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Metoprolol Tartrate

METOROPROLOL TARTRATE

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 145.0

Quick Summary

Metoprolol Tartrate is a beta 1-selective adrenergic receptor blocking agent used to reduce cardiovascular mortality in hemodynamically stable patients with suspected or definite acute myocardial infarction. It is administered intravenously in a coronary care or similar unit, with an initial dose of three bolus injections of 5 mg each, followed by oral metoprolol maintenance therapy. The drug has several contraindications, including hypersensitivity to metoprolol or related derivatives, heart rate less than 45 beats per minute, and significant first-degree heart block. Common adverse reactions include tiredness, dizziness, shortness of breath, bradycardia, and hypotension. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients
  • Reduces cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy

Important Safety Information

Warning

Hypersensitivity to metoprolol or related derivatives, heart rate less than 45 beats per minute, and significant first-degree heart block are contraindications

Contraindications

  • Hypersensitivity to metoprolol or related derivatives
  • Heart rate less than 45 beats per minute
  • Second- and third-degree heart block
  • Significant first-degree heart block
  • Systolic blood pressure less than 100 mmHg
  • Decompensated cardiac failure

Adverse Reactions

  • Tiredness
  • Dizziness
  • Shortness of breath
  • Bradycardia
  • Hypotension
  • Pruritus

Dosing Recommendations

General Guidance

Monitor blood pressure, heart rate, and electrocardiogram during administration

Acute myocardial infarction

Adult Dose

Three bolus injections of 5 mg each, administered at approximately 2-minute intervals

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy
  • Untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus

Nursing Mothers

  • Beta blockers, including metoprolol, may cause erectile dysfunction and inhibit sperm motility
  • No evidence of impaired fertility due to metoprolol was observed in rats

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established

Geriatric Use

  • In worldwide clinical trials of Metoprolol Tartrate Injection in myocardial infarction, no age-related differences in safety and effectiveness were found
  • Greater sensitivity of some elderly individuals taking Metoprolol Tartrate Injection cannot be categorically ruled out