Dabigatran etexilate

SPAF AND DVT/PE — DOSE REDUCTION RECOMMENDED (SPC Table 2): patients aged 80 years or above, and patients who receive concomitant verapamil, should take a daily dose of 220 mg dabigatran etexilate taken as one 110 mg capsule TWICE daily (not 220 mg once daily — that once-daily regimen belongs to the orthopaedic indication only). DOSE REDUCTION FOR CONSIDERATION (SPC Table 2): patients between 75-80 years — a daily dose of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding; patients with moderate renal impairment (CrCL 30-50 mL/min); patients with gastritis, esophagitis or gastroesophageal reflux; and other patients at increased risk of bleeding. For DVT/PE the recommendation for 220 mg taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in that clinical setting. When excessive dabigatran exposure is identified in patients at high risk of bleeding, a reduced dose of 220 mg taken as one 110 mg capsule twice daily is recommended; when clinically relevant bleeding occurs, treatment should be interrupted. ORTHOPAEDIC VTE PROPHYLAXIS — REDUCED REGIMEN (SPC Table 1) for patients with moderate renal impairment (CrCL 30-50 mL/min), patients who receive concomitant verapamil, amiodarone or quinidine, and patients aged 75 or above: a single capsule of 75 mg 1-4 hours after completed surgery, then 150 mg once daily taken as 2 capsules of 75 mg, for 10 days (knee) or 28-35 days (hip). For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed; if treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily. DURATION: SPAF — therapy should be continued long term. DVT/PE — individualise after careful assessment of treatment benefit against bleeding risk; a short duration (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations on permanent risk factors or idiopathic DVT or PE. MISSED DOSE: for SPAF/DVT/PE a forgotten dose may still be taken up to 6 hours prior to the next scheduled dose, after which the missed dose should be omitted; for orthopaedic prophylaxis, continue with the remaining daily doses at the same time of the next day. No double dose should be taken to make up for missed individual doses. DISCONTINUATION: treatment should not be discontinued without medical advice; patients should contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia. SWITCHING: to a parenteral anticoagulant — wait 12 hours after the last dose (SPAF/DVT/PE and paediatric) or 24 hours (orthopaedic prophylaxis). From a parenteral anticoagulant — discontinue it and start dabigatran 0-2 hours before the next dose of the alternate therapy would be due, or at the time of discontinuation for continuous treatment such as intravenous unfractionated heparin. To a vitamin K antagonist — start the VKA 3 days before discontinuing dabigatran if CrCL >=50 mL/min, or 2 days before if CrCL >=30 to <50 mL/min; because dabigatran can affect the INR, the INR will better reflect the VKA effect only after dabigatran has been stopped for at least 2 days. From a VKA — stop the VKA and give dabigatran as soon as the INR is <2.0. CARDIOVERSION (SPAF): patients can stay on dabigatran while being cardioverted. CATHETER ABLATION for AF: there are no data available for the 110 mg twice daily regimen. PCI WITH STENTING (SPAF): patients with non-valvular AF undergoing PCI with stenting can be treated with dabigatran in combination with antiplatelets after haemostasis is achieved. WEIGHT: for SPAF/DVT/PE no dose adjustment is necessary, but close clinical surveillance is recommended in patients with body weight <50 kg; for orthopaedic prophylaxis there is very limited clinical experience below 50 kg or above 110 kg and no adjustment is necessary, but close surveillance is recommended. GENDER: no dose adjustment necessary. REVERSAL: for adult patients with life-threatening or uncontrolled bleeding requiring rapid reversal, the specific reversal agent idarucizumab is available (efficacy and safety not established in paediatric patients); haemodialysis can remove dabigatran; fresh whole blood, fresh frozen plasma, coagulation factor concentrate, recombinant factor VIIa or platelet concentrates are other options in adults. PAEDIATRIC: capsules can be used in patients aged 8 years or older who are able to swallow them whole; coated granules may be more appropriate in children under 12 as soon as the child can swallow soft food, and powder and solvent for oral solution should only be used in children under 1 year — when changing between formulations the prescribed dose may need to be altered. For treatment of VTE and prevention of recurrent VTE in paediatric patients the dose is based on the patient's WEIGHT AND AGE (SPC Table 4) and is adjusted as treatment progresses; the milligram values of Table 4 were NOT included in the fetched text (only the capsule-combination legend for 300, 260, 220, 185 and 150 mg single doses), so no paediatric dose is given here and none should be inferred. Paediatric treatment of VTE should be initiated following at least 5 days of a parenteral anticoagulant; capsules are taken twice daily, morning and evening, as close to 12 hours apart as possible. Estimate eGFR by the Schwartz formula before initiation — treatment is contraindicated in paediatric patients with eGFR <50 mL/min/1.73m2. There is no relevant paediatric use for SPAF or for VTE prophylaxis after hip or knee replacement. Verify any under-18 dosing against a children's formulary and the full SPC. PRIOR VERIFY HOLD — NOW RESOLVED BY THE 2026-08-05 RE-FETCH: an adversarial verification pass held this entry because the earlier fetch of §4.2 was 'truncated mid-table at exactly Dose reduction recommended Patients aged >=80 years daily dose of 220 mg', so the reduced regimen carried no per-dose amount or frequency (a reader could give 220 mg once daily instead of 110 mg twice daily), the remaining reduction triggers (verapamil, age 75-80, CrCL 30-50 mL/min, gastritis/oesophagitis/GORD, raised bleeding risk) were missing, and interactions pointed amiodarone/quinidine/verapamil at Table 1 (orthopaedic dosing) rather than the AF/VTE table. The re-fetched bundle (§4.2 now 18,364 characters) contains the complete Table 2 including the words 'taken as one 110 mg capsule twice daily' and every reduction row; all of them are reproduced above. STILL OPEN: the paediatric Table 4 milligram values remain absent (hold point 4), so paedDose is null. SOURCE CAVEAT: the SPC record is the 'Dabigatran Etexilate 110 mg hard capsule' presentation (eMC product 100715) although its §4.2 text prescribes 150 mg and 75 mg capsules for some regimens; §4.4 and §4.8 are truncated at the source-fetch limit and §4.5 (interactions) was not retrieved.