displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Metoprolol succinate is a beta1-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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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 pacemaker is in place), and in patients who are hypersensitive to any component of this product.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Metoprolol succinate extended-release tablets are intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release metoprolol to metoprolol succinate extended-release tablets, the same total daily dose of metoprolol succinate extended-release tablets should be used. Dosages of metoprolol succinate extended-release tablets should be individualized and titration may be needed in some patients.
Metoprolol succinate extended-release tablets are scored and can be divided; however, the whole or half tablet should be swallowed whole and not chewed or crushed.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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.)
KV Pharmaceutical Co. for
St. Louis, MO 63044