Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
METOPROLOL TARTRATE
Stada Arzneimittel AG
METOPROLOL TARTRATE
100 Milligram
Tablets
Withdrawn
2007-07-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoprolol 100 Stada Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Metoprolol tartrate 100 mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat tablet, scored on one side. Approximate dimensions: diameter 9.5 mm x height 3.85 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to treatment of thyrotoxicosis. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown to reduce mortality when administered to patients with acute myocardial infarction. Prophylaxis of migraine. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral use only. Metoprolol 100 Stada tablets should be swallowed whole; not chewed. The dose must always be adjusted to suit the individual needs of each patient but should not exceed 400mg daily. The following are guidelines: _Adults:_ Hypertension: The starting dose is 100 mg in the morning taken either in single or divided doses. Depending on the patient’s response, the dosage may be increased to 200 mg daily taken in single or divided doses. Most patients may be expected to respond rapidly and satisfactorily within this dosage range. Further antihypertensive effect may be achieved by the addition of an antihypertensive diuretic or other hypotensive agent. Metoprolol 100 Stada may prove beneficial when administered in patients with previously untreated hypertension; and in whom the response to previous therapy was inadequate. Previous therapy may be continued, and Metoprolol 100 Stada added into the regime with adjustment of the concurrent t Belgenin tamamını okuyun