metoprolol tartrate injection, USP - VIAL Description | Pfizer Medical Information - US

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11 DESCRIPTION

Metoprolol tartrate Injection, USP, is a selective beta1-adrenoreceptor blocking agent, available in 5 mL vials for intravenous administration. Each vial contains a sterile solution of metoprolol tartrate USP, 5 mg, and sodium chloride USP, 45 mg. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is:

Chemical Structure

Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.83. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.

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metoprolol tartrate injection, USP - VIAL Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Metoprolol tartrate Injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in...

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2 DOSAGE AND ADMINISTRATION

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

Initiate treatment in a...

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3 DOSAGE FORMS AND STRENGTHS

Injection: 5 mg metoprolol tartrate supplied in 5 mL Single-dose glass Fliptop Vial.

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4 CONTRAINDICATIONS

Hypersensitivity to Metoprolol tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur).

Metoprolol...

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5 WARNINGS AND PRECAUTIONS

5.1 Bradycardia

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol tartrate....

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6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in labeling:

Worsening angina or myocardial infarction [see Warnings and Precautions (5...

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7 DRUG INTERACTIONS

7.1 Catecholamine Depleting Drugs and Monoamine Oxidate (MAO) Inhibitors

Catecholamine depleting drugs (e.g., reserpine) and monoamine oxidase (...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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10 OVERDOSAGE

Signs and Symptoms - Overdosage of metoprolol may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical...

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11 DESCRIPTION

Metoprolol tartrate Injection, USP, is a selective beta1-adrenoreceptor blocking agent, available in 5 mL vials for intravenous administration. Each vial contains a sterile solution of...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Metoprolol is a beta1-selective (cardioselective) adrenergic receptor blocking agent. This...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have been conducted to evaluate the carcinogenic...

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14 CLINICAL STUDIES

In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Metoprolol tartrate was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Metoprolol tartrate Injection, USP is available as:

...

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17 PATIENT COUNSELING INFORMATION

Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy with Metoprolol tartrate has been...

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.