Description

Statpure-F 20MG – Strip of 10 Tablets

🔬 Composition:

Each film-coated tablet contains:

• Rosuvastatin Calcium IP equivalent to Rosuvastatin 20 mg

• Fenofibrate IP (Micronized) equivalent to Fenofibrate 145 mg

• Excipients – q.s.

🧾 Description:

Statpure-F 20MG is a fixed-dose combination of a statin (Rosuvastatin) and a fibrate (Fenofibrate). This dual therapy is effective in treating patients with mixed dyslipidemia, particularly when high LDL cholesterol is accompanied by elevated triglycerides.

🩺 Indications:

• Mixed Dyslipidemia (high LDL + high triglycerides)

• Severe Hypertriglyceridemia

• Patients at high risk of cardiovascular events who require aggressive lipid management

• Adjunct to diet and exercise when monotherapy is not sufficient

⚙️ Mechanism of Action:

• Rosuvastatin: Inhibits HMG-CoA reductase, lowering LDL, total cholesterol, and triglycerides, while increasing HDL.

• Fenofibrate: Activates PPAR-α, increasing lipolysis and elimination of triglyceride-rich particles.

💊 Dosage & Administration:

• Usual adult dose: One tablet once daily, or as prescribed by the physician

• Can be taken with or without food

• Swallow whole with water; do not chew or crush

⚠️ Precautions & Warnings:

• Regular monitoring of lipid profile, liver function, and creatine kinase (CK)

• Use cautiously in patients with renal impairment, gallbladder disease, or hypothyroidism

• Not recommended in pregnancy, lactation, or in active liver disease

• Avoid alcohol and grapefruit juice

💢 Common Side Effects:

• Muscle pain, cramps, or weakness

• Elevated liver enzymes

• Nausea, abdominal discomfort, flatulence

• Headache or dizziness

• Rare: Myopathy, rhabdomyolysis (report immediately if suspected)

📦 Packaging & Storage:

• Pack Size: Strip of 10 Tablets

• Storage: Store below 25°C, in a dry place away from sunlight and moisture

• Keep out of reach of children

📌 Caution:

Schedule H Drug
To be sold by retail on the prescription of a Registered Medical Practitioner only.