Pravastatin 40mg Tablet, 90ct Bottle

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Description

What is Pitavastatin and how is it used?

Pitavastatin is used to reduce fats in the blood.

What is Pitavastatin and how is it used?

Common side effects of Pitavastatin include:


PROFESSIONAL

Drug Description

What is Pitavastatin and how is it used?

Pitavastatin is used to reduce fats in the blood.

What is Pitavastatin and how is it used?

Common side effects of Pitavastatin include:

DESCRIPTION

PITAVASTATIN (pitavastatin) is an inhibitor of HMG-CoA reductase. It is a synthetic lipid-lowering agent for oral administration.

The chemical name for pitavastatin is Sodium (3R, 5S, E)-7-(2-cyclopropyl-4-(4-fluorophenyl)­quinolin-3-yl)-3, 5-dihydroxyhept-6-enoate. The structural formula is:

The empirical formula for pitavastatin is C25H23FNO4Na and the molecular weight is 443.15. Pitavastatin occurs as white to pale yellow powder. It is slightly soluble in N, N-Dimethylformamide. Pitavastatin is slightly hygroscopic in nature and slightly unstable in light.

Each film-coated tablet of PITAVASTATIN contains 1.052 mg, 2.103 mg, or 4.206 mg of pitavastatin sodium, which is equivalent to 1 mg, 2 mg, or 4 mg, respectively of pitavastatin, and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropylcellulose, magnesium stearate and sodium bicarbonate and film coating containing the following inactive ingredients: colloidal anhydrous silica, hypromellose, titanium dioxide and triethyl citrate.

Indications & Dosage

INDICATIONS

PITAVASTATIN is indicated as an adjunctive therapy to diet in:

  • Adult patients with primary hyperlipidemia or mixed dyslipidemia 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).

Limitations Of Use

  • The effect of PITAVASTATIN on cardiovascular morbidity and mortality has not been determined.

Pediatric use information is approved for Kowa Co Ltd’s LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd’s marketing exclusivity rights, this drug product is not labeled with that information.

DOSAGE AND ADMINISTRATION

General Dosage And Administration Information

  • Take PITAVASTATIN orally once daily with or without food at the same time each day.
  • Individualize the dose of PITAVASTATIN according to patient characteristics, goal of therapy, and response.
  • After initiation or upon titration of PITAVASTATIN, analyze lipid levels after 4 weeks and adjust the dosage accordingly.

Recommended Dosage For Adults

  • The recommended starting PITAVASTATIN dosage is 2 mg once daily.
  • The maximum recommended dosage is PITAVASTATIN 4 mg once daily [see WARNINGS AND PRECAUTIONS].

Recommended Dosage In Patients With Renal Impairment

  • The recommended starting dose for adults with moderate and severe renal impairment (estimated glomerular filtration rate 30 to 59 mL/minute/1.73 m² and 15 to 29 mL/minute/1.73 m², respectively) and patients with end-stage renal disease receiving hemodialysis is PITAVASTATIN 1 mg once daily.
  • The maximum recommended dose for these patients is PITAVASTATIN 2 mg once daily [see Use In Specific Populations].

PITAVASTATIN Dosage Adjustments Due To Drug Interactions

  • In patients taking erythromycin, do not exceed PITAVASTATIN 1 mg once daily [see DRUG INTERACTIONS].
  • In patients taking rifampin, do not exceed PITAVASTATIN 2 mg once daily [see DRUG INTERACTIONS].

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