Metoprolol (Page 4 of 4)

Potential Adverse Reactions

A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol tartrate.

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 performance on neuropsychometrics.

Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS).

Hematologic: Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura.

Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Postmarketing Experience

The following adverse reactions have been reported during postapproval use of metoprolol tartrate: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency.

OVERDOSAGE

Acute Toxicity

Several cases of overdosage have been reported, some leading to death.

Oral LD 50 ‘s (mg/kg): mice, 1158-2460; rats, 3090-4670.

Signs and Symptoms

Potential signs and symptoms associated with overdosage with metoprolol tartrate are bradycardia, hypotension, bronchospasm, and cardiac failure and death.

Management

There is no specific antidote.

In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS, Myocardial Infarction).

On the basis of the pharmacologic actions of metoprolol tartrate, the following general measures should be employed:

Elimination of the Drug: Gastric lavage should be performed.

Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care.

Hypotension: Administer a vasopressor, e.g., norepinephrine or dopamine.

Bronchospasm: Administer a beta 2 -stimulating agent and/or a theophylline derivative.

Cardiac Failure: Administer digitalis glycoside and diuretic. In shock resulting from inadequate cardiac contractility, consider administration of dobutamine, isoproterenol, or glucagon.

DOSAGE AND ADMINISTRATION

Myocardial Infarction

Early Treatment: During the early phase of definite or suspected acute myocardial infarction, initiate treatment with metoprolol tartrate can be initiated 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 Metoprolol Tartrate Injection, USP each; give the injections at approximately 2-minute intervals. During the intravenous administration of Metoprolol Tartrate Injection, USP, monitor blood pressure, heart rate, and electrocardiogram.

In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tartrate 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 orally twice daily.

Start patients who appear not to tolerate the full intravenous dose on metoprolol tartrate 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 metoprolol tartrate (see WARNINGS).

Special populations

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

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

Hepatic impairment: Metoprolol tartrate blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, metoprolol tartrate 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:

Parenteral administration of metoprolol tartrate should be done in a setting with intensive monitoring.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Metoprolol Tartrate Injection, USP is available as 5 mL vials, each containing 5 mg of metoprolol tartrate.

Carton of 10 vials

AIN00234

NDC 36000-033-10

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP controlled room temperature]. Do not freeze. Protect from light and heat.

To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured for:
Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Manufactured by:

Baxter Pharmaceuticals India Private Ltd

Ahmedabad 382213, India

2018-10-08

1400006477

PRINCIPAL DISPLAY PANEL — OUTER PACKAGE

NDC 71872-7155-1

1 — 5 mL sterile single use vial

Metoprolol Tartrate Injection, USP

5 mg/5 mL

(1 mg/mL)

For Intravenous Use

Rx Only

meto5label
(click image for full-size original)
METOPROLOL metoprolol tartrate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71872-7155(NDC:36000-033)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 45 mg in 5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71872-7155-1 1 VIAL in 1 BAG contains a VIAL
1 5 mL in 1 VIAL This package is contained within the BAG (71872-7155-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078950 09/25/2012
Labeler — Medical Purchasing Solutions, LLC (601458529)
Establishment
Name Address ID/FEI Operations
Medical Purchasing Solutions, LLC 601458529 repack (71872-7155)

Revised: 05/2023 Medical Purchasing Solutions, LLC

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