METOPROLOL TARTRATE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

American Health Packaging

INN (שם בינלאומי):

METOPROLOL TARTRATE

הרכב:

METOPROLOL TARTRATE 25 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets, USP are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets, USP therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS , and WARNINGS ). Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Hypersensitivity to metoprolol 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 tablets are contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval ≥ 0.24 sec); systolic blood pressure < 100 mmHg; or moderate-to-severe cardiac failure (see WARNINGS ).

leaflet_short:

Metoprolol Tartrate Tablets, USP are available as follows: Tablets 25 mg are white round shaped, film coated tablets debossed with ‘C over 73’ on one side and deep break line on other side. Unit dose packages of 100 (10 x 10) NDC 62584-265-01 Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side. Unit dose packages of 100 (10 x 10) NDC 62584-266-01 Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side. Unit dose packages of 100 (10 x 10) NDC 62584-267-01 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 moisture and heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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METOPROLOL TARTRATE TABLETS, USP
8026501/0722
RX ONLY
DESCRIPTION
Metoprolol tartrate USP is a selective beta
-adrenoreceptor blocking agent, available as
25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate
is (±)-1-
(isopropylamino)-3-[ _p_-(2-methoxyethyl)phenoxy]-2-propanol (2:1)
_dextro_-tartrate salt.
Its structural formula is:
Metoprolol tartrate USP is a white, practically odorless, crystalline
powder with a
molecular weight of 684.82. It is very soluble in water; freely
soluble in methylene
chloride, in chloroform, and in alcohol; slightly soluble in acetone;
and insoluble in ether.
Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of
metoprolol
tartrate.
The tablets contain the following inactive ingredients:
microcrystalline cellulose, corn
starch, sodium starch glycollate, colloidal silicon dioxide, sodium
lauryl sulfate, talc,
magnesium stearate, hypromellose, titanium dioxide, polyethylene
glycol and
polysorbate 80. In addition, 50 mg tablet contains D&C Red #30
Aluminium Lake and
100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol tartrate is a beta
-selective (cardioselective) adrenergic receptor blocker.
This preferential effect is not absolute, however, and at higher
plasma concentrations,
metoprolol also inhibits beta
-adrenoreceptors, chiefly located in the bronchial and
vascular musculature.
Clinical pharmacology studies have demonstrated the beta-blocking
activity of
metoprolol, 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.
_HYPERTENSION_
The mechanism of the antihypertensive effects of beta-blocking agents
has not been
fully elucidated. However, several possible mechanisms have been
propos