5ML

Timobest

Timolol Maleate Eye Drops IP

Timolol Maleate Eye Drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Composition:

Timolol Maleate IP
Eq. to Timolol 0.5% w/v
Stabilized Oxychloro Complex 0.005% w/v
(As preservative)
Sterile Aqueous Base q.s.

Indications:

Timolol Maleate Eye Drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dosage and Administration:

The usual starting dose is one drop of 0.5% solution in the affected eye(s) twice a day. Since in some patients the pressure-lowering response to timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day. Dosages above one drop of a 0.5% Timolol solution twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical betaadrenergic blocking agents is not recommended.

Contraindications:

Timolol Maleate Eye Drops is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; or hypersensitivity to any component of this product.

Storage:

Store below 30°C. Protect from light & moisture. Do not freeze.

As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration.
For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of Timolol Maleate.

If irritation persists or increases, discontinue the use and consult the ophthalmologist.
Do not touch the nozzle tip or other dispensing tip to any surface since this may contaminate the solution.
Use the solution within one month after opening the container.
If the solution becomes dark brown, it should be discarded.
Keep out of reach of children.
NOT FOR INJECTION. FOR EXTERNAL USE ONLY.

Drug Interactions:

Although timolol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with timolol and epinephrine has been reported occasionally.
Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and timolol should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.

Pregnancy:

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Timolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Timolol Maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from timolol in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

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

Symptoms And Treatment Of Overdosage:

There have been reports of inadvertent overdosage with Timolol Maleate Eye Drops resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest. An in vitro hemodialysis study, using 14C timolol added to human plasma or whole blood, showed that timolol was readily dialyzed from these 􀃸uids; however, a study of patients with renal failure showed that timolol did not dialyze readily.

Special Instructions:

Patients should be advised to avoid contamination of the dispensing tip.

Presentation:

Timobest Eye Drops are available in 5ml sterile plastic bottles.