FDA
Metoprolol Tartrate
The FDA lists this product in 60 strengths and forms.
Indications
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. 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 )
Contraindications
Hypersensitivity to Metoprolol tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). Metoprolol tartrate 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.
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. ( 5.6 )
5.1Bradycardia
Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol tartrate. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Metoprolol tartrate. If severe bradycardia develops, reduce or stop Metoprolol tartrate.
5.2Heart Failure
Worsening cardiac failure may occur during metoprolol use. If such symptoms occur, increase diuretics and restore clinical stability before administering the next dose of metoprolol [see Dosage and Administration (2) ] . Such episodes do not preclude subsequent successful titration of oral metoprolol.
At a glance
- Brand name
- Metoprolol Tartrate
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Hospira
- Status
- Prescription
- FDA approval
- 29 Apr 2008
- Application
- ANDA078085-001



