Metoprolol

Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure. …

• Administer once daily with food or after a meal
• Titrate at weekly or longer intervals as needed and tolerated. • Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. • Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses. • Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information
• Hypertension Individualize the dosage of metoprolol tartrate tablets
• Metoprolol tartrate tablets should be taken with or immediately following meals
• The usual initial dosage is 100 mg daily in single or divided doses
• Adjust 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 metoprolol tartrate tablets is 100 mg to 450 mg per day
• Dosages above 450 mg per day have not been studied
• While once-daily dosing 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
• Larger or more frequent daily doses may be required
• Measure blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day
• Angina Pectoris The dosage of metoprolol tartrate tablets should be individualized
• Metoprolol tartrate tablets should be taken with or immediately following meals. …

Metoprolol tartrate tablets, USP are supplied as: 25 mg tablets having functional scoring are white to off white film coated, round, biconvex tablet debossed with ‘L150’ on one side and breakline on other side. 50 mg tablets having functional scoring are pink, film coated, round, biconvex tablet debossed with ‘L151’ on one side and breakline on other side. …

• Safety and effectiveness of metoprolol tartrate have not been established
• In pediatric patients

Clinical studies of metoprolol tartrate in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. …

• Advise patients to take metoprolol tartrate tablets regularly and continuously, as directed, preferably with or immediately following meals
• If a dose is missed, the patient should take only the next scheduled dose (without doubling it)
• Patients should not interrupt or discontinue metoprolol tartrate tablets without consulting the physician
• Advise patients to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with metoprolol tartrate tablet has been determined; to contact the physician if any difficulty in breathing occurs; to inform the physician or dentist before any type of surgery that he or she i …

Metoprolol tartrate tablets are contraindicated in severe bradycardia, second-or third-degree heart block, cardiogenic shock, systolic blood pressure

• Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. ( 7.1 ) • Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. ( 7.2 ) • CYP2D6 Inhibitors are likely to increase metoprolol concentration. ( 7.3 ) • Concomitant use of glycosides, clonidine, and diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. ( 7.4 ) • Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. …

• Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) • Heart Failure: Worsening cardiac failure may occur. ( 5.2 ) • Bronchospastic Disease: Avoid beta-blockers. ( 5.3 ) • Pheochromocytoma: Initiate therapy with an alpha blocker. ( 5.4 ) • Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery. Do not routinely withdraw chronic beta-blocker therapy prior to surgery. ( 5.5 , 6.1 ) • Diabetes: May mask symptoms of hypoglycemia. ( 5.6 ) • Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. …

The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions (5)] Worsening heart failure [see Warnings and Precautions (5)]. Worsening AV block [see Contraindications (4)]. • Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy ( see Data). Untreated hypertension and myocardial infarction during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). …

Signs and Symptoms – Overdosage of metoprolol tartrate may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block, heart failure, bronchospasm, hypoxia, impairment of consciousness/coma, nausea and vomiting. Treatment – Consider treating the patient with intensive care. Patients with myocardial infarction or heart failure may be prone to significant hemodynamic instability. Beta-blocker overdose may result in significant resistance to resuscitation with adrenergic agents, including beta-agonists. …

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