Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEXILETINE HYDROCHLORIDE
Boehringer Ingelheim Limited
250/10 Mg/Ml
Solution for Injection
1975-11-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mexitil Ampoules 25mg/ml Solution for Injection and Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 25 mg/ml mexiletine hydrochloride. One 10 ml ampoule contains 250 mg mexiletine hydrochloride. Also contains 0.75mg (33mmol) Sodium per ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection and infusion Clear, colourless or almost colourless solution. 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 agents of Vaughan Williams classification 1 including mexiletine 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 creatinine clearance of less than 10 ml/min: individual dose titration is advised in these conditions. 1 INTRAVENOUS MEXITIL Mexitil should never be injected in bolus form. _(a)_ _Loading Dose_ IV injection of 4 – 10 ml (100 – 250 mg) Mexitil given at a suggested rate of 1 ml per minute (25 mg per minute). THEN Add 500 mg (2 ampoules) Mexitil to 500 ml of a suitable infusion solution. Administer the first 250 ml by IV infusion over 1 hour (4 ml per minute). THEN Administer the second 250 ml by IV infusion over 2 hours (2 ml per minute). _(b)_ _Maintenance Dose_ Add 250 mg (1 ampoule) Mexitil to 500 ml of suitable infusion solution. Administer at a suggested rate of 1 ml per minute (0.5 mg per minute), according to patient response. Continue fo Read the complete document