metoprolol tartrate injection, USP - VIAL Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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

METOPROLOL TARTRATE Injection, for intravenous use
Initial U.S. Approval: 1978

INDICATIONS AND USAGE

Metoprolol tartrate is a beta-adrenergic receptor inhibitor indicated for the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. (1)

DOSAGE AND ADMINISTRATION

  • Initiate therapy in a coronary care or similar unit immediately after the patients hemodynamic condition has stabilized. (2)
  • Begin treatment with an intravenous administration of three bolus injections of 5 mg each, at approximately 2-minute intervals. Monitor blood pressure, heart rate and electrocardiogram. (2)
  • Following administration of Metoprolol tartrate Injection, transition the patient to an oral formulation of metoprolol. (2)

DOSAGE FORMS AND STRENGTHS

Injection: 5 mg metoprolol tartrate supplied in Single-dose glass Fliptop Vial. (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

  • Worsening cardiac failure may occur. (5.2)
  • Bronchospastic Disease: Avoid beta-blockers. (5.3)
  • Pheochromocytoma: First initiate therapy with an alpha blocker. (5.4)
  • May aggravate symptoms of arterial insufficiency. (5.5)

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 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 tartrate therapy at low doses while monitoring closely for adverse events. (8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2020

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

METOPROLOL TARTRATE Injection, for intravenous use
Initial U.S. Approval: 1978

INDICATIONS AND USAGE

Metoprolol tartrate is a beta-adrenergic receptor inhibitor indicated for the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. (1)

DOSAGE AND ADMINISTRATION

  • Initiate therapy in a coronary care or similar unit immediately after the patients hemodynamic condition has stabilized. (2)
  • Begin treatment with an intravenous administration of three bolus injections of 5 mg each, at approximately 2-minute intervals. Monitor blood pressure, heart rate and electrocardiogram. (2)
  • Following administration of Metoprolol tartrate Injection, transition the patient to an oral formulation of metoprolol. (2)

DOSAGE FORMS AND STRENGTHS

Injection: 5 mg metoprolol tartrate supplied in Single-dose glass Fliptop Vial. (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

  • Worsening cardiac failure may occur. (5.2)
  • Bronchospastic Disease: Avoid beta-blockers. (5.3)
  • Pheochromocytoma: First initiate therapy with an alpha blocker. (5.4)
  • May aggravate symptoms of arterial insufficiency. (5.5)

ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 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 tartrate therapy at low doses while monitoring closely for adverse events. (8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2020

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