Atorvastatin oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of atorvastatin.
Drugs List
Therapeutic Indications
Uses
Combined (mixed) hyperlipidaemia (type IIb): Adjunct to diet
Heterozygous familial hypercholesterolaemia: Adjunct to diet
Homozygous familial hypercholesterolaemia: Adjunct to diet
Primary hypercholesterolaemia (hyperlipidaemia type IIa): Adjunct to diet
Primary prevention of cardiovascular events
Unlicensed Uses
Secondary prevention of cardiovascular events
Dosage
Adjustment of dosage should be made at intervals of at least four weeks.
Adults
Homozygous familial hypercholesterolaemia, primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
10mg once daily, up to a maximum of 80mg once daily.
Heterozygous familial hypercholesterolaemia
10mg daily, up to a maximum of 80mg daily. Alternatively, 40mg daily may be used when combined with a bile acid sequestrant.
Primary prevention of cardiovascular disease
10mg once daily (an unlicensed dose of 20mg may be suitable).
Secondary prevention of cardiovascular events (unlicensed)
80mg once daily.
Children
Hyperlipidaemia including familial hypercholesterolaemia
Children aged 10 to 18 years
10mg once daily, up to 20mg once daily. The dose may be increased up to 80mg once daily in heterozygous familial hypercholesterolaemia.
Homozygous familial hypercholesterolaemia (unlicensed)
Children aged 10 to 18 years
10mg once daily, up to 80mg once daily.
Additional Dosage Information
Dose adjustments due to interactions
Adults
Concurrent use of ciclosporin
Maximum dose is 10mg daily.
Concurrent use of anion-exchange resin for heterozygous familial hypercholesterolaemia
Maximum dose is 40mg daily.
Concurrent use of elbasvir with grazoprevir
Maximum dose is 20mg daily.
Concurrent use of letermovir without ciclosporin
Maximum dose is 20mg daily.
Concurrent use of sofosbuvir with velpatasvir and voxilaprevir
Maximum dose is 20mg daily.
Children under 18 years
Concurrent use of ciclosporin
Maximum dose is 10mg daily.
Contraindications
Children under 10 years
Creatine kinase levels over 5 times upper limit of normal
Within 7 days of discontinuing systemic fusidic acid
Active liver disease
Acute porphyria
Breastfeeding
Galactosaemia
Myopathy
Pregnancy
Serum transaminases above 3 times upper limit of normal
Severe hepatic impairment
Precautions and Warnings
Family history of hereditary muscular disorders
Females of childbearing potential
High alcohol intake
Major surgery
Patients over 70 years
Severe trauma
Elevated serum transaminases
Glucose-galactose malabsorption syndrome
Haemorrhagic stroke
Hepatic impairment
Hereditary muscular disorder
History of haemorrhagic cerebrovascular accident
History of hepatic disorder
History of lacunar infarct
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
Phenylketonuria
Renal impairment
Transient ischaemic attack
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Correct hypothyroidism before treatment
Exclude secondary causes of hypercholesterolaemia before treatment
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Exclude pregnancy prior to initiation of treatment
Perform liver function tests before commencing therapy
Monitor creatine kinase levels in patients at risk of rhabdomyolysis
Monitor creatine kinase levels in patients reporting myalgia
Repeat liver function tests within 3 months and at 12 months
Advise patient to report any symptoms of interstitial lung disease
Advise patients to report muscle pain/tenderness/weakness
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Discontinue if myopathy is suspected
Patient should be made aware of possible adverse effects on mood/behaviour
Advise patient to seek advice at first indications of pregnancy
Discontinue if ALT level exceed 3 times the upper limit of normal & persist
Discontinue if AST level exceed 3 times the upper limit of normal & persist
Discontinue if creatine kinase levels >5 times upper limit of normal
Discontinue if evidence of interstitial lung disease
Discontinue if muscular symptoms are severe
Discontinue if significant/persistent hepatic function abnormalities occur
Discontinue immediately if rhabdomyolysis occurs
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Dietary restrictions should be maintained
Female: Contraception required during and for 3 months after treatment
Patients who have had a recent stroke or transient ischaemic attack have a higher risk of haemorrhagic stroke in patients initiated on 80mg of atorvastatin. This increased risk was particularly seen in patients with prior haemorrhagic stroke or lacunar infarct. Use with caution in this population.
Some evidence suggests that statins as a class raise blood glucose and in some patients, at a high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (raised fasting glucose, raised body mass index at baseline, history of hypertension and raised triglycerides)should be monitored both clinically and biochemically according to national guidelines.
There have been very rare reports of an immune mediated necrotizing myopathy (IMNM) during or after treatment with some statins. IMNM is clinically characterised by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Statin therapy has been associated with the development of myalgia, myopathy and rhabdomyolysis, particularly in patients receiving higher than 20mg doses.
Do not measure creatine kinase levels following strenuous exercise or in the presence of other factors affecting creatine kinase levels. If creatine kinase is greater than 5 times the upper limit of normal (ULN) levels prior to treatment, re-measure 5 to 7 days later. If symptoms of myopathy resolve and levels of creatinine kinase reduce, treatment can be reinitiated at the lowest dose and with close monitoring.
Pregnancy and Lactation
Pregnancy
Atorvastatin is contraindicated in pregnancy.
Use of atorvastatin during pregnancy is contraindicated by the manufacturer. It is unknown if atorvastatin crosses the placenta. A mixture of human malformations have been reported with the use of statins in the first trimester, these include; VATER-association, neural tube defects, holoprosencephaly, other CNS malformations and limb abnormalities. None of these malformations have occurred in significant enough quantities to enable causality to be concluded. However, the theoretical risks of reducing cholesterol availability during embryo development should be considered (Briggs, 2015). The suspension of treatment throughout pregnancy is not considered likely to have a detrimental effect on the long term course of hyperlipidaemia. For these reasons atorvastatin should not be used during pregnancy. Schaefer (2015) suggests that inadvertent treatment with a statin during pregnancy, does not require a termination of pregnancy, however, treatment should be stopped immediately and a detailed ultrasound examination should be considered.
Lactation
Atorvastatin is contraindicated in breastfeeding.
Use of atorvastatin when breastfeeding is contraindicated by the manufacturer. It is unknown if atorvastatin is excreted into human breast milk but its high molecular weight (1161) suggests excretion into breast milk would be inhibited (Briggs, 2015). At the time of writing, there is no published experience concerning the use of statins during breastfeeding. The products of cholesterol biosynthesis, including cholesterol are essential for neonatal development. Therefore, the use of statins is contraindicated while breastfeeding. However Schaefer (2015) concluded that inadvertent taking of the medication does not require any limitation of breastfeeding although the continuation of treatment should be critically reviewed.
Side Effects
Abdominal pain
Allergic reaction
Alopecia
Amnesia
Anaphylaxis
Angioneurotic oedema
Anorexia
Arthralgia
Asthenia
Back pain
Blurred vision
Bullous reactions
Chest pain
Cholestatic jaundice
Constipation
Cough
Creatine phosphokinase increased
Depression
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dyspnoea
Epistaxis
Eructation
Erythema multiforme
Fatigue
Flatulence
Gastro-intestinal discomfort
Gynaecomastia
Headache
Hearing loss
Hepatic failure
Hepatitis
Hyperglycaemia
Hypoesthesia
Hypoglycaemia
Immune mediated necrotizing myopathy
Increase in ALT level
Increase in AST level
Insomnia
Interstitial lung disease
Joint swelling
Lupus erythematosus-like syndrome
Malaise
Muscle spasm
Muscle weakness
Muscular cramps
Musculoskeletal pain
Myalgia
Myopathy
Myositis
Nasopharyngitis
Nausea
Neck pain
Nightmares
Painful extremities
Pancreatitis
Paraesthesia
Peripheral neuropathy
Peripheral oedema
Pharyngolaryngeal pain
Precipitation of diabetes
Pruritus
Pyrexia
Rash
Rhabdomyolysis
Sexual dysfunction
Stevens-Johnson syndrome
Tendinopathy
Tendon rupture
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Visual disturbances
Vomiting
Weight gain
Weight loss
White blood cells in the urine
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 2013
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.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Atorvastatin 10mg film-coated tablets. Actavis UK Limited. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 20mg film-coated tablets. Actavis UK Limited. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 40mg film-coated tablets. Actavis UK Limited. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 10mg film-coated tablets. Consilient Health Limited. Revised August 2011.
Summary of Product Characteristics: Atorvastatin 20mg film-coated tablets. Consilient Health Limited. Revised August 2011.
Summary of Product Characteristics: Atorvastatin 30mg film-coated tablets. Consilient Health Limited. Revised July 2012.
Summary of Product Characteristics: Atorvastatin 40mg film-coated tablets. Consilient Health Limited. Revised August 2011.
Summary of Product Characteristics: Atorvastatin 60mg film-coated tablets. Consilient Health Limited. Revised July 2012.
Summary of Product Characteristics: Atorvastatin 80mg film-coated tablets. Consilient Health Limited. Revised August 2011.
Summary of Product Characteristics: Atorvastatin Pfizer 10mg, 20mg, 40mg, 80mg Tablets. Pfizer Limited. Revised June 2012.
Summary of Product Characteristics: Atorvastatin 4mg/ml Oral Suspension. Rosemont Pharmaceuticals Ltd. Revised January 2022.
Summary of Product Characteristics: Atorvastatin 10mg film-coated tablets. Sandoz Limited. Revised July 2013.
Summary of Product Characteristics: Atorvastatin 20mg film-coated tablets. Sandoz Limited. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 40mg film-coated tablets. Sandoz Limited. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 80mg film-coated tablets. Sandoz Limited. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 10mg, 20mg, 40mg and 80mg film-coated tablets. Wockhardt UK Ltd. Revised September 2012.
Summary of Product Characteristics: Atorvastatin 10mg film-coated tablets. Zentiva. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 20mg film-coated tablets. Zentiva. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 40mg film-coated tablets. Zentiva. Revised May 2012.
Summary of Product Characteristics: Atorvastatin 80mg film-coated tablets. Zentiva. Revised May 2012.
Summary of Product Characteristics: Lipitor 10mg film-coated tablets. Pfizer Limited. Revised March 2015.
Summary of Product Characteristics: Lipitor 20mg film-coated tablets. Pfizer Limited. Revised March 2015.
Summary of Product Characteristics: Lipitor 40mg film-coated tablets. Pfizer Limited. Revised March 2015.
Summary of Product Characteristics: Lipitor 80mg film-coated tablets. Pfizer Limited. Revised March 2015.
Summary of Product Characteristics: Lipitor 10mg chewable tablets. Pfizer Limited. Revised March 2015.
Summary of Product Characteristics: Lipitor 20mg chewable tablets. Pfizer Limited. Revised March 2015.
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Atorvastatin Last revised: June 7, 2013
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Atorvastatin Last revised: September, 2013.
Last accessed: October 18, 2013.
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