Lopressor
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Questions & Answers
Side Effects & Adverse Reactions
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating 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 impending cardiac failure, fully digitalize patients and/or give a diuretic. The response should be observed closely. If cardiac failure continues, despite adequate digitalization and diuretic therapy, withdraw Lopressor.
Bronchospastic Diseases: PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS, including Lopressor. Because of its relative beta1 selectivity, however, Lopressor may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta1 selectivity is not absolute, a beta2-stimulating agent should be administered concomitantly, and the lowest possible dose of Lopressor should be used. In these circumstances it would be prudent initially to administer Lopressor in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION).
Major Surgery: Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and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.
Diabetes and Hypoglycemia: Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.
Pheochromocytoma: If Lopressor 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. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.
Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta blockade, which might precipitate a thyroid storm.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function, and beta blockade carries the potential hazard of depressing myocardial contractility and precipitating or exacerbating minimal cardiac failure.
During treatment with Lopressor, monitor the hemodynamic status of the patient. If heart failure occurs or persists despite appropriate treatment, discontinue Lopressor.
Bradycardia: Lopressor produces a decrease in sinus heart rate in most patients; this decrease is greatest among patients with high initial heart rates and least among patients with low initial heart rates. Acute myocardial infarction (particularly inferior infarction) may in itself produce significant lowering of the sinus rate. If the sinus rate decreases to <40 beats/min, particularly if associated with evidence of lowered cardiac output, atropine (0.25-0.5 mg) should be administered intravenously. If treatment with atropine is not successful, discontinue Lopressor and consider cautious administration of isoproterenol or installation of a cardiac pacemaker.
AV Block: Lopressor slows AV conduction and may produce significant first- (P-R interval ≥0.26 sec), second-, or third-degree heart block. Acute myocardial infarction also produces heart block.
If heart block occurs, discontinue Lopressor and administer atropine (0.25-0.5 mg) intravenously. If treatment with atropine is not successful, consider administration of isoproterenol or installation of a cardiac pacemaker.
Hypotension: If hypotension (systolic blood pressure ≤90 mmHg) occurs, discontinue Lopressor, and assess the hemodynamic status of the patient and the extent of myocardial damage. Invasive monitoring of central venous, pulmonary capillary wedge, and arterial pressures may be required. Institute appropriate therapy with fluids, positive inotropic agents, balloon counterpulsation, or other treatment modalities. If hypotension is associated with sinus bradycardia or AV block, direct treatment at reversing these (see above).
Legal Issues
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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
Lopressor tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Lopressor is indicated in the long-term treatment of angina pectoris.
Lopressor ampuls and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous Lopressor can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).
History
There is currently no drug history available for this drug.
Other Information
Lopressor, metoprolol tartrate USP, is a selective beta1-adrenoreceptor blocking agent, available as 50- and 100-mg tablets for oral administration and in 5-mL ampuls for intravenous administration. Each ampul contains a sterile solution of metoprolol tartrate USP, 5 mg, and sodium chloride USP, 45 mg, and water for injection USP. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is
Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.
Inactive Ingredients: Tablets contain cellulose compounds, colloidal silicon dioxide, D&C Red No. 30 aluminum lake (50-mg tablets), FD&C Blue No. 2 aluminum lake (100-mg tablets), lactose, magnesium stearate, polyethylene glycol, propylene glycol, povidone, sodium starch glycolate, talc, and titanium dioxide.
Sources
Lopressor Manufacturers
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Novartis Pharmaceuticals Corporation
![Lopressor (Metoprolol Tartrate) Tablet [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lopressor | Novartis Pharmaceuticals Corporation
HypertensionIndividualize the dosage of Lopressor tablets. Lopressor tablets should be taken with or immediately following meals.
The usual initial dosage of Lopressor tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range of Lopressor tablets is 100-450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of Lopressor is increased.
Angina PectorisThe dosage of Lopressor tablets should be individualized. Lopressor tablets should be taken with or immediately following meals.
The usual initial dosage of Lopressor tablets is 100 mg daily, given in two divided doses. gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Lopressor tablets is 100-400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1-2 weeks (see WARNINGS).
Myocardial InfarctionEarly Treatment: During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Lopressor as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.
Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Lopressor each; give the injections at approximately 2-minute intervals. During the intravenous administration of Lopressor, monitor blood pressure, heart rate, and electrocardiogram.
In patients who tolerate the full intravenous dose (15 mg), initiate Lopressor tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below).
Start patients who appear not to tolerate the full intravenous dose on Lopressor tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Lopressor (see WARNINGS).
Late Treatment: Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Lopressor tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Lopressor beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1-3 years.
Special populationsPediatric patients: No pediatric studies have been performed. The safety and efficacy of Lopressor in pediatric patients have not been established.
Renal impairment: No dose adjustment of Lopressor is required in patients with renal impairment.
Hepatic impairment: Lopressor blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Lopressor should be initiated at low doses with cautious gradual dose titration according to clinical response.
Geriatric patients (>65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Method of administration:Parenteral administration of Lopressor (ampoule) should be done in a setting with intensive monitoring.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
For oral treatment, the tablets should be swallowed un-chewed with a glass of water. Lopressor should always be taken in standardized relation with meals. If the physician asks the patient to take Lopressor either before breakfast or with breakfast, then the patient should continue taking Lopressor with the same schedule during the course of therapy.
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Novartis Pharmaceuticals Corporation
Lopressor | Rite Aid Corporation
• take only as directed – see overdose warning • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
2 softgels with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
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Validus Pharmaceuticals Llc
Lopressor | Validus Pharmaceuticals Llc
HypertensionIndividualize the dosage of Lopressor tablets. Lopressor tablets should be taken with or immediately following meals.
The usual initial dosage of Lopressor tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range of Lopressor tablets is 100-450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of Lopressor is increased.
Angina PectorisThe dosage of Lopressor tablets should be individualized. Lopressor tablets should be taken with or immediately following meals.
The usual initial dosage of Lopressor tablets is 100 mg daily, given in two divided doses. gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Lopressor tablets is 100-400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1-2 weeks (see WARNINGS).
Myocardial InfarctionEarly Treatment: During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Lopressor as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.
Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Lopressor each; give the injections at approximately 2-minute intervals. During the intravenous administration of Lopressor, monitor blood pressure, heart rate, and electrocardiogram.
In patients who tolerate the full intravenous dose (15 mg), initiate Lopressor tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below).
Start patients who appear not to tolerate the full intravenous dose on Lopressor tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Lopressor (see WARNINGS).
Late Treatment:Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Lopressor tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Lopressor beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1-3 years.
Special populationsPediatric patients: No pediatric studies have been performed. The safety and efficacy of Lopressor in pediatric patients have not been established.
Renal impairment: No dose adjustment of Lopressor is required in patients with renal impairment.
Hepatic impairment: Lopressor blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Lopressor should be initiated at low doses with cautious gradual dose titration according to clinical response.
Geriatric patients (>65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Method of administration:For oral treatment, the tablets should be swallowed un-chewed with a glass of water. Lopressor should always be taken in standardized relation with meals. If the physician asks the patient to take Lopressor either before breakfast or with breakfast, then the patient should continue taking Lopressor with the same schedule during the course of therapy.
![Lopressor (Metoprolol Tartrate) Injection, Solution [Novartis Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=94500e3c-972b-408c-947c-5051bb91c2b9&name=a7b63f79-5ffc-490d-b92a-b4a5539d423a-01.jpg)
![Lopressor (Metoprolol Tartrate) Tablet [Validus Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0283bc9d-6998-493a-824a-d4c85f704111&name=lopressor-tablets-03.jpg)
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