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:

Contract Pharmacy Services-PA

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 t

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 67046-472-07 blisterpacks of 7 NDC 67046-472-14 blisterpacks of 14 NDC 67046-472-15 blisterpacks of 15 NDC 67046-472-20 blisterpacks of 20 NDC 67046-472-21 blisterpacks of 21 NDC 67046-472-28 blisterpacks of 28 NDC 67046-472-30 blisterpacks of 30 NDC 67046-472-60 blisterpacks of 60 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2016 MTPL:R17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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472 METOPROLOL 25 MG
DESCRIPTION
Metoprolol tartrate is a selective beta
-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50
mg, 75 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, 37.5 mg, 50 mg, 75
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. In addition, the 37.5
mg product contains FD&C Blue No. 2 Aluminum Lake, the 50 mg product
contains FD&C Blue No. 2
Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40
Aluminum Lake and the 100
mg product contains FD&C Blue No. 2 Aluminum Lake as coloring agents.
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 a