METOPROLOL TARTRATE injection, solution METOPROLOL TARTRATE- metoroprolol tartrate injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hikma Pharmaceuticals USA Inc.

INN (Међународно име):

METOPROLOL TARTRATE

Састав:

METOPROLOL TARTRATE 5 mg in 5 mL

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Metoprolol Tartrate Injection, USP 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 (PR 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 t

Резиме производа:

5 mL Single Dose Vials – each containing 5 mg of Metoprolol Tartrate, USP Carton of 10 vials.......................................................................................................................NDC 0143-9873-10 Carton of 25 vials.......................................................................................................................NDC 0143-9873-25 Also available in oversized vials (10 mL) with large mouth (20 mm) Carton of 10 vials.......................................................................................................................NDC 0143-9660-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and heat. Do not freeze. Retain in carton until time of use.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

METOPROLOL TARTRATE- METOPROLOL TARTRATE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOPROLOL TARTRATE INJECTION,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METOPROLOL TARTRATE INJECTION, USP
METOPROLOL TARTRATE INJECTION, USP, 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 single dose
vials. Also available in oversized vials (10 mL) with large
mouth (20 mm) (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 HIKMA PHARMACEUTIC