Metoroprolol Tartrate
Generic Name: metoroprolol tartrate
Brand Names:
Metoprolol Tartrate
11 DESCRIPTION Metoprolol Tartrate Injection, USP is a selective beta 1 -adrenoreceptor blocking agent, available in 5 mL and oversized 10 mL vials for intravenous administration. Each vial contains a sterile solution of Metoprolol Tartrate USP, 5 mg, and Sodium Chloride, USP, 45 mg, and Water for Injection, USP.
Overview
11 DESCRIPTION Metoprolol Tartrate Injection, USP is a selective beta 1 -adrenoreceptor blocking agent, available in 5 mL and oversized 10 mL vials for intravenous administration. Each vial contains a sterile solution of Metoprolol Tartrate USP, 5 mg, and Sodium Chloride, USP, 45 mg, and Water for Injection, USP.
Uses
1 INDICATIONS AND USAGE 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. 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
2 DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Initiate treatment in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Metoprolol Tartrate Injection each; give the injections at approximately 2-minute intervals. During the intravenous administration of Metoprolol Tartrate Injection, monitor blood pressure, heart rate, and electrocardiogram. Transition to Oral Metoprolol: Following administration of Metoprolol Tartrate Injection, transition patients to an oral formulation of metoprolol.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions (5) ] Worsening heart failure [see Warnings and Precautions (5) ] Worsening AV block [see Contraindications (4) ] • Most common adverse reactions: tiredness, dizziness, shortness of breath, bradycardia, hypotension, pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 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 ) 7.1 Catecholamine Depleting Drugs and Monoamine Oxidate (MAO) Inhibitors Catecholamine depleting drugs (e.g., reserpine) and monoamine oxidase (MAO) inhibitors may have an additive effect when given with beta-blocking agents.
Warnings
5 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 ) 5.1 Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol Tartrate Injection. 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 Injection. If severe bradycardia develops, reduce or stop Metoprolol Tartrate Injection. 5.2 Heart Failure Worsening cardiac failure may occur during metoprolol use. 4 CONTRAINDICATIONS 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).
Pregnancy
8.1 Pregnancy 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 adverse outcomes for the mother and the fetus (see Clinical Considerations ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 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........................................................................................................................
Frequently Asked Questions
What is Metoroprolol Tartrate used for?▼
1 INDICATIONS AND USAGE 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. 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 ).
What are the side effects of Metoroprolol Tartrate?▼
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions (5) ] Worsening heart failure [see Warnings and Precautions (5) ] Worsening AV block [see Contraindications (4) ] • Most common adverse reactions: tiredness, dizziness, shortness of breath, bradycardia, hypotension, pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Metoroprolol Tartrate during pregnancy?▼
8.1 Pregnancy 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 adverse outcomes for the mother and the fetus (see Clinical Considerations ).
What are the important warnings for Metoroprolol Tartrate?▼
5 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 ) 5.1 Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol Tartrate Injection. 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 Injection. If severe bradycardia develops, reduce or stop Metoprolol Tartrate Injection. 5.2 Heart Failure Worsening cardiac failure may occur during metoprolol use. 4 CONTRAINDICATIONS 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).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.