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:

Mylan Institutional Inc.

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 25 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 tablets 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 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

Product summary:

Metoprolol Tartrate Tablets, USP are available containing 25 mg or 50 mg of metoprolol tartrate, USP. The 25 mg tablets are white, film-coated, round, scored tablets debossed with M over 18 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-255-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 50 mg tablets are pink, film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-801-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12628 6/20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
----------
DESCRIPTION
Metoprolol tartrate is a selective beta
-adrenoreceptor blocking agent, available as 25
mg, 50 mg 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 and the following inactive ingredients: anhydrous lactose,
colloidal silicon dioxide,
croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate,
titanium dioxide and
triacetin. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum
Lake, D&C Red No.
27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets
also
contain FD&C Blue No. 2 Aluminum Lake.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol 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
proposed: (1)
1
1