Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)
Rising Pharma Holdings, Inc.
METOPROLOL TARTRATE
METOPROLOL TARTRATE 25 mg
ORAL
PRESCRIPTION DRUG
Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, 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 Tartrate Tablets, USP are available as follows: Tablets 25 mg are white round shaped, film coated tablets debossed with ‘C over 73’ on one side and deep break line on other side. Bottles of 100 NDC 57237-100-01 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-100-99 (Non Child Resistant Closure) Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side. Bottles of 100 NDC 57237-101-01 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-101-99 (Non Child Resistant Closure) Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side. Bottles of 100 NDC 57237-102-01 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-102-99 (Non Child Resistant Closure) Store at 20° to 25 °C (68° to 77 °F); excursions permitted to 15 ° to 30 °C (59 ° to 86 °F) [see USP Controlled Room Temperature ]. Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED RISING PHARMA HOLDINGS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOPROLOL TARTRATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOPROLOL TARTRATE TABLETS. METOPROLOL TARTRATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Metoprolol tartrate tablets are a beta-adrenergic blocker 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) Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients (1.3) DOSAGE AND ADMINISTRATION Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. (2) Hypertension: Recommended starting dosage is 100 mg daily, in single or divided doses. (2.1) Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses. (2.2) Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. (2.3) DOSAGE FORMS AND STRENGTHS Metoprolol tartrate tablets, USP: 25 mg, 50 mg and 100 mg. (3) CONTRAINDICATIONS Known hypersensitivity to product components. (4) Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. (4) Cardiogenic shock or decompensated heart failure. (4) WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. (5.1) Heart Failure: Worsening cardiac failure may occur. (5.2) Bronchospastic Disease: Avoid beta-blockers. (5.3) Pheochromocytoma: Initiate therapy with an alpha blocker. (5.4) Major Surgery: Avoid initiation of high-dose extended-release Belgenin tamamını okuyun