Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEXILETINE HYDROCHLORIDE
Boehringer Ingelheim Limited
200 Milligram
Capsule
1975-11-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mexitil Capsules 200mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200 mg mexiletine hydrochloride. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules Red/red gelatin capsules imprinted with the notation 200 mg and the company symbol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of ventricular arrhythmias which are considered as life-threatening by the physician. Note: In deciding about the use of Mexitil it should be borne in mind that no anti-arrhythmic agent of Vaughan Williams classification 1 used in the long-term treatment of arrhythmias has been shown to prolong life. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Plasma elimination half-life may be prolonged in moderate to severe hepatic disease, and in patients with a creatinine clearance of less than 10 ml/min; individual dose titration is advised in these conditions. The dosage of Mexitil must be individualised on the basis of response and tolerance, both of which are dose related. (a)Capsules should be swallowed whole with ample liquid, preferably with the patient in an upright position. It is advisable to take Mexitil after food. _(i) Loading dose:_Initially, if more rapidly effective blood levels are required, a loading dose, usually 400 mg may be desirable. _(ii)Maintenance dose:_Give 200-250 mg Mexitil three to four times daily commencing 2 hours after the loading dose. The usual daily dose is between 600-800 mg in divided doses; optimal doses range from 300-1200 mg daily in divided doses. _NOTE:_Mexitil is absorbed in the upper part of the small intestine. In acute myocardial infarction and particularly when opiates have been given, rate of absorption but no Read the complete document