Drugs List

Therapeutic Indications

Uses

Hyperlipidaemia type IIa, IIb and IV

Alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments for: a) Hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia)

b) Hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) Acipimox should be used only after other lipid-lowering measures have been taken, such as dietary and lifestyle changes.

Contraindications

Children under 18 years
Breastfeeding
Peptic ulcer
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute

Precautions and Warnings

Renal impairment - creatinine clearance 30-60ml/minute

Reduce dose in patients with creatinine clearance of 30-60ml/min
Monitor hepatic function
Monitor renal function
Dietary restrictions should be maintained

Pregnancy and Lactation

Pregnancy

Acipimox is contraindicated during pregnancy.

Acipimox has not been studied sufficiently in human pregnancy for safety to be established. Schaefer (2015) concludes that this lipid reducers should not be used during pregnancy because their safety has not been established

There is no evidence from animal studies to show that acipimox is teratogenic, however a higher incidence of immature and underweight foetuses was seen when higher doses of acipimox were given.

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

Acipimox is contraindicated during breastfeeding.

As there is limited animal data regarding the levels of acipimox excreted in milk, the manufacturer recommends that acipimox is not used during breastfeeding.

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

Anaphylactoid reaction
Angioedema
Arthralgia
Asthenia
Bronchospasm
Diarrhoea
Dryness and irritation of eyes
Dyspepsia
Erythema
Feeling hot
Flushing
Headache
Heat sensation
Malaise
Myalgia
Myositis
Nausea
Pruritus
Rash
Upper abdominal pain
Urticaria
Vasodilatation

Presentation

Oral formulations containing acipimox

Drugs List

Therapeutic Indications

Uses

Hyperlipidaemia type IIa, IIb and IV

Alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments for: a) Hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia)

b) Hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) Acipimox should be used only after other lipid-lowering measures have been taken, such as dietary and lifestyle changes.

Dosage

Daily dosage should be adjusted individually depending on plasma triglyceride and cholesterol levels. Improvements are usually seen after the first month of treatment.

Adults

Elderly

Patients with Renal Impairment

Contraindications

Children under 18 years
Breastfeeding
Peptic ulcer
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute

Precautions and Warnings

Renal impairment - creatinine clearance 30-60ml/minute

Reduce dose in patients with creatinine clearance of 30-60ml/min
Monitor hepatic function
Monitor renal function
Dietary restrictions should be maintained

Pregnancy and Lactation

Pregnancy

Acipimox is contraindicated during pregnancy.

Acipimox has not been studied sufficiently in human pregnancy for safety to be established. Schaefer (2015) concludes that this lipid reducers should not be used during pregnancy because their safety has not been established

There is no evidence from animal studies to show that acipimox is teratogenic, however a higher incidence of immature and underweight foetuses was seen when higher doses of acipimox were given.

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

Acipimox is contraindicated during breastfeeding.

As there is limited animal data regarding the levels of acipimox excreted in milk, the manufacturer recommends that acipimox is not used during breastfeeding.

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

Anaphylactoid reaction
Angioedema
Arthralgia
Asthenia
Bronchospasm
Diarrhoea
Dryness and irritation of eyes
Dyspepsia
Erythema
Feeling hot
Flushing
Headache
Heat sensation
Malaise
Myalgia
Myositis
Nausea
Pruritus
Rash
Upper abdominal pain
Urticaria
Vasodilatation

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: February 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.

Summary of Product Characteristics: Olbetam Capsules 250. Pfizer Limited. Revised February 2014.