Data from FDA - Curated by EPG Health - Last updated 19 December 2016

Indication(s)

1 INDICATIONS AND USAGE 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 a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma (1).

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Advisory information

contraindications

4 CONTRAINDICATIONS 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.

• 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)

Adverse reactions

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.

6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials with Timolol GFS, transient blurred vision upon instillation of the drop was reported in approximately one in three patients.

The frequency of patients reporting burning and stinging upon instillation was approximately one in eight patients which was comparable to that observed for TIMOPTIC *.

Adverse reactions reported in 1-5 % of patients were: Ocular: Blepharitis, conjunctivitis, crusting, discomfort, foreign body sensation, hyperemia, pruritus and tearing; Systemic: Headache, hypertension, and upper respiratory infections.

In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reactions profile of Timolol GFS 0.25 % and 0.5 % was comparable to that seen in adult patients.

6.2 Additional Potential Adverse Reactions Associated with Timolol Maleate The following additional adverse experiences have been reported with the ocular administration of this or other timolol maleate formulations: BODY AS A WHOLE Asthenia/fatigue and chest pain.

CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, dizziness, edema, claudication, Raynaud 's phenomenon, and cold hands and feet.

DIGESTIVE Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.

IMMUNOLOGIC Systemic lupus erythematosus.

NERVOUS SYSTEM/PSYCHIATRIC Increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, depression, disorientation, nervousness, and memory loss.

SKIN Alopecia and psoriasiform rash or exacerbation of psoriasis.

HYPERSENSITIVITY Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria and localized and generalized rash.

RESPIRATORY Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, and cough.

ENDOCRINE Masked symptoms of hypoglycemia in diabetic patients [see Warnings and Precautions (5.5)].

SPECIAL SENSES Signs and symptoms of ocular irritation including blepharitis, keratitis, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery [see Warnings and Precautions (5.9)]; and tinnitus.

UROGENITAL Retroperitoneal fibrosis, decreased libido, impotence and Peyronie 's disease.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Instill one drop of Timolol GFS (either 0.25% or 0.5%) in the affected eye(s) once daily. It may be used alone or in combination with other intraocular pressure lowering medications. • Instill one drop in the affected eye(s) once daily (2).
Use in special populations

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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 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 GFS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers Timolol maleate has been detected in human milk following oral and ophthalmic drug administration.

Because of the potential for serious adverse reactions in nursing infants from Timolol GFS, 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.

8.4 Pediatric Use Safety and IOP-lowering effect of Timolol GFS 0.25 % and 0.5 % has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.

8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Pregnancy and lactation
8.3 Nursing Mothers Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions in nursing infants from Timolol GFS, 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.

Interactions

7 DRUG INTERACTIONS • Oral beta-adrenergic receptor inhibitors may have additive effects (7.1) • Digitalis and calcium antagonists may have additive effects (7.2) • Catecholamine-depleting drugs may have additive effects (7.3) • Quinidine may have additive effects (7.4) 7.1 Oral Beta-Adrenergic Receptor Inhibitors Patients who are receiving a beta-adrenergic receptor inhibiting agent orally and Timolol GFS should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure.

Patients should not usually receive two topical ophthalmic beta-adrenergic receptor inhibiting agents concurrently.

7.2 Digitalis and Calcium Antagonists The concomitant use of beta-adrenergic receptor inhibiting agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

Caution should be used in the co-administration of beta-adrenergic receptor inhibitors, such as Timolol GFS, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension.

In patients with impaired cardiac function, co-administration should be avoided.

7.3 Catecholamine-Depleting Drugs Close observation of the patient is recommended when a beta receptor inhibitor is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

7.4 Quinidine Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with quinidine and timolol, possibly because quinidine inhibits the metabolism of timolol via the P-450 enzyme, CYP2D6.

7.5 Clonidine Oral beta-adrenergic receptor inhibiting agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.

There have been no reports of exacerbation of rebound hypertension with ophthalmic timolol maleate.

7.6 Injectable Epinephrine [See Warnings and Precautions (5.11)]

More information

Category Value
Authorisation number NDA020963
Orphan designation No
Product NDC 61314-225,61314-224
Date Last Revised 14-12-2011
Type HUMAN PRESCRIPTION DRUG
RXCUI 313408
Marketing authorisation holder Sandoz Inc