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| __NOTOC__
| | #REDIRECT [[Dabigatran#Use in Specific Populations]] |
| {{Dabigatran}}
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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 C'''''
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| There are no adequate and well-controlled studies in pregnant women.
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| Dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at maximum recommended human dose [MRHD] of 300 mg/day based on area under the curve [AUC] comparisons) prior to mating and up to implantation (gestation Day 6). Treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. Although dabigatran increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat, it did not induce major malformations in rats or rabbits.
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| ===Labor and Delivery===
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| Safety and effectiveness of PRADAXA during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using PRADAXA in this setting [see Warnings and Precautions (5.2)].
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| Death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation Day 7) to weaning (lactation Day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at MRHD of 300 mg/day based on AUC comparisons).
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| ===Nursing Mothers===
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| It is not known whether dabigatran is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PRADAXA is administered to a nursing woman.
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| ===Pediatric Use===
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| Safety and effectiveness of PRADAXA in pediatric patients have not been established.
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| ===Geriatric Use===
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| Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over. The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see Warnings and Precautions (5), Adverse Reactions (6.1), and Clinical Studies (14)].
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| ===Renal Impairment===
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| No dose adjustment of PRADAXA is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)]. Reduce the dose of PRADAXA in patients with severe renal impairment (CrCl 15-30 mL/min) [see Dosage and Administration (2.1, 2.2) and Clinical Pharmacology (12.3)]. Dosing recommendations for patients with CrCl <15 mL/min or on dialysis cannot be provided.
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| Adjust dose appropriately in patients with renal impairment receiving concomitant P-gp inhibitors [see Warnings and Precautions (5.4), Drug Interactions (7), and Clinical Pharmacology (12.3)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = 31 January 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Direct thrombin (II) inhibitors]]
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| [[Category:Anticoagulants]]
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| [[Category:Cardiovascular Drugs]]
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