Fenostad 160

Rx

Indications: 

Fenostad 160 is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

• Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
• Mixed hyperlipidaemia when a statin is contraindicated or not tolerated or in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

Dosage:

• Adults, geriatric populations: The recommended dose is one tablet containing 160 mg fenofibrate taken once daily. Patients currently taking one fenofibrate 200 mg capsule can be changed to one fenofibrate 160 mg tablet without further dose adjustment.
• Renal impairment: Dosage reduction is required.
• Severe chronic kidney disease, hepatic impairment, children < 18 years: Fenofibrate is not recommended for use.

Usage: 

Fenostad 160 should be swallowed whole during a meal.

• Known hypersensitivity to any of the active substance or excipients.
• Severe renal dysfunction.
• Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
• Known gallbladder disease.

Common: Gastrointestinal disorders, epigastric fullness, nausea, meteorism, mild diarrhea; hives, urticaria, cutaneous non-specific rash; rise in serum transaminases; muscular pain.

• Measurement of transaminases every 3 months, during the first 12 months of treatment. If serum aminotransferase concentrations of 3 times the upper limit of normal or higher persists, fenofibrate should be discontinued.
• Fenofibrate therapy should be discontinued if gallbladder studies indicate the presence of gallstones, serum CPK concentrations become markedly elevated or if myositis/myopathy is suspected or diagnosed.
• Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis, pancreatitis.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine.
• This drug should not be used during pregnacy and lactation.
• Patients should be aware of how they react to drug before driving or operating machinery.