Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
METOPROLOL SUCCINATE (UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)
Mylan Institutional Inc.
METOPROLOL SUCCINATE
METOPROLOL TARTRATE 25 mg
ORAL
PRESCRIPTION DRUG
Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic
Metoprolol Succinate Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg or 95 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP, respectively. The 25 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M above the score on one side of the tablet and MT1 on the other side. They are available as follows: NDC 51079-169-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 50 mg tablets are white to off-white, film-coated, oval, scored tablets debossed with M on one side of the score on one side of the tablet and MT2 on the other side. They are available as follows: NDC 51079-170-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 100 mg tablets are white to off-white, film-coated, oval, scored tablets debossed with M on one side of the score on one side of the tablet and MT3 on the other side. They are available as follows: NDC 51079-171-03 – Unit dose blister packages of 30 (5 cards of 6 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE MYLAN INSTITUTIONAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 WARNING: ISCHEMIC HEART DISEASE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FOLLOWING ABRUPT CESSATION OF THERAPY WITH BETA-BLOCKING AGENTS, EXACERBATIONS OF ANGINA PECTORIS AND MYOCARDIAL INFARCTION HAVE OCCURRED. WARN PATIENTS AGAINST INTERRUPTION OR DISCONTINUATION OF THERAPY WITHOUT THE PHYSICIAN’S ADVICE. ( 5.1) INDICATIONS AND USAGE Metoprolol succinate is a beta -selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Angina Pectoris. ( 1.2) Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. ( 1.3) DOSAGE AND ADMINISTRATION Administer once daily. Dosing of metoprolol succinate extended-release tablets should be individualized. ( 2) Heart Failure: Recommended starting dose is 12.5 mg or 25 mg doubled every 2 weeks to the highest dose tolerated or up to 200 mg. ( 2.3) Hypertension: Usual initial dosage is 25 mg to 100 mg once daily. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. Dosages above 400 mg per day have not been studied. ( 2.1) Angina Pectoris: Usual initial dosage is 100 mg once daily. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is an unacceptable bradycardia. D Pročitajte cijeli dokument