Active Ingredient: Nalmefene
Nalmefene is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification.
Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.
Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
18.06 - 18.06 mg
From 18.06 To 18.06 mg once every day
At an initial visit, the patient’s clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated. Thereafter, the patient should be asked to record his or her alcohol consumption for approximately two weeks.
At the next visit, nalmefene may be initiated in patients who continued to have a high DRL over this two-week period, in conjunction with psychosocial intervention focused on treatment adherence and reducing alcohol consumption.
Nalmefene is to be taken as-needed: On each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking nalmefene, the patient should take one tablet as soon as possible.
The maximum dose of nalmefene is one tablet per day.
During pivotal trials the greatest improvement was observed within the first 4 weeks. The patient’s response to treatment and the need for continued pharmacotherapy should be evaluated on a regular (for example, monthly) basis. The physician should continue to assess the patient’s progress in reducing alcohol consumption, overall functioning, treatment adherence, and any potential side effects. Clinical data for the use of nalmefene under randomised controlled conditions are available for a period of 6 to 12 months. Caution is advised if nalmefene is prescribed for more than 1 year.
Nalmefene can be taken with or without food.
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