Metoprolol
Generic Name: metoprolol
Brand Names:
Metoprolol Tartrate
11 DESCRIPTION Metoprolol tartrate tablets, USP contain metoprolol tartrate, USP a selective beta 1 -adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) salt, and its structural formula is Metoprolol tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82.
Overview
11 DESCRIPTION Metoprolol tartrate tablets, USP contain metoprolol tartrate, USP a selective beta 1 -adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) salt, and its structural formula is Metoprolol tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82.
Uses
1 INDICATIONS AND USAGE Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure.
Dosage
2 DOSAGE AND ADMINISTRATION • Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. ( 2 ) • Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. ( 2.1 ) • Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses. ( 2.2 ) • Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. ( 2.3 ) 2.1 Hypertension Individualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg daily in single or divided doses.
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, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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 Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents.
Warnings
5 WARNINGS AND PRECAUTIONS • Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) • Heart Failure: Worsening cardiac failure may occur. ( 5.2 ) • Bronchospastic Disease: Avoid beta-blockers. ( 5.3 ) • Pheochromocytoma: Initiate therapy with an alpha blocker. ( 5.4 ) • Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery. Do not routinely withdraw chronic beta-blocker therapy prior to surgery. ( 5.5 , 6.1 ) • Diabetes: May mask symptoms of hypoglycemia. ( 5.6 ) • Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. ( 5.7 ) • Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. 4 CONTRAINDICATIONS Metoprolol tartrate tablets are contraindicated in severe bradycardia, second-or third-degree heart block, cardiogenic shock, systolic blood pressure <100, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. • Known hypersensitivity to product components.
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 myocardial infarction during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Metoprolol Tartrate Tablets, USP are available containing 100 mg of metoprolol tartrate, USP. The 100 mg tablets having functional scoring are blue, film coated, round, biconvex tablets debossed with ‘L152’ on one side and breakline on other side. They are available as follows: NDC 68071-3942-3 bottles of 30 tablets Storage: Store at 20° to 25°C (68° to 77°F).
Frequently Asked Questions
What is Metoprolol used for?▼
1 INDICATIONS AND USAGE Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure.
What are the side effects of Metoprolol?▼
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, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Metoprolol 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 myocardial infarction during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations).
What are the important warnings for Metoprolol?▼
5 WARNINGS AND PRECAUTIONS • Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) • Heart Failure: Worsening cardiac failure may occur. ( 5.2 ) • Bronchospastic Disease: Avoid beta-blockers. ( 5.3 ) • Pheochromocytoma: Initiate therapy with an alpha blocker. ( 5.4 ) • Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery. Do not routinely withdraw chronic beta-blocker therapy prior to surgery. ( 5.5 , 6.1 ) • Diabetes: May mask symptoms of hypoglycemia. ( 5.6 ) • Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. ( 5.7 ) • Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. 4 CONTRAINDICATIONS Metoprolol tartrate tablets are contraindicated in severe bradycardia, second-or third-degree heart block, cardiogenic shock, systolic blood pressure <100, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. • Known hypersensitivity to product components.
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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.