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| __NOTOC__
| | #REDIRECT [[Metoprolol succinate#Use in Specific Populations]] |
| {{Metoprolol}}
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| {{CMG}}
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| ==={{pcat}} '''C'''===
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| Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/m<sup>2</sup> basis, the daily dose of 200 mg in a 60-kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired [[fertility]] or [[teratogenicity]]. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use this drug during pregnancy only if clearly needed.
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| ===Nursing Mothers===
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| Metoprolol is excreted in breast milk in very small quantities. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Consider possible infant exposure when TOPROL-XL is administered to a nursing woman. | |
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| ====Pediatric Use====
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| One hundred forty-four [[hypertensive]] [[pediatric]] patients aged 6 to 16 years were randomized to [[placebo]] or to one of three dose levels of TOPROL-XL (0.2, 1.0 or 2.0 mg/kg once daily) and followed for 4 weeks. The study did not meet its primary endpoint (dose response for reduction in SBP). Some pre-specified secondary endpoints demonstrated effectiveness including:
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| Dose-response for reduction in DBP,
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| mg/kg vs. placebo for change in SBP, and
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| mg/kg vs. placebo for change in SBP and DBP.
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| The mean placebo corrected reductions in SBP ranged from 3 to 6 mmHg, and DBP from 1 to 5 mmHg. Mean reduction in [[heart rate]] ranged from 5 to 7 bpm but considerably greater reductions were seen in some individuals ''[see [[Toprol XL dosage and administration|Dosage and Administration]]]''.
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| No clinically relevant differences in the adverse event profile were observed for [[pediatric]] patients aged 6 to 16 years as compared with adult patients.
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| Safety and effectiveness of TOPROL-XL have not been established in patients < 6 years of age.
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| ====Geriatric Use====
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| Clinical studies of TOPROL-XL in [[hypertension]] did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in [[hypertensive]] patients has not identified differences in responses between elderly and younger patients.
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| Of the 1,990 patients with [[heart failure]] randomized to TOPROL-XL in the MERIT-HF trial, 50% (990) were 65 years of age and older and 12% (238) were 75 years of age and older. There were no notable differences in efficacy or the rate of adverse reactions between older and younger patients.
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| In general, use a low initial starting dose in elderly patients given their greater frequency of decreased [[hepatic]], [[renal]], or [[cardiac]] function, and of concomitant disease or other drug therapy.
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| ====Hepatic Impairment====
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| No studies have been performed with TOPROL-XL in patients with hepatic impairment. Because TOPROL-XL is metabolized by the liver, metoprolol blood levels are likely to increase substantially with poor hepatic function. Therefore, initiate therapy at doses lower than those recommended for a given indication; and increase doses gradually in patients with impaired hepatic function.
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| ====Renal Impairment====
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| The systemic availability and half-life of metoprolol in patients with [[renal failure]] do not differ to a clinically significant degree from those in normal subjects. No reduction in dosage is needed in patients with [[chronic renal failure]] ''[see [[Toprol XL clinical pharmacology|Clinical Pharmacology]''.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=01038198-b4f0-41f3-9a9c-5c84e5a0d3b9 | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Beta blockers]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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