Drugs List

Therapeutic Indications

Uses

Maintenance of abstinence in alcohol dependent patients

Maintenance of abstinence in alcohol dependent patients. It should be combined with counselling.

Contraindications

Children under 16 years
Patients over 65 years
Breastfeeding
Renal impairment - serum creatinine above 120micromol/l
Severe hepatic impairment - Child-Pugh score greater than or equal to 10

Precautions and Warnings

Children aged 16 to 18 years
Suicidal ideation
Depression
Pregnancy

Not a treatment for alcohol withdrawal period
Initiate treatment only after weaning patients off alcohol
Maintain treatment if relapse occurs
Monitor patient for underlying psychiatric disorder(s)
Patient should report worrying psychological changes esp. suicidal thoughts
Continued alcohol abuse negates benefit: risk of treatment failure
Does not prevent harmful effects of continuous alcohol abuse

Pregnancy and Lactation

Pregnancy

Use acamprosate with caution in pregnancy.

Manufacturer advises that acamprosate should only be used in pregnancy after careful benefit/risk assessment when the patient cannot abstain from drinking alcohol without being treated with acamprosate.

It is not known if acamprosate crosses the placenta, but it is thought likely, given its molecular weight, low metabolism and long elimination half life.

There are no reports on the use of acamprosate in human pregnancy at the time of writing. Animal studies do not indicate any evidence of foetotoxicity or teratogenicity. Given that alcohol use during pregnancy is associated with neonatal neurotoxicity, Briggs concludes that the use of acamprosate in alcohol dependent pregnant women may be deemed preferable to continued alcohol abuse.

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

Acamprosate is contraindicated in breastfeeding.

Manufacturer advises against the use of acamprosate in breastfeeding women.

No reports on the use of acamprosate during human breastfeeding have been located at the time of writing, but acamprosate is excreted into breast milk of lactating animals. The effect on the nursing infant of exposure to acamprosate in breast milk is unknown.

However, given that alcohol is known to be a neurotoxin, and is excreted into breast milk, Briggs concludes that if a lactating woman requires acamprosate to refrain from drinking, the benefit to the nursing infant from lack of alcohol may be deemed to outweigh the unknown risk from the drug.

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

Abdominal pain
Anaphylactic reaction
Angioedema
Bullous eruption
Changes in libido
Diarrhoea
Flatulence
Hypersensitivity reactions
Impotence
Maculopapular rash
Nausea
Pruritus
Psychiatric disorders
Urticaria
Vomiting

Presentation

Tablets containing acamprosate calcium

Drugs List

Therapeutic Indications

Uses

Maintenance of abstinence in alcohol dependent patients

Maintenance of abstinence in alcohol dependent patients. It should be combined with counselling.

Dosage

Initiate treatment as soon as possible after the withdrawal period and maintain if patient has a temporary relapse. Treatment should be stopped if the patient returns to regular drinking that persists for four to six weeks.

The recommended treatment period is one year, and should be combined with counselling.

Adults

Children

Contraindications

Children under 16 years
Patients over 65 years
Breastfeeding
Renal impairment - serum creatinine above 120micromol/l
Severe hepatic impairment - Child-Pugh score greater than or equal to 10

Precautions and Warnings

Children aged 16 to 18 years
Suicidal ideation
Depression
Pregnancy

Not a treatment for alcohol withdrawal period
Initiate treatment only after weaning patients off alcohol
Maintain treatment if relapse occurs
Monitor patient for underlying psychiatric disorder(s)
Patient should report worrying psychological changes esp. suicidal thoughts
Continued alcohol abuse negates benefit: risk of treatment failure
Does not prevent harmful effects of continuous alcohol abuse

Pregnancy and Lactation

Pregnancy

Use acamprosate with caution in pregnancy.

Manufacturer advises that acamprosate should only be used in pregnancy after careful benefit/risk assessment when the patient cannot abstain from drinking alcohol without being treated with acamprosate.

It is not known if acamprosate crosses the placenta, but it is thought likely, given its molecular weight, low metabolism and long elimination half life.

There are no reports on the use of acamprosate in human pregnancy at the time of writing. Animal studies do not indicate any evidence of foetotoxicity or teratogenicity. Given that alcohol use during pregnancy is associated with neonatal neurotoxicity, Briggs concludes that the use of acamprosate in alcohol dependent pregnant women may be deemed preferable to continued alcohol abuse.

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

Acamprosate is contraindicated in breastfeeding.

Manufacturer advises against the use of acamprosate in breastfeeding women.

No reports on the use of acamprosate during human breastfeeding have been located at the time of writing, but acamprosate is excreted into breast milk of lactating animals. The effect on the nursing infant of exposure to acamprosate in breast milk is unknown.

However, given that alcohol is known to be a neurotoxin, and is excreted into breast milk, Briggs concludes that if a lactating woman requires acamprosate to refrain from drinking, the benefit to the nursing infant from lack of alcohol may be deemed to outweigh the unknown risk from the drug.

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

Abdominal pain
Anaphylactic reaction
Angioedema
Bullous eruption
Changes in libido
Diarrhoea
Flatulence
Hypersensitivity reactions
Impotence
Maculopapular rash
Nausea
Pruritus
Psychiatric disorders
Urticaria
Vomiting

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: October 2015

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Campral EC. Merck Serono. Revised March 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 June 2017