Metoprolol Tartrate (Immediate Release) 50 mg Tablets — Generic For Lopressor — Aurobindo

These highlights do not include all the information needed to use METOPROLOL TARTRATE TABLETS safely and effectively. See full prescribing information for METOPROLOL TARTRATE TABLETS.

METOPROLOL TARTRATE tablets, for oral use

Initial U.S. Approval: 1992

Indications And Usage

Metoprolol tartrate tablets are 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)

Dosage And Administration

Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. (2)

Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. (2.1)

Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses. (2.2)

Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. (2.3)

Dosage Forms And Strengths

Metoprolol tartrate tablets, USP: 25 mg, 50 mg and 100 mg. (3)

Contraindications

Known hypersensitivity to product components. (4)

Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. (4)

Cardiogenic shock or decompensated heart failure. (4)

Warnings And Precautions

• 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. (5.7)
• Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. (5.9)

• 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. (5.7)
• Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. (5.9)

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. (5.7)

Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. (5.9)

Adverse Reactions

­Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

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. (7.4)

Use In Specific Populations

Hepatic Impairment: Consider initiating metoprolol therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events. (8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2024