FDA

Lopressor

Approved 28 Aug 2025OralTablet

The FDA lists this product in 5 strengths and forms.

Indications

LOPRESSOR is a beta-adrenergic blocker indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality. ( 1.1 )

1.1Myocardial Infarction

LOPRESSOR is indicated in the treatment of hemodynamically stable adult patients with myocardial infarction (MI) to reduce cardiovascular mortality.

Contraindications

LOPRESSOR is 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. Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. ( 4 ) Cardiogenic shock or decompensated heart failure.

( 4 ) Known hypersensitivity to product components. ( 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 ) Pheochromocytoma: Initiate therapy with an alpha blocker. ( 5.4 ) Major Surgery: Avoid initiation of high-dose 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. ( 5.9 )

5.1Abrupt Cessation of Therapy

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered LOPRESSOR, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. Warn patients not to interrupt therapy without their physician’s advice.

5.2Heart Failure

At a glance

Brand name: Lopressor
Active substance: metoprolol tartrate
Route: Oral
Dosage form: Tablet
Applicant: XTM Consulting
Status: Prescription
FDA approval: 28 Aug 2025
Application: NDA218698-001

Indications

LOPRESSOR is a beta-adrenergic blocker indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality. ( 1.1 )

1.1Myocardial Infarction

LOPRESSOR is indicated in the treatment of hemodynamically stable adult patients with myocardial infarction (MI) to reduce cardiovascular mortality.

Contraindications

( 4 ) Known hypersensitivity to product components. ( 4 )

Warnings and precautions

5.1Abrupt Cessation of Therapy

5.2Heart Failure

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 )

7.1Catecholamine Depleting Drugs

Observe patients treated with LOPRESSOR plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents.

7.2Epinephrine

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as metoprolol. Higher doses of epinephrine might be necessary for patients taking metoprolol.

7.3CYP2D6 Inhibitors

Monitor patients closely when the combination use of CYP2D6 inhibitor and metoprolol cannot be avoided. Drugs that are strong inhibitors of CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these may also increase metoprolol concentration. Increases in plasma concentration decrease the beta 1 cardioselectivity of metoprolol [see Clinical Pharmacology (12.3) ] .

7.4Negative Chronotropes

If clonidine and metoprolol are coadministered, withdraw the beta-blocker several days before the gradual withdrawal of clonidine because metoprolol may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. If replacing clonidine with metoprolol, delay the introduction of metoprolol for several days after clonidine discontinuation. Digitalis glycosides, clonidine, diltiazem, and verapamil slow atrioventricular conduction and decrease heart rate.

Concomitant use with beta blockers can increase the risk of bradycardia.

Adverse reactions

The following adverse reactions are described elsewhere in labeling: Worsening Ischemia with Abrupt Discontinuation [see Warnings and Precautions (5) ] Worsening heart failure [see Warnings and Precautions (5) ]. Worsening atrioventricular (AV) block [see Contraindications (4) ]. Most common adverse reactions in the setting of treatment of myocardial infarction are hypotension and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Myocardial Infarction In a randomized comparison of LOPRESSOR and placebo in the setting of acute MI [see Clinical studies 14.1 ] the following adverse reactions were reported: Adverse Reaction LOPRESSOR N=698 % Placebo N=697 % Hypotension (systolic BP < 90 mm Hg) 27.4% 23.2% Bradycardia (heart rate < 40 beats/min) 15.9% 6.7% Second- or third-degree heart block 4.7% 4.7% First-degree heart block (P-R ≥ 0.26 sec) 5.3% 1.9% Heart failure 27.5% 29.6%

6.2Post-Marketing Experience

The following adverse reactions have been reported during post-approval use of LOPRESSOR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased cognitive performance.

Cardiovascular: Worsening AV block [see Contraindications (4) ]. Hematologic: Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura. Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm and respiratory distress. Laboratory Findings: Increase in blood triglycerides, elevated transaminase and decrease in high-density lipoprotein (HDL)

Lopressor

Indications

1.1Myocardial Infarction

Contraindications

Warnings and precautions

5.1Abrupt Cessation of Therapy

5.2Heart Failure

At a glance

Two medicines in one question?

Lopressor

Indications

1.1Myocardial Infarction

Contraindications

Warnings and precautions

5.1Abrupt Cessation of Therapy

5.2Heart Failure

At a glance

Two medicines in one question?

5.3Bronchospastic Disease Patients

5.4Pheochromocytoma If

5.5Major Surgery

5.6Hypoglycemia

5.7Thyrotoxicosis

5.8Risk of Anaphylactic Reactions

5.9Peripheral Vascular Disease

Interactions

7.1Catecholamine Depleting Drugs

7.2Epinephrine

7.3CYP2D6 Inhibitors

7.4Negative Chronotropes

Adverse reactions

6.1Clinical Trials Experience

6.2Post-Marketing Experience

Composition

Strengths and forms

Official product information