMIDE 20 mg in 1 mL

Manustamisviis:

OPHTHALMIC

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

TRUSOPT® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. TRUSOPT 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 TRUSOPT. 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 clinical exposure). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general populati

Toote kokkuvõte:

TRUSOPT (dorzolamide hydrochloride ophthalmic solution) 2% is supplied in an OCUMETER® PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with orange label as follows: NDC 0006-3519-36, 10 mL, in an 18 mL capacity bottle. Storage Store TRUSOPT at 15°C to 30°C (59°F to 86°F). Protect from light. After opening, TRUSOPT can be used until the expiration date on the bottle.

Volitamisolek:

New Drug Application

Toote omadused

TRUSOPT- DORZOLAMIDE HYDROCHLORIDE SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRUSOPT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRUSOPT.
TRUSOPT (DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION) 2%, FOR
TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
TRUSOPT 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 TRUSOPT in the affected eye(s) three times
daily. TRUSOPT 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
TRUSOPT 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 TRUSOPT
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 MERCK SHARP & DOHME
CORP., A
SUBSIDIARY OF MERCK & CO., INC., AT 1-877-888-4231 OR FDA AT
1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potential additive effect of oral carbonic anhydrase inhibitor with
TRUSOPT. (7.1)
Potential acid-base and electrolyte disturbances. (7.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2021
FULL PRESCRIBI