TIMOLOL GFS- timolol maleate solution, gel forming / drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

TIMOLOL MALEATE

Composition:

TIMOLOL ANHYDROUS 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol GFS is contraindicated in patients with: • bronchial asthma • history of bronchial asthma • severe chronic obstructive pulmonary disease • sinus bradycardia • second or third degree atrioventricular block • overt cardiac failure • cardiogenic shock • hypersensitivity to any component of this product. Teratogenic effects Pregnancy Category C: 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

Product summary:

Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package. • 0.25% 2.5 mL fill NDC 61314-224-25               5 mL fill NDC 61314-224-05 • 0.5%   2.5 mL fill NDC 61314-225-25               5 mL fill NDC 61314-225-05 Storage and Handling Store at 2° to 25°C (36° to 77°F). Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

TIMOLOL GFS- TIMOLOL MALEATE SOLUTION, GEL FORMING, EXTENDED RELEASE
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIMOLOL GFS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TIMOLOL GFS.
TIMOLOL GFS (TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION) 0.25%
AND 0.5%, STERILE TOPICAL OPHTHALMIC
DRO PS
INITIAL U.S. APPROVAL: 1978
RECENT MAJOR CHANGES
Use in Specific Populations, Pediatric Use (8.4) 6/2007
INDICATIONS AND USAGE
Timolol GFS is a beta-adrenergic receptor inhibitor indicated for the
treatment of elevated intraocular pressure in patients
with ocular hypertension or open-angle glaucoma (1)
DOSAGE AND ADMINISTRATION
• Instill one drop in the affected eye(s) once daily (2)
DOSAGE FORMS AND STRENGTHS
• 5 mL size bottle filled with 2.5 mL or 5 mL of 0.25% or 0.5%
sterile ophthalmic gel forming solution (3)
CONTRAINDICATIONS
• Bronchial asthma (or history of) (4)
• Severe chronic obstructive pulmonary disease (4)
• Sinus bradycardia (4)
• Second or third degree atrioventricular block (4)
• Overt cardiac failure (4)
• Cardiogenic shock (4)
• Hypersensitivity to any component of this product (4)
WARNINGS AND PRECAUTIONS
• Same adverse reactions found with systemic administration of
beta-adrenergic receptor inhibitors may occur with topical
ophthalmic administration (5.1).
• Beta-adrenergic receptor inhibitors may mask signs and symptoms of
hypoglycemia and should be administered with
caution in diabetic patients subject to hypoglycemia (5.5).
• Beta-adrenergic receptor inhibitors may mask certain clinical
signs (e.g. tachycardia) of hyperthyroidism (5.6).
ADVERSE REACTIONS
Most common adverse reactions occur upon instillation and include
transient blurred vision, burning, and stinging (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
• Oral beta-adrenergic receptor inhibitors may have additive e