DESCRIPTION
id: 37dd941c-bfb7-4194-b7a7-fd0565361141
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 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP. 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.
The USP dissolution test is pending.
CONTRAINDICATIONS
id: 7720d5cb-7370-484f-bf70-6f0e6cc58d01
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
id: 2e9b6d1f-de76-40ed-a4db-a3f7e2c56152
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.
HOW SUPPLIED
id: 93a429ff-62c5-4632-b90e-821dc5908cac
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Metoprolol succinate extended-release tablets for oral administration are supplied as follows:
50 mg: White, lightly mottled, film-coated round tablets containing 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP and debossed “369” on one side with a bisect on the other side.
NDC 58177-369-04………………….…Bottles of 100
NDC 58177-369-09………………….…Bottles of 1000
NDC 58177-369-11………………….…Packages of 100 (10 x 10 cards)
Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]
Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63044
P4878-9
03/09
