Class: beta-Adrenergic Blocking Agents
VA Class: CV100
CAS Number: 26921-17-5
Brands: Blocadren, Timolide
Introduction
Nonselective β-adrenergic blocking agent.111
Uses for Timolol Maleate
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents).111
One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, ischemic heart disease, and/or diabetes mellitus.175
Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferrred by JNC 7.175
AMI
Secondary prevention following AMI to reduce the risk of reinfarction and mortality.111
Angina
Management of chronic stable angina pectoris†.a
A component of the standard therapeutic measures in the management of unstable angina or non-ST-segment elevation/non-Q-wave MI†.143 169 172
Vascular Headache
Prophylaxis of common or classic migraine headache.106 107 108 110 111 127 128
Timolol Maleate Dosage and Administration
General
Monitor reductions in heart rate and BP as a guide for determining optimum dosage.111
If long-term therapy is discontinued, reduce dosage gradually over a period of 1–2 weeks.111 (See Abrupt Withdrawal of Therapy under Cautions.)
Administration
Oral Administration
Administer orally, usually twice daily.111
For management of hypertension, once-daily dosing may be possible in some patients.a
In patients with chronic stable angina pectoris†, administer orally in 3 or 4 divided doses.a
During maintenance therapy in patients with vascular headaches (migraine), may administer daily dosage as a single rather than divided dose.111
Dosage
Available as timolol maleate; dosage expressed in terms of the salt.111
Adults
Hypertension
Monotherapy
Oral
Initially, 10 mg twice daily.111
Increase dosage gradually at weekly (or longer) intervals until optimum effect is obtained.111
Usual maintenance dosage is 20–40 mg daily, given in 2 divided doses; once daily dosing may be possible in some patients.111 Increases up to a maximum of 60 mg daily (given in 2 divided doses) may be necessary.111
Timolol/Hydrochlorothiazide Combination Therapy
Oral
Timolol/hydrochlorothiazide fixed combination is not recommended for initial therapy; adjust initial and subsequent dosages by administering each drug separately.158 a c May use if optimum maintenance dosage corresponds to ratio in the commercial combination preparation.158
AMI
Oral
Usual dosage is 10 mg twice daily.111
Initiation within 7–28 days following AMI reduces cardiovascular mortality and nonfatal reinfarction111 .a 111 Some experts recommend initiation within a few days after AMI (if not already initiated acutely).112 113 114 116 118 119 120 121 129 143
Optimum benefit may be achieved when oral β-adrenergic blocking agent is continued for at least 1–3 years after infarction (if not contraindicated).112 114 126 Some experts recommend continuing indefinitely unless contraindicated.143
Angina
Chronic Stable Angina Pectoris†
Oral
15–45 mg daily, given in 3 or 4 divided doses.a Adjust dosage according to clinical response and to maintain a resting heart rate of 55–60 bpm.a 169
Unstable Angina or Non-ST-segment Elevation MI†
In patients at high risk for ischemic events, ACC and AHA suggest initiation with IV loading dose of a β-blocker (in patients who tolerate IV therapy) followed by oral therapy; oral therapy is recommended for lower risk patients.169
Oral
10 mg twice daily.169
The target resting heart rate is 50–60 bpm in the absence of dose-limiting adverse effects.169
Vascular Headaches
Migraine
Oral
Initially, 10 mg twice daily.107 108 110 111 Adjust dosage according to clinical response and patient tolerance; do not exceed 30 mg daily, given in divided doses (e.g., 10 mg in the morning and 20 mg in the evening).108 111
During maintenance therapy, can administer 20-mg daily dosage as a single rather than divided dose; some patients may respond adequately to 10 mg once daily.111
If an adequate response is not achieved after 6–8 weeks at the maximum recommended dosage, discontinue therapy.111
Prescribing Limits
Adults
Hypertension
Oral
Maximum 60 mg daily.111
Vascular Headaches (Migraine)
Oral
Maximum 30 mg daily.108 111
Special Populations
Hepatic Impairment
Must modify doses and/or frequency of administration in response to degree of hepatic impairment.111
Renal Impairment
Must modify doses and/or frequency of administration in response to degree of renal impairment.111
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.b Initiate at low end of dosing range.b
Cautions for Timolol Maleate
Contraindications
Known hypersensitivity to the timolol or any ingredient in the formulation.111 c
Bronchial asthma (or a history of bronchial asthma), allergic bronchospasm, or severe COPD; severe bradycardia, heart block greater than first degree, overt cardiac failure, or cardiogenic shock.111
Warnings/Precautions
Warnings
Cardiac Failure
Possible precipitation of CHF.111
Avoid use in patients with overt CHF; may use cautiously in patients with inadequate myocardial function and, if necessary, in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics).111
Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.111
Abrupt Withdrawal of Therapy
Abrupt withdrawal of therapy is not recommended as it may exacerbate angina symptoms or precipitate MI in patients with coronary artery disease.111
Gradually decrease dosage over a period of 1–2 weeks and monitor patients carefully; advise patients to temporarily limit their physical activity during withdrawal of therapy.111
If exacerbation of angina occurs or acute coronary insufficiency develops, reinstitute therapy promptly, at least temporarily, and initiate appropriate measures for management of unstable angina pectoris.111
Bronchospastic Disease
Possible inhibition of bronchodilation produced by endogenous catecholamines.111
Generally should not be used in patients with bronchospastic disease, but may use with caution in patients who do not respond to or cannot tolerate alternative treatment.111 a Use with caution in patients with nonallergic bronchospasm (e.g., chronic bronchitis, emphysema) or a history of nonallergic bronchospasm.a (See Contraindications under Cautions.)
Major Surgery
Possible increased risks associated with general anesthesia (e.g., severe hypotension, difficulty restarting or maintaining heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.111 Use with caution in patients undergoing major surgery involving general anesthesia.111
Some clinicians recommend gradual withdrawal before elective surgery.111 b Manufacturers recommend administration of β-agonists (e.g., dopamine, dobutamine, isoproterenol) to reverse β-adrenergic blockade if necessary during surgery.111 a b
Diabetes and Hypoglycemia
Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, but not sweating or dizziness).111 Use with caution in patients with diabetes mellitus receiving hypoglycemic drugs.111
Thyrotoxicosis
May mask signs of hyperthyroidism (e.g., tachycardia).111 Possible thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.111
Sensitivity Reactions
Anaphylaxic Reactions
Patients with a history of atopy or anaphylactic reactions to a variety of allergens may be more reactive to repeated, accidental, diagnostic, or therapeutic challenges with such allergens while taking β-blocking agents; such patients may be unresponsive to usual doses of epinephrine.111
General Precautions
Muscle Weakness
β-Adrenergic blockade reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, generalized weakness).111 b Increased muscle weakness reported rarely in some patients with myasthenia gravis or myasthenic symptoms.111 b
Cerebrovascular Insufficiency
Possible cardiovascular effects (e.g., hypotension, bradycardia) that can adversely affect cerebral blood flow.111 Use with caution in patients with cerebrovascular insufficiency.111 If signs or symptoms suggestive of reduced cerebral blood flow occur, consider discontinuance.111
Other Precautions
Shares the toxic potentials of β-adrenergic blocking agents; observe usual precautions of these agents.a In addition, when used in fixed-combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with thiazide diuretics.a c
Specific Populations
Pregnancy
Category C.111
Lactation
Distributed into milk.111 Discontinue nursing or the drug.111
Pediatric Use
Safety and efficacy not established.111
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.111
Substantially eliminated by the kidneys; assess renal function periodically and adjust dosage since geriatric patients are more likely to have decreased renal function.111 (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use with caution; dosage adjustment may be necessary.111 (See Hepatic Impairment under Dosage and Administration.)
Renal Impairment
Use with caution; dosage adjustment may be necessary.111 (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
Fatigue, headache, bradycardia, arrhythmia, pruritis, dizziness, dyspnea, eye irritiation.111
Interactions for Timolol Maleate
Appears to be metabolized partly by CYP2D6.b d
Drugs Affecting Hepatic Microsomal Enzymes
CYP2D6 inhibitors: Potential pharmacodynamic (increased β-adrenergic blockade) and pharmacokinetic interaction (increased plasma timolol concentrations).b d
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Calcium-channel blocking agents | Potential hypotension, AV conduction disturbances, and left ventricular failure111 | Avoid concomitant use in patients with impaired cardiac function111 |
Clonidine | β-Adrenergic blockade may exacerbate rebound hypertension which may occur following clonidine discontinuance145 146 | Discontinue β-adrenergic blocking agents several days before gradual withdrawal of clonidine145 146 If clonidine therapy is to be replaced by a β-adrenergic blocking agent, delay administration for several days after clonidine discontinuance145 146 |
Digoxin | Possible additive effect in prolonging AV conduction time when used concomitantly with diltiazem or verapamil111 | |
Hypotensive agents (hydralazine, methyldopa) | Possible increased hypotensive effecta | Careful dosage adjustment is recommendeda |
NSAIAs | Potential blunting of hypotensive effects111 | Monitor patients carefully111 |
Quinidine | Possible potentiation of β-adrenergic blockade (e.g., decreased heart rate)111 | |
Reserpine | Possible additive effects111 | Observe closely for evidence of marked bradycardia or hypotension (may be manifested as vertigo, presyncope or syncope, or orthostatic changes in BP without compensatory tachycardia)111 |
Timolol Maleate Pharmacokinetics
Absorption
Bioavailability
Absorption from GI tract is rapid; approximately 90% absorbed following oral administration.111 Peak plasma concentraton are usually attained within 1–2 hours.111
Distribution
Extent
Distributed into milk.111
Plasma Protein Binding
10–60%, depending on assay method employed.111
Elimination
Metabolism
Approximately 80% metabolized in the liver to inactive metabolites.111 a
Elimination Route
Excreted in urine as unchanged drug and metabolites.111
Half-life
3–4 hours.111 a
Special Populations
Only small amounts of drug are removed by hemodialysis.111 a
Stability
Storage
Oral
Tablets
Tight containers at 15–30°C.111 Protect from light.111 c
ActionsActions
Inhibits response to adrenergic stimuli by competitively blocking β-adrenergic receptors within the myocardium (β1-receptors) and bronchial and vascular smooth muscle (β2-receptors).111
Decreases resting and exercise-stimulated heart rate and reflex orthostatic tachycardia; slows conduction in the AV node; slightly reduces cardiac output, probably secondary to its effect on heart rate.111 a
No intrinsic sympathomimetic activity or membrane-stabilizing effect on the heart.111 a
Suppresses plasma renin activity and suppresses the renin-aldosterone-angiotensin system.111 a
Reduces BP by decreasing cardiac output, decreasing sympathetic outflow from the CNS, and/or suppressing renin release.111 a
Increases airway resistance.111 a
Advice to Patients
Importance of taking timolol exactly as prescribed.111
Importance of not interrupting or discontinuing therapy without consulting clinician;111 advise patients to temporarily limit physical activity when discontinuing therapy.111 a
Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure (e.g., weight gain, increased shortness of breath) or if any difficulty in breathing occurs.111
In patients with heart failure, importance of informing clinician of signs or symptoms of exacerbation (e.g., weight gain, difficulty in breathing).111
Importance of patients informing anesthesiologist or dentist that they are receiving timolol therapy prior to undergoing major surgery.111
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.111
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.111
Importance of informing patients of other important precautionary information.111 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 5 mg* | Blocadren | Merck |
Timolol Maleate Tablets | Mylan | |||
10 mg* | Blocadren (scored) | Merck | ||
Timolol Maleate Tablets | Mylan | |||
20 mg* | Blocadren (scored) | Merck | ||
Timolol Maleate Tablets | Mylan |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 10 mg Timolol Maleate and Hydrochlorothiazide 25 mg | Timolide | Merck |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Timolol Maleate 10MG Tablets (MYLAN): 60/$39.99 or 120/$69.98
Timolol Maleate 20MG Tablets (MYLAN): 60/$65.99 or 180/$169.97
Timolol Maleate 5MG Tablets (MYLAN): 60/$34.99 or 180/$79.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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