Drugs List

Therapeutic Indications

Uses

Alcoholism (adjunctive treatment)

Contraindications

Alcohol withdrawal syndrome
Breastfeeding
Galactosaemia
Opioid dependence
Pregnancy
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
Lactose intolerance
Mild hepatic impairment
Mild renal impairment
Psychiatric disorder
Seizures
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
Contains lactose
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

Pregnancy

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 ).

Lactation

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

Side Effects

Asthenia
Attention disturbances
Confusion
Decreased appetite
Dissociation
Dizziness
Dry mouth
Fatigue
Feeling abnormal
Hallucinations
Headache
Hyperhidrosis
Hypoaesthesia
Insomnia
Malaise
Muscle spasm
Nausea
Palpitations
Paraesthesia
Reduced libido
Restlessness
Sleep disturbances
Somnolence
Tachycardia
Tremor
Vomiting
Weight loss

Presentation

Oral formulations of nalmefene.

Drugs List

Therapeutic Indications

Uses

Alcoholism (adjunctive treatment)

Dosage

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.

Adults

Contraindications

Alcohol withdrawal syndrome
Breastfeeding
Galactosaemia
Opioid dependence
Pregnancy
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
Lactose intolerance
Mild hepatic impairment
Mild renal impairment
Psychiatric disorder
Seizures
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
Contains lactose
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

Pregnancy

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 ).

Lactation

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

Side Effects

Asthenia
Attention disturbances
Confusion
Decreased appetite
Dissociation
Dizziness
Dry mouth
Fatigue
Feeling abnormal
Hallucinations
Headache
Hyperhidrosis
Hypoaesthesia
Insomnia
Malaise
Muscle spasm
Nausea
Palpitations
Paraesthesia
Reduced libido
Restlessness
Sleep disturbances
Somnolence
Tachycardia
Tremor
Vomiting
Weight loss

Overdosage

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 ).

Further Information

Last Full Review Date: April 2016

Reference Sources

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