Livalo

Livalo

pitavastatin

Manufacturer:

Kowa

Distributor:

DKSH
Concise Prescribing Info
Contents
Pitavastatin Ca
Indications/Uses
Reduction of elevated total cholesterol & LDL-C in adults, adolescents & childn ≥6 yr w/ primary hypercholesterolaemia including heterozygous familial hypercholesterolaemia & combined (mixed) dyslipidaemia w/ inadequate response to diet & other non-pharmacological measures.
Dosage/Direction for Use
Adult Initially 1-2 mg once daily, dose adjustments at ≥4 wk intervals. Max: 4 mg daily. Heterozygous familial hypercholesterolaemia Childn & adolescent ≥6 yr Initially 1 mg once daily, dose adjustments at ≥4 wk intervals, 6-9 yr Max: 2 mg daily, ≥10 yr Max: 4 mg daily. Mild to moderate hepatic & moderate to severe renal impairment, ESRD on hemodialysis Initially 1 mg once daily. Max: 2 mg once daily.
Administration
May be taken with or without food: For patients w/ difficulty swallowing, tab may be dispersed in a glass of water to be taken immediately. Do not disperse in acidic fruit juices or milk.
Contraindications
Hypersensitivity to pitavastatin or other statins. Myopathy; active liver disease or unexplained persistent elevated serum transaminases >3 x ULN. Concomitant use w/ ciclosporin. Severe hepatic impairment. Women of childbearing potential not taking adequate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatinine kinase (>5 x ULN) or ILD is suspected. Predisposing factors for rhabdomyolysis eg, hypothyroidism, history of hereditary muscular disorders or toxicity. Immune-mediated necrotising myopathy; DM. Perform LFTs prior to initiation & periodically thereafter. Avoid excessive alcohol consumption. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be co-administered w/ fusidic acid or w/in 7 days of discontinuation; erythromycin, other macrolide antibiotics. Concomitant use w/ myopathy-causing drugs eg, fibrates or niacin. May affect ability to drive & use machines. History of liver disease; hepatic & renal impairment. Women of childbearing potential should use effective contraception during treatment. Childn <6 yr. Elderly >70 yr.
Adverse Reactions
Headache; constipation, diarrhoea, dyspepsia, nausea; myalgia, arthralgia.
Drug Interactions
Increased AUC w/ ciclosporin, erythromycin, rifampicin, gemfibrozil, fenofibrates. Increased myopathy & rhabdomyolysis w/ fibrates, niacin, fusidic acid. Monitor INR & prothrombin time w/ warfarin. Minor AUC change w/ lopinavir/ritonavir, darunavir/ritonavir, atazanavir, efavirenz.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Livalo FC tab 2mg
Packing/Price
3 × 10's
Form
Livalo FC tab 4 mg
Packing/Price
3 × 10's
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