METOPROLOL TARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.  Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. 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 and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (c

Product summary:

Metoprolol Tartrate Tablets USP, 25 mg - White, circular, film coated tablets with “1” on one side and plain on the other side   Metoprolol Tartrate Tablets USP, 50 mg - Round, white film coated tablets with “477” debossed on one side and scored on the other side Blisterpacks of 30                                                      NDC 0615-3552-39 Blisterpacks of 15                                                      NDC 0615-3552-05 Metoprolol Tartrate Tablets USP, 50 mg - Capsule-shaped, biconvex, white, scored (debossed 166) Metoprolol Tartrate Tablets USP, 100 mg - Round-shaped, film coated, white colored tablets debossed with "162" on one side and "scored" on the other side. Metoprolol Tartrate Tablets USP, 100 mg - Capsule-shaped, biconvex, white, scored (debossed 167) Blisterpacks of 30                                                     NDC 0615-3553-39 Unit Dose Boxes of 30                                               NDC 0615-3553-30 Samples, when available, are identified by the word SAMPLE appearing on each bottle.  Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture. To report SUSPECTED ADVERSE REACTIONS, contact Caraco Pharmaceutical Laboratories, Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512                                            5094T88        Iss: 10/14

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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METOPROLOL TARTRATE TABLETS, USP 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, and its structural
formula is:
(C
H NO ) • C H O
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.
_Inactive Ingredients._ Tablets contain colloidal silicon dioxide,
hydroxypropyl methylcellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate,
povidone, sodium starch glycolate, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Metoprolol Tartrate is a beta1-selective (cardioselective) adrenergic
receptor blocker. This
preferential effect is not absolute, however, and at higher plasma
concentrations, Metoprolol
Tartrate also inhibits beta2- 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 proposed: (1)
competitive antagonism of
catecholamines at peripheral (especially cardiac) adrenergic neuron
sites, leading to decreased cardiac
output; (2) a central effect leading to reduced sympathetic outflow to
t