DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

थमां उपलब्ध:

Bryant Ranch Prepack

प्रशासन का मार्ग:

OPHTHALMIC

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution 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 dorzolamide hydrochloride and timolol maleate ophthalmic solution 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)]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1)]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution 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)]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.3)]. Teratogenic Effects. Developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (37 times the recommended human ophthalmic dose) 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 (15 times the recommended human ophthalmic dose). Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. There are no adequate and well-controlled studies in pregnant women. Dorzolamide hydrochloride and timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether dorzolamide is excreted in human milk. Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from dorzolamide hydrochloride and timolol maleate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older. Use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults. Safety and efficacy in pediatric patients below the age of 2 years have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP (dor-ZOE-la-mide HYE-droe-KLOR-ide and TIM-oh-lol MAL-ee-ate) for topical ophthalmic use Read this Instructions for Use before you start using dorzolamide hydrochloride and timolol maleate ophthalmic solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Important Information: Figure A Figure B Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 09/2023 9633205 (11" x 5" folded) 9633305 (0.9375" x 5" folded)

उत्पाद समीक्षा:

Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP, 2% / 0.5% is supplied in a white low-density polyethylene (LDPE) bottle with a white LDPE dropper tip and a blue polypropylene cap as follows: NDC 72162-2166-2, 10 mL in a 10 mL capacity bottle. Storage: Store at 20°C to 25°C (68°F to 77°F). Protect from light. After opening, dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP can be used until the expiration date on the bottle. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE- DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE AND
TIMOLOL
MALEATE OPHTHALMIC SOLUTION.
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION, FOR
TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
•Dorzolamide hydrochloride and timolol maleate ophthalmic solution
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 dorzolamide hydrochloride and timolol maleate
ophthalmic solution 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) (1)
DOSAGE AND ADMINISTRATION
The dose is one drop of dorzolamide hydrochloride and timolol maleate
ophthalmic solution in the affected
eye(s) two times daily. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing dorzolamide 20 mg/mL (2%) and timolol 5
mg/mL (0.5%). (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is
contraindicated in patients with:
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WARNINGS AND PRECAUTIONS
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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 patients. Conjunctival
hyperemia, blurred vision, superficial
punctate keratitis or eye itching were reported between 5 to 15% of
patients. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH & LOMB
INCORPORATED AT 1-800-
553-5340 OR FDA AT