Drugs List

Therapeutic Indications

Uses

Mixed hyperlipidaemia when statin is contraindicated or not tolerated
Severe hypertriglyceridaemia with or without low HDL cholesterol

Contraindications

Children under 18 years
Creatine kinase levels over 5 times upper limit of normal
Photoallergic or phototoxic reactions to fibrates
Acute porphyria
Breastfeeding
Galactosaemia
Gall bladder disorder
Gallbladder disease
Myopathy
Pregnancy
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

High alcohol intake
Hypoalbuminaemia
Major surgery
Patients over 70 years
Severe infection
Severe trauma
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
History of non-traumatic rhabdomyolysis
Hypothyroidism
Lactose intolerance
Nephrotic syndrome
Renal impairment

Reduce dose in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Correct hypothyroidism before treatment
Exclude/correct secondary causes of dyslipidaemia prior to treatment
Contains lactose
Monitor hepatic function periodically
Monitor serum transaminases every 3 months during first 12 months of use
Review if an adequate response not obtained within 3 months
Advise patients to report muscle pain/tenderness/weakness
Discontinue if abnormal liver function tests persist or worsen
Discontinue if myopathy is suspected
Discontinue if ALT level exceeds 3 times the upper limit of normal
Discontinue if AST level exceeds 3 times the upper limit of normal
Discontinue if CPK rises progressively
Discontinue if CPK rises to > or equal to 5x upper limit of normal range
Discontinue if creatine kinase concentration increases significantly
Discontinue immediately if rhabdomyolysis occurs
Dietary restrictions should be maintained
Patients should not exceed recommended dose

Pregnancy and Lactation

Pregnancy

Ciprofibrate is contraindicated in pregnancy.

At the time of writing there is limited published experience concerning the use of ciprofibrate during human pregnancy. No evidence of teratogenicity has been found but high doses of ciprofibrate have shown signs of embryotoxicity in animal studies. Schaefer concludes that fibrates should not be prescribed during pregnancy, however inadvertent treatment with lipid reducers during pregnancy does not necessitate either termination of the pregnancy or invasive diagnostic procedures (Schaefer, 2007).

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

Ciprofibrate is contraindicated in breastfeeding.

At the time of writing there is limited published experience concerning the use of ciprofibrate during breastfeeding. Ciprofibrate is excreted in the milk of lactating rats, however no data is available from human studies.

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
Abnormal liver function tests
Alopecia
Cholestasis
Creatine phosphokinase increased
Cytolysis
Diarrhoea
Dizziness
Dyspepsia
Eczema
Fatigue
Gallstones
Headache
Impotence
Myalgia
Myopathy
Myositis
Nausea
Photosensitivity
Pneumonitis
Pruritus
Pulmonary fibrosis
Rash
Rhabdomyolysis
Somnolence
Thrombocytopenia
Urticaria
Vertigo
Vomiting

Presentation

Oral formulation of ciprofibrate

Drugs List

Therapeutic Indications

Uses

Mixed hyperlipidaemia when statin is contraindicated or not tolerated
Severe hypertriglyceridaemia with or without low HDL cholesterol

Dosage

Adults

Elderly

Patients with Renal Impairment

Contraindications

Children under 18 years
Creatine kinase levels over 5 times upper limit of normal
Photoallergic or phototoxic reactions to fibrates
Acute porphyria
Breastfeeding
Galactosaemia
Gall bladder disorder
Gallbladder disease
Myopathy
Pregnancy
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

High alcohol intake
Hypoalbuminaemia
Major surgery
Patients over 70 years
Severe infection
Severe trauma
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
History of non-traumatic rhabdomyolysis
Hypothyroidism
Lactose intolerance
Nephrotic syndrome
Renal impairment

Reduce dose in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Correct hypothyroidism before treatment
Exclude/correct secondary causes of dyslipidaemia prior to treatment
Contains lactose
Monitor hepatic function periodically
Monitor serum transaminases every 3 months during first 12 months of use
Review if an adequate response not obtained within 3 months
Advise patients to report muscle pain/tenderness/weakness
Discontinue if abnormal liver function tests persist or worsen
Discontinue if myopathy is suspected
Discontinue if ALT level exceeds 3 times the upper limit of normal
Discontinue if AST level exceeds 3 times the upper limit of normal
Discontinue if CPK rises progressively
Discontinue if CPK rises to > or equal to 5x upper limit of normal range
Discontinue if creatine kinase concentration increases significantly
Discontinue immediately if rhabdomyolysis occurs
Dietary restrictions should be maintained
Patients should not exceed recommended dose

Pregnancy and Lactation

Pregnancy

Ciprofibrate is contraindicated in pregnancy.

At the time of writing there is limited published experience concerning the use of ciprofibrate during human pregnancy. No evidence of teratogenicity has been found but high doses of ciprofibrate have shown signs of embryotoxicity in animal studies. Schaefer concludes that fibrates should not be prescribed during pregnancy, however inadvertent treatment with lipid reducers during pregnancy does not necessitate either termination of the pregnancy or invasive diagnostic procedures (Schaefer, 2007).

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

Ciprofibrate is contraindicated in breastfeeding.

At the time of writing there is limited published experience concerning the use of ciprofibrate during breastfeeding. Ciprofibrate is excreted in the milk of lactating rats, however no data is available from human studies.

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
Abnormal liver function tests
Alopecia
Cholestasis
Creatine phosphokinase increased
Cytolysis
Diarrhoea
Dizziness
Dyspepsia
Eczema
Fatigue
Gallstones
Headache
Impotence
Myalgia
Myopathy
Myositis
Nausea
Photosensitivity
Pneumonitis
Pruritus
Pulmonary fibrosis
Rash
Rhabdomyolysis
Somnolence
Thrombocytopenia
Urticaria
Vertigo
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: July 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 15 July 2015.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 13 July 2015.

Summary of Product Characteristics: Ciprofibrate 100mg tablets. Zentiva. Revised January 2014.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.