Timolol Maleate Ophthalmic Gel Generic Name & Formulations
Legal Class
Rx
General Description
Timolol maleate 0.25%, 0.5%; oph gel forming soln.
Pharmacological Class
Noncardioselective beta-blocker.
See Also
How Supplied
Soln, gel—contact supplier; Ocudose—60
Manufacturer
Mechanism of Action
Timolol maleate is a beta1 and beta2 (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. When applied topically on the eye, it has the action of reducing elevated, as well as normal intraocular pressure, whether or not accompanied by glaucoma. The precise mechanism of the ocular hypotensive action is not clearly established at this time. Tonography and fluorophotometry studies in man suggest that its predominant action may be related to reduced aqueous formation.
Timolol Maleate Ophthalmic Gel Indications
Indications
Elevated intraocular pressure in ocular hypertension or open-angle glaucoma.
Timolol Maleate Ophthalmic Gel Dosage and Administration
Adults and Children
<2yrs: not established. Invert closed bottle and shake once before each use. ≥2yrs: 1 drop once daily. Give other oph. drugs at least 10 minutes before.
Timolol Maleate Ophthalmic Gel Contraindications
Contraindications
Greater than 1st-degree AV block. Uncompensated cardiac failure. Cardiogenic shock. Sinus bradycardia. History of bronchospasm. Bronchial asthma. Severe COPD.
Timolol Maleate Ophthalmic Gel Boxed Warnings
Not Applicable
Timolol Maleate Ophthalmic Gel Warnings/Precautions
Warnings/Precautions
Not for use as sole agent in angle-closure glaucoma. Poor cardiac reserve should be controlled with digitalis and diuretics. Diabetes. Presbyopia. May mask hypoglycemia or thyrotoxicosis. Myasthenia gravis. Cerebrovascular insufficiency. Measure intraocular pressure after 4 weeks of treatment. Avoid abrupt cessation. Discontinue at 1st sign of cardiac failure and before surgery. Pregnancy. Nursing mothers: not recommended.
Timolol Maleate Ophthalmic Gel Pharmacokinetics
Elimination
Renal. Half-life: ~2.9 hours.
Timolol Maleate Ophthalmic Gel Interactions
Interactions
May potentiate systemic β-blockers, reserpine, hypoglycemics and mydriatic effect of topical epinephrine. Additive cardiac and pulmonary effects with anticholinesterase miotics. May antagonize bronchodilation from β-adrenergic agonists. May cause conduction defects with calcium channel blockers, digoxin. May be potentiated by CYP2D6 inhibitors (eg, quinidine, SSRIs).
Timolol Maleate Ophthalmic Gel Adverse Reactions
Adverse Reactions
Ocular irritation, sensitization, rash, dizziness, blurred vision, corneal anesthesia, headache, GI upset, paresthesias. Systemic β-blocker effects (bradycardia, arrhythmias, hypotension, bronchospasm, heart failure). Aphakic maculopathy (rare).
Timolol Maleate Ophthalmic Gel Clinical Trials
See Literature
Timolol Maleate Ophthalmic Gel Note
Notes
Formerly known under the brand name Timoptic-XE.
Timolol Maleate Ophthalmic Gel Patient Counseling
See Literature