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Pitavas FB

Contains:

  • Pitavastatin Calcium equivalent to Pitavastatin 2 mg

  • Fenofibrate IP 67.5 mg (Micronized)
    Therapeutic Class: Lipid-Lowering Agent (Statin + Fibrate Combination)
    Schedule: Schedule H (Prescription Drug)

PITAVAS FB combines two complementary lipid-modifying agents—Pitavastatin, a potent statin, and Fenofibrate, a fibrate—designed to target mixed dyslipidemia effectively.

  • Pitavastatin reduces LDL-C, total cholesterol, and triglycerides, while modestly increasing HDL-C.

  • Fenofibrate primarily lowers triglycerides and increases HDL-C, with additional benefits on small, dense LDL particles and atherogenic remnants.

This dual-action therapy is ideal for patients with atherogenic dyslipidemia, diabetes, or metabolic syndrome, who often require broader lipid control than statin monotherapy can provide.

Usage of PITAVAS FB

  • Mixed dyslipidemia with elevated LDL-C and triglycerides

  • Diabetic dyslipidemia (high TGs, low HDL)

  • Metabolic syndrome with multiple lipid abnormalities

  • Residual CV risk reduction in patients already on statins

  • Patients with atherogenic dyslipidemia not controlled by statin alone

Common Side Effects

  • Pitavastatin-related:

    • Headache, mild myalgia, elevated liver enzymes

  • Fenofibrate-related:

    • Gastrointestinal discomfort, abdominal pain, elevated creatinine

  • Combination-related (rare but serious):

    • Myopathy, rhabdomyolysis (risk increases in elderly or renal impairment)

    • Liver dysfunction

    • Gallstones (rare with fibrates)

Precautions

  • Hepatic dysfunction: Avoid in active liver disease; monitor LFTs

  • Renal impairment: Use caution; assess eGFR before and during treatment

  • History of gallbladder disease: Fibrates may increase risk of gallstones

  • Monitor CK levels if patient reports muscle pain or weakness

  • Avoid alcohol to reduce hepatotoxicity risk

  • Contraindicated in pregnancy and breastfeeding – Category X

Drug Interactions

  • Other lipid-lowering agents (esp. fibrates): Increased risk of myopathy

  • Anticoagulants (e.g., warfarin): Potentiation of anticoagulant effect – monitor INR

  • Cyclosporine: May increase both Pitavastatin and Fenofibrate levels

  • Bile acid sequestrants: May reduce bioavailability; separate doses by ≥4–6 hrs

  • Minimal CYP450 interaction – Pitavastatin is safe in polypharmacy settings

Dosage and Administration

  • Once daily, preferably at bedtime

  • Take after meals for better absorption of fenofibrate

  • Routine monitoring of lipid profile, liver enzymes, renal function, and CK recommended

Storage

  • Store in a cool, dry place, below 25°C

  • Protect from light and moisture

Patient Counselling Tips

  • Continue therapy even after lipid levels normalize

  • Inform about signs of muscle pain, weakness, or dark urine

  • Advise regular follow-ups to monitor lipid levels and lab parameters

  • Maintain a low-fat diet and engage in regular physical activity

  • Avoid alcohol and grapefruit juice

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