Omnipix 135

Omnipix 135

Manufacturer:

Unison

Distributor:

Unison

Marketer:

Unison
Concise Prescribing Info
Contents
Choline fenofibrate (as fenofibric acid)
Indications/Uses
In combination w/ statins for mixed dyslipidemia in patients w/ CHD or CHD risk equiv who are receiving optimal statin therapy; decrease elevated serum total cholesterol & LDL, triglyceride, & Apo B conc & increase HDL conc in the management of primary hypercholestrolemia & mixed dyslipidemia; severe hypertrigylceridemia.
Dosage/Direction for Use
Hypercholesterolemia or mixed hyperlipidemia 135 mg once daily. Hypertriglyceridemia 45-135 mg once daily.
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. Active liver disease including primary biliary cirrhosis & unexplained, persistent liver function abnormality. Pre-existing gallbladder disease. Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia. Severe renal impairment or ESRD including those receiving dialysis. Lactation.
Special Precautions
May significantly elevate hepatic transaminases. Patients w/ mild to moderate renal impairment. Discontinue in patients who develop markedly elevated creatine phosphokinase conc or if myopathy/myositis is suspected or diagnosed. Severe hypertriglyceridemia. Pancreatitis.
Adverse Reactions
Dizziness, pain, skin rash, abdominal pain, cholecystitis, constipation, diarrhea, dyspepsia, abnormal hepatic function tests, hepatocellular hepatitis, increased serum ALT/AST, arthralgia, increased creatine phosphokinase, myalgia, myopathy, sinusitis, URTI.
Drug Interactions
May increase risk of myopathy including rhabdomyolysis w/ colchicine & statins. May enhance effect of anticoagulants. May increase conc of ezetimibe. May increase risk of hypoglycemia w/ insulin, glimepiride. Increased risk of renal function deterioration w/ cyclosporine.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AB11 - choline fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Omnipix 135 cap 135 mg
Packing/Price
3 × 10's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in