Metoprolol Tartrate (Immediate Release) 50 mg Tablets — Generic For Lopressor — Granules

Metoprolol Succinate Extended-release Tablets

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 is a beta-adrenergic blocker indicated for the treatment of:

(1.1)

(1.2)

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

4)

4)

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)

5.1)

5.2)

5.3)

5.4)

5.5)

5.6,

6.1)

5.7)

5.8)

5.9)

5.10)

Adverse Reactions

(6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc.‚ at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

7.1)

7.2)

7.3)

Use In Specific Populations

(8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2023