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| __NOTOC__
| | #REDIRECT [[Pravastatin#Use in Specific Populations]] |
| {{Pravastatin}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use In Specific Populations==
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| ===Pregnancy===
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| '''Pregnancy Category X'''
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| [See Contraindications (4.3).]
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| Safety in pregnant women has not been established. Available data in women inadvertently taking pravastatin while pregnant do not suggest any adverse clinical events. However, there are no adequate and well-controlled studies in pregnant women. Therefore, it is not known whether pravastatin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pravastatin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus and patients have been informed of the potential hazards.
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| Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. In a review2 of approximately 100 prospectively followed pregnancies in women exposed to [[simvastatin]] or [[lovastatin]], the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥3- to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. As safety in pregnant women has not been established and there is no apparent benefit to therapy with PRAVACHOL during pregnancy [seeContraindications (4.3)], treatment should be immediately discontinued as soon as pregnancy is recognized. PRAVACHOL should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards.
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| Pravastatin was neither embryolethal nor teratogenic in rats at doses up to 1000 mg/kg daily or in rabbits at doses of up to 50 mg/kg daily. These doses resulted in 10 times (rabbit) or 120 times (rat) the human exposure at 80 mg/day maximum recommended human dose (MRHD) based on surface area (mg/m2).
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| 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 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/m2).
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| In pregnant rats given oral gavage doses of 10, 100, and 1000 mg/kg/day from gestation day 17 through lactation day 21 (weaning) increased mortality of offspring and developmental delays were observed at 100 mg/kg/day systemic exposure, 12 times the human exposure at 80 mg/day MRHD based on body surface area (mg/m2).
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| ===Nursing Mothers===
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| A small amount of pravastatin is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, women taking PRAVACHOL should not nurse [see Contraindications (4.4)].
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| Pravastatin crosses the placenta and is found in fetal tissue at 30% maternal plasma levels following a single 20 mg/kg dose given to pregnant rats on gestation day 18. Similar studies in lactating rats indicate secretion of pravastatin into breast milk at 0.2 to 6.5 times higher levels than maternal plasma at exposures equivalent to 2 times human exposure at the MRHD. | |
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| ===Pediatric Use===
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| The safety and effectiveness of PRAVACHOL in children and adolescents from 8 to 18 years of age have been evaluated in a placebo-controlled study of 2 years duration. Patients treated with pravastatin had an adverse experience profile generally similar to that of patients treated with placebo with influenza and headache commonly reported in both treatment groups. [See Adverse Reactions (6.4).] Doses greater than 40 mg have not been studied in this population. Children and adolescent females of childbearing potential should be counseled on appropriate contraceptive methods while on pravastatin therapy [see Contraindications (4.3) and Use in Specific Populations (8.1)]. For dosing information [see Dosage and Administration (2.3).]
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| Double-blind, placebo-controlled pravastatin studies in children less than 8 years of age have not been conducted.
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| ===Geriatric Use===
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| Two secondary prevention trials with pravastatin (CARE and LIPID) included a total of 6593 subjects treated with pravastatin 40 mg for periods ranging up to 6 years. Across these 2 studies, 36.1% of pravastatin subjects were aged 65 and older and 0.8% were aged 75 and older. The beneficial effect of pravastatin in elderly subjects in reducing cardiovascular events and in modifying lipid profiles was similar to that seen in younger subjects. The adverse event profile in the elderly was similar to that in the overall population. Other reported clinical experience has not identified differences in responses to pravastatin between elderly and younger patients.
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| Mean pravastatin AUCs are slightly (25%-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)].
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| Since advanced age (≥65 years) is a predisposing factor for myopathy, PRAVACHOL should be prescribed with caution in the elderly [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
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| ===Homozygous Familial Hypercholesterolemia===
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| Pravastatin has not been evaluated in patients with rare homozygous familial [[hypercholesterolemia]]. In this group of patients, it has been reported that statins are less effective because the patients lack functional LDL receptors.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PRAVACHOL (PRAVASTATIN SODIUM) TABLET [E.R. SQUIBB & SONS, L.L.C.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=897ad8b7-921d-eb02-a61c-3419e662a2da | publisher = | date = | accessdate = 18 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Statins]]
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| [[Category:Bristol-Myers Squibb]]
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| [[Category:Diols]]
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| [[Category:Carboxylic acids]]
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| [[Category:Carboxylate esters]]
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| [[Category:Naphthalenes]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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