||Slow direct intravenous injection: 0,75 mg/kg body mass over 2 minutes and repeated at 5 minute intervals until the arrhythmia is controlled - but not exceeding 4 mg/kg body mass in the first hour.|
Subsequent i.v. regimen 0,4 mg/kg body mass/hour by infusion, but it is preferable to convert to oral dosing as soon as possible.
Transition from i.v. to oral route: The patient should be transferred to the oral dosage form as soon as possible.
||Slow intravenous infusion: May be given at a rate of 50 mg per hour up to a total dose of 300 mg followed by oral administration as given below -|
||one 100 mg capsule one hour before end of the infusion|
||two more capsules 4 hours after the end of the infusion|
||and then one capsule every 4 to 8 hours without exceeding a total of 800 mg per 24 hours.|
||In determining the intervals between administration of Rythmodan it should be borne in mind that its elimination half life in normal volunteers is approximately 7 hours and in patients with heart failure approximately 12 hours. If the clinician wishes to use more than 800 mg daily, the possible increase in the therapeutic efficiency must be weighed against the probable side-effects and close monitoring of the patient should be undertaken in an intensive care unit.|
|Oral 100 mg:
||Size no. 2, two-coloured, hard gelatin capsules containing a white powder. The cap is opaque green and the body is opaque beige.|
The capsule is overprinted with RY RL.
|Oral 150 mg:
||Size no. 2, white opaque, hard gelatin capsules containing a white powder.|
The capsule is overprinted with RY 150.
||White, circular, biconvex tablets, 12 mm in diameter, film coated with a break-line. Tablets are marked RY above R on one side and the Roussel logo on the reverse.|
||Clear neutral glass 5 ml ampoule containing aqueous clear solution without any specific odour, miscible with water.|