Adehep 400 mg N20 Tablet

Adehep, enteric-coated tablets that dissolve in the intestine

Composition of Adehep

Active ingredient: Each tablet contains 400 mg of ademetionine (ademetionine in the form of 1,4-butanedisulfonate).

Contraindications

Hypersensitivity to the active ingredient or to any other component of the medicinal product;
genetic disorders affecting the methionine cycle and/or disorders that cause homocystinuria and/or hyperhomocysteinemia (e.g., deficiency of cystathionine beta-synthase, disorders of vitamin B12 metabolism).

Use during pregnancy and lactation

Pregnancy
When ademetionine is used in therapeutic doses during the III trimester of pregnancy, no additional adverse effects have been reported. Ademetionine can be used during the I and II trimesters of pregnancy only after assessing the benefit to the mother/risk to the fetus ratio.
Lactation
During breastfeeding, ademetionine is used only if the expected benefit of treatment for the mother outweighs the potential risk to the baby.

Dosage and method of administration

Dosage
Treatment may be started by taking ademetionine orally directly (enteric-coated Adehep tablets that dissolve in the intestine). Treatment may also be started by administering ademetionine parenterally (liofilizate for preparing the Adehep injection solution), followed by a switch to subsequent oral administration (enteric-coated Adehep tablets that dissolve in the intestine).
Initial therapy
The recommended dose of ademetionine is 10–25 mg/kg per day based on body weight. The initial dose of the medicinal product is 800 mg per day (2 tablets); the total daily dose must not exceed 1600 mg (4 tablets).
Supportive therapy
The recommended daily dose of ademetionine is 800–1600 mg (2–4 tablets).
Special patient groups
Elderly patients
It is not possible to assess differences in response to treatment between elderly and younger patients (in clinical studies, a sufficient number of patients aged over 65 years were not included). According to available data from clinical practice, the response to treatment in elderly patients does not differ from that in younger patients.
The dose of the medicinal product in elderly patients should be selected with caution.
In this patient group, treatment should be initiated with the recommended minimum dose of the medicinal product, taking into account the higher risk of disorders of liver, kidney, or heart function, concomitant diseases, and the simultaneous use of other medicinal products.
Children
The efficacy and safety of the medicinal product in children have not been established.
Method of administration
Tablets are taken orally, whole, without chewing.
Tablets have a special coating that dissolves only in the intestine; therefore
the active ingredient of ademetionine is released in the duodenum. To increase absorption of the medicinal product and to achieve a full therapeutic effect, the tablets should be taken between meals.
Tablets must be removed from the blister immediately before use. Do not use the tablets if their color differs from orange-pink (due to a hole in the blister).