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Toprol XL/Toprol-XL

Generic Name: Metoprolol Succinate
Drug Category: Beta Blocker
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 2 years.

Approved Uses

Indicated for:

Hypertension:

• The treatment of hypertension, to lower blood pressure. TOPROL-XL may be administered with other antihypertensive agents.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Dosages above 400 mg per day have not been studied.

Angina Pectoris:

• The long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.

Dosages above 400 mg per day have not been studied.

Heart Failure:

• To reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure.

Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of TOPROL-XL.

Metoprolol succinate extended-release is not recommended in pediatric patients under 6 years of age.

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred.

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered TOPROL-XL, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly reinstate TOPROL-XL, and take measures appropriate for the management of unstable angina. Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing TOPROL-XL in patients treated only for hypertension.

TOPROL-XL is contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, and sick sinus syndrome (unless a permanent pacemaker is in place).

Patients with bronchospastic disease should, in general, not receive beta blockers. Because of its relative beta1 cardio-selectivity, however, metoprolol succinate extended-release may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment.

Worsening cardiac failure may occur during up-titration of TOPROL-XL.

If TOPROL-XL is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated.

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of TOPROL-XL. Patients with first-degree atrioventricular block, sinus node dysfunction, conduction disorders (including Wolff- Parkinson-White) or on concomitant drugs that cause bradycardia may be at increased risk. Monitor heart rate in patients receiving TOPROL-XL. If severe bradycardia develops, reduce or stop TOPROL- XL.

Avoid initiation of a high-dose regimen of extended-release metoprolol in patients undergoing non-cardiac surgery, since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke and death. Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may precipitate a thyroid storm.

Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomitantly.

Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents.

Drugs that are strong inhibitors of CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these too are likely to increase metoprolol concentration. Increases in plasma concentration decrease the cardioselectivity of metoprolol. Monitor patients closely, when the combination cannot be avoided.

Digitalis glycosides, clonidine, diltiazem and verapamil slow atrioventricular conduction and decrease heart rate.

Concomitant use with beta blockers can increase the risk of bradycardia.

Based on the published literature, beta blockers (including metoprolol) may cause erectile dysfunction and inhibit sperm motility.

Available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. However, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta blockers, including metoprolol, during pregnancy.

Animal studies: Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival.

Limited available data from published literature report that metoprolol is present in human milk.

GoToSource

Off-label Uses

• Hyperthyroidism. GoToSource

• Marfan syndrome to slow progression of aortic dilation. GoToSource

• Use in patients under the age of 6. GoToSource

• Prevention of migraines. GoToSource

• Tremors. GoToSource

• Arrhythmias. GoToSource

• Central sleep apnea. GoToSource

• Noninfectious uveitis. GoToSource

Adverse Events

New-onset diabetes. GoToSource

Erythema multiforme (skin disease that causes lesions and redness around the lesions). GoToSource

Muscular fatigue and cramping, bradycardia (slow heart rate), myopathy (disorder of the skeletal muscles), lactic acidosis and elevation of creatinine kinase levels. GoToSource

Bronchospasm. GoToSource

Increased risk of stroke and death after non-cardiac surgery. GoToSource    

Insomnia and hallucinations. GoToSource

Depression. GoToSource

Memory loss, impotence, hypotension (low blood pressure) and liver injury. GoToSource

Intermittent claudication (pain, cramp or sense of fatigue in a muscle group) and raynaud’s phenomenon (spasm of the arteries limiting blood flow to extremities especially fingers/toes). GoToSource

Delirium and psychosis. GoToSource

Exacerbation of psoriasis, psoriatic and rheumatoid arthritis, anaphylaxis, contact dermatitis, and occupational contact dermatitis, alopecia (hair loss), lichen planus-like drug eruption, hyperhidrosis (excessive sweating), vitiligo (patchy loss of skin coloring) and peyronie’s disease (abnormal curvature of the penis caused by scar tissue). GoToSource

Litigation

No major injury lawsuits reported.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024