TIMOLOL MALEATE solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

Pieejams no:

Apotex Corp

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Timolol Maleate Ophthalmic Solution, USP 0.5% is a non-selective beta-adrenergic receptor blocking agent indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Timolol maleate ophthalmic solution  is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease (see WARNINGS AND PRECAUTIONS, 5.1, 5.3). Timolol maleate ophthalmic solution  is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure (see WARNINGS AND PRECAUTIONS, 5.2 ); cardiogenic shock. Timolol maleate ophthalmic solution  is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this product in the past. Teratogenic Effects: Pregnancy Category C: Teratogenicity studies have been performed in animals. 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. Timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from 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. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Produktu pārskats:

Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1) 2.5 mL in 5 mL container (NDC 60505-1005-4) STORAGE Store at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
APOTEX CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIMOLOL MALEATE
OPHTHALMIC SOLUTION, USP 0.5% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP.
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.5%
INITIAL U.S. APPROVAL: 1978
STERILE
INDICATIONS AND USAGE
Timolol Maleate Ophthalmic Solution, USP is a non-selective
beta-adrenergic receptor blocking agent
indicated for the treatment of elevated intraocular pressure in
patients with ocular hypertension or open-
angle glaucoma (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once a day in the AM (2)
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution containing timolol maleate, 0.5% (5 mg/mL)
(3)
CONTRAINDICATIONS
Bronchial asthma, a history of bronchial asthma, severe chronic
obstructive pulmonary disease. (4.1,
5.1, 5.3)
Sinus bradycardia, second or third degree atrioventricular block,
overt cardiac failure, cardiogenic
shock. (4.2, 5.2)
Hypersensitivity to any component of this product (4.3)
WARNINGS AND PRECAUTIONS
Potentiation of Respiratory Reactions Including Asthma (5.1)
Cardiac Failure (5.2)
Obstructive Pulmonary Disease (5.3)
Increased Reactivity to Allergens (5.4)
Potentiation of Muscle Weakness (5.5)
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus
(5.6)
Masking of Thyrotoxicosis (5.7)
ADVERSE REACTIONS
The most frequently reported adverse reactions have been burning and
stinging upon instillation in 38% of
patients treated with timolol maleate ophthalmic solution. Additional
reactions reported with timolol
maleate ophthalmic solution at a frequency of 4 to 10% include:
blurred vision, cataract, conjunctival
injection, headache, hypertension, infection, itching and decreased
visual acuity. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP. AT
1-800-667-4708 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Concomitant us