Active ingredient: Adulthionin Busylate
Therapeutic group: Antidepressants
Pharmaceutical form: Powder
Treatment may be initiated through parenteral administration and continued orally or may be initiated orally.
Vials: 1 vial per day for cycles of 15-20 days, intravenously or intramuscularly (equivalent to 400 mg / day).
Tablets: 2 - 3 tablets a day according to medical prescription (equivalent to 800-1200 mg / day).
Therapy can be initiated by parenteral route (one vial per day intravenously or intramuscularly for 15 to 20 days) and continued orally (2 to 3 tablets per day).
Pediatric population: The safety and efficacy of ademetionin in children has not been established.
Dose selection for an elderly patient should be done with caution, usually starting at the lowest dose within the therapeutic range, and considering the highest frequency of decreased hepatic, renal or cardiac function, concomitant diseases or other pharmacological therapies.
Patients with renal impairment.
There are limited clinical data in patients with renal impairment. Therefore caution is advised when ademetionin is administered to such patients.
Method of administration:
Powder and solvent for solution for injection
The lyophilized powder must be dissolved using the relative solvent at the time of use, the unused portion must be discarded.
Ademetionin should not be mixed with alkaline solutions or solutions containing calcium ions. If the lyophilised powder appears different from the white / yellowish color (due to an injury of the vial or due to exposure to heat), the product should not be used.
The intravenous administration of powder ademetine and solvent for solution for injection should be practiced slowly.
Ademetionin tablets should be swallowed whole and not chewed.
For better absorption of the active substance and for a complete therapeutic effect, ademetionin tablets should not be taken with meals.
Ademetionin tablets should be extracted from the blister immediately before use. If the tablets appear different from the white / yellowish color (due to the presence of holes in the aluminum casing), it is recommended not to use the product.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with genetic defects that influence the methionine cycle and / or cause homocystinuria and / or hyperhomocysteinemia
Interactions with other medicines and other forms of interaction:
Serotonin syndrome has been reported in patients taking ademetionine and clomipramine. Therefore caution is recommended when ademetionin is administered concomitantly with selective serotonin reuptake inhibitors.
Before taking "Samyr 400" along with other medicines like, etc., ask your doctor or pharmacist to verify that it is safe and not harmful to your health.