Pravalip Tablet

Pravastatin is a specific inhibitor of the hepatic HMG-CoA reductase in humans. The inhibition of this enzyme produces a reduction in cholesterol biosynthesis as HMG-CoA reductase activity is an early-limiting step in cholesterol biosynthesis. The inhibitory mechanism of action produces a reduction in cholesterol synthesis which in order has been observed to increase the number of LDL receptors on cell surfaces and an enhancement in receptor-mediated metabolism of LDL and clearance. On the other hand, pravastatin-driven inhibition of LDL production inhibits hepatic synthesis of VLDL as the LDL is the precursor for these molecules.

General Dosing Information: The patient should be placed on a standard cholesterol-lowering diet before receiving pravastatin and should continue on this diet during treatment with pravastatin.

Adult Patients: The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended. pravastatin can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

Children (Ages 8 to 13 Years): The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.

Adolescents (Ages 14 to 18 Years): The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population. Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C.

Concomitant lipid-lowering therapies: use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with Pravalip.

Cyclosporine: combination increases exposure. Limit pravastatin to 20 mg once daily.

Clarithromycin: combination increases exposure. Limit pravastatin to 40 mg once daily.

• Hypersensitivity to any component of this medication.
• Active liver disease or unexplained, persistent elevations of serum transaminases.
• Women who are pregnant or may become pregnant.
• Nursing mothers.

In short-term clinical trials, the most commonly reported adverse reactions (≥2% and >placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.

Pregnancy Category X. Safety in pregnant women has not been established. Available data in women inadvertently taking pravastatin while pregnant do not suggest any adverse clinical events. However, there are no adequate and well-controlled studies in pregnant women. Therefore, it is not known whether pravastatin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pravastatin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus and patients have been informed of the potential hazards. A small amount of pravastatin is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, women taking Pravastatin should not nurse.

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to report promptly any symptoms of myopathy. Pravalip therapy should be discontinued if myopathy is diagnosed or suspected.

Liver enzyme abnormalities: persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.

Statins

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.