Metoprolol Succinate Extended Release
Extended Release, oral, Tablets: 47.5 mg
Indication & Usage
Myocarmet-Once, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent.
Myocarmet-Once is 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.
- Angina Pectoris.
- Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.
Dosage & Administration
Administer once daily. Dosing of Myocarmet-Once should be individualized.
- Heart Failure: Recommended starting dose is 12.5 mg or 25 mg doubled every two weeks to the highest dose tolerated or up to 200 mg.
- Hypertension: Usual initial dosage is 25 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.
- 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. Dosages above 400 mg per day have not been studied.
Switching from immediate-release Metoprolol to Myocarmet-Once: use the same total daily dose of Myocarmet-Once
- Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash.
- Known hypersensitivity to product components.
- Severe bradycardia.
- Heart block greater than first degree.
- Cardiogenic shock.
- Decompensated cardiac failure.
- Sick sinus syndrome without a pacemaker.
- Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents.
- CYP2D6 Inhibitors are likely to increase metoprolol concentration.
- Concomitant use of glycosides, clonidine, and diltiazem and verapamil with beta-blockers can increase the risk of bradycardia.
- Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine.
Warning & Precaution
- Heart Failure: Worsening cardiac failure may occur.
- Bronchospastic Disease: Avoid beta blockers.
- Pheochromocytoma: If required, first initiate therapy with an alpha blocker.
- Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery because it has been associated with bradycardia, hypotension, stroke and death. Do not routinely withdraw chronic beta blocker therapy prior to surgery.
- Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia.
- Patients with Hepatic Impairment:
- Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm.
- Anaphylactic Reactions: Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
- Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency.
- Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomitantly.
Pregnancy & Lactation
Pregnancy Category C
Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/m2 basis, the daily dose of 200 mg in a 60-kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired fertility or teratogenicity. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use this drug during pregnancy only if clearly needed.
Metoprolol is excreted in breast milk in very small quantities. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Consider possible infant exposure when Myocarmet-Once is administered to a nursing woman.
Keep out of the reach of children.
Store below 30°C and protect from light and moisture.
Carton containing 10 Blister strips of 10 tablets each.
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