METOPROLOL TARTRATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ). Hypersensitvity to metoprolol and related derivatives, or to any of the excipients; hypersensiti

Product summary:

Metoprolol Tartrate Tablets, USP are available as follows: 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. Bottles of 30         NDC 63187-532-30 Bottles of 60       NDC 63187-532-60 Bottles of 90       NDC 63187-532-90 Bottles of 120       NDC 63187-532-72 Bottles of 180       NDC 63187-532-78 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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Distributed by: Citron Pharma LLC Suite - 1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/19/1993 Made in India Issued: 08/2014 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
PROFICIENT RX LP
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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.
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.
1
1
2
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