Lopressor: Package Insert and Label Information (Page 3 of 3)

Myocardial Infarction

Early Treatment: During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Lopressor as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.

Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Lopressor each; give the injections at approximately 2-minute intervals. During the intravenous administration of Lopressor, monitor blood pressure, heart rate, and electrocardiogram.

In patients who tolerate the full intravenous dose (15 mg), initiate Lopressor tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below).

Start patients who appear not to tolerate the full intravenous dose on Lopressor tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Lopressor (see WARNINGS).

Late Treatment: Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Lopressor tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Lopressor beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.

Special populations

Pediatric patients: No pediatric studies have been performed. The safety and efficacy of Lopressor in pediatric patients have not been established.

Renal impairment: No dose adjustment of Lopressor is required in patients with renal impairment.

Hepatic impairment: Lopressor blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Lopressor should be initiated at low doses with cautious gradual dose titration according to clinical response.

Geriatric patients (>65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Method of administration:

For oral treatment, the tablets should be swallowed un-chewed with a glass of water. Lopressor should always be taken in standardized relation with meals. If the physician asks the patient to take Lopressor either before breakfast or with breakfast, then the patient should continue taking Lopressor with the same schedule during the course of therapy.

HOW SUPPLIED

Lopressor Tablets

m etoprolol tartrate USP Tablets

Tablets 50 mg – capsule-shaped, biconvex, pink, scored (imprinted LOPRESSOR on one side and 458 twice on the scored side)

Bottles of 100………………………………………….………NDC 30698-458-01

Tablets 100 mg – capsule-shaped, biconvex, light blue, scored (imprinted LOPRESSOR on one side and 459 twice on the scored side)

Bottles of 100………………………………………………… NDC 30698-459-01

Storage: Store at 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Protect from moisture and heat.

Dispense in a tight, light-resistant container (USP).

Manufactured for and Distributed by:
Validus Pharmaceuticals LLC

Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438

Product of Spain

© 2022 Validus Pharmaceuticals LLC

60025-04October 2022

PRINCIPAL DISPLAY PANEL

NDC 30698-458-01
Lopressor
(metoprolol tartrate USP) Tablets
50 mg
100 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 30698-459-01
Lopressor
(metoprolol tartrate USP) Tablets
100 mg
100 Tablets
Rx Only

LOPRESSOR metoprolol tartrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30698-458 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 50 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE D&C RED NO. 30 LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE

Product Characteristics Color pink (pink) Score 2 pieces Shape CAPSULE (CAPSULE) Size 13mm Flavor Imprint Code LOPRESSOR;458;458 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:30698-458-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017963 05/05/2014

LOPRESSOR metoprolol tartrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30698-459 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 100 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE FD&C BLUE NO. 2 LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE

Product Characteristics Color blue (light blue) Score 2 pieces Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code LOPRESSOR;459;459 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:30698-459-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017963 05/05/2014

Labeler — Validus Pharmaceuticals LLC (801194619)

Establishment
Name	Address	ID/FEI	Operations
Halo Pharmaceutical Inc		829609168	manufacture (30698-458), manufacture (30698-459)

Revised: 01/2023 Validus Pharmaceuticals LLC