COSOPT PF- dorzolamide hydrochloride and timolol maleate solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Dorzolamide Hydrochloride (UNII: QZO5366EW7) (Dorzolamide - UNII:9JDX055TW1), Timolol Maleate (UNII: P8Y54F701R) (Timolol Anhydrous - UNII:5JKY92S7BR)

Tilgjengelig fra:

Akorn

INN (International Name):

Dorzolamide Hydrochloride

Sammensetning:

Dorzolamide 20 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

COSOPT® PF is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT® administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)]. COSOPT PF is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1)]. COSOPT PF is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see Warnings and Precautions (5.2)]. COSOPT PF is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.3

Produkt oppsummering:

COSOPT PF is supplied in a foil pouch containing 15 low density polyethylene 0.2 mL single-use containers. NDC 17478-604-30, package of 60 single-use vials. NDC 17478-604-90, package of 180 single-use vials. Store COSOPT PF at 20° to 25°C (68° to 77°F). Do not freeze. Store in the original pouch. After the pouch is opened, store the remaining single-use containers in the foil pouch to protect from light. Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 15 days after first opening the pouch.

Autorisasjon status:

New Drug Application

Preparatomtale

COSOPT PF- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/
DROPS
AKORN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COSOPT PF SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR COSOPT PF.
COSOPT® PF (DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC
SOLUTION) 2%/0.5%
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
COSOPT PF is a carbonic anhydrase inhibitor with a beta-adrenergic
receptor blocking agent indicated for the reduction
of elevated intraocular pressure (IOP) in patients with open-angle
glaucoma or ocular hypertension who are
insufficiently responsive to beta-blockers.
The IOP-lowering of COSOPT twice daily was slightly less than that
seen with the concomitant administration of 0.5%
timolol twice daily, and 2% dorzolamide three times daily. (1)
DOSAGE AND ADMINISTRATION
The dose is one drop of COSOPT PF in the affected eye(s) two times
daily. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 20 mg/mL dorzolamide and 5 mg/mL timolol. (3)
CONTRAINDICATIONS
COSOPT PF is contraindicated in patients with:
Bronchial asthma or a history of bronchial asthma, severe chronic
obstructive pulmonary disease. (4.1)
Sinus bradycardia, second or third degree atrioventricular block,
overt cardiac failure, cardiogenic shock. (4.2)
Hypersensitivity to any component of this product. (4.3, 5.3)
WARNINGS AND PRECAUTIONS
Potentiation of Respiratory Reactions Including Asthma (5.1)
Cardiac Failure (5.2)
Sulfonamide Hypersensitivity (5.3)
Obstructive Pulmonary Disease (5.4)
Increased Reactivity to Allergens (5.5)
Potentiation of Muscle Weakness (5.6)
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus
(5.7)
Masking of Thyrotoxicosis (5.8)
Renal and Hepatic Impairment (5.9)
Impairment of Beta-Adrenergically Mediated Reflexes During Surgery
(5.10)
ADVERSE REACTIONS
The most frequently reported adverse reactions were taste perversion
(bitter, sour, or unusual taste) or ocular burning
and/or stinging in up to 30% of