PRAVASTATIN SODIUM tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)

Saatavilla:

Proficient Rx LP

INN (Kansainvälinen yleisnimi):

PRAVASTATIN SODIUM

Koostumus:

PRAVASTATIN SODIUM 20 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets, USP are indicated to: In patients with clinically evident CHD, pravastatin sodium tablet is indicated to: Pravastatin sodium tablet is indicated: a.   LDL-C remains ≥ 190 mg/dL or b.   LDL-C remains ≥ 160 mg/dL and: Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). Hypersensitivity to any component of this medication. Active liver disease or unexplained, persistent elevations of serum transaminases [see

Tuoteyhteenveto:

Pravastatin Sodium Tablets USP, 20 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC45' on one side and plain on the other side and are supplied as follows: NDC 63187-415-30 bottles of 30 Pravastatin Sodium Tablets USP, 40 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC44' on one side and plain on the other side and are supplied as follows: NDC 63187-413-30 in bottles of 30 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PRAVASTATIN SODIUM TABLETS.
PRAVASTATIN SODIUM TABLETS, USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Pravastatin sodium tablet, USP is an HMG-CoA reductase inhibitor
(statin) indicated as an adjunctive therapy to diet to:
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Limitations of use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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)
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ADVERSE REACTIONS
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 ZYDUS PHARMACEUTICALS
USA INC. AT 1-877-993-8779, OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
1.1 Prevention of Cardiovascular Disease
1.2 Hyperlipidemia
1.3 Limitations of Use
2. DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Adult Patients
2.3 Pediatric Patients
2.4 Concomitant Lipid-Altering Therapy
2.5 Dosage in Patients Taking Cyclosporine
2.6 Dosage in Patients Taking Clarithromycin
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Liver
4.3 Pregnancy
4.4 Nursing Mo