METOPROLOL- metoprolol tartrate injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)

Fáanlegur frá:

Fresenius Kabi USA, LLC

INN (Alþjóðlegt nafn):

METOPROLOL TARTRATE

Samsetning:

METOPROLOL TARTRATE 5 mg in 5 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 conjunction with oral metoprolol maintenance therapy. Hypersensitivity to metoprolol tartrate injection and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). Metoprolol tartrate injection is contraindicated in patients with a heart rate <45 beats/min; second-and third-degree heart block (unless a functioning pacemaker is present); significant first-degree heart block (P-R interval ≥0.24 sec); systolic blood pressure <100 mmHg; or decompensated cardiac failure. Risk Summary Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy (see Data). Untreated hypertension and heart failure during pregnancy can lead to a

Vörulýsing:

Metoprolol Tartrate Injection, USP is available as 5 mL vials, each containing 5 mg of metoprolol tartrate: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Retain in carton until time of use. The container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

METOPROLOL - METOPROLOL TARTRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOPROLOL TARTRATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METOPROLOL
TARTRATE INJECTION
METOPROLOL TARTRATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
Metoprolol tartrate injection is a beta adrenergic receptor inhibitor
indicated for the treatment of definite
or suspected acute myocardial infarction in hemodynamically stable
patients to reduce cardiovascular
mortality when used in conjunction with oral metoprolol maintenance
therapy (1).
DOSAGE AND ADMINISTRATION
Initiate therapy in a coronary care or similar unit immediately after
the patients hemodynamic condition
has stabilized (2).
Begin treatment with an intravenous administration of three bolus
injections of 5 mg each, at
approximately 2-minute intervals. Monitor blood pressure, heart rate
and electrocardiogram (2).
Following administration of metoprolol tartrate injection, transition
the patient to an oral formulation of
metoprolol (2).
DOSAGE FORMS AND STRENGTHS
Injection: 5 mg metoprolol tartrate supplied in 5 mL vials (3)
CONTRAINDICATIONS
Known hypersensitivity to product components. (4)
Severe bradycardia, greater than first degree heart block, or sick
sinus syndrome without a pacemaker.
(4)
Cardiogenic shock or decompensated heart failure. (4)
WARNINGS AND PRECAUTIONS
Worsening cardiac failure may occur. (5.1)
Bronchospastic Disease: Avoid beta blockers. (5.2)
Pheochromocytoma: First initiate therapy with an alpha blocker. (5.3)
May aggravate symptoms of arterial insufficiency. (5.4)
ADVERSE REACTIONS
Most common adverse reactions: tiredness, dizziness, shortness of
breath, bradycardia, hypotension,
pruritus. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FRESENIUS KABI USA, LLC
AT 1-800-551-
7176 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Catecholamine-depleti