METOPROLOL TARTRATE injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

metoprolol tartrate (UNII: W5S57Y3A5L) (metoprolol - UNII:GEB06NHM23)

Доступна с:

Athenex Pharmaceutical Division, LLC.

ИНН (Международная Имя):

metoprolol tartrate

состав:

metoprolol tartrate 5 mg in 5 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

Metoprolol Tartrate Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light and heat. Do not freeze. Retain in carton until time of use. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

METOPROLOL TARTRATE- METOPROLOL TARTRATE INJECTION, SOLUTION
ATHENEX PHARMACEUTICAL DIVISION, 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 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 ATHENEX PHARMACEUTICAL
DIVISION, LLC.
AT 1-855-273-0154 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Cate