Data from FDA - Curated by EPG Health - Last updated 19 December 2016
4 CONTRAINDICATIONS Timolol GFS is contraindicated in patients with: • bronchial asthma • history of bronchial asthma •
• Bronchial asthma (or history of) (4) •
To report SUSPECTED
6.1 Clinical Studies Experience Because clinical trials are conducted under widely
In clinical trials with Timolol GFS, transient
The frequency of patients reporting burning and stinging upon instillation was approximately one in eight patients which was comparable to that observed for TIMOPTIC *.
In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the
CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart
IMMUNOLOGIC Systemic lupus erythematosus.
SKIN Alopecia and psoriasiform rash or
HYPERSENSITIVITY Signs and symptoms of systemic
RESPIRATORY Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory
ENDOCRINE Masked symptoms of hypoglycemia in diabetic patients [see Warnings and Precautions (5.5)].
UROGENITAL Retroperitoneal fibrosis, decreased libido, impotence and Peyronie 's disease.
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic effects Pregnancy Category C: Teratogenicity studies with timolol in mice,
Doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum
Timolol GFS should be used during pregnancy only if the potential
8.3 Nursing Mothers Timolol maleate has been detected in human milk following oral and ophthalmic drug administration.
Because of the
8.4 Pediatric Use
8.5 Geriatric Use
|Date Last Revised||14-12-2011|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Sandoz Inc|