METOPROLOL TARTRATE injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Physicians Total Care, Inc.

INN (Jina la Kimataifa):

METOPROLOL TARTRATE

Tungo:

METOPROLOL TARTRATE 5 mg in 5 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient's clinical condition allows (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION ). Metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). 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). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Metoprolol tartrate is contraindicated in patients with a heart rate <45 beats/min; second- and third-degree hear

Bidhaa muhtasari:

Metoprolol Tartrate Injection USP is supplied in 5 mL vials, each mL contains 1 mg metoprolol tartrate. NDC 54868-5726-0 , cartons of 10. 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. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Bedford Laboratories at 1-800-521-5169 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

METOPROLOL TARTRATE - METOPROLOL TARTRATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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METOPROLOL TARTRATE INJECTION USP
RX ONLY
DESCRIPTION
Metoprolol Tartrate Injection USP is a selective beta -adrenoreceptor
blocking agent, available in 5 mL
vials for intravenous administration. Each vial contains a sterile
solution of metoprolol tartrate, 5 mg,
sodium chloride, 45 mg, and water for injection. Metoprolol tartrate
is (±)-1-(isopropylamino)-3-[_p_-(2-
methoxyethyl)phenoxy]-2-propanoI L-(+)-tartrate (2:1) (salt), and its
structural formula is:
Molecular Formula: (C
H NO ) •C H O
Metoprolol tartrate is a white, practically odorless, crystalline
powder with a molecular weight of
684.83. It is very soluble in water; freely soluble in methylene
chloride, in chloroform, and in alcohol;
slightly soluble in acetone; and insoluble in ether. The pH range is
5.0 to 8.0.
CLINICAL PHARMACOLOGY
Metoprolol tartrate is a beta-adrenergic receptor blocking agent. _In
vitro_ and _in vivo_ animal studies have
shown that it has a preferential effect on beta adrenoreceptors,
chiefly located in cardiac muscle. This
preferential effect is not absolute, however, and at higher doses,
metoprolol tartrate also inhibits beta
adrenoreceptors, chiefly located in the bronchial and vascular
musculature.
Clinical pharmacology studies have confirmed the beta-blocking
activity of metoprolol in man, as
shown by (1) reduction in heart rate and cardiac output at rest and
upon exercise, (2) reduction of
systolic blood pressure upon exercise, (3) inhibition of
isoproterenol-induced tachycardia, and (4)
reduction of reflex orthostatic tachycardia.
Relative beta selectivity has been confirmed by the following: (1) In
normal subjects, metoprolol
tartrate is unable to reverse the beta -mediated vasodilating effects
of epinephrine. This contrasts with
the effect of nonselective (beta plus beta ) beta blockers, which
completely reverse the vasodilating
effects of epinephrine. (2) In asthmatic patients, metoprolol tartrate
reduces FEV and FVC