Lipanthyl Penta 145mg Tab

Manufacturer
Abbott Laboratories (M) Sdn Bhd

Registraction Number     
MAL08021430AZ


 

Content

• Active Ingredient: Each film-coated tablet contains 145 mg of fenofibrate (nanoparticles).
• Excipients: Each tablet contains 132 mg of lactose monohydrate, 145 mg of sucrose, and 0.5 mg of soybean lecithin.
• Appearance: The tablet is white, oblong, and film-coated, engraved with “145” on one side and the Fournier logo on the other.

Indications

• Hyperlipidemia: For the treatment of hypercholesterolemia and hypertriglyceridemia (types IIa, IIb, III, IV, and V dyslipidemias) in patients unresponsive to dietary and other non-drug therapeutic measures, particularly when there is evidence of associated risk factors such as hypertension and smoking.
• Secondary Hyperlipoproteinemia: Indicated when hyperlipoproteinemia persists despite effective treatment of the underlying disease (e.g., dyslipidemia in diabetes mellitus).
• Diabetic Retinopathy: For the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy.

Instructions

• Dosage: The recommended dose is one tablet containing 145 mg fenofibrate taken once daily.
• Administration: Lipanthyl Penta 145 may be taken at any time of the day, with or without food. Swallow the tablet whole with a glass of water.
• Monitoring: Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g., 3 months), complementary or different therapeutic measures should be considered.
• Special Populations:
  • Elderly: In elderly patients without renal impairment, the usual adult dose is recommended.
  • Renal Impairment: Dosage reduction is required in patients with renal impairment. In patients with severe chronic kidney disease, Lipanthyl Penta 145 is not recommended.
  • Hepatic Impairment: Lipanthyl Penta 145 is not recommended for use in patients with hepatic impairment due to the lack of data.
  • Pediatric Population: The safety and efficacy of fenofibrate in children and adolescents younger than 18 years have not been established. Therefore, the use of fenofibrate is not recommended in pediatric subjects under 18 years.