Pravastatin

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin Sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. …

• Adults: the recommended starting dose is 40 mg once daily
• Use 80 mg dose only for patients not reaching LDL-C goal with 40 mg
• Significant renal impairment: the recommended starting dose is pravastatin 10 mg once daily
• Children (ages 8 to 13 years, inclusive): the recommended starting dose is 20 mg once daily
• Adolescents (ages 14 to 18 years): the recommended starting dose is 40 mg once daily
• General Dosing Information The patient should be placed on a standard cholesterol-lowering diet before receiving Pravastatin Sodium and should continue on this diet during treatment with Pravastatin Sodium [see NCEP Treatment Guidelines for details on dietary therapy]
• 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
• Pravastatin Sodium 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
• Patients with Renal Impairment In patients with severe renal impairment, a starting dose of 10 mg pravastatin daily is recommended
• Pediatric Patients Children (Ages 8 to 13 Years, Inclusive) 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. …

Pravastatin Sodium Tablets, USP are supplied as: 10 mg tablets: White to off-white, Rectangular-shaped, biconvex tablets, debossed with “B 10” on one side and plain on other side. 20 mg tablets: White to off-white, Rectangular-shaped, biconvex tablets, debossed with “B 20” on one side and plain on other side. …

• The safety and effectiveness of Pravastatin Sodium in children and adolescents from 8 to 18 years of age have been evaluated in a placebo-controlled study of 2 years duration
• Patients treated with pravastatin had an adverse experience profile generally similar to that of patients treated with placebo with influenza and headache commonly reported in both treatment groups. [See Adverse Reactions .] Doses greater than 40 mg have not been studied in this population. …

Two secondary prevention trials with pravastatin (CARE and LIPID) included a total of 6593 subjects treated with pravastatin 40 mg for periods ranging up to 6 years. Across these 2 studies, 36.1% of pravastatin subjects were aged 65 and older and 0.8% were aged 75 and older. The beneficial effect of pravastatin in elderly subjects in reducing cardiovascular events and in modifying lipid profiles was similar to that seen in younger subjects. …

• Muscle Pain Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing Pravastatin Sodium [see Warnings and Precautions ]
• Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of Pravastatin Sodium, and thereafter when clinically indicated
• All patients treated with Pravastatin Sodium should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions ]. …

• Hypersensitivity to any component of this medication
• Active liver disease or unexplained, persistent elevations of serum transaminases
• Pregnancy Lactation Hypersensitivity Hypersensitivity to any component of this medication
• Liver Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions ]. …

For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. 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 Pravastatin Sodium. (7) Cyclosporine: combination increases exposure. Limit pravastatin to 20 mg once daily. (2.6, 7.1) Clarithromycin: combination increases exposure. Limit pravastatin to 40 mg once daily. …

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients should be advised to promptly report to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness. Pravastatin therapy should be discontinued if myopathy is diagnosed or suspected. (5.1, 8.5) Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. …

Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant. 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. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc. …

8.1 Pregnancy Risk Summary Pravastatin Sodium is contraindicated for use in pregnant woman because of the potential for fetal harm. As safety in pregnant women has not been established and there is no apparent benefit to therapy with Pravastatin Sodium during pregnancy, Pravastatin Sodium should be immediately discontinued as soon as pregnancy is recognized [see Contraindications (4.3) ]. …

To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.