Mevalotin Protect

Mevalotin Protect

pravastatin

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo
Concise Prescribing Info
Contents
Pravastatin Na
Indications/Uses
Primary hypercholesterolaemia or mixed dyslipidemia, as an adjunct to diet, in patients who have not responded adequately to diet & other appropriate measures. Primary prevention of CV mortality & morbidity in patients w/ moderate or severe hypercholesterolemia & at high risk of 1st CV event, as an adjunct to diet. Secondary prevention of CV mortality & morbidity (MI, revascularization, ischemic stroke & TIA) in patients w/ history of MI or unstable angina pectoris & w/ either normal or increased cholesterol levels, as an adjunct to correction of other risk factors. Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation.
Dosage/Direction for Use
Hypercholesterolemia 10-40 mg once daily. Max: 40 mg daily. CV prevention Starting & maintenance dose: 40 mg once daily. Organ transplantation (dose after transplantation) Patients receiving immunosuppressive therapy Initially 20 mg daily. May be adjusted up to 40 mg depending on the response of lipid parameters. Moderate to severe renal impairment or significant hepatic impairment Initially 10 mg daily. Concomitant therapy w/ cyclosporin Initially 20 mg once daily. Titration to 40 mg should be performed w/ caution.
Administration
May be taken with or without food: Take in the evening.
Contraindications
Hypersensitivity. Active liver disease including unexplained persistent elevations of serum transaminase exceeding 3 x ULN. Pregnancy & lactation.
Special Precautions
Patients w/ homozygous familial hypercholesterolaemia. History of liver disease & or heavy alcohol ingestion. Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs during treatment; creatine kinase (CK) levels are >5 x ULN. Concomitant use w/ fibrates & colchicine. Myalgia, myopathy & rhabdomyolysis. Do not co-administer w/ systemic formulation of fusidic acid or w/in 7 days of dicontinuation of fusidic acid treatment; reintroduce therapy 7 days after the last dose of fusidic acid. Measure CK levels prior to starting statin therapy in patients w/ predisposing factors (eg, renal impairment, hypothyroidism, previous history of muscular toxicity w/ a statin or fibrate, personal or familial history of hereditary muscular disorders, or alcohol abuse), patients >70 yr, & during treatment in patients developing muscular symptoms; do not re-start therapy in patients w/ hereditary muscular disease. Discontinue if increases in ALT & AST >3 x ULN & if interstitial lung disease develops. Monitor patients at risk of DM. Dizziness may occur & affect driving or operating machinery.
Adverse Reactions
Dizziness, headache, sleep disturbance eg, insomnia or nightmares; vision disturbances (including blurred vision & diplopia); dyspepsia/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, flatulence; pruritus, rash, urticaria, scalp/hair abnormality (including alopecia); abnormal urination (including dysuria, pollakiuria, nocturia); sexual dysfunction; fatigue.
Drug Interactions
Increased risk of muscle-related adverse events w/ fibrates, fusidic acid, colchicine & lenalidomide. Increased systemic exposure w/ cyclosporin. Increased AUC & Cmax w/ rifampicin, erythromycin & clarithromycin. Increased risk of myopathy w/ systemic fusidic acid.
ATC Classification
C10AA03 - pravastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Mevalotin Protect tab 20 mg
Packing/Price
3 × 10's
Form
Mevalotin Protect tab 40 mg
Packing/Price
3 × 10's
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