- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of nalmefene.
Alcoholism (adjunctive treatment)
Only to be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.
Initially evaluate the patient's clinical status, alcohol dependence and level of alcohol consumption. Thereafter the patient should record their alcohol consumption for two weeks. Nalmefene can then be initiated only in patients who continued to have a high drinking risk level during the two week period, in conjunction with psychosocial intervention.
18 mg daily, 1 to 2 hours before drinking.
Maximum 18 mg daily.
If the patient starts drinking without taking nalmefene, one tablet should be taken as soon as possible.
Use with caution if treatment is followed for more than 1 year
Alcohol withdrawal syndrome
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Precautions and Warnings
Children under 18 years
Patients over 65 years
Glucose-galactose malabsorption syndrome
Mild hepatic impairment
Mild renal impairment
Serum transaminases above 3 times upper limit of normal
Safety of maintenance treatment beyond 12 months has not been established
Advise ability to drive/operate machinery may be affected by side effects
Provide supportive therapy in conjunction with treatment
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Reassess need for continued treatment at regular intervals
Advise patient against the use of opioids during treatment
Nalmefene is indicated for reduction of alcohol consumption, which is an intermediate goal on the way to abstinence, not immediate abstinence.
Discontinue temporarily for one week prior to anticipated use of opioids.
In an emergency situation requiring opioid administration, the amount required may be greater than usual. Monitor for respiratory depression. Titrate the dose individually and observe closely if large doses are necessary.
Avoid concomitant use with opioid based over the counter products. The patient may not benefit from the effect of those.
Pregnancy and Lactation
Nalmefene is contraindicated in pregnancy.
At the time of writing, there is very limited data on the use of nalmefene in pregnancy. Animal studies have shown reproductive toxicity. The manufacturer therefore does not recommend use during pregnancy.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Nalmefene is contraindicated in breastfeeding.
It is not known whether nalmefene is excreted in human milk. Pharmacodynamic and toxicological animal data have shown excretion in milk and a risk to neonates can therefore not be excluded. The manufacturer recommends that either breastfeeding or nalmefene therapy must be discontinued, taking into account the benefit of breastfeeding to the infant, and the benefit of therapy to the mother.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2016
Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press. Accessed on 05 February 2015.
Summary of Product Characteristics: Selincro 18mg tablets. Lundbeck Ltd. Revised December 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 July 2017
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.