METOPROLOL TARTRATE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Gland Pharma Limited

INN (International Nazwa):

METOPROLOL TARTRATE

Skład:

METOPROLOL TARTRATE 5 mg in 5 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). Metoprolol 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 adverse outcomes for the mother and the

Podsumowanie produktu:

Metoprolol Tartrate Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Protect from light and heat. Do not freeze. Retain in carton until time of use.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

METOPROLOL TARTRATE - METOPROLOL TARTRATE INJECTION
GLAND PHARMA LIMITED
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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 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 GLAND PHARMA AT
864-879-9994 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
• Catechol