Adehep 400MG N5 Amp

Adehep, enteric-coated tablets that dissolve in the intestine

Adehep composition

Active ingredient:  Each tablet contains 400 mg of ademetionine (as ademetionine 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 hyperhomocysteinemia and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase 
deficiency, disorders of vitamin B12 metabolism).

Use during pregnancy and lactation 

Pregnancy 
During the use of ademetionine in therapeutic doses in the third trimester of pregnancy, no additional adverse effects have been reported. Ademetionine can be used in the first and second 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 infant.

Directions for use and dosage 

Dosage 
Treatment may be started with direct oral administration of ademetionine (enteric-coated Adehep tablets). Treatment may also be started by administering ademetionine parenterally (liofilizate for preparing an Adehep injection solution), followed by a switch to subsequent oral administration (enteric-coated Adehep tablets). 
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 should 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 in clinical practice, the response to treatment in elderly patients does not differ from that in younger patients. 
In elderly patients, the dose of the medicinal product should be selected with caution. 
In this category of patients, treatment should be started with the recommended minimum dose of the medicinal product, taking into account the high 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. 
Directions for use 
Tablets are taken orally, whole, without chewing. 
Tablets have a special coating that dissolves only in the intestine; for this reason, 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).