NALTIMA-50 contains naltrexone, a long-acting opioid receptor antagonist. It blocks the effects of externally administered opioids and does not produce opioid euphoria. In alcohol dependence, naltrexone is used as part of a comprehensive treatment program intended to reduce the risk of alcohol use and support abstinence.
The medication may be used:
Naltrexone has been extensively studied in clinical practice. Controlled clinical studies described in regulatory materials demonstrated the effectiveness of 50 mg once daily as an adjunctive treatment for alcohol dependence for periods of up to 12 weeks. For opioid dependence, treatment is initiated only after opioid abstinence has been confirmed and physical opioid dependence has been excluded, because naltrexone can precipitate significant opioid withdrawal.
Naltrexone should not be considered a standalone treatment for addiction. The best treatment outcomes are associated with comprehensive management that may include medical supervision, behavioral therapy, psychosocial support, and adherence to the treatment plan.
Naltrexone is used as part of comprehensive treatment for alcohol dependence and to block the pharmacological effects of exogenously administered opioids in appropriately detoxified patients. It binds to opioid receptors and prevents their activation, thereby reducing or blocking the effects of opioid medications and other opioid agonists. In alcohol dependence, its therapeutic effect is associated with modulation of the brain's opioid system, which may reduce the reinforcing effects of alcohol.
The medication is taken orally strictly as prescribed by a healthcare professional. For alcohol dependence, the standard regimen evaluated in clinical studies was 50 mg once daily. For opioid dependence, treatment should only begin after opioid abstinence has been confirmed and withdrawal symptoms have been excluded; appropriate medical assessment should be performed when necessary. Treatment duration and dosing schedules are determined individually by the physician.
Side Effects
