LIVALO Film-coated tablet Ref.[11118] Active ingredients: Pitavastatin

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

LIVALO (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor.

The chemical name for pitavastatin is (+)monocalcium bis{(3R, 5S, 6E)7[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}.

The structural formula is:

The empirical formula for pitavastatin is C50H46CaF2N2O8 and the molecular weight is 880.98. Pitavastatin is odorless and occurs as white to pale-yellow powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light.

Each film-coated tablet of LIVALO contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropylcellulose, magnesium aluminometasilicate, and magnesium stearate. The film coating contains the following inactive ingredients: colloidal anhydrous silica, hypromellose, titanium dioxide, and triethyl citrate.

Dosage Forms and Strengths

Tablets:

  • 1 mg: Round white tablet, debossed “KC” on one side and “1” on the other side.
  • 2 mg: Round white tablet, debossed “KC” on one side and “2” on the other side.
  • 4 mg: Round white tablet, debossed “KC” on one side and “4” on the other side.
How Supplied

LIVALO tablets are supplied as follows:

Tablet StrengthPackage SizeTablet DescriptionNDC
1 mg Bottle of 90 Round white film-coated tablet debossed “KC” on one face and “1” on the reverse 66869-104-90
2 mg Bottle of 90 Round white film-coated tablet debossed “KC” on one face and “2” on the reverse 66869-204-90
4 mg Bottle of 90 Round white film-coated tablet debossed “KC” on one face and “4” on the reverse 66869-404-90

Manufactured for: Kowa Company, Limited Tokyo 103-8433 Japan

Manufactured by: Patheon Pharmaceuticals, Inc. Cincinnati, OH 45237 USA or by Kowa Company, LTD Nagoya, 462-0024 Japan

Marketed and Distributed by: Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117 USA

Drugs

Drug Countries
LIVALO Brazil, Japan, Singapore, United States

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