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metoprolol tartrate injection, USP - CARPUJECT
metoprolol tartrate injection, USP - CARPUJECT Quick Finder
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...
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...
3 DOSAGE FORMS AND STRENGTHS
Injection: 5 mg metoprolol tartrate supplied in 5 mL Carpuject Luer Lock Glass Syringes (no needle) (3)
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).
5 WARNINGS AND PRECAUTIONS
Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol tartrate....
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in labeling:
- Worsening angina or myocardial infarction [see Warnings and Precautions (5...
7 DRUG INTERACTIONS
7.1 Catecholamine Depleting Drugs and Monoamine Oxidate (MAO) Inhibitors
Catecholamine depleting drugs (e.g., reserpine) and monoamine oxidase (...
8 USE IN SPECIFIC POPULATIONS
Available data from...
Signs and Symptoms - Overdosage of metoprolol may lead to severe bradycardia,...
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Metoprolol is a beta1-selective (cardioselective) adrenergic receptor blocking agent. This...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have been conducted to evaluate the carcinogenic...
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...
16 HOW SUPPLIED/STORAGE AND HANDLING
Metoprolol tartrate injection, USP is available as:
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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