Timolol Maleate Solution/ Drops
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Questions & Answers
Side Effects & Adverse Reactions
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 (see CONTRAINDICATIONS).
Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.
In Patients Without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, timolol maleate ophthalmic solution should be discontinued.
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 timolol maleate ophthalmic solution is contraindicated [see CONTRAINDICATIONS]) should, in general, not receive beta-blockers, including timolol maleate ophthalmic solution.
The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents.
If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.
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. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.
Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
History
There is currently no drug history available for this drug.
Other Information
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:
Its molecular formula is C13H24N4O3S•C4H4O4 and its structural formula is:
Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature.
Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of Timolol maleate in two dosage strengths: Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is approximately 7.0, and the osmolarity is 274-328 mOsm. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.
Sources
Timolol Maleate Solution/ Drops Manufacturers
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Remedyrepack Inc.
![Timolol Maleate Solution/ Drops [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Timolol Maleate Solution/ Drops | Remedyrepack Inc.
Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution 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 percent solution in the affected eye(s) administered twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Solution.
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 percent Timolol Maleate Ophthalmic 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 beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
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Rising Pharmaceuticals, Inc.
Timolol Maleate Solution/ Drops | Rising Pharmaceuticals, Inc.
Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution 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 percent solution in the affected eye(s) twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Solution.
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 percent Timolol Maleate Ophthalmic 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 beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
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Bausch & Lomb Incorporated
Timolol Maleate Solution/ Drops | Teva Pharmaceuticals Usa Inc
Bacteriologic studies to determine the causative organisms and their sensitivity to the penicillinase-resistant penicillins should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with penicillinase-resistant penicillins should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer term of therapy.
Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels.
Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General). Oral therapy with the penicillinase-resistant penicillins may be used to follow up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
NB: INFECTIONS CAUSED BY GROUP A BETA-HEMOLYTIC STREPTOCOCCI SHOULD BE TREATED FOR AT LEAST 10 DAYS TO HELP PREVENT THE OCCURRENCE OF ACUTE RHEUMATIC FEVER OR ACUTE GLOMERULONEPHRITIS.
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Apotex Corp.
Timolol Maleate Solution/ Drops | Apotex Corp.
Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution 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 percent solution in the affected eye(s) administered twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Solution.
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 percent Timolol Maleate Ophthalmic 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 beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
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Pack Pharmaceuticals Llc
Timolol Maleate Solution/ Drops | Pack Pharmaceuticals Llc
Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution 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 percent solution in the affected eye(s) administered twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Solution.
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 percent Timolol Maleate Ophthalmic 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 beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
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Pack Pharmaceuticals Llc
Timolol Maleate Solution/ Drops | Pack Pharmaceuticals Llc
Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution 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 percent solution in the affected eye(s) administered twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Solution.
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 percent Timolol Maleate Ophthalmic 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 beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
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Akorn, Inc.
Timolol Maleate Solution/ Drops | Unit Dose Services
2.1 General Dosing ConsiderationsTramadol Hydrochloride Extended-Release is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The tablets must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the tablet could result in the uncontrolled delivery of tramadol, in overdose and death [seeWARNINGS AND PRECAUTIONS( ), 5.11DRUG ABUSE AND DEPENDENCE( ), and 9OVERDOSE( )]. 10.1
Do not administer Tramadol Hydrochloride Extended-Release at a dose exceeding 300 mg per day. Do not use Tramadol Hydrochloride Extended-Release more than once daily or concomitantly with other tramadol products [seeWARNINGS AND PRECAUTIONS( )]. 5.12
2.2 Patients Not Currently on Tramadol Immediate-Release ProductsInitiate treatment with Tramadol Hydrochloride Extended-Release at a dose of 100 mg once daily and titrated up as necessary to 150 mg, 200 mg and 300 mg every five days to achieve a balance between relief of pain and tolerability.
2.3 Patients Currently on Tramadol Immediate-Release ProductsCalculate the 24-hour tramadol IR dose and initiate a total daily dose of Tramadol Hydrochloride Extended-Release rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Tramadol Hydrochloride Extended-Release, some patients maintained on tramadol IR products may not be able to convert to Tramadol Hydrochloride Extended-Release.
2.4 Patients 65 Years of Age and OlderInitiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
2.5 Patients with Renal ImpairmentThe limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [seeUSE IN SPECIFIC POPULATIONS ( ) 8.6andCLINICAL PHARMACOLOGY ( ) 12.3].
2.6 Patients with Hepatic ImpairmentThe limited availability of dose strengths and once daily dosing of tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment (Child-Pugh Class C) . [seeUSE IN SPECIFIC POPULATIONS ( ) 8.7andCLINICAL PHARMACOLOGY ( ) 12.3]
2.7 Discontinuation of TreatmentWithdrawal symptoms may occur if Tramadol Hydrochloride Extended-Release is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol Hydrochloride Extended-Release and . [see WARNINGS AND PRECAUTIONS ( ) 5.10DRUG ABUSE AND DEPENDENCE ( )] 9.3
2.8 Food EffectsTramadol Hydrochloride Extended-Release may be taken without regard to food [seeCLINICAL PHARMACOLOGY( )]. 12.3
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Hi-tech Pharmacal Co., Inc.
Timolol Maleate Solution/ Drops | Hi-tech Pharmacal Co., Inc.
Timolol maleate ophthalmic solution is available in a concentration of 0.5 percent. The usual starting dose is one drop of 0.25 percent timolol maleate ophthalmic solution 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 percent solution in the affected eye(s) twice a day.
Since in some patients the pressure-lowering response to timolol maleate may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol maleate.
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 percent timolol maleate ophthalmic 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 beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
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Remedyrepack Inc.
Timolol Maleate Solution/ Drops | Remedyrepack Inc.
Timolol Maleate ophthalmic solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of the 0.25 percent Timolol solution 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 percent 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 percent 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 beta-adrenergic blocking agents is not recommended (see PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents).
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Remedyrepack Inc.
Timolol Maleate Solution/ Drops | Remedyrepack Inc.
Timolol Maleate ophthalmic solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of the 0.25 percent Timolol solution 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 percent 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 percent 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 beta-adrenergic blocking agents is not recommended (see PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents).
![Timolol Maleate Solution/ Drops [Rising Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2ed21930-1e05-46de-8acd-cb6f4798a7fa&name=timololrising2014-figure-09.jpg)
![Timolol Maleate Solution/ Drops [Bausch & Lomb Incorporated]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8478f242-c715-4984-ac1d-dc79dc28665e&name=image-02.jpg)
![Timolol Maleate Solution/ Drops [Apotex Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=45c57114-5f79-4d70-9423-7b87fb554971&name=timolol-05-5ml.jpg)
![Timolol Maleate Solution/ Drops [Pack Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fe2832de-114f-49e1-8851-99d01c4361ff&name=timolol-05-5ml.jpg)
![Timolol Maleate Solution/ Drops [Pack Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=acbba38a-dbd6-4d3b-8788-cadb7d5246ee&name=timolol-025-5ml.jpg)
![Timolol Maleate Solution/ Drops [Akorn, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e30cb6a9-e3ed-42c1-9d70-e1f54bcf41c4&name=rspl50436-0822.jpg)
![Timolol Maleate Solution/ Drops [Hi-tech Pharmacal Co., Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=63f36fa6-bd5a-49b2-b7bf-28ce0db3c6dc&name=a782a309-ee0f-4ed5-af4b-37238446e990-05.jpg)
![Timolol Maleate Solution/ Drops [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=23b61c26-75fb-4d2a-9282-b7af27cbc6cb&name=MM8.jpg)
![Timolol Maleate Solution/ Drops [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6d83efec-cd72-4093-a8d4-4dd5021e151e&name=MM8.jpg)
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