pharmacopeia
GET
/api/v1/drug/pravastatin
2D structure
(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid
SMILES CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)O)O)O)O
InChIKey TUZYXOIXSAXUGO-PZAWKZKUSA-N

Mechanism of action

Sourced from openFDA

Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, pravastatin reduces VLDL and TG and increases HDL-C.

Hydroxymethylglutaryl-CoA Reductase

Indications

Sourced from openFDA
  • Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.ICD-10: E78.00

Contraindications

Sourced from openFDA
  • Hypersensitivity to any component of this medication. (4.1, 6.2, 11) Active liver disease or unexplained, persistent elevations of serum transaminases.contraindicated

Dosage & administration

Sourced from openFDA

Adults: the recommended starting dose is 40 mg once daily. Use 80 mg dose only for patients not reaching LDL-C goal with 40 mg. (2.2) Significant renal impairment: the recommended starting dose is pravastatin 10 mg once daily. (2.3) Children (ages 8 to 13 years, inclusive): the recommended starting dose is 20 mg once daily. (2.4) Adolescents (ages 14 to 18 years): the recommended starting dose is 40 mg once daily. (2.4) 2.1 General Dosing Information The patient should be placed on a standard cholesterol-lowering diet before receiving Pravastatin Sodium and should continue on this diet during treatment with Pravastatin Sodium [see NCEP Treatment Guidelines for details on dietary therapy]. 2.2 Adult Patients The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. Pravastatin Sodium can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines. 2.3 Patients with Renal Impairment In patients with severe renal impairment, a starting dose of 10 mg pravastatin daily is recommended. 2.4 Pediatric Patients Children (Ages 8 to 13 Years, Inclusive) The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.

Warnings & precautions

Sourced from openFDA

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to promptly report to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness. Pravastatin therapy should be discontinued if myopathy is diagnosed or suspected. (5.1, 8.5) Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment, positive anti-HMG CoA reductase antibody, muscle biopsy showing necrotizing myopathy and improvement with immunosuppressive agents ( 5.2 ). Liver enzyme abnormalities: persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. ( 5.3 ) 5.1 Skeletal Muscle Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with pravastatin and other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects. Uncomplicated myalgia has also been reported in pravastatin-treated patients [see Adverse Reactions (6) ].

Adverse reactions

Sourced from openFDA

Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant. In short-term clinical trials, the most commonly reported adverse reactions (≥2% and > placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc. at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Clinical Events Short-Term Controlled Trials In the Pravastatin Sodium placebo-controlled clinical trials database of 1313 patients (age range 20-76 years, 32.4% women, 93.5% Caucasians, 5% Blacks, 0.9% Hispanics, 0.4% Asians, 0.2% Others) with a median treatment duration of 14 weeks, 3.3% of patients on Pravastatin Sodium and 1.2% patients on placebo discontinued due to adverse events regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: liver function test increased, nausea, anxiety/depression, and dizziness.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Pravastatin Sodium is contraindicated for use in pregnant woman because of the potential for fetal harm. As safety in pregnant women has not been established and there is no apparent benefit to therapy with Pravastatin Sodium during pregnancy, Pravastatin Sodium should be immediately discontinued as soon as pregnancy is recognized [see Contraindications (4.3) ]. Limited published data on the use of Pravastatin Sodium in pregnant women are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, no evidence of fetal malformations was seen in rabbits or rats exposed to 10 times to 120 times, respectively, the maximum recommended human dose (MRHD) of 80 mg/day. Fetal skeletal abnormalities, offspring mortality, and developmental delays occurred when pregnant rats were administered 10 times to 12 times the MRHD during organogenesis to parturition [see Data ]. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
General Absorption: Pravastatin Sodium is administered orally in the active form. In studies in man, peak plasma pravastatin concentrations occurred 1 to 1.5 hours upon oral administration.

Overdosage

Sourced from openFDA

To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.

Approval history

Sourced from openFDA
  • Apr 24, 2006ANDAANDA076056Aurobindo Pharma Usa
  • Oct 23, 2006ANDAANDA076714Dr Reddys Labs Inc
  • Oct 23, 2006ANDAANDA076341Apotex
  • May 11, 2007ANDAANDA077987Glenmark Pharms Ltd
  • Jan 8, 2008ANDAANDA077917Chartwell Rx
  • Jan 15, 2008ANDAANDA077793Aurobindo Pharma Usa
  • Feb 11, 2008ANDAANDA077491Senores Pharms
  • Nov 17, 2016ANDAANDA207068Accord Hlthcare

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
19,326 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue1,3016.7%
  2. 2Diarrhoea1,1355.9%
  3. 3Nausea9775.1%
  4. 4Dyspnoea9635.0%
  5. 5Headache8664.5%
  6. 6Drug Ineffective8594.4%
  7. 7Fall8554.4%
  8. 8Dizziness7694.0%
  9. 9Arthralgia7213.7%
  10. 10Asthenia7173.7%
  11. 11Pain6963.6%
  12. 12Cough6943.6%
  13. 13Pruritus6503.4%
  14. 14Myalgia6493.4%
  15. 15Malaise6353.3%

Literature

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Recent PubMed references pinned to Pravastatin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 190 ClinicalTrials.gov registrations naming Pravastatin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Pravastatin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Pravastatin work?
Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, pravastatin reduces VLDL and TG and increases HDL-C.
What is Pravastatin used for?
According to FDA labeling, Pravastatin carries indications including: Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pravastatin?
Pravastatin is classified as HMG CoA reductase inhibitors, HMG-CoA Reductase Inhibitor, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Decreased Cholesterol Synthesis.
What are the brand names for Pravastatin?
Pravastatin is marketed under brand names including Pravachol.
What are the contraindications for Pravastatin?
Pravastatin labeling lists contraindications including: Hypersensitivity to any component of this medication. (4.1, 6.2, 11) Active liver disease or unexplained, persistent elevations of serum transaminases.. Always consult the full prescribing information and a clinician.
Note. Data for pravastatin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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