DORZOLAMIDE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Leading Pharma, LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 ophthalmic solution should b

Product summary:

Dorzolamide hydrochloride ophthalmic solution USP, 2% is supplied as a 5ml and 10 ml labeled LDPE bottle with insert cap assembly comprising of orange colored screw cap over a LDPE nozzle with tamper evident LDPE dust cover sealing the bottle cap. NDC 69315-304-05, 5 mL in a 5 ml bottle NDC 69315-304-10, 10 mL in a 10 ml bottle Storage Store dorzolamide hydrochloride ophthalmic solution USP at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE- DORZOLAMIDE HYDROCHLORIDE SOLUTION
LEADING PHARMA, LLC
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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 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. (5.1) (4)
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 LEADING PHARMA AT
1-844-740-7500 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6)
DRUG INTERACTIONS
Potential additive effect of oral carbonic anhydrase inhibitor with