PRAVASTATIN SODIUM

Electrolyte / Mineral

Brand names: PRAVASTATIN SODIUM, Pravachol

Oral

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

revascularization

and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1) Reduce the risk of total mortality by reducing coronary death

revascularization

stroke/TIA

and the progression of coronary atherosclerosis in patients with clinically evident CHD. (1.1) Reduce elevated Total-C

LDL-C

Contraindications

• 4 CONTRAINDICATIONS Hypersensitivity to any component of this medication. (4.1
• 6.2
• 11) Active liver disease or unexplained
• persistent elevations of serum transaminases. (4.2
• 5.3 ) Pregnancy (4.3

FDA Warnings

5 WARNINGS AND PRECAUTIONS Skeletal muscle effects (e
A history of renal impairment may be a risk factor for the development of rhabdomyolysis
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pravastatin
If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Pravastatin Sodium, promptly interrupt therapy

Known Side Effects

14 documented side effects by frequency

Fatigue

>10%

Diarrhea

1-10%

Nausea

1-10%

Shortness of Breath

1-10%

Headache

1-10%

Falls

1-10%

Drug Not Working

1-10%

Dizziness

1-10%

Joint Pain

1-10%

Weakness

1-10%

Cough

1-10%

Muscle Pain

1-10%

Itching

1-10%

General Unwellness

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral