Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
metoprolol tartrate (UNII: W5S57Y3A5L) (metoprolol - UNII:GEB06NHM23)
Baxter Healthcare Corporation
metoprolol tartrate
metoprolol tartrate 5 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Metoprolol tartrate injection is indicated in 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. Hypersensitivity to metoprolol tartrate injection and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). Metoprolol tartrate injection is contraindicated in patients with a heart rate <45 beats/min; second- and third-degree heart block (unless a functioning pacemaker is present); significant first-degree heart block (P-R interval ≥0.24 sec); systolic blood pressure <100 mmHg; or decompensated cardiac failure. 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 heart failure during pregnancy can lead to a
Metoprolol Tartrate Injection, USP is available as 5 mL vials, each containing 5 mg of metoprolol tartrate, USP. Carton of 10 vials AIN00234 36000-033-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Protect from light and heat.
Abbreviated New Drug Application
METOPROLOL - METOPROLOL TARTRATE INJECTION BAXTER HEALTHCARE CORPORATION ---------- 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 injection 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 • • • DOSAGE FORMS AND STRENGTHS Injection: 5 mg metoprolol tartrate supplied in 5 mL vials (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE CORPORATION AT 1- 877-725-2747 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • • USE IN SPECIFIC POPULATIONS • 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). 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) 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) Most common adverse reactions: tirednes Baca dokumen lengkapnya