PITAVASTATIN

Other

Brand names: Pitavastatin Calcium

Oral

Mechanism of Action

12.1 Mechanism of Action Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic pathway for cholesterol. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very low density lipoproteins.

Indications

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Contraindications

• rash
• pruritus
• and urticaria have been reported with pitavastatin tablets [see Adverse Reactions (6) ] . • Cyclosporine ( 4
• 7 ) • Active liver failure or decompensated cirrhosis ( 4
• 5.3 ) • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Myopathy and Rhabdomyolysis: Risk factors include age 65 or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher pitavastatin tablets dosage
Temporarily discontinue pitavastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the pitavastatin tablets dosage
Rare reports of fatal and non-fatal hepatic failure have occurred

Known Side Effects

15 documented side effects by frequency

Muscle Pain

>10%

Diarrhea

1-10%

Fatigue

1-10%

Nausea

1-10%

Headache

1-10%

Joint Pain

1-10%

Dizziness

1-10%

Shortness of Breath

1-10%

General Unwellness

1-10%

Falls

1-10%

Itching

1-10%

Fever

1-10%

Weakness

1-10%

Decreased Appetite

1-10%

Insomnia

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral