Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
Hikma Pharmaceuticals USA Inc.
METOPROLOL TARTRATE
METOPROLOL TARTRATE 5 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Metoprolol Tartrate Injection, USP 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 (PR 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 t
5 mL Single Dose Vials – each containing 5 mg of Metoprolol Tartrate, USP Carton of 10 vials.......................................................................................................................NDC 0143-9873-10 Carton of 25 vials.......................................................................................................................NDC 0143-9873-25 Also available in oversized vials (10 mL) with large mouth (20 mm) Carton of 10 vials.......................................................................................................................NDC 0143-9660-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and heat. Do not freeze. Retain in carton until time of use.
Abbreviated New Drug Application
METOPROLOL TARTRATE- METOPROLOL TARTRATE INJECTION, SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOPROLOL TARTRATE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOPROLOL TARTRATE INJECTION, USP METOPROLOL TARTRATE INJECTION, USP, 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 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 5 mL single dose vials. Also available in oversized vials (10 mL) with large mouth (20 mm) (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. (5.1) Bronchospastic Disease: Avoid beta blockers. (5.2) Pheochromocytoma: First initiate therapy with an alpha blocker. (5.3) May aggravate symptoms of arterial insufficiency. (5.4) ADVERSE REACTIONS • Most common adverse reactions: tiredness, dizziness, shortness of breath, bradycardia, hypotension, pruritus. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTIC Lire le document complet