Omnipix 135 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Choline fenofibrate (as fenofibric acid)

Indications/Uses

Adjunct to dietary therapy for mixed dyslipidemia, in combination w/ statin, in patients w/ CHD or CHD risk equiv [other clinical forms of atherosclerotic disease (peripheral arterial & symptomatic carotid artery disease, abdominal aortic aneurysm), diabetes, multiple risk factors that confer 10-yr risk for CHD >20%] who are receiving optimal statin therapy; to decrease elevated serum total cholesterol & LDL-C, triglyceride, & Apo B conc & to increase HDL-C conc in management of primary hypercholestrolemia & mixed dyslipidemia; for management of severe hypertrigylceridemia.

Click to view Omnipix 135 detailed prescribing information

Dosage/Direction for Use

Adult Hypercholesterolemia or mixed hyperlipidemia 135 mg once daily. Hypertriglyceridemia 45-135 mg once daily. Renal impairment (eGFR 30-59 mL/min/1.73 m²) Initially 45 mg once daily.

Click to view Omnipix 135 detailed prescribing information

Overdosage

View Omnipix 135 overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: Swallow whole, do not open/chew/crush/dissolve.

Contraindications

Hypersensitivity to fenofibrates or fenofibric acid. Known photoallergy or phototoxic reaction during treatment w/ fibrates or ketoprofen. Chronic or acute pancreatitis w/ exception of acute pancreatitis due to severe hypertriglyceridemia. Active liver disease including primary biliary cirrhosis & unexplained, persistent liver function abnormality. Pre-existing gallbladder disease. Severe renal impairment or ESRD including those receiving dialysis. Lactation.

Click to view Omnipix 135 detailed prescribing information

Special Precautions

Discontinue therapy in patients whose enzyme levels persist >3x ULN; who develop markedly elevated creatine phosphokinase conc or if myopathy/myositis is suspected or diagnosed. Dose-related elevation of hepatic transaminases; hepatocellular, chronic active & cholestatic hepatitis after wk to several yr of therapy. Patients w/ severe hypertriglyceridemia; diabetes. Regularly monitor baseline LFTs. Mild to moderate renal impairment. Ped. Elderly.

Click to view Omnipix 135 detailed prescribing information

Use In Pregnancy & Lactation

Click to view Omnipix 135 detailed prescribing information

Adverse Reactions

Pulmonary embolism, thrombophlebitis; dizziness, pain; skin rash, SJS, TEN, urticaria; abdominal pain, cholecystitis (requiring surgery), constipation, diarrhea, dyspepsia; agranulocytosis, decreased hematocrit, Hb & WBC, thrombocytopenia; abnormal hepatic function tests, cholestatic, chronic active & hepatocellular hepatitis, increased serum ALT & AST; arthralgia, increased creatine phosphokinase, limb pain, myalgia, myopathy, toxic myopathy; nasopharyngitis, rhinitis, sinusitis, URTI; acute renal failure, anemia, decreased HDL cholesterol, hepatic cirrhosis, hepatitis, muscle spasm, myalgia, pancreatitis, renal failure, rhabdomyolysis.

Click to view Omnipix 135 detailed prescribing information

Drug Interactions

Increased risk of myopathy including rhabdomyolysis w/ colchicine, simvastatin, atorvastatin, pitavastatin, rosuvastatin, pravastatin, or fluvastatin. Enhanced anticoagulant effect w/ anticoagulants. Paradoxical decrease in HDL-C w/ rosiglitazone. Increased ezetimibe conc & risk of cholelithiasis w/ concomitant use. Increased risk of neutropenia w/ mycophenolate. Increased risk of hypoglycemia w/ glimepiride & insulin. Increased glimepiride exposure. Decreased effectiveness w/ cholestyramine. Increased risk of renal function deterioration w/ cyclosporine.

Click to view Omnipix 135 detailed prescribing information

Storage

View Omnipix 135 storage conditions for details to ensure optimal shelf-life.

Description

View Omnipix 135 description for details of the chemical structure and excipients (inactive components).

Action

View Omnipix 135 mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Dyslipidaemic Agents

ATC Classification

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

Thai FDA Category

Presentation/Packing

Form

Omnipix 135 MR cap 135 mg

Packing/Price

3 × 10's

Omnipix 135

Manufacturer:

Unison

Distributor:

Unison

Marketer:

B.Grimm Pharma