Pravastatin

1. Introduction

Pravastatin is a lipid-lowering medication classified as a statin (HMG-CoA reductase inhibitor). It is prescribed to reduce cholesterol and triglyceride levels, thereby lowering the risk of heart attacks, strokes, and other cardiovascular events. Pravastatin works by inhibiting the enzyme HMG-CoA reductase, which is critical in cholesterol synthesis in the liver.

2. Indications

  • Primary hypercholesterolaemia (high cholesterol levels)
  • Mixed dyslipidaemia
  • Prevention of cardiovascular events in patients with a history of coronary heart disease, stroke, or other vascular diseases
  • Familial hypercholesterolaemia (heterozygous)

3. Dosage

Adults:

  • Primary hypercholesterolaemia and cardiovascular prevention:
    • Initial dose: 10–40 mg once daily.
    • Maintenance dose: 10–80 mg once daily (maximum dose: 80 mg/day).

Children (8–13 years):

  • 10–20 mg once daily.

Adolescents (14–18 years):

  • 10–40 mg once daily.

Elderly:

  • No specific dose adjustment is required; however, lower doses may be initiated based on comorbidities.

Renal Impairment:

  • Mild to moderate: No dose adjustment is needed.
  • Severe: Start with 10 mg once daily, titrate cautiously.

4. Administration

  • Take orally once daily, preferably in the evening as cholesterol synthesis is higher at night.
  • Can be taken with or without food.

5. Forms Available

  • Tablets: 10 mg, 20 mg, 40 mg, 80 mg

6. Side Effects

6.1 Common Side Effects:

  • Headache
  • Nausea
  • Diarrhoea
  • Muscle pain (myalgia)
  • Fatigue

6.2 Less Common Side Effects:

  • Dizziness
  • Rash
  • Constipation

6.3 Rare but Serious Side Effects:

  • Rhabdomyolysis (muscle breakdown)
  • Liver toxicity (elevated liver enzymes)
  • Hypersensitivity reactions (e.g., angioedema)

7. Warnings

  • Rhabdomyolysis: Monitor for unexplained muscle pain, weakness, or tenderness, particularly if accompanied by dark urine. Discontinue if suspected.
  • Hepatotoxicity: Elevated liver enzymes may occur; monitor regularly. Discontinue if significant liver injury is suspected.
  • Diabetes Risk: Statins can increase the risk of new-onset diabetes in predisposed individuals.

8. Precautions

  • Use cautiously in patients with a history of liver disease or heavy alcohol consumption.
  • Avoid in patients with active liver disease or unexplained persistent elevations in liver enzymes.
  • Advise patients to report symptoms such as muscle pain, weakness, or dark-coloured urine immediately.

9. Interactions

  • Fibrates (e.g., gemfibrozil): Increased risk of rhabdomyolysis.
  • Cyclosporine: Increases pravastatin levels; use the lowest effective dose.
  • Erythromycin and clarithromycin: Increased risk of muscle-related side effects.
  • Antacids: May reduce pravastatin absorption; administer pravastatin 1–2 hours before or 4 hours after antacids.

10. Monitoring Parameters

  • Lipid profile (baseline, then 4–6 weeks after initiation, and periodically).
  • Liver function tests (ALT, AST) before initiation and periodically during therapy.
  • Monitor for signs of muscle toxicity (e.g., myopathy, rhabdomyolysis).

11. Use in Children

  • Approved for children aged 8 years and older with familial hypercholesterolaemia.
  • Doses should be weight-based and adjusted as needed.

12. Use in Pregnancy

  • Contraindicated. Statins can harm the developing foetus by interfering with cholesterol synthesis. Discontinue immediately if pregnancy is detected.

13. Use in Elderly

  • Pravastatin is generally safe in elderly patients. However, monitor closely for muscle toxicity and adjust doses based on renal function and comorbidities.

14. Use in Kidney Disease

  • No dose adjustment is required for mild or moderate renal impairment. In severe renal impairment, start with 10 mg/day and titrate cautiously.

15. Use in Liver Disease

  • Avoid in patients with active liver disease or unexplained elevated liver enzymes. Monitor liver function regularly in those with a history of liver conditions.

16. Patient Counselling Points

  • Take pravastatin at the same time daily, preferably in the evening.
  • Report any muscle pain, weakness, or dark urine to your doctor immediately.
  • Maintain a healthy lifestyle, including a balanced diet, exercise, and weight control, to maximise benefits.
  • Avoid excessive alcohol consumption while taking pravastatin.
  • Pravastatin is contraindicated during pregnancy and breastfeeding. Use reliable contraception during treatment.

17. Table of Brand Names, Manufacturer, and Prices in USD

Brand NameManufacturerStrength/Dosage FormPrice (USD)
PravacholBristol-Myers Squibb40 mg Tablet$60 (30 tablets)
Generic PravastatinVarious40 mg Tablet$15 (30 tablets)

18. 15 FAQs (Frequently Asked Questions)

1. What is Pravastatin used for?
Pravastatin is used to lower cholesterol and triglycerides and prevent cardiovascular events such as heart attacks and strokes.

2. How does Pravastatin work?
It inhibits HMG-CoA reductase, reducing cholesterol production in the liver.

3. What is the usual dose of Pravastatin?
The typical starting dose is 10–40 mg once daily, with a maximum of 80 mg/day.

4. Can Pravastatin cause muscle pain?
Yes, muscle pain (myalgia) is a common side effect, and severe pain may indicate rhabdomyolysis.

5. How long does Pravastatin take to work?
Improvements in lipid levels are usually seen within 4–6 weeks.

6. Can Pravastatin be used during pregnancy?
No, it is contraindicated due to the risk of foetal harm.

7. Can children take Pravastatin?
Yes, it is approved for children aged 8 years and older with familial hypercholesterolaemia.

8. Does Pravastatin interact with other medications?
Yes, it interacts with fibrates, cyclosporine, erythromycin, and antacids.

9. Can Pravastatin cause liver problems?
Yes, it may elevate liver enzymes or cause liver damage. Regular monitoring is recommended.

10. Can I drink alcohol while taking Pravastatin?
Avoid excessive alcohol, as it increases the risk of liver damage.

11. Can Pravastatin be taken with food?
Yes, it can be taken with or without food.

12. How should Pravastatin be stored?
Store at room temperature, away from moisture and heat.

13. Can I stop taking Pravastatin abruptly?
No, consult your doctor before stopping, as cholesterol levels may rise again.

14. Is Pravastatin suitable for patients with kidney disease?
Yes, but dose adjustments may be needed in severe renal impairment.

15. Do I need regular blood tests while on Pravastatin?
Yes, regular lipid profiles and liver function tests are necessary to monitor effectiveness and safety.