PRAVASTATIN SODIUM tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Accord Healthcare Inc.

Designació comuna internacional (DCI):

PRAVASTATIN SODIUM

Composición:

PRAVASTATIN SODIUM 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Pravastatin sodium tablet is indicated: - To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). - To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. - As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. - As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). - As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia - Primary dysbetalipoproteinemia - Hypertriglyceridemia - Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)] . - Hypersensitivity to any pravastatin or any excipients in pravastatin sodium tablets. Risk Summary Discontinue pravastatin sodium tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pravastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin sodium tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid- lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with pravastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no evidence of fetal malformations was seen in pregnant rats or rabbits orally administered pravastatin during the period of organogenesis at doses that resulted in 10 times and 120 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg/day, based on body surface area (mg/m 2 ). An imbalance in some fetal skeletal variations, increased offspring mortality, and developmental delays occurred when pregnant rats were exposed to 10 times to 12 times the MRHD during organogenesis to parturition (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential cofounders -including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for cofounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data Embryofetal and neonatal mortality was observed in rats given pravastatin during the period of organogenesis or during organogenesis continuing through weaning. In pregnant rats given oral gavage doses of 4, 20, 100, 500, and 1000 mg/kg/day from gestation days 7 through 17 (organogenesis) increased mortality of offspring and increased cervical rib skeletal anomalies were observed at ≥100 mg/kg/day systemic exposure, 10 times the human exposure at 80 mg/day MRHD based on body surface area (mg/m 2 ). In other studies, no teratogenic effects were observed when pravastatin was dosed orally during organogenesis in rabbits (gestation days 6 through 18) up to 50 mg/kg/day or in rats (gestation days 7 through 17) up to 1000 mg/kg/day. Exposures were 10 times (rabbit) or 120 times (rat) the human exposure at 80 mg/day MRHD based on body surface area (mg/m 2 ). In pregnant rats given oral gavage doses of 10, 100, and 1000 mg/kg/day from gestation day 17 through lactation day 21 (weaning), developmental delays were observed at ≥100 mg/kg/day systemic exposure, corresponding to 12 times the human exposure at 80 mg/day MRHD, based on body surface area (mg/m 2 ). In pregnant rats, pravastatin crosses the placenta and is found in fetal tissue at 30% of the maternal plasma levels following administration of a single dose of 20 mg/day orally on gestation day 18, which corresponds to exposure 2 times the MRHD of 80 mg daily based on body surface area (mg/m 2 ). Risk Summary Based on one lactation study in published literature, pravastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Statins, including pravastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with pravastatin sodium tablets. [see Use in Specific Populations (8.1), Clinical Pharmacology (12.1)] . The safety and effectiveness of pravastatin sodium tablets as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of pravastatin for this indication is based on a double-blind, placebo-controlled clinical study in 214 pediatric patients (100 males and 114 females) 8 years of age and older with HeFH. Doses greater than 40 mg daily have not been studied in this population. The safety and effectiveness of pravastatin sodium tablets have not been established in pediatric patients younger than 10 years of age with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH). In clinical studies, 4,797 (36.4%) pravastatin -treated patients were aged 65 and older and 110 (0.8%) were aged 75 and older. No significant differences in efficacy or safety were observed between geriatric patients and younger patients. Mean pravastatin AUCs are 25% to 50% higher in elderly subjects than in healthy young subjects, but mean maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and half-life (t½) values are similar in both age groups and substantial accumulation of pravastatin would not be expected in the elderly [see Clinical Pharmacology (12.3)]. Advanced age (≥65 years) is a risk factor for pravastatin -associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving pravastatin for the increased risk of myopathy [see Warnings and Precautions (5.1)]. Renal impairment is a risk factor for myopathy and rhabdomyolysis. Monitor all patients with renal impairment for development of myopathy. In patients with severe renal impairment, the recommended starting dose is pravastatin sodium 10 mg once daily. The maximum recommended dosage in patients with severe renal impairment is pravastatin sodium 40 mg once daily. The recommended dosage for patients with mild or moderate renal impairment is the same as patients with normal renal function. [see Dosage and Administration (2.4), Warnings and Precautions (5.1), Clinical Pharmacology (12.3)]. Pravastatin shows a large inter-subject variability in pharmacokinetics in patients with liver cirrhosis [ Clinical Pharmacology (12.3)]. Pravastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4) , Warnings and Precautions (5.3)].

Resumen del producto:

Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: Pink coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘1’ on other side. They are supplied in bottles containing desiccant canister as follows. 20 mg tablets: Yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side. They are supplied in bottles containing desiccant canister as follows. 40 mg tablets: Light Green coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘8’ on other side. They are supplied in bottles containing desiccant canister as follows. 80 mg tablets: Yellow coloured, mottled, oval shaped, uncoated tablets, debossed ‘PB’ on one side and ‘4’ on other side. They are supplied in bottles containing desiccant canister as follows. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
ACCORD HEALTHCARE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PRAVASTATIN SODIUM
TABLETS.
PRAVASTATIN SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Contraindications, Pregnancy and Lactation Removed (4)
05/2022
Warnings and Precautions,
Immune-Mediated Necrotizing Myopathy Updated (5.2)
05/2022
INDICATIONS AND USAGE
Pravastatin is an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of myocardial infarction, myocardial
revascularization procedures, and cardiovascular
mortality in adults with elevated low-density lipoprotein cholesterol
(LDL-C) without clinically evident
coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction,
myocardial revascularization procedures,
stroke or transient ischemic attack, and slow the progression of
coronary atherosclerosis in adults with
clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary
hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8
years and older with heterozygous
familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
DOSAGE AND ADMINISTRATION
Take orally once daily at any time of the day, with or without food
(2.1).
For patients that require a high-intensity statin or are unable to
achieve their LDL-C goal receiving
pravastatin 80 mg daily, prescribe alternative LDL- C-lowering
treatment (2.1).
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiating pravastatin, and adjust the
dosage if necessary (2.1).
Adults: recommended starting dosage is pravastatin 40 mg to 80 mg once
daily. (2.2)
Pediatric Patients (2.3):
aged 8 to 13 years, the recommended dosage is 20 mg once daily.
aged 14 to 18 years, the recom