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metoprolol tartrate injection, USP - CARPUJECT
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
metoprolol tartrate injection, USP - CARPUJECT Quick Finder
Highlights
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 5 mg metoprolol tartrate supplied in 5 mL Carpuject Luer Lock Glass Syringes (no needle) (3)
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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in labeling:
- Worsening angina or myocardial infarction [see
6.1 Clinical Trials Experience
...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
Signs and Symptoms - Overdosage of metoprolol may lead to severe bradycardia,...
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Description
11 DESCRIPTION
Metoprolol tartrate injection, USP is a selective beta1-adrenoreceptor blocking agent, available in 5 mL ampuls and 5 mL Carpuject™ sterile cartridge units, for intravenous...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Metoprolol is a beta1-selective (cardioselective) adrenergic receptor blocking agent. This...
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Nonclinical Toxicology
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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Clinical Studies
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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Metoprolol tartrate injection, USP is available as:
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Medication Guide
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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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this 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.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.