DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

DORZOLAMIDE HYDROCHLORIDE

Composition:

DORZOLAMIDE 20 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 betablockers (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. Pregnancy Category C. 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.

Product summary:

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied sterile in 10 mL white LDPE plastic dropper bottles with white LDPE dropper tips and blue P/P caps of the following sizes: 10 mL Storage Store Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution between 20 and 25°C (68-77°F). Protect from light. After opening, Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution can be used until the expiration date on the bottle.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE- DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION.
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
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a
combination of dorzolamide
hydrochloride, carbonic anhydrase inhibitor, and timolol maleate, 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)
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) (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing dorzolamide 20 mg/mL (2%) and timolol 5
mg/mL (0.5%). (3) (3)
CONTRAINDICATIONS
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is
contraindicated in patients with: (4)
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