Mixed hyperlipidemia combined with Coronary heart disease or CHD risk equivalent, e.g. Peripheral arterial disease, Celiac aneurysm, Carotid artery disease, diabetes, or within multiple CHD risk factor (age, gender, family history, raised levels of blood cholesterol, raised triglycerides with low HDL- cholesterol, hyper blood pressure, diabetes, smoking, obesity, alcoholism, stress, inactivity

HMG CoA reductase inhibitors; PPAR alpha(Peroxisome Proliferator Activated Receptor type alpha) agonist

Pravastatin Onset of action: Several daysPeak effect: 4 weeksLDL-reduction: 40 mg/day: 34% (for each doubling of this dose, LDL-C is lowered by ~6%)Absorption: Rapidly absorbed; average absorption 34%Distribution: Vd: 0.46 L/kgProtein binding: ~50%Metabolism: Hepatic multiple metabolites; primary metabolite is 3 alpha-hydroxy-iso-pravastatin (2.5% to 10% activity of parent drug), 6-epi-pravastatin; extensive first-pass metabolism, isomerization, hydroxylation, oxidation and conjugationBioavailability: 17%Half-life elimination:Children and Adolescents (4.9 to 15.6 years): 1.6 hours; range: 0.85 to 4.2 hours (Hedman 2003)Clearance:0.81 l/h/kg; renal clearance:0.38l/h/kg secreted by renal tubuleAdults: 77 hours (including all metabolites); Pravastatin: ~2 to 3 hours (Pan 1990); 3 alpha-hydroxy-iso-pravastatin: ~1.5 hours (Gustavson 2005)Time to peak, serum: 1 to 1.5 hoursFenofibrateAbsorption: Increased when taken with mealsDistribution: Widely to most tissues,Vd: 30 LProtein binding: ~99%Metabolism: Fenofibrate is metabolized in the tissue and plasma via esterases to the active form, fenofibric acid; fenofibric acid then undergoes inactivation by glucuronidation hepatically or renallyBioavailability: Fenofibric acid: ~81%Half-life elimination: Fenofibric acid: Mean: 20 hours (range: 10 to 35 hours); half-life prolonged in patients with renal impairment; can not be eliminated by hemodialysisTime to peak: 2 to 8 hoursExcretion: Urine (~60% as metabolites); feces (25%); hemodialysis has no effect on removal of fenofibric acid from plasmaExcretion: Feces (70%); urine (~20%, 8% as unchanged drug)

Hepatic insufficiency, including primary biliary cirrhosis ,active liver disease, unexplained persistent liver function abnormalitiesGallbladder diseaseSevere renal impairmentSerum transaminases, unexplained persistent elevationsNursing mother , Women who are pregnant or may become pregnant; it may cause fetal harm.Concomitant use with gemfibrozil, cyclosporine, danazol, strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, erythromycin, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, voriconazole), or cobicistat-containing products Acute or chronic pancreatitis,except for pancreatitis caused by severe high triglycerideemiaHypersensitivity to fenofibrate, including severe skin rashes (e.g, Stevens-Johnson syndrome, toxic epidermal necrolysis) , or to fenofibric acid, the active metabolite of fenofibrate

Pravastatin is contraindicated in women who are or may become pregnant.Fetal risk of Fenofibrate cannot be ruled out.

Infant risk has been demonstrated.An alternative to this drug should be prescribed or patients should be advised to discontinue breastfeeding.

Pravastatin:As reported in short-term trials; safety and tolerability with long-term use were similar to placebo.1% to 10%:Cardiovascular: Chest pain (4%)Central nervous system: Headache (2% to 6%), fatigue (4%), dizziness (1% to 3%)Dermatologic: Skin rash (4%)Gastrointestinal: Nausea (?7%), vomiting (?7%), diarrhea (6%), heartburn (3%)Genitourinary: Cystitis (interstitial; Huang 2015)Hepatic: Increased serum transaminases (>3x normal on 2 occasions: 1%)Infection: Influenza (2%)Neuromuscular & skeletal: Myalgia (2%)Respiratory: Cough (3%)Fenofibrate:>10%: Hepatic: Increased serum transaminases (?3 x ULN: 5% to 13%)1% to 10%:Cardiovascular: Pulmonary embolism (?5%), thrombophlebitis (?5%)Central nervous system: Dizziness (?3%), pain (?3%)Dermatologic: Skin rash (1%), urticaria (1%)Gastrointestinal: Abdominal pain (5%), diarrhea (?3%), dyspepsia (?3%), constipation (2%)Hepatic: Abnormal hepatic function tests (8%), increased serum alanine aminotransferase (3%), increased serum aspartate aminotransferase (3%)Neuromuscular & skeletal: Arthralgia (?3%), limb pain (?3%), myalgia (?3%), increased creatine phosphokinase in blood specimen (3%)Respiratory: Nasopharyngitis (?3%), sinusitis (?3%), upper respiratory tract infection (?3%), rhinitis (2%)

1 cap contained with pravastatin sodium 40mg and fenofibrate mg QDNote that:in patients receiving clarithromycin, pravastatin dose should be limited to 40 mg/day; in patients receiving cyclosporine: initially, 10 mg/day; max. 20 mg/day

Safety and efficacy not established in pediatric patients.

Renal dysfunction is the contraindication with Pravafen.

Liver dysfunction is the contraindication with Pravafen.

The Certificate of Suitability provided by the to manufactures covers the re -test period and packaging. Moreover, one of ther manufacturer present stability studies for batches stored in long term conditions (2°C~8°C) and accelerated conditions (25°C/60%RH).