Description

STATPURE-F 10 – Strip of 10 Tablets

• Composition: ROSUVASTATIN-10Mg+FENOFIBRATE-145Mg

• Statpure-F 10 – Strip of 10 Tablets

  🧪 Composition (per tablet):

  Ingredient	Strength	Class	Function
  Rosuvastatin	10 mg	Statin (HMG-CoA reductase inhibitor)	Lowers LDL (“bad”) cholesterol and triglycerides, raises HDL (“good”) cholesterol
  Fenofibrate	145 mg	Fibrate (PPAR-α agonist)	Primarily lowers triglycerides and moderately increases HDL cholesterol

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  🎯 Therapeutic Indications (Uses):

  Statpure-F 10 is used in the management of mixed dyslipidemia, particularly in patients with:

  • High triglycerides (hypertriglyceridemia) with or without high LDL

  • Atherogenic dyslipidemia (low HDL, high TG, small dense LDL)

  • Diabetes-associated lipid abnormalities

  • Combined hyperlipidemia

  • Patients not adequately controlled by a statin or fibrate alone

  ✅ It’s especially helpful in patients with high triglycerides and low HDL, which are common in metabolic syndrome and type 2 diabetes.

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  🕒 Dosage & Administration:

  • Usual Dose: One tablet once daily, or as directed by your physician

  • Route: Oral

  • Administration: Preferably with food to improve absorption of fenofibrate

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  ⚠️ Warnings & Precautions:

  1. Muscle Toxicity (Statin + Fibrate Combination):

  • Combining Rosuvastatin and Fenofibrate increases the risk of myopathy or rhabdomyolysis

  • Report any muscle pain, weakness, or dark-colored urine immediately

  2. Liver Effects:

  • Both drugs can raise liver enzymes

  • Monitor LFTs regularly

  3. Renal Function:

  • Fenofibrate is renally excreted; use cautiously in patients with impaired kidney function

  • Monitor serum creatinine and eGFR

  4. Gallbladder Risk:

  • Fenofibrate may increase risk of gallstones

  5. Pregnancy & Breastfeeding:

  • Contraindicated during pregnancy and lactation

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  🔄 Drug Interactions:

  Interacting Drug/Class	Effect or Concern
  Other statins or fibrates	↑ Risk of muscle toxicity
  Anticoagulants (e.g., warfarin)	↑ Bleeding risk due to fenofibrate
  Cyclosporine	May increase risk of kidney damage with fenofibrate
  Bile acid sequestrants	May interfere with statin absorption

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  📋 Contraindications:

  • Active liver disease

  • Severe kidney impairment

  • History of gallbladder disease

  • Known hypersensitivity to Rosuvastatin or Fenofibrate

  • Pregnancy or breastfeeding

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  ⚠️ Common Side Effects:

  System	Possible Side Effects
  Musculoskeletal	Muscle pain, tenderness, cramps, rarely rhabdomyolysis
  Hepatic	Elevated liver enzymes
  GI	Nausea, abdominal pain, diarrhea
  Skin	Rash, photosensitivity
  Renal	Elevated creatinine, especially with fenofibrate

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  🧾 Monitoring Parameters:

  • Lipid profile (LDL, HDL, TG)

  • Liver function tests (ALT, AST)

  • Renal function (serum creatinine, eGFR)

  • Creatine kinase (CK) if muscle symptoms present

  • Signs of gallstones (e.g., RUQ pain)

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  📦 Packaging:

  • Strip of 10 tablets

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  🏷️ Storage:

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

  • Protect from light and moisture

  • Keep out of reach of children

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  🧾 Legal Status (India):

  • Schedule H drug – Prescription only