Fenofibrate


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Severe hypertriglyceridaemia
Adult: As an adjunct to diet and other non-pharmacological treatment: Dose is individualised according to the patient’s response. Standard micronised formulation: Initially, 200 mg once daily; may increase if necessary to 267 mg once daily. Max: 200 mg once daily (with concomitant statin therapy); 267 mg once daily (if not on concomitant statin therapy). Alternatively, 67 mg up to 200 mg once daily may be given. Micronised formulations with improved bioavailability are also available in doses of 160 mg once daily. Non-micronised formulation: Initially, 54 mg up to 160 mg once daily. Nanoparticle formulation: 145 mg once daily. Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.

Oral
Mixed hyperlipidaemia, Primary hypercholesterolaemia
Adult: In patients at high CV risk in addition to a statin, or when a statin is contraindicated or not tolerated: As an adjunct to diet and other non-pharmacological treatment: Dose is individualised according to the patient’s response. Standard micronised formulation: Initially, 200 mg once daily; may increase if necessary to 267 mg once daily. Max: 200 mg once daily (with concomitant statin therapy); 267 mg once daily (if not on concomitant statin therapy). Micronised formulations with improved bioavailability are also available in doses of 160 mg once daily. Non-micronised formulation: 160 mg once daily. Nanoparticle formulation: 145 mg once daily. Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Suy thận
eGFR <30 mL/min/1.73 m2: Contraindicated. eGFR 30-59 mL/min/1.73 m2: Max: 67 mg once daily (micronised formulation); 100 mg once daily (non-micronised formulation). Dosage recommendations may vary based on individual product preparations and between countries. Refer to specific product guidelines.
Suy gan
Contraindicated.
Cách dùng
Should be taken with food.
Chống chỉ định
Hypersensitivity. Active liver disease, including primary biliary cirrhosis, unexplained persistent liver function abnormality; known gallbladder disease, chronic or acute pancreatitis (except acute pancreatitis due to severe hypertriglyceridaemia), known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen. Severe renal impairment or ESRD, including those receiving haemodialysis. Lactation.
Thận trọng
Patients with pre-disposing factors for myopathy and/or rhabdomyolysis (e.g. diabetes mellitus, personal or familial history of hereditary muscular disorders, hypoalbuminaemia, hypothyroidism, high alcohol intake, concomitant use with HMG-CoA reductase inhibitors or colchicine), risk factors for venous thromboembolism. Mild to moderate renal impairment. Elderly. Pregnancy.
Tác dụng không mong muốn
Significant: Cholelithiasis, severe decrease in HDL cholesterol; agranulocytosis, thrombocytopenia, delayed hypersensitivity reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms), myositis, myopathy, rhabdomyolysis, pancreatitis, photosensitivity, DVT, pulmonary embolism, increased level of serum creatinine, ALT, AST.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, flatulence, constipation.
General disorders and administration site conditions: Fatigue.
Hepatobiliary disorders: Jaundice, cholangitis, cholecystitis, biliary colic.
Investigations: Increased blood homocysteine level.
Musculoskeletal and connective tissue disorders: Myalgia, muscular spasms and weakness, arthralgia.
Nervous system disorders: Headache.
Reproductive system and breast disorders: Sexual dysfunction.
Respiratory, thoracic and mediastinal disorders: Interstitial lung disease.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Potentially Fatal: Serious drug-induced liver injury; acute hypersensitivity reactions (e.g. angioedema, anaphylaxis).
Chỉ số theo dõi
Monitor blood counts (during 1st year of therapy), lipid profile (periodically), LFT (baseline and periodically thereafter); renal function (in patients with renal impairment or with risk for developing renal impairment). Monitor for signs and symptoms of myopathy.
Tương tác
May increase the risk of bleeding with oral anticoagulants (e.g. warfarin). May increase the risk of nephrotoxicity with ciclosporin and tacrolimus. Increased risk of myopathy and rhabdomyolysis with colchicine, HMG-CoA reductase inhibitors, and other fibrates. Increased risk of reversible paradoxical reduction of HDL-cholesterol with glitazones. May decrease absorption with bile acid sequestrants.
Tương tác với thức ăn
Increased rate of absorption with food.
Tác dụng
Description: Fenofibrate, a fibric acid derivative, elicits its lipid-modifying effect by activating the peroxisome proliferator-activated receptor-α (PPAR-α) which induces the synthesis of apoproteins A-I and A-II. It also increases VLDL catabolism, fatty acid oxidation, and elimination of atherogenic triglyceride-rich particles by activating lipoprotein lipase and reducing the production of apoprotein CIII (an inhibitor of lipoprotein lipase).
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract. Increased absorption with food. Bioavailability: Approx 81% (fenofibric acid). Time to peak plasma concentration: 2-8 hours.
Distribution: Widely distributed to most tissues. Plasma protein binding: Approx 99% (fenofibric acid).
Metabolism: Rapidly hydrolysed in the tissue and plasma by esterases to its active metabolite, fenofibric acid, then undergoes hepatic or renal inactivation via glucuronidation.
Excretion: Mainly via urine (approx 60% as metabolites); faeces (25%). Elimination half-life: Approx 20 hours (fenofibric acid).
Đặc tính

Chemical Structure Image
Fenofibrate

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3339, Fenofibrate. https://pubchem.ncbi.nlm.nih.gov/compound/Fenofibrate. Accessed May 26, 2022.

Bảo quản
Store between 15-30°C. Protect from light and moisture.
Phân loại MIMS
Thuốc trị rối loạn lipid máu
Phân loại ATC
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Tài liệu tham khảo
Anon. Fenofibrate and Derivatives. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/05/2022.

Anon. Fenofibric acid/Fenofibrate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/05/2022.

Antara Capsules (Lupin Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/05/2022.

Buckingham R (ed). Fenofibrate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/05/2022.

Fenofibrate Capsule (Ajanta Pharma USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/05/2022.

Fenofibrate Tablet (Ajanta Pharma USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/05/2022.

Fenoglide Tablets (Salix Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/05/2022.

Joint Formulary Committee. Fenofibrate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/05/2022.

Lipanthyl Penta 145, Film-coated Tablet (Abbott Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/05/2022.

Lipanthyl Supra 160 mg Tablet (Abbott Laboratories). MIMS Philippines. http://www.mims.com/philippines. Accessed 23/05/2022.

Lipantil Micro 200 mg Capsules (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2022.

Lipantil Micro 267 mg Capsules (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2022.

Lipantil Micro 67 mg Capsules (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2022.

Lipofen Capsules (ANI Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2022.

Supralip 160 mg, Film-coated Tablet (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2022.

Tricor Tablet (AbbVie Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2022.

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