It is used in patients with intrahepatic cholestasis, chronic hepatitis of various etiologies, and liver cirrhosis.
Each enteric-coated tablet contains:
Active ingredient: 400 mg of ademetionine (as ademetionine 1,4-butanedisulfonate)
Excipients: Microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate
Coating ingredients: Iron oxide yellow, iron oxide red, methacrylic acid and ethyl acrylate copolymer (1:1), macrogol 6000, polysorbate 80, simethicone, sodium hydroxide, talc
Ademta 400 mg tablets are indicated for:
Intrahepatic cholestasis in adults, including patients with chronic hepatitis and liver cirrhosis of various etiologies
Intrahepatic cholestasis during pregnancy
Depressive syndromes
Initial therapy:Treatment can be started with oral ademetionine (Ademta enteric-coated tablets) or with parenteral administration (Ademta lyophilized powder for injection), followed by switching to oral therapy.
The recommended initial dose is 10–25 mg/kg of body weight per day.
The starting dose is typically 800 mg daily (2 tablets), and the maximum daily dose should not exceed 1600 mg (4 tablets).
Maintenance therapy:
Recommended daily dose: 800–1600 mg (2–4 tablets)
Special populations:
Elderly patients:
Due to limited clinical trial data in patients aged 65 and older, it is not possible to determine if older patients respond differently than younger ones. However, current clinical experience has not shown age-related differences in response.
Dose selection for elderly patients should be cautious, starting at the lowest recommended dose, taking into account the increased likelihood of impaired liver, kidney, or heart function, and the presence of comorbidities and concomitant medications.
Pediatric use:
The safety and efficacy of ademetionine in children have not been established.
Tablets should be taken orally, swallowed whole without chewing.
The enteric coating dissolves only in the intestine, ensuring ademetionine release occurs in the duodenum.
For optimal absorption and therapeutic effect, tablets should be taken between meals.
Tablets should be removed from the blister immediately before use. Do not use tablets that are discolored (i.e., not orange-pink), which may indicate damaged packaging.
The daily dose may be divided into 2–3 administrations.
Treatment duration depends on the severity of the condition and is determined by the physician on an individual basis.
Pregnancy:No adverse effects were observed when ademetionine was used during the third trimester of pregnancy.
Use during the first and second trimesters is only recommended if the physician determines that the potential benefit to the mother outweighs the potential risk to the fetus.
Lactation:
Use during breastfeeding is only recommended when the expected benefit to the mother outweighs any potential risk to the infant.
Store below 25°C.
Keep out of reach of children.
