Lopressor

2 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. 1 ) Angina Pectoris: Recommended starting dosage is 100 mg daily, given as two divided doses.

2 ) Myocardial Infarction: The starting dosage depends upon tolerance of intravenous metoprolol, see full prescribing information. 1 Hypertension Individualize the dosage of Lopressor tablets. Lopressor tablets should be taken with or immediately following meals.

The usual initial dosage is 100 mg daily in single or divided doses. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy.

The effective dosage range of Lopressor tablets is 100 mg to 450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period.

Larger or more frequent daily doses may be required. Measure blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. 2 Angina Pectoris The dosage of Lopressor tablets should be individualized.

Lopressor tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate.

The effective dosage range of Lopressor tablets is 100 to 400 mg per day. Dosages above 400 mg per day have not been studied. 1 ) ]. 3 Myocardial Infarction See prescribing information of intravenous metoprolol for dosage instructions for intravenous therapy.

In patients who tolerate the full intravenous dose, initiate Lopressor tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose of metoprolol and continue for 48 hours. In the case of intolerance, reduce dose to 25 mg and administer for 48 hours.

Titrate, based on tolerability, to a maintenance dosage of 100 mg twice daily. Continue therapy for at least 3 months. Although the efficacy of Lopressor beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions ( 5 )] Worsening heart failure [see Warnings and Precautions ( 5 ) ] .

Worsening AV block [see Contraindications ( 4 ) ] . Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Hypertension and Angina Most adverse effects have been mild and transient.

Central Nervous System:

Tiredness and dizziness have occurred in about 10% of patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported.

Cardiovascular:

Shortness of breath and bradycardia have occurred in approximately 3% of patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; heart failure exacerbations; peripheral edema; and hypotension have been reported in about 1% of patients.

Gangrene in patients with pre-existing severe peripheral circulatory disorders has also been reported. 2 )] . 3 )] . Rhinitis has also been reported.

Gastrointestinal:

Diarrhea has occurred in about 5% of patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1% of patients. Vomiting was a common occurrence.

5 WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. 1 ) Heart Failure: Worsening cardiac failure may occur. 2 ) Bronchospastic Disease: Avoid beta-blockers. 3 ) Pheochromocytoma: Initiate therapy with an alpha blocker.

4 ) Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery. Do not routinely withdraw chronic beta-blocker therapy prior to surgery. 1 ) Diabetes: May mask symptoms of hypoglycemia.

6 ) Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. 7 ) Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. 1 Abrupt Cessation of Therapy Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred.

When discontinuing chronically administered LOPRESSOR, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly reinstate LOPRESSOR, and take measures appropriate for the management of unstable angina.

Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing LOPRESSOR in patients treated only for hypertension. 2 Heart Failure Worsening cardiac failure may occur during up-titration of LOPRESSOR.

If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of LOPRESSOR [see Dosage and Administration ( 2 )]. It may be necessary to lower the dose of LOPRESSOR or temporarily discontinue it.

Such episodes do not preclude subsequent successful titration of LOPRESSOR. 3 Bronchospastic Disease Patients with bronchospastic disease, should in general, not receive beta-blockers, including Lopressor. Because of its relative beta 1 cardio-selectivity, however, LOPRESSOR may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment.

4 CONTRAINDICATIONS LOPRESSOR is contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, systolic blood pressure <100, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.

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 )