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Fenofibrate 200 mg capsules
| Fenofibrate 200 mg capsules are 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. - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled. |
| Adults The recommended initial dose is one capsule taken daily during a main meal. In elderly patients without renal impairment, the normal adult dose is recommended. Since it is less well absorbed from an empty stomach, Fenofibrate 200 mg capsules should always be taken with food. Dietary restrictions instituted before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. Rapid reduction of serum lipid levels usually follows Fenofibrate 200 mg capsule treatment, but treatment should be discontinued if an adequate response has not been achieved within three months. Renal failure A dose reduction is recommended in renal impairment (see section 4.4) Paediatric population The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore, the use of fenofibrate is not recommended in paediatric subjects under 18 years |
| Fenofibrate 200 mg capsules are contraindicated in children, in patients with severe liver dysfunction, gallbladder disease, bilary cirrhosis, severe renal disorders and in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen. Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia. Use during pregnancy and lactation (see section 4.6). This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. |
| Secondary causes of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is initiated. Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-C, triglycerides). If an adequate response has not been achieved after several months (e.g. 3 months) complementary or different therapeutic measures should be considered. Renal impairment In renal dysfunction the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance. In this case, Fenofibrate 67 mg capsules should be used, e.g. 2 Fenofibrate 67 mg capsules daily for creatinine clearance levels of <60 ml/min and 1 Fenofibrate 67 mg capsule daily for creatinine clearance levels of <20 ml/min. It is recommended that creatinine is measured during the first three months after initiation of treatment and thereafter periodically. Treatment should be interrupted in case of an increase in creatinine levels > 50% of (upper limit of normal). Use of Fenofibrate 67 mg capsules are also to be preferred in elderly patients with renal impairment where dosage reduction may be required. Serum Transaminases Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment. However, it is recommended that serum transaminases should be monitored every three months during the first twelve months of treatment. Treatment should be interrupted in the event of ALAT (SGPT) or ASAT (SGOT) elevations to more than 3 times the upper limit of the normal range or more than one hundred international units. Pancreatitis Pancreatitis has been reported in patients taking fenofibrate (see section 4.8). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct. Myopathy Muscle toxicity, including very rare cases of rhabdomyolysis, has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency. Patients with pre-disposing factors for myopathy and/or rabdomyolysis, including age above 70 years, personal or family history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may also be at an increased risk of developing rabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up. Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in CPK (levels exceeding 5 times the normal range). In such cases treatment with fenofibrate should be stopped. The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in cases of pre-existing muscular disease. Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity. For hyperlipidaemic patients taking oestrogens or contraceptives containing oestrogen it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by oral oestrogen). |
| Oral anti-coagulants Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. In patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by about one-third at the commencement of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring. HMG-CoA reductase inhibitors or Other Fibrates The risk of serious muscle toxicity is increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity(see Section 4.4). There is currently no evidence to suggest that fenofibrate affects the pharmacokinetics of simvastatin. Ciclosporin Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters. Other No proven clinical interactions of fenofibrate with other drugs have been reported, although in vitro interaction studies suggest displacement of phenylbutazone from plasma protein binding sites. In common with other fibrates, fenofibrate induces microsomal mixed-function oxidases involved in fatty acid metabolism in rodents and may interact with drugs metabolised by these enzymes. |
| The adverse drug reactions are stated in the table below using the following convention: Very common (>1/10); common (>1/100; <1/10); uncommon (>1/1,000; <1/100); rare (>1/10,000; <1/1,000); very rare (<1/10,000) including isolated reports.
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Dear Teman dan Dokter Milis.Ingin bertanya, saya karena trigleserida yang agak tinggi, sedang minum fenofibrate 200mg.Apakah ada efek nya..?Saya merasakan saat ini seperti susah bernafas..apakah ini efek dari obat ini atau bukan..?thanksAri
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"Absolutely Drug less Health Care solution Organization"
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