COSOPT PF- dorzolamide hydrochloride and timolol maleate solution/ drops

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Thea Pharma Inc.

Пут администрације:

OPHTHALMIC

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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)]. Teratogenic Effects . Pregnancy Category C. Developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (31 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 (13 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 1000 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. COSOPT PF 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 COSOPT PF 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. Read these instructions before using your COSOPT PF and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. Important: - COSOPT PF is for the eye only. Do not swallow COSOPT PF. - COSOPT PF single-use containers are packaged in a foil pouch. - Write down the date you open the foil pouch in the space provided on the pouch. Every time you use COSOPT PF: Step 1. Wash your hands. Step 2. Take the strip of single-use containers from the pouch. Step 3. Pull off 1 single-use container from the strip. Step 4. Put the remaining strip of single-use containers back in the pouch and fold the edge to close the pouch. (Figure A) (Figure B) (Figure C) (Figure D) - If your doctor has told you to use drops in both eyes, repeat steps 7 to 11 for your other eye. - There is enough COSOPT PF in 1 single-use container for 1 or both of your eyes. - Throw away the opened single-use container with any remaining COSOPT PF right away. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured for: Thea Pharma Inc. Lexington, MA 02420 The COSOPT trademark is owned by Merck Sharp & Dohme Corp. and is used under license. © 2022. Thea Pharma Inc. All rights reserved Rev. 05/22

Резиме производа:

COSOPT PF is supplied in a foil pouch containing 15 low density polyethylene 0.2 mL single-use containers. NDC 52584-604-30, package of 60 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.

Статус ауторизације:

New Drug Application

Карактеристике производа

COSOPT PF- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/
DROPS
THEA PHARMA 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 stin