API Pravastatin Sodium

Pravastatin Sodium More Info

Pravastatin Sodium is a prescription medication belonging to the class of HMG-CoA reductase inhibitors, commonly known as statins. It is used primarily to lower cholesterol levels and reduce the risk of cardiovascular events. The product is also known by its brand name Pravachol.

2. Chemical Properties

English Name: Pravastatin Sodium

CAS Number: 81131-70-6

Molecular Formula: C₂₃H₃₅NaO₇

Molecular Weight: 446.51 - 447.52 g/mol

Chemical Name: [1S-[1α(βS',δS')2α,6α,8β(R')8αα]-1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-1-naphthaleneheptanoic acid, monosodium salt

Appearance: White powder

Melting Point: 171°C - 173°C

Solubility: Soluble in water (19 mg/mL)

3. Pharmacological Classification

Pravastatin Sodium belongs to the following drug classes:

HMG-CoA Reductase Inhibitors (Statins)

Cholesterol-Lowering Agents

Chemosensitizers (under investigation for cancer treatment)

4. Mechanism of Action

Pravastatin Sodium works by:

Inhibiting HMG-CoA Reductase: Blocks an enzyme that helps make cholesterol in the body

Inhibiting Sterol Synthesis: IC50 value of 5.6 μM

Lowering LDL Cholesterol: Significantly reduces low-density lipoprotein (LDL) levels in the blood

Reducing Triglycerides: Decreases triglyceride and total cholesterol levels

Increasing HDL: May elevate high-density lipoprotein (HDL) cholesterol levels

5. Therapeutic Indications

Pravastatin Sodium is indicated for:

Treatment of Hypercholesterolemia: Reducing elevated blood cholesterol and lipid levels

Cardiovascular Disease Prevention: Preventing heart attacks, stroke, and other cardiovascular events

Coronary Artery Disease: Reducing risk of coronary death or non-fatal myocardial infarction

Organ Transplantation: Managing lipid levels in transplant patients

Cancer Research: Being studied for potential use in cancer treatment due to tumor cell sensitization effects

6. Product Specifications

Dosage Forms and Strengths:

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

Route of Administration: Oral (by mouth)

Product Type: Human Prescription Drug

Tablet Appearance: Yellow, round, rectangular, bi-convex tablets

7. Inactive Ingredients

Common excipients include:

Silicon Dioxide

Crospovidone

Hypromellose

Magnesium Stearate

Mannitol

Meglumine

Microcrystalline Cellulose

Corn Starch

D&C Yellow No. 10

Lactose

8. Pharmacokinetics

Absorption: Approximately 34%

Absolute Bioavailability: 17%

Metabolism: Hepatic (liver enzyme metabolism)

Excretion: Renal and biliary elimination

9. Dosage and Administration

Typical Dose: Taken once daily as directed by the physician

Maximum Dose: Up to 40 mg per day

With Food: Can be taken with or without food

Timing: Usually taken in the evening for optimal effect

10. Contraindications and Warnings

Contraindications:

Pregnancy

Breastfeeding (active substance passes into breast milk)

Active liver disease

Hypersensitivity to pravastatin or any component

Precautions:

Kidney disease patients should consult a doctor before use

Monitor for signs of muscle pain or weakness

Use caution in patients taking vitamin K antagonists

11. Drug Interactions

Notable Interactions:

Macrolide Antibiotics: Azithromycin

CYP450 Substrates: Diltiazem, Verapamil

Antifungals: Itraconazole, Ketoconazole

Protease Inhibitors: HIV medications

CYP2C9 Inhibitors: Fluconazole

Vitamin K Antagonists: Warfarin

Oral Fusidic Acid: May cause rhabdomyolysis

Colchicine: Used for gout treatment

Rifampicin: Tuberculosis treatment

Lenalidomide: Multiple myeloma treatment

12. Adverse Reactions

Common Side Effects:

Muscle pain or tenderness

Headache

Dizziness

Digestive discomfort

Allergic reactions

Serious Adverse Reactions:

Rhabdomyolysis (rare)

Liver toxicity

Severe allergic reactions

Driving and Machine Operation:

Usually does not affect the ability to drive, but caution is advised if experiencing dizziness.

13. Storage Conditions

Powder: -20°C for 3 years

In Solvent: -80°C for 1 year

General Storage: 2°C - 8°C, keep away from direct sunlight and moisture

Shipping: With blue ice or at ambient temperature