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AA-FENO-SUPER is a brand name for Fenofibrate, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................................................3 CONTRAINDICATIONS .........................................................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Patients should be placed on a standard cholesterol-lowering diet (at least equivalent to the Adult Treatment Panel III (ATP III TLC diet)) before receiving AA-FENO-SUPER (fenofibrate tablets), and should continue on this diet during treatment with AA-FENO-SUPER.
If appropriate, a program of weight control and physical exercise should be implemented. Prior to initiating therapy with AA-FENO-SUPER, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed.
If a significant serum lipid response is not obtained in three months, AA-FENO-SUPER should be discontinued. In patients with renal insufficiency (creatinine clearance between 30 and 60 ml/min), AA-FENO- SUPER treatment should be initiated at the dose of 100 mg/day and increased only after evaluation of the tolerance and effects on the lipid parameters.
If no low dose is available, then fenofibrate is not recommended. AA-FENO-SUPER is contraindicated when the creatinine clearance is lower than 30 ml/min. Recommended Dose and Dosage Adjustment The usual recommended dose for AA-FENO-SUPER in adults is one 160 mg tablet daily taken with the main meal.
Tablets should be swallowed whole with a glass of water. The maximum recommended total daily dose of AA-FENO-SUPER is 200 mg (2 tablets of 100 mg).
Missed Dose:
If a dose is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose. Administration Tablets can be taken any time with or without food and should be swallowed whole (not crushed or chewed) with a glass of water.
OVERDOSAGE While there has been no reported case of overdosage, symptomatic and supportive measures should be taken. Fenofibrate is not dialysable because the main metabolite (fenofibric acid) is highly bound to plasma proteins. Page 17 of 38 For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Fenofibrate lowers elevated serum lipids by decreasing the low density lipoprotein (LDL) fraction rich in cholesterol and the very low density lipoprotein (VLDL) fraction rich in triglycerides.
Patients who are hypersensitive to fenofibrate or to any ingredients in the formulation of components of the container. For complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING. Hepatic insufficiency (including primary biliary cirrhosis and unexplained persistent liver function abnormality).
Pre-existing gallbladder disease (see WARNINGS AND PRECAUTIONS). Severe renal dysfunction (creatinine clearance of < 30ml/min). Chronic or acute pancreatitis. Hypersensitivity to fenofibrate, any component of this medication or other drugs of the fibrate class.
Should not be taken in patients allergic to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions. The drug should not be used during pregnancy and breast-feeding. Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
Should not be co-administered with HMG-CoA reductase inhibitors (statins) in patients with pre-disposing factors for myopathy. Under 18 years of age. WARNINGS AND PRECAUTIONS General Fenofibrate and HMG-CoA Reductase Inhibitors (Statins) The concomitant administration of fenofibrate and statins should be avoided unless the benefit for further alteration in lipid levels is likely to outweigh the increased risk of this combination.
The concomitant administration of fenofibrate with Pravastatin (40 mg) once daily for 10 days, in healthy adults, increased the mean Cmax and AUC values for pravastatin by 36% (range: from a 69% decrease to a 321% increase) and 28% (range: from a 54% decrease to a 128% increase), respectively.
Co-administration of fenofibrate with Pravastatin also increased the mean Cmax and AUC of the major metabolites, 3-alpha-hydroxy- isopravastatin by 55% (range: from a 32% decrease to a 314% increase) and 39% (range: from a 24% decrease to a 261% increase), respectively.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In addition, fenofibrate increases the high density lipoprotein (HDL) cholesterol fraction. Fenofibrate appears to have a greater depressant effect on the VLDL than on the low density lipoproteins (LDL). Therapeutic doses of fenofibrate produce elevations of HDL cholesterol, a reduction in the content of the low density lipoproteins cholesterol, and a substantial reduction in the triglyceride content of VLDL.
Pharmacodynamics:
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated by the activation of a specific nuclear receptor called peroxisome proliferator activated receptor alpha (PPARα), which produces: • a reduction in apo C-III, and therefore a reduction in the level of dense atherogenic LDL particles; • a stimulation of mitochondrial beta-oxidation, and therefore a reduction in triglyceride secretion; • a rise in lipoprotein lipase production, and therefore an acceleration of triglyceride rich lipoprotein breakdown; • a rise in apo A-I and apo A-II production.
Absorption:
Fenofibrate’s absorption is low and variable when the product is administered under fasting conditions. Fenofibrate’s absorption is increased when the compound is given with food.
Distribution:
Fenofibric acid is extensively bound (> 99 %) to plasma albumin. This binding is not saturable. Metabolism and Excretion After oral administration, fenofibrate is rapidly hydrolysed to fenofibric acid. Page 18 of 38 Excretion In man it is mainly excreted through the kidney.
Half-life is about 20 hours.
Special Populations and Conditions Pediatrics:
Limited experience is available in children and adolescents, at the dose of 5 mg/kg/day fenofibrate non-micronized formulation. However, safety and effectiveness have not been established in this sub-population (see selected bibliography).
Renal Insufficiency:
In patients with severe renal failure, significant accumulation was observed with a large increase in half-life. Therefore, fenofibrate is contraindicated. (See Dosing Considerations, DOSAGE AND ADMINISTRATION) STORAGE AND STABILITY Store at 15oC to 30oC.
Protect from moisture and light. DOSAGE FORMS, COMPOSITION AND PACKAGING AA-FENO-SUPER (fenofibrate tablets) contain, in addition to fenofibrate, the following non- medicinal ingredients: Croscarmellose sodium, hydroxypropyl cellulose Type LF, hydroxypropyl methylcellulose 2910 E5, polyethylene glycol 8000, titanium dioxide and purified water.
AA-FENO-SUPER (fenofibrate) 100 mg Tablets:
Each white, oval, biconvex, film-coated tablet, plain on one side and, "FEN100" on the other side, contains 100 mg of fenofibrate. Available in bottles of 100 tablets and in blister packs of 30 tablets.
AA-FENO-SUPER (fenofibrate) 160 mg Tablets:
Each white, oval, biconvex, film-coated tablet, plain on one side and, "FEN160" on the other side, contains 160 mg of fenofibrate. Available in bottles of 100 tablets and in blister packs of 30 tablets.
AA-FENO-SUPER (fenofibrate) 200 mg Tablets:
Each white, oval, biconvex, film-coated tablet, plain engraved “APO” on one side and "200" on the other side, contains 200 mg of fenofibrate. Available in HDPE bottles of 100 tablets.
Page 19 of 38 PART II:
SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION Drug Substance Proper Name: Fenofibrate Chemical Name: 1) Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2- methylpropionate. 2) 2-(4-(4-chlorobenzoyl) phenoxy)-2-methyl-propanoic acid 1- methylethyl ester.
84 g/mol Description: Fenofibrate is a crystalline, white to off-white odourless powder. It has a melting point range of 79o to 82 o C. It is practically insoluble in water, sparingly soluble in methanol, and freely soluble in acetone and ether.
It is […]
The combined use of fibric acid derivatives and HMG-CoA reductase inhibitors has been associated, in the absence of a marked pharmacokinetic action, in numerous case reports, with rhabdomyolysis, markedly elevated creatine kinase (CK) levels and myoglobinuria, leading to a high proportion of cases to acute renal failure.
Page 5 of 38 This combination therapy must not be used in patients with predisposing factors for myopathy (pre-existing myopathy, age >70 years, renal impairment, hepatic impairment, severe infection, surgery and trauma, frailty, hypothyroidism or electrolyte imbalance, personal or family history of hereditary muscular disorders, previous history of muscle toxicity with another HMG-CoA reductase inhibitor, concomitant use of a fibrate, niacin or ezetimibe, alcohol abuse, excessive physical exercise, diabetes with hepatic fatty change situations where an increase in plasma levels of active ingredient may occur).
For information on a specific HMG-CoA reductase inhibitor, consult a respective Product Monograph. The use of fibrates alone, including fenofibrate, may occasionally be associated with myositis, myopathy or rhabdomyolysis. Patients receiving fenofibrate and complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myopathy, including serum creatine kinase level determination.
If myopathy and or myositis is suspected or diagnosed, fenofibrate therapy should be stopped. Initial Therapy Before instituting AA-FENO-SUPER therapy, laboratory tests should be conducted to ensure that lipid levels are consistently abnormal.
Attempts should be made to control serum lipids with appropriate diet, exercise and weight loss in obese patients. Secondary causes of hypercholesterolemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment and excessive alcohol intake should be adequately treated before fenofibrate therapy is initiated.
In patients at high risk, consideration should be given to the control of other risk factors such as smoking, use of preparations containing estrogen and inadequately controlled hypertension. Long-term therapy Because long-term administration of fenofibrate is recommended, the potential risks and benefits should be carefully weighed.
Adequate pretreatment laboratory studies should be performed to ensure that patients have elevated serum cholesterol and/or triglycerides or low HDL-cholesterol levels. g. total cholesterol, LDL-C, triglycerides). If a significant serum lipidil response is not obtained in 3 months, AA-FENO-SUPER should be discontinued.
Carcinogenesis and Mutagenesis Carcinogenicity In long-term animal toxicity and carcinogenicity studies fenofibrate has been shown to be tumorigenic for the liver in male rats at 12 times the human dose. At this dose level in male rats there was also an increase in benign Leydig cell tumors.
Pancreatic acinar cell tumors were increased in male rats at 9 and 40 times the human dose. However, mice and female rats were unaffected at similar doses. Florid hepato-cellular peroxisome proliferation has been observed Page 6 of 38 following fenofibrate administration to rats.
5 years of fenofibrate administration. Hematologic Haematologic changes Mild hemoglobin, haematocrit and white blood cell decreases have been observed occasionally in patients following initiation of fenofibrate therapy. However, these levels stabilize during long-term administration.
Periodic blood counts are recommended during the first 12 months of fenofibrate administration. Hepatic/Biliary/Pancreatic Hepatobiliary disease AA-FENO-SUPER is not recommended for use in patients with hepatic impairment due to the lack of data.
Fenofibrate may increase cholesterol excretion into the bile, and may lead to cholelithiasis. Pancreatitis In common with some other fibrates, pancreatitis has been reported in patients […]