Prava 40

Prava 40

pravastatin

Manufacturer:

Intas Pharmaceuticals

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Pravastatin Na
Indications/Uses
As adjunct to diet in treatment of primary hypercholesterolaemia or mixed dyslipidaemia when response to diet & other non-pharmacological treatments is inadequate. As adjunct to diet in reduction of CV mortality & morbidity in patients w/ moderate or severe hypercholesterolaemia & high risk of a 1st CV event. As adjunct to correction of other risk factors in reduction of CV mortality & morbidity in patients w/ history of MI or unstable angina pectoris & w/ either normal or increased cholesterol levels. Reduction of post-transplantation hyperlipidemia in-patient receiving immunosuppresive therapy following solid organ transplantation.
Dosage/Direction for Use
Hypercholesterolaemia Recommended dose: 10-40 mg once daily. May be increased to 80 mg daily. CV prevention 40 mg daily. Post-transplantation Initially 10 mg daily. May be adjusted up to 20 mg. Childn & adolescent w/ heterozygous familial hypercholesterolaemia 14-18 yr Recommended dose: 10-40 mg once daily, 8-13 yr 10-20 mg once daily. Moderate or severe renal impairment, significant hepatic impairment 10 mg daily. Patients taking cyclosporine w/ or w/o other immunosuppressive drugs Initially 10 mg once daily. Max: 20 mg/day.
Administration
May be taken with or without food: Take in the evening.
Contraindications
Hypersensitivity. Active liver disease or unexplained, persistent elevations of serum transaminase elevation exceeding 3x ULN. Pregnancy & lactation.
Special Precautions
Use in patients w/ hepatic disease is contraindicated. Evaluate liver function prior to therapy & after 6 & 12 wk of treatment. Examine for liver function every 6 mth in patients receiving long-term therapy. Discontinue use if transaminase level is 3x ULN; if serious liver injury &/or hyperbilirubinemia or jaundice occurs. Concomitant use w/ digoxin or warfarin; azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone; colchicine especially for elderly or w/ renal impairment; gemfibrozil. Risk of rhabdomyolysis is increased by use of high dosage, elderly patients, patients w/ hepatic or renal impairment, chronic alcohol intake, hypothyroidism. Risk of hyperglycemia. Heavy alcohol use, recent history or suspected liver disease. Preexisting amyotrophic lateral sclerosis. Temporarily withhold or discontinue in any patients w/ predisposing conditions to renal failure secondary to rhabdomyolysis. Patients <8 yr.
Adverse Reactions
Dizziness, headache, sleep disturbances, insomnia; vision disturbance (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, frequency, nocturia); sexual dysfunction; fatigue.
Drug Interactions
Increased risk of muscle-related adverse events including rhabdomyolysis w/ fibrates (eg, gemfibrozil, fenofibrate). Decreased bioavailability w/ cholestyramine/colestipol. Increased AUC  w/ cyclosporine. Increased AUC & Cmax w/ erythromycin & clarithromycin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA03 - pravastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Prava 40 tab 40 mg
Packing/Price
3 × 10's
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