pi-TAVa-sta-tin

• Treatment of primary hyperlipidemia and mixed dyslipidemia (adjunctive therapy to diet); to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).

• Inhibits 3–hydroxy-3–methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which is responsible for catalyzing an early step in cholesterol synthesis.

• Lowering of TC, LDL-C, Apo B and TG; increasing HDL-C.
• In conjuction with multiple risk factor interventions, lowering of cardiovascular risk.

Absorption: Well absorbed (51%) following oral administration.

Distribution: unknown.

Protein Binding: >99%.

Metabolism/Excretion: Mostly metabolized by the liver; 15% excreted in urine, 79% excreted in feces mostly as metabolites.

Half-life: 12 hr.

Contraindicated in:

• Hypersensitivity
• Active liver disease, including unexplained elevations in liver function tests
• Concurrent use of cyclosporine
• Severe renal impairment (CCr <30 mL/min)
• OB: Pregnancy or women who may become pregnant
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment (↑ risk of myopathy, dosage ↓ recommended for CCr <60 mL/min)
• Hypothyroidism, concurrent use of fibrates or lipid-lowering doses of niacin (↑ risk of myopathy)
• Geri: ↑risk of myopathy
• History of alcohol abuse or moderate alcohol consumption (↑ risk of liver damage) Pedi: Safety and effectiveness not established.

CNS: amnesia, confusion, memory loss.

GI: constipation, diarrhea, ↑ liver enzymes.

Derm: pruritus, rash, urticaria.

Endo: hyperglycemia.

MS: RHABDOMYOLYSIS, myositis, back pain, extremity pain, myalgia, arthralgia, immune-mediated necrotizing myopathy.

Misc: hypersensitivity reactions.

Drug-Drug:

• Cyclosporine↑ levels and the risk for myopathy; concurrent use contraindicated.
• Risk of myopathy is ↑ by concurrent use of erythromycin, rifampin, fibrates, colchicine or large doses of niacin; use ↓ doses with erythromycin, rifampin, and niacin; concurrent use with gemfibrozil should be avoided.
• Alcohol may ↑ risk of liver toxicity.

• PO (Adults): 2 mg once daily initially, may be ↑ up to 4 mg depending on response.Concurrent erythromycin therapy — Dose should not exceed 1 mg/day; Concurrent rifampin therapy — Dose should not exceed 2 mg/day.

• PO: May be administered at any time of the day without regard to food.

Livalo

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: hmg coa reductase inhibitors (statins)

(Generic available)

• Tablets: 1 mg; 2 mg; 4 mg;

(effect on lipids)

• Obtain a diet history, especially with regard to fat consumption.

• Evaluate serum cholesterol and triglyceride levels before initiating, after 4 wk of therapy, and periodically thereafter.
  • Monitor liver function tests prior to initiation of therapy and as clinically indicated. If symptoms of serious liver injury, hyperbilirubinemia, or jaundice occurs, discontinue pitavastatin and do not restart. May also cause ↑ alkaline phosphatase and bilirubin levels.
  • If patient develops muscle tenderness during therapy, CK levels should be monitored. If CK levels are markedly elevated or myopathy occurs, therapy should be discontinued.

• Noncompliance (Patient/Family Teaching).

• Instruct patient to take medication exactly as directed, not to skip doses or double up on missed doses. Medication helps control but does not cure elevated serum cholesterol levels.
• Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
• Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Advise women of child bearing age to use effective contraception during therapy and discuss plans to discontinue pitavastatin if trying to conceive. Instruct female patients to notify health care professional promptly if pregnancy is suspected. Advise patients to avoid breastfeeding during therapy.
• Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.

• Decrease in LDL, apolipoprotein, and total cholesterol levels.
  • Increase in HDL cholesterol levels.
  • Decrease in triglyceride levels.

NDC Code^*

• 66869- Kowa Pharmaceuticals America, Inc.
  • 66869-104- Livalo
    • 66869-104-90- 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-104-90)

• 66869- Kowa Pharmaceuticals America, Inc.
  • 66869-204- Livalo
    • 66869-204-07- 7 TABLET, FILM COATED in 1 CARTON (66869-204-07)

• 66869- Kowa Pharmaceuticals America, Inc.
  • 66869-204- Livalo
    • 66869-204-90- 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90)

• 66869- Kowa Pharmaceuticals America, Inc.
  • 66869-404- Livalo
    • 66869-404-07- 7 TABLET, FILM COATED in 1 CARTON (66869-404-07)

• 66869- Kowa Pharmaceuticals America, Inc.
  • 66869-404- Livalo
    • 66869-404-90- 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-404-90)