- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of pravastatin
History of MI or unstable angina: reduce risk of cardiovascular events
Mixed dyslipidaemia (type IIb) - adjunct to diet
Post-transplantation hyperlipidaemia: patients on immunosuppressive therapy
Reduction of cardiac events in hypercholesterolaemia
Treatment of primary hypercholesterolaemia resistant to diet
The usual dosage range is 10 to 40 mg once daily at bedtime. The therapeutic response is seen within a week and the maximal effect of a dose occurs within four weeks, therefore periodic lipid determinations should be performed and the dosage adjusted accordingly. The dose should be adjusted at intervals of at least 4 weeks.
Maximum daily dose 40 mg.
40 mg daily at bedtime.
Initial dose: 20 mg once daily at bedtime in patients receiving immunosuppressive therapy
Adjust up to 40 mg once daily at bedtime depending on the response of the patient, and under close medical supervision.
(See Dosage; Adult)
Dose adjustments should be made at intervals of not less than 4 weeks.
Hyperlipidaemia including familial hypercholesterolaemia
Children 14 to 18 years old
The recommended dose range is 10 to 40 mg once daily.
Children 8 to 13 years old
The recommended dose range is 10 to 20 mg once daily.
Doses greater than 20 mg have not been studied.
Patients with Renal Impairment
An initial dose of 10 mg daily is recommended in patients with moderate or severe renal impairment. The dosage should be adjusted according to the response of lipid parameters and under medical supervision.
Patients with Hepatic Impairment
An initial dose of 10 mg daily is recommended in patients with significant hepatic disease. The dosage should be adjusted according to the response of lipid parameters and under medical supervision.
Additional Dosage Information
The effects of pravastatin on lowering total and LDL cholesterol are enhanced when combined with a bile acid-binding resin. When administering a bile acid-binding resin (e.g. colestyramine, colestipol) pravastatin should be given either one hour before or at least four hours after the resin.
Patients taking immunosuppressive drugs such as ciclosporin concurrently with pravastatin should start treatment with 20 mg of pravastatin once daily and be titrated to 40 mg with caution.
Children under 8 years
Creatine kinase levels over 5 times upper limit of normal
Renal impairment - creatinine clearance below 30 ml/minute
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
Patients over 70 years
Glucose-galactose malabsorption syndrome
Hereditary muscular disorder
History of hepatic impairment
History of muscular toxicity secondary to fibrates
History of muscular toxicity secondary to HMG-CoA reductase inhibitors
History of non-traumatic rhabdomyolysis
Renal impairment - creatinine clearance 30-60ml/minute
Advise ability to drive/operate machinery may be affected by side effects
Correct hypothyroidism before treatment
Exclude secondary causes of hypercholesterolaemia before treatment
Measure creatine kinase levels prior to treatment if risk of rhabdomyolysis
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
Monitor lipids periodically and adjust dose accordingly
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
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
Not licensed for all indications in all age groups
Dietary restrictions should be maintained
Female: Contraception required during and for 3 months after treatment
Advise patient to report any signs of liver toxicity such as yellow colour to the skin or eyes or generalised itching.
Statin therapy has been associated with the development of myalgia, myopathy and rhabdomyolysis, which can rarely be fatal. Myopathy is dose related.
Do not measure creatine kinase levels following strenuous exercise or in the presence of other factors affecting CK levels. If CK is greater than 5 times the upper limit of normal (ULN) levels prior to treatment, re-measure 5 to 7days later.
If symptoms of myopathy resolve and levels of creatinine kinase reduce, treatment can be reinitiated at the lowest dose and with close monitoring.
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.
Pregnancy and Lactation
Pravastatin is contraindicated in pregnancy.
A mixture of human malformations have been reported with the used of statins in the first trimester, these include; VATER-association, neural tube defects, holoprosencephaly, other CNS malformations and limb abnormalities (Schaefer, 2007). 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 since pravastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. 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 pravastatin should not be used during pregnancy. Schaefer (2007) concludes 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 considered.
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 ).
Pravastatin is contraindicated in breastfeeding.
At the time of writing, there is little published experience concerning the use of statins during breastfeeding. Due to the possible inhibition of cholesterol biosynthesis by statins, there is a theoretical risk posed to the neonate. The products of cholesterol biosynthesis, including cholesterol are essential for neonatal development. Therefore, the use of statins is contraindicated while breastfeeding. The suspension of treatment while breastfeeding is not considered likely to detrimentally affect the long term course of hyperlipidaemia, therefore pravastatin use during breastfeeding is not recommended.
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
Altered liver function tests
Changes in scalp or body hair
Creatine kinase increased
Fulminant hepatic necrosis
Increase in serum transaminases
Interstitial lung disease
Lupus erythematosus-like syndrome
Precipitation of diabetes
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 ).
Last Full Review Date: February 2014
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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Summary of Product Characteristics: Lipostat 10mg, 20mg and 40mg Tablets. Bristol-Myers Squibb Pharmaceuticals Ltd. Revised April 2013.
Summary of Product Characteristics: Pravastatin Sodium 10mg Tablets. Accord Healthcare Ltd. Revised June 2012.
Summary of Product Characteristics: Pravastatin Sodium 20mg Tablets. Accord Healthcare Ltd. Revised June 2012.
Summary of Product Characteristics: Pravastatin Sodium 40mg Tablets. Accord Healthcare Ltd. Revised June 2012.
Summary of Product Characteristics: Pravastatin Sodium 20mg Tablets (Arrow). Actavis UK Ltd. Revised May 2012.
Summary of Product Characteristics: Pravastatin Sodium 40mg Tablets (Arrow). Actavis UK Ltd. Revised May 2012.
Summary of Product Characteristics: Pravastatin Sodium 10mg Tablets. Sandoz Ltd. Revised December 2012.
Summary of Product Characteristics: Pravastatin Sodium 20mg Tablets. Sandoz Ltd. Revised December 2012.
Summary of Product Characteristics: Pravastatin Sodium 40mg Tablets. Sandoz Ltd. Revised December 2012.
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Last accessed: February 11, 2014.
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National Institute for Health and Care Excellence, NICE 71, Identification and management of familial hypercholesterolaemia, issued August 2008.
Available at: https://www.nice.org.uk/nicemedia/pdf/CG071NICEGuideline.pdf
Accessed: February 11, 2014.
NAPOS, The Drug Database for Acute Porphyria.
Available at: https://www.drugs-porphyria.com/monograph.php?id=1561
Pravastatin last revised: June 7, 2013.
Last accessed: February 11, 2014.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
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Pravastatin Last revised: September 07, 2013.
Last accessed: February 11, 2014.
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