Acamprosate [Discontinued in SA Market]

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

• Alcoholism

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Breastfeeding
• Renal impairment
• Alcohol-dependent patients with hepatic insufficiency (Childs-Pugh Classification C)

Caution

• Pregnancy
• Severe hepatic impairment
• Elderly

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Forms avail. in SA and covered in this monograph: tab

Prevent relapse in alcoholics successfully weaned off alcohol

• Oral (tab): 666mg, 8hrly; Treatment duration: 6-12 months

Take with meals

Do not cut/crush/chew/dissolve

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Not established for use in children

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Pregnancy

• Caution; not recommended
• There is no adequate data from the use of acamprosate in pregnant women
• Animal studies do not indicate any evidence of foetotoxicity or tetragenicity
• Acamprosate must therefore only be used during pregnancy after a careful benefit/risk assessment when the patient cannot abstain from drinking alcohol without being treated with acamprosate and when there is consequently a risk of foetotoxicity or teratogenicity due to alcohol

Breastfeeding

• Contraindicated
• It is known that acamprosate is excreted in the milk of lactating animals. It is not known whether acamprosate is excreted in human milk
• There is no adequate data from the use of acamprosate in infants
• Acamprosate must therefore not be used in breastfeeding women
• If a breastfeeding woman cannot abstain from drinking alcohol without being treated with acamprosate, a decision must be made whether to discontinue nursing or to discontinue acamprosate, taking into account the importance of the medicinal product to the woman

Fertility

• In animal studies, no adverse effects on fertility were observed. Whether or not acamprosate affects the fertility in humans is unknown

Renal Impairment

• Contraindicated

Hepatic Impairment

• Severe: Caution; no information available

Elderly

• Caution; no information available

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warning

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Gastrointestinal Disorders

• Diarrhoea
• Abdominal pain
• Nausea and vomiting
• Flatulence

Genitourinary Disorders

• Frigidity 
• Impotence
• Decreased libido
• Increased libido

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Maculopapular rash
• Vesiculo-bullous eruptions

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylactic reactions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

No information available

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

None routine

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Administering acamprosate with food diminishes the bioavailability of the drug compared with its administration in the fasting state

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: October 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

Acamprosate is structurally similar to gamma amino butyric acid (GABA), and appears to increase the activity of the GABA system, and decreases activity of glutamate within the central nervous system, including a decrease in activity at N-methyl D-aspartate receptors. It may also affect central nervous system calcium channels. This restores balance to GABA and glutamate activities which appears to be disrupted in alcohol dependence.

Tablet 333mg

• Besobrial (Merck) originator (Discontinued - 04/10/19)