Omnipix 135

Opaque dark blue/yellow capsule no. 0 with printed 135 in black color and contained 12 white mini-tablets.
Each modified release capsule contains Choline fenofibrate 178.80 mg eq. to Fenofibric acid 135 mg.

Pharmacology: Pharmacodynamics: Fenofibric acid is an agonist for the nuclear transcription factor peroxisome proliferator activated receptor-alpha (PPAR-α).
Fenofibric acid downregulates apoprotein C-III (an inhibitor of lipoprotein lipase) and upregulates the synthesis of apolipoprotein A-I, fatty acid transport protein, and lipoprotein lipase resulting in an increase in VLDL catabolism, fatty acid oxidation, and elimination of triglyceride-rich particles; as a result of a decrease in VLDL levels, total plasma triglycerides are reduced by 30% to 60%; modest increase in HDL occurs in some hypertriglyceridemic patients.
Pharmacokinetics: Absorption: Increased when taken with meals. Peak concentrations and AUC were not significantly different when a single dose was administered under fasting and nonfasting conditions. Administer with or without food.
Distribution: Widely to most tissues, Protein binding: ~99%.
Metabolism: Fenofibric acid undergoes inactivation by glucuronidation.
Bioavailability: ~81%.
Half-life elimination: Mean: 20 hours (range: 10 to 35 hours); half-life prolonged in patients with renal impairment.
Time to peak: 2 to 8 hours.
Excretion: Urine (~60% as metabolites); feces (25%).
Hemodialysis has no effect on removal of fenofibric acid from plasma.

Used as adjuncts to dietary therapy: Fenofibric acid is used in combination with statin for treatment of mixed dyslipidemia in patients with coronary heart disease (CHD) or CHD risk equivalents [Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease), diabetes, multiple risk factors that confer a 10-year risk for CHD >20%] who are receiving optimal statin therapy.
Fenofibric acid is used to decrease elevated serum total and low-density lipoprotein (LDL)-cholesterol, triglyceride, and apolipoprotein B (apo B) concentrations, and to increase high-density lipoprotein (HDL)-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia.
Fenofibric acid is used in the management of severe hypertriglyceridemia.

Administer with or without food. Swallow whole, do not open (capsules), crush, dissolve, or chew.
When fenofibric acid is used in combination with statin, the daily dose of fenofibric acid may be administered at the same time as the statin.
Adult: Hypercholesterolemia or mixed hyperlipidemia: Oral: 135 mg once daily.
Hypertriglyceridemia: Oral 45 to 135 mg once daily.
Geriatric: Adjust dosage based on renal function.
Renal impairment: eGFR 30-59 mL/min/1.73 m²; Initiate at 45 mg once daily.
eGFR <30 mL/min/1.73 m²; Use is contraindicated.
Hepatic impairment: Fenofibric acid have not been evaluated in patients with hepatic impairment.
Use is contraindicated. Regular monitoring of liver function tests is required; discontinue therapy in patients whose enzyme levels persist above 3 times the upper limit of normal.
Pediatric: Safety and efficacy of fenofibric acid has not been established in pediatric patients.

A specific toxic dose has not been established.
Treatment is symptomatic and supportive. Observe clinical status and vital signs in substantial ingestions.

Hypersensitivity to fenofibrate or fenofibric acid or any component of the formulation.
Active liver disease, including primary biliary cirrhosis and unexplained, persistent liver function abnormality.
Severe renal impairment or end-stage renal disease (ESRD), including those receiving dialysis.
Preexisting gallbladder disease.
Breast-feeding.
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.
When Omnipix is co-administered with a statin, refer to the contraindications section of the respective statin labeling.

Hepatic transaminases can become significantly elevated (dose-related); hepatocellular, chronic active, and cholestatic hepatitis have been reported after weeks to several years of therapy. Baseline and regular monitoring of liver function tests is required; discontinue therapy in patients whose enzyme levels persist above 3 times the upper limit of normal.
Use with caution in patients with mild to moderate renal impairment; monitoring renal function in patients with renal impairment and consider monitoring patients with increased risk for developing renal impairment (eg, elderly and patients with diabetes).
Therapy should be discontinued in patients who develop markedly elevated creatine phosphokinase (CPK) concentrations or if myopathy/myositis is suspected or diagnosed.
In patients with severe hypertriglyceridemia, the occurrence of pancreatitis may represent a failure of efficacy, a direct effect of the drug, or obstruction of the common bile duct due to biliary tract stone or sludge formation.

Pregnancy risk factor C.
It is not known if fenofibrate is excreted in breast milk. Use of fenofibrate in breast-feeding mothers is contraindicated. Due to the potential for serious adverse reactions in breast-feeding infant, a decision should be made whether to discontinue breast-feeding or to discontinue this drug, taking into account the importance of treatment to the mother.

Cardiovascular: Pulmonary embolism, thrombophlebitis.
Central nervous system: Dizziness, pain.
Dermatologic: Skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Gastrointestinal: Abdominal pain, cholecystitis (requiring surgery), constipation, diarrhea, dyspepsia.
Hematologic & Oncologic: Agranulocytosis, decreased hematocrit (acute; levels stabilize with chronic therapy), decreased hemoglobin (acute; levels stabilize with chronic therapy), decreased white blood cell count (acute; levels stabilize with chronic therapy), thrombocytopenia.
Hepatic: Abnormal hepatic function tests, cholestatic hepatitis, chronic active hepatitis, hepatocellular hepatitis, increased serum ALT (>3 x ULN; dose dependent), increased serum AST (>3 x ULN; dose dependent).
Neuromuscular & skeletal: Arthralgia, increased creatine phosphokinase, limb pain, myalgia, myopathy, toxic myopathy.
Respiratory: Nasopharyngitis, rhinitis, sinusitis, upper respiratory tract infection.
Rare but important or life-threatening: Acute renal failure, anemia, decreased HDL cholesterol, hepatic cirrhosis, hepatitis, muscle spasm, myalgia, pancreatitis, renal failure, rhabdomyolysis.

Concurrent use of fenofibric acid and colchicine, simvastatin, atorvastatin, pitavastatin, rosuvastatin, pravastatin or fluvastatin may result in an increased risk of myopathy, including rhabdomyolysis.
Concurrent use of fenofibrate and anticoagulants may result in enhanced anticoagulant effect.
Concurrent use of fenofibrate and rosiglitazone may result in paradoxical decrease in HDL-C.
Concurrent use of fenofibrate and ezetimibe may result in increased ezetimibe concentrations and an increased risk of cholelithiasis.
Concurrent use of fenofibrate and mycophenolate may result in an increased risk of neutropenia.
Concurrent use of fenofibrate and glimepiride may result in increased glimepiride exposure and increased blood glucose lowering effect and risk of hypoglycemia.
Concurrent use of fenofibric acid and cholestyramine may result in decreased fenofibric acid effectiveness.
Concurrent use of fibrates and insulin may result in increased risk of hypoglycemia.
Concurrent use of fenofibric acid and cyclosporine may result in increased risk of renal function deterioration.

Store below 30°C.

Dyslipidaemic Agents

C10AB11 - choline fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

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