APO-METOPROLOL 50 MG — DIN 00618632

What is APO-METOPROLOL?

APO-METOPROLOL 50 MG contains METOPROLOL TARTRATE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 00618632, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 31-Dec-1984. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is APO-METOPROLOL used for?

APO-METOPROLOL / APO-METOPROLOL (Type L) (metoprolol tartrate) is indicated for mild or moderate hypertension. Usually combined with other antihypertensive agents (thiazide diuretics), it may be tried alone when the physician judges that a beta-blocker, rather than a diuretic, should be the initial treatment. Combining metoprolol tartrate with a diuretic or peripheral vasodilator has been found to be compatible and generally more effective than metoprolol tartrate alone. Limited experience with other antihypertensive agents has not shown evidence of incompatibility with metoprolol tartrate. APO-METOPROLOL / APO-METOPROLOL (Type L) is not recommended for the emergency treatment of hypertensive crises. APO-METOPROLOL / APO-METOPROLOL (Type L) is indicated for the long-term treatment of angina pectoris due to ischemic heart disease. APO-METOPROLOL / APO-METOPROLOL (Type L) is indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction, to reduce cardiovascular mortality. In patients with proven myocardial infarction, oral treatment can begin within 3 to 10 days of the acute event. Data are not available as to whether benefit would ensue if the treatment is initiated later. Clinical trials have shown that patients with unconfirmed myocardial infarction received no benefit from early metoprolol tartrate therapy.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

APO-METOPROLOL / APO-METOPROLOL (Type L) tablets should be swallowed whole without being chewed, preferably with or following a meal. APO-METOPROLOL / APO-METOPROLOL (Type L) tablets should be taken in the morning. Hypertension: Treatment should be initiated with doses of 50 mg b.i.d. If an adequate response is not seen after one week, dosage should be increased to 100 mg b.i.d. In some cases the daily dosage may need to be increased by further 100 mg increments at intervals of not less than two weeks up to a maximum of 200 mg b.i.d., which should not be exceeded. The usual maintenance dose is within the range of 100 to 200 mg daily. When combined with another antihypertensive agent, metoprolol tartrate should be added initially at a dose of 50 mg b.i.d. After one or two weeks the daily dosage may be increased if required, in increments of 100 mg, at intervals of not less than two weeks, until adequate blood pressure control is obtained. Administer with or immediately following meals. Angina Pectoris: The recommended dosage range is 100 to 400 mg per day in divided doses. Treatment should be initiated with 50 mg b.i.d. for the first week. If response is not adequate, the daily dosage should be increased by 100 mg for the next week. The usual maintenance dose is 200 mg/day. Dosage can be increased in 100 mg increments to a maximum of 400 mg/day in two or three divided doses. A dose of 400 mg/day should not be exceeded. Tablets should be taken once daily in the morning. Myocardial Infarction: Early Treatment: Not intended for early treatment. For definite or suspected acute myocardial infarction, treatment can be initiated as soon as possible after patient's arrival in hospital, once hemodynamic condition has stabilized. Begin with three bolus injections of 5 mg metoprolol tartrate each, given at approximately 2-minute intervals. Monitor blood pressure, heart rate, and electrocardiogram. If adverse cardiovascular effects occur, stop intravenous administration. If the full intravenous dose (15 mg) is tolerated, initiate 50 mg metoprolol tartrate tablets every 6 hours, 15 minutes after the last intravenous dose, and continue for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily. Patients not tolerating the full intravenous dose should start on 25 mg or 50 mg every 6 hours (depending on intolerance) 15 minutes after the last intravenous dose or as clinical condition allows. If severe intolerance, discontinue treatment. Late Treatment (For proven myocardial infarction patients only): For patients with contraindications to early treatment, those not tolerating early treatment, or when delaying therapy, start metoprolol tartrate tablets, 100 mg twice daily, as soon as clinical condition allows. Treatment can begin within 3 to 10 days of the acute event and should be continued for at least 3 months. Data suggest continuation for 1 to 3 years. Missed Dose: Take as soon as remembered. If next dose is due at the same time, omit the missed dose. Do not take a double dose.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

APO-METOPROLOL / APO-METOPROLOL (Type L) (metoprolol tartrate) is contraindicated in patients with: * Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container or other beta-blockers (cross-sensitivity between beta-blockers can occur). * Sinus bradycardia * Sick sinus syndrome * Second and third degree A-V block * Right ventricular failure secondary to pulmonary hypertension * Overt heart failure * Cardiogenic shock * Severe peripheral arterial circulatory disorders * Anesthesia with agents that produce myocardial depression, (e.g., ether) * Pheochromocytoma in the absence of alpha-blockade Myocardial Infarction Patients - Additional Contraindications: * Heart rate < 45 beats/min * Significant heart block greater than first degree (PR interval ≥ 0.24 s) * Systolic blood pressure < 100 mmHg * Moderate to severe cardiac failure

Warnings and precautions

Abrupt withdrawal: Patients with angina or hypertension should be warned against abrupt discontinuation of APO-METOPROLOL / APO-METOPROLOL (Type L). Severe exacerbation of angina, myocardial infarction or ventricular arrhythmias have been reported following abrupt discontinuation of beta-blocker therapy. Dosage should be gradually reduced over a period of about two weeks, maintaining the same frequency of administration. If angina worsens or acute coronary insufficiency develops, treatment should be reinstituted promptly. Patients should not interrupt or discontinue therapy without physician's advice. Due to common and often unrecognized coronary artery disease, abrupt discontinuation is not recommended even for hypertension. Cardiovascular system: Special caution is needed for patients with a history of heart failure. Beta-blockade can depress myocardial contractility and precipitate cardiac failure. Digitalis' positive inotropic action may be reduced by metoprolol tartrate's negative inotropic effect. Beta-blockers and digitalis have additive effects on depressing A-V conduction. This also applies to combinations with verapamil-type calcium-antagonists or some antiarrhythmics. In patients without a history of cardiac failure, continued myocardial depression can lead to cardiac failure and/or hypotension. At the first sign of impending cardiac failure, patients should be fully digitalized and/or given a diuretic, and response observed closely. If cardiac failure persists, APO-METOPROLOL / APO-METOPROLOL (Type L) therapy should be reduced or withdrawn. Severe Sinus Bradycardia: May occur due to unopposed vagal activity. Pre-existing A-V conduction disorder may be aggravated. Dosage should be reduced or gradually withdrawn. Atropine, isoproterenol or dobutamine should be considered in acute myocardial infarction. If heart rate falls below 40 beats/min with signs of decreased cardiac output, administer atropine (0.25 to 0.5 mg) intravenously. If unsuccessful, discontinue APO-METOPROLOL / APO-METOPROLOL (Type L) and consider isoproterenol or cardiac pacemaker. A-V Conduction: Slows A-V conduction and may produce significant first-, second-, or third-degree heart block. In acute myocardial infarction, if heart block occurs, discontinue APO-METOPROLOL / APO-METOPROLOL (Type L) and administer atropine. If unsuccessful, consider isoproterenol or cardiac pacemaker. Use with caution in patients with first degree atrioventricular block. Hypotension: If systolic blood pressure ≤ 90 mmHg occurs, discontinue APO-METOPROLOL / APO-METOPROLOL (Type L). Assess hemodynamic status and myocardial ischemia. Appropriate therapy with fluids, positive inotropic agents, balloon counterpulsation, or other modalities should be instituted. If associated with sinus bradycardia or A-V block, treatment should reverse these conditions. Driving and operating machinery: Dizziness, fatigue or visual impairment may occur, affecting ability to drive or use machines. Patients should avoid these activities until response to therapy is determined. Thyrotoxicosis: Beta-blockade may mask clinical signs of hyperthyroidism or its complications. Abrupt withdrawal may exacerbate hyperthyroidism symptoms, including thyroid storm. Diabetic patients: Administer cautiously to patients with spontaneous hypoglycemia or those receiving insulin/oral hypoglycemic agents. Beta-blockers affect glucose metabolism and may mask signs of acute hypoglycemia. Beta-blockade may lead to loss of diabetic control and delayed recovery from hypoglycemia. Insulin or oral hypoglycemic agent dose may need adjustment. Monitor diabetic patients to ensure diabetes control. Pheochromocytoma: If a beta-blocker is prescribed for pheochromocytoma, an alpha-blocker should be given concomitantly and initiated first. Anaphylactic reactions: Increased difficulty in treating allergic reactions. Avoid beta-blockers in patients at risk of anaphylaxis. Reactions may be more severe. Epinephrine should be