The recommended dosing is 10-25 mg/kg/day orally. The usual starting dose is 400-800 mg/day, total daily dose not to exceed 1600 mg.
Maintenance therapy: 500-1,600 mg/day.
Pediatric Population: The safety and efficacy of ademetionine for the use in children has not been established.
Elderly Population: Clinical studies of ademetionine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment: There is limited clinical data in patients with renal impairment. Caution is recommended when administering ademetionine to these patients.
Hepatic Impairment: Pharmacokinetic parameters are similar in healthy volunteers and patients with chronic liver disease.
Method of Administration: Ademetionine tablets should be swallowed whole and not chewed.
For better absorption of the active ingredient and complete therapeutic effect, ademetionine tablets should not be taken with meals.
Ademetionine tablets should be extracted from the blister package immediately before use. If the tablets appear other than white to yellowish in color (due to presence of holes in the aluminum wrapper), it is recommended the product not be used.