IMPORTANT SAFETY INFORMATION (ISI)

INDICATIONS AND USAGE

Hypertension

LOPRESSOR® is indicated for the treatment of hypertension in adult patients, to lower blood pressure. LOPRESSOR may be administered with other antihypertensive agents.

Angina Pectoris

LOPRESSOR® is indicated in the long-term treatment of angina pectoris in adult patients, to reduce angina attacks and to improve exercise tolerance.

Myocardial Infarction

LOPRESSOR® is indicated in the treatment of hemodynamically stable adult patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol.

ADMINISTRATION

LOPRESSOR Oral Solution should be taken with or immediately following meals.

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.

WARNINGS AND PRECAUTIONS

Abrupt 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. Gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient.

Heart Failure:
Worsening cardiac failure may occur during up-titration of LOPRESSOR. Adjust diuretics and stabilize clinically before increasing dosage.

Bronchospastic Disease:
Use LOPRESSOR cautiously in patients with bronchospastic disease; use lowest effective dose and ensure availability of bronchodilators.

Pheochromocytoma:
Use only after initiating an alpha blocker. Beta-blockers alone may paradoxically increase blood pressure.

Major Surgery:
Avoid starting high-dose beta-blockers before non-cardiac surgery. Continue existing therapy cautiously.

Hypoglycemia:
Beta-blockers may mask signs of hypoglycemia and increase the risk, particularly in diabetics, fasting patients, and children.

Thyrotoxicosis:
LOPRESSOR may mask symptoms; abrupt withdrawal can trigger thyroid storm.

Risk of Anaphylactic Reaction:
Patients with prior severe allergic reactions may be unresponsive to epinephrine.

Peripheral Vascular Disease:
May worsen symptoms of arterial insufficiency.

ADVERSE REACTIONS

Includes worsening angina or myocardial infarction, worsening heart failure, and worsening AV block.

To report suspected adverse reactions, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or the FDA at www.fda.gov/medwatch.

DRUG INTERACTIONS

Catecholamine Depleting Drugs

May enhance effects of beta-blockers. Monitor for hypotension and bradycardia.

Epinephrine

Patients may be less responsive to epinephrine during allergic reactions.

CYP2D6 Inhibitors

May increase metoprolol levels; monitor for increased side effects.

Negative Chronotropes

Use caution with digitalis, clonidine, diltiazem, and verapamil. Withdraw beta-blocker before clonidine to prevent rebound hypertension.

USE IN SPECIFIC POPULATIONS

Pregnancy

Untreated hypertension or myocardial infarction during pregnancy can be harmful. Metoprolol crosses the placenta and may cause neonatal bradycardia, hypoglycemia, and respiratory depression.

Lactation

No adverse effects identified in breastfed infants. Effects on milk production are unknown.

Females and Males of Reproductive Potential

May cause reversible effects on spermatogenesis and erectile dysfunction based on animal studies and literature.

Pediatric Use

Not studied.

Geriatric Use

Start with a low dose due to potential for decreased organ function and polypharmacy.

Hepatic Impairment

Not studied.

Renal Impairment

No dosage adjustment required; pharmacokinetics unaffected by renal function.

DOSAGE FORMS AND STRENGTHS

LOPRESSOR Oral Solution (10 mg/mL): Clear, colorless solution. Prescription only.

OVERDOSAGE

May cause severe bradycardia, hypotension, cardiogenic shock, AV block, heart failure, bronchospasm, coma, and vomiting.

Please see Full Prescribing Information at https://liquid.lopressor.us.com/

LOP-003-25