METOPROLOL SUCCINATE- metoprolol succinate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

metoprolol succinate (UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)

Available from:

Ethex Corporation

INN (International Name):

metoprolol succinate

Composition:

metoprolol succinate 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris. Metoprolol succinate extended-release tablets are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure. Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemak

Product summary:

Metoprolol succinate extended-release tablets for oral administration are supplied as follows: 100 mg: White film-coated round tablets with a bevel edge containing 95 mg of metoprolol succinate equivalent to 100 mg of metoprolol tartrate, USP and debossed “368” on one side with a bisect on the other side.     NDC 58177-368-04………………….…Bottles of 100     NDC 58177-368-09………………….…Bottles of 1000     NDC 58177-368-12………………….…Bottles of 5000     NDC 58177-368-11………………….…Packages of 100 (10 x 10 cards) 200 mg: White film-coated oval tablets containing 190 mg of metoprolol succinate equivalent to 200 mg of metoprolol tartrate, USP and debossed “358” on one side with a bisect on the other side.     NDC 58177-358-04………………….…Bottles of 100     NDC 58177-358-09………………….…Bottles of 1000 Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature.) Manufactured by KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO 63044 P5081-7 02/09

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL SUCCINATE EXTENDED-RELEASE - METOPROLOL SUCCINATE TABLET,
FILM
COATED, EXTENDED RELEASE
ETHEX CORPORATION
----------
METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, USP
100 MG AND 200 MG
Rx Only
P5081-7 02/09
DESCRIPTION
Metoprolol succinate is a beta -selective (cardioselective)
adrenoceptor blocking agent, for oral
administration, available as extended-release tablets. Metoprolol
succinate extended-release tablets
have been formulated to provide a controlled and predictable release
of metoprolol for once daily oral
administration. The tablets comprise a multiple unit system containing
metoprolol succinate in a
multitude of controlled-release pellets. Each pellet acts as a
separate drug delivery unit and is designed
to deliver metoprolol continuously over the dosage interval. The
tablets contain 95 and 190 mg of
metoprolol succinate equivalent to 100 and 200 mg of metoprolol
tartrate, USP, respectively. Its
chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl)
phenoxy]-2-propanol succinate (2:1)
(salt). Its structural formula is:
Metoprolol succinate is a white crystalline powder with a molecular
weight of 652.8. It is freely
soluble in water; soluble in methanol; sparingly soluble in ethanol;
slightly soluble in dichloromethane
and 2-propanol; practically insoluble in ethyl-acetate, acetone,
diethylether and heptane. Inactive
ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba
wax, croscarmellose sodium,
glyceryl behenate, hydrogenated vegetable oil, hypromellose,
maltodextrin, methacrylic acid
copolymer, microcrystalline cellulose, polydextrose, polyethylene
glycol, povidone, sodium stearyl
fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate
copolymer.
Does not comply with the dissolution test of the USP monograph for
metoprolol succinate extended-
release tablets.
CLINICAL PHARMACOLOGY
GENERAL
Metoprolol is a beta -selective (cardioselective) adrenergic receptor
blocking agent. This preferential
effect is not absolute, however, and at higher plasma conc