Indications and Important Safety Information IFU

Buy Timolol (Timoptic) eye drops online

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Forms:eye drops (ophthalmic solution) 0.5% 5 ml
Quantity:1-20 bottles
Type:Timolol brand, Glucomol brand, Nyolol brand, Timoptic generics
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Indications and usage:

Timolol Maleate (Timoptic) ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.


Dosage and administration:

Timolol eye drops is available in concentrations of 0.25 and 0.5%. The usual starting dose is one drop of 0.25% timolol in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) twice a day.

Since in some patients the pressure-lowering response to Timoptic may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with this medication.

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 0.5% timolol maleate 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 beta-adrenergic blocking agents is not recommended.


Overdosage:

There have been reports of inadvertent overdosage with Timoptic 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.

Overdosage has been reported with timolol maleate tablets. A 30-year-old female ingested 650 mg of timolol maleate tablets (maximum recommended oral daily dose is 60 mg) and experienced second and third degree heart block. She recovered without treatment but approximately two months later developed irregular heartbeat, hypertension, dizziness, tinnitus, faintness, increased pulse rate, and borderline first degree heart block.

An in vitro hemodialysis study, using 14C timolol added to human plasma or whole blood, showed that timolol was readily dialyzed from these fluids; however, a study of patients with renal failure showed that timolol did not dialyze readily.


Dosage forms and strengths:

Timoptic (Timolol Maleate) ophthalmic solution is a clear, colorless to light yellow solution.

Timoptic 0.25% and 0.5% timolol equivalent is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow polypropylene cap.


Contraindications:

Timoptic (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
  • hypersensitivity to any component of this medicine.


    Warnings:

  • Cardiac failure: sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition of beta-adrenergic receptor blockade may precipitate more severe failure.
  • Obstructive pulmonary disease: patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which Timoptic is contraindicated should, in general, not receive beta-blockers, including timolol.
  • Major surgery: the necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial.
  • Diabetes mellitus: beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
  • Thyrotoxicosis: beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.


    Precautions:

  • Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Timoptic, alternative therapy should be considered.
  • There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
  • Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g., timolol).
  • Angle-closure glaucoma: in patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil. Timolol maleate has little or no effect on the pupil. Timolol should not be used alone in the treatment of angle-closure glaucoma.
  • Anaphylaxis: while taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
  • Muscle weakness: beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness).
  • Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.


    Adverse reactions, side effects:

    The most frequently reported adverse experiences with timolol have been burning and stinging upon instillation (approximately one in eight patients).

    The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations: headache, asthenia/fatigue, chest pain, bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, nausea, diarrhea, dyspepsia, anorexia, dry mouth, systemic lupus erythematosus, dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, alopecia and psoriasiform rash or exacerbation of psoriasis, signs and symptoms of systemic allergic reactions, bronchospasm (predominantly in patients with preexisting bronchospastic disease), respiratory failure, dyspnea, nasal congestion, masked symptoms of hypoglycemia in diabetic patients, signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease.

    To report suspected side effects of Timoptic (Timolol Maleate) ophthalmic solution contact Merck pharmaceutical company or your local FDA.


    Drug interactions:

  • Although Timoptic 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 Timoptic 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.
  • Calcium antagonists: caution should be used in the coadministration of beta-adrenergic blocking agents, such as Timoptic, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided.
  • Catecholamine-depleting drugs: close observation of the patient is recommended when a beta blocker 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.
  • Digitalis and calcium antagonists: the concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
  • CYP2D6 inhibitors: potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol.
  • Clonidine: oral beta-adrenergic blocking 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.
  • Injectable epinephrine: some patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

    Related medications:

  • Bimatoprost ophthalmic solution 0.03%
  • Cefuroxime Axetil


    Use in specific populations:

    Pregnancy

    There are no adequate and well-controlled studies in pregnant women. Timoptic (Timolol Maleate) eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Lactation

    Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Timoptic in nursing infants, 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.

    Pediatric use

    Safety and effectiveness of timolol maleate ophthalmic solution have been established when administered in pediatric patients aged 2 years and older. Use of timolol maleate ophthalmic solution in these children is supported by evidence from adequate and well controlled studies in children and adults. Safety and efficacy in pediatric patients below the age of 2 years have not been established.

    Geriatric use

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


    Information for patients:

    Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

    Patients should also be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

    Patients should also be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.

    Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take timolol ophthalmic solution.


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    Here is a list of popular medications containing timolol as a main active pharmaceutical ingredient; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:

    Trade name of the drug Pharmaceutical forms and doses Companies
    Betimol
  • Solution; Ophthalmic; Timolol Maleate 0.25%, 0.5%
  • Novartis
  • Santen Pharmaceutical
  • Cusimolol
  • Drops; Ophthalmic; Timolol Maleate 0.25%, 0.5%
  • Alcon
  • Kener Laboratorios
  • Summit
  • Glucomol
  • Drops; Ophthalmic; Timolol Maleate 0.25%, 0.5%
  • Allergan
  • Nyolol
  • Gel; Ophthalmic; Timolol Maleate 0.1%
  • Solution; Ophthalmic; Timolol Maleate 0.5%
  • Novartis
  • Timoptic
  • Solution; Ophthalmic; Timolol Maleate 0.25%, 0.5%
  • Merck
  • Aton Pharma
  • Timoptic-XE
  • Solution; Ophthalmic; Timolol Maleate 0.25%, 0.5%
  • Merck
  • Aton Pharma


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