Metoprolol Succinate (Extended Release) 50 mg Tablets — Generic For Toprol XL — Camber

These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS.

METOPROLOL SUCCINATE extended-release tablets, for oral use

Initial U.S. Approval: 1992

Indications And Usage

Metoprolol succinate extended-release tablets, are 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)

Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (

1.3)

Dosage And Administration

Administer once daily. Titrate at weekly or longer intervals as needed and tolerated. (

2)

Hypertension: Starting dose is 25 to 100 mg. (

2.1)

Angina Pectoris: Starting dose is 100 mg. (

2.2)

Heart Failure: Starting dose is 12.5 or 25 mg. (

2.3)

Switching from immediate-release metoprolol to metoprolol succinate extended-release tablets: use the same total daily dose of metoprolol succinate extended-release tablets. (

2)

Dosage Forms And Strengths

Metoprolol succinate extended-release tablets: 25 mg, 50 mg, 100 mg, and 200 mg. (

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

• Abrupt cessation may exacerbate myocardial ischemia. ( 5.1)
• Heart Failure: Worsening cardiac failure may occur. ( 5.2)
• Bronchospastic Disease: Avoid beta-blockers. ( 5.3)
• Concomitant use of glycosides, clonidine, diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. ( 5.4)
• Pheochromocytoma: Initiate therapy with an alpha-blocker. ( 5.5)
• 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. ( 5.6, 6.1)
• Hypoglycemia: May increase risk for hypoglycemia and mask early warning signs. ( 5.7)
• Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. ( 5.8)

• Abrupt cessation may exacerbate myocardial ischemia. ( 5.1)
• Heart Failure: Worsening cardiac failure may occur. ( 5.2)
• Bronchospastic Disease: Avoid beta-blockers. ( 5.3)
• Concomitant use of glycosides, clonidine, diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. ( 5.4)
• Pheochromocytoma: Initiate therapy with an alpha-blocker. ( 5.5)
• 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. ( 5.6, 6.1)
• Hypoglycemia: May increase risk for hypoglycemia and mask early warning signs. ( 5.7)
• Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. ( 5.8)

Abrupt cessation may exacerbate myocardial ischemia. (

5.1)

Heart Failure: Worsening cardiac failure may occur. (

5.2)

Bronchospastic Disease: Avoid beta-blockers. (

5.3)

Concomitant use of glycosides, clonidine, diltiazem and verapamil

with beta-blockers can increase the risk of bradycardia. (

5.4)

Pheochromocytoma: Initiate therapy with an alpha-blocker. (

5.5)

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. (

5.6,

6.1)

Hypoglycemia: May increase risk for hypoglycemia and mask early warning signs. (

5.7)

Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. (

5.8)

Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. (

5.9)

Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. (

5.10)

Adverse Reactions

Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. (

6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

Drug Interactions

Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. (

7.1)

CYP2D6 Inhibitors are likely to increase metoprolol concentration. (

7.2)

Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. (

7.3)

Use In Specific Populations

Hepatic Impairment: Consider initiating metoprolol succinate extended-release tablets therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events. (

8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2024