PITAVASTATIN CALCIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P)

Available from:

Zydus Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pitavastatin is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: - Adults with primary hyperlipidemia. - Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin is contraindicated in the following conditions: - Concomitant use of cyclosporine [see Drug Interactions (7)]. - Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)]. - Hypersensitivity to pitavastatin or any excipents in pitavastatin. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin [see Adverse Reactions (6)]. Risk Summary Discontinue pitavastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pitavastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pitavastatin may cause fetal harm when administered to pregn

Product summary:

Pitavastatin Tablets, 1 mg are white to off-white, beveled-edge, round-shaped, film-coated tablets debossed with "481" on one side and plain on the other side and are supplied as follows: NDC 68382-481-16 in bottle of 90 tablets with child-resistant closure. Pitavastatin Tablets, 2 mg are white to off-white, beveled-edge, round-shaped, film-coated tablets debossed with "482" on one side and plain on the other side and are supplied as follows: NDC 68382-482-16 in bottle of 90 tablets with child-resistant closure. Pitavastatin Tablets, 4 mg are white to off-white, beveled-edge, round-shaped, film-coated tablets debossed with "483" on one side and plain on the other side and are supplied as follows: NDC 68382-483-16 in bottle of 90 tablets with child-resistant closure. Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture and light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PITAVASTATIN CALCIUM- PITAVASTATIN CALCIUM TABLET
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PITAVASTATIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PITAVASTATIN TABLETS.
PITAVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Contraindications, Pregnancy and Lactation (4)
Removed 11/2022
Warnings and Precautions, Immune-Mediated Necrotizing Myopathy
(5.2)11/2022
INDICATIONS AND USAGE
Pitavastatin tablets are HMG-CoA reductase inhibitor (statin)
indicated as an adjunct to diet to reduce low-
density lipoprotein cholesterol (LDL-C) in: (1)
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 8 years and older with heterozygous
familial hypercholesterolemia
(HeFH).
DOSAGE AND ADMINISTRATION
Take orally once daily with or without food at the same time each day.
(2.1)
For patients requiring a high-intensity statin or are unable to
achieve their LDL-C goal receiving
pitavastatin 4 mg daily, prescribe alternative LDL-C-lowering
treatment. (2.1)
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiation of pitavastatin, and adjust
the dosage if necessary. (2.1)
Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended
dosage is 4 mg once
daily. (2.2)
Recommended starting dosage for patients with moderate and severe
renal impairment and end-stage
renal disease on hemodialysis is 1 mg once daily. Maximum recommended
dosage is 2 mg once daily.
(2.3)
See full prescribing information for pitavastatin dosage modifications
due to drug interactions. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg and 4 mg (3)
CONTRAINDICATIONS
Cyclosporine (4, 7)
Active liver failure or decompensated cirrhosis (4, 5.3)
Hypersensitivity to pitavastatin or any excipients in pitavastatin
tablets (4)
WARNINGS AND PRECAUTIONS
_Myopathy and Rhabdomyolysis:_Risk factors include age 65 or greater,
uncontrolled hypothyroidism,
renal impairment, con