Pradaxa Capsule 150 mg (Dabigatran etexilate mesylate)

Adult dose

This drug should be taken with water, with or without food. 1. Adults (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Administer 150 mg orally twice daily. There is limited experience with administering this drug (110mg or 150mg per dose, twice daily) in combination with a P2Y12 inhibitor (e.g., clopidogrel) after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who underwent percutaneous coronary intervention (PCI) with stent placement. (See 15. Clinical Study Information) (2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism After at least 5 days of parenteral anticoagulant use, administer this drug orally at 150mg per dose twice daily. (3) For patients at increased risk of bleeding for any of the three indications above (see “3. Patients Requiring Caution” under Precautions for Use), administration of 110 mg orally twice daily may be considered. Such patients should be carefully monitored clinically for signs of bleeding or anemia, and coagulation tests such as aPTT should be used to assess whether excessive exposure to this drug is increasing risk. 2. Switching medications (1) Switching from this drug to a parenteral anticoagulant Start the parenteral anticoagulant 12 hours after the last dose of this drug. (2) Switching from a parenteral anticoagulant to this drug For patients currently receiving a parenteral anticoagulant, administer this drug 0~2 hours before the next scheduled dose of the parenteral anticoagulant, or at the time the continuous administration (e.g., intravenous administration of unfractionated heparin) is discontinued. (3) Switching from this drug to a vitamin K antagonist Adjust the time to start the vitamin K antagonist as follows according to creatinine clearance (Creatinine Clearance, CrCl). • CrCl 50 mL/min or higher: Start the vitamin K antagonist 3 days before discontinuing this drug. • CrCl ≥ 30~<50 mL/min: Start the vitamin K antagonist 2 days before discontinuing this drug. As this drug may increase INR, INR testing at least 2 days after discontinuing this drug best reflects the effect of the vitamin K antagonist; until then, INR values should be interpreted with caution. (4) Switching from a vitamin K antagonist to this drug Discontinue the vitamin K antagonist and administer this drug immediately when the INR is below 2.0. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment (50 ≤ CrCL ≤ 80 mL/min). For patients with moderate renal impairment (30 ≤ CrCL < 50 mL/min), administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. This drug is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). 4. Older adults aged 75 years or older Administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. 5. If you miss a dose of this drug If you miss a dose, take it as soon as possible on the same day, but no later than 6 hours before the next scheduled dose. Do not take twice the recommended daily dose to make up for a missed dose.

This medication is an anticoagulant that prevents blood clotting and thrombus formation. However, it can cause bleeding, so special care must be taken in patients at high risk of bleeding. If bleeding symptoms occur or there is an unexplained decrease in blood counts, the bleeding site should be checked immediately. If severe bleeding occurs, the use of this medication should be discontinued, and the bleeding site should be examined quickly. It is important to monitor closely for signs of bleeding or anemia during treatment, especially in patients with multiple risk factors. Patients with rapidly deteriorating renal function should discontinue this medication. Patients with antiphospholipid syndrome should carefully consider other treatment options before using this medication. This medication should not be administered to patients who are allergic to it or have significant renal impairment or clinically significant bleeding. Patients with a recent history of gastrointestinal ulcers, malignant tumors, brain or spinal cord injury, or surgeries with high bleeding risk should also avoid this medication. It is contraindicated to use this medication in conjunction with other anticoagulants. Patients taking platelet aggregation inhibitors or certain medications together may have an increased risk of bleeding and should be cautious. Elderly patients or those with reduced renal function may have higher blood levels of this medication, necessitating dose adjustment and renal function tests. Before and after surgery, administration of this medication should be suspended temporarily or the timing of resumption should be adjusted to reduce the risk of bleeding. Due to the risk of bleeding, careful management is required in situations with a high risk of bleeding such as surgery, invasive procedures, or trauma. It is advised to avoid use during pregnancy and to discontinue breastfeeding while using this medication. This medication may interact with other drugs, especially with P-gp inhibitors or inducers, anticoagulants, and antiplatelet agents, which may increase the risk of bleeding, so consult with a physician. In case of overdose, the risk of bleeding significantly increases, and medical personnel must be notified immediately; specific antidotes may be used if necessary. Care should be taken when opening capsules or removing them from their packaging, and they should be stored out of reach of children in a cool and dry place.

Hemorrhage, decreased hemoglobin, decreased hematocrit, thrombocytopenia, drug hypersensitivity, rash, pruritus, anaphylactic reaction, angioedema, urticaria, intracranial hemorrhage, hematoma, wound bleeding, epistaxis, hemoptysis, gastrointestinal bleeding, abdominal pain, diarrhea, dyspepsia, nausea, rectal bleeding, hemorrhoidal bleeding, esophageal ulcer, esophagitis, gastroesophageal reflux disease, vomiting, dysphagia, liver dysfunction, abnormal liver function tests, increased ALT, increased AST, elevated liver enzymes, hyperbilirubinemia, skin bleeding, alopecia, vascular joint disease, hematuria, injection site bleeding, catheter site bleeding, blood-stained secretion, traumatic bleeding, incision site bleeding, postoperative hematoma, postoperative bleeding, postoperative anemia, postoperative secretion, wound secretion, wound drainage, postoperative drainage, myocardial infarction, dizziness, headache, dementia, stuttering, tremor, orthostatic dizziness, brainstem infarction, cerebellar infarction, epilepsy, seizure, status epilepticus, transient ischemic attack, stuttering, cerebellar infarction, chest discomfort, weakness, edema, death, hemoptysis, pleural effusion, chronic obstructive pulmonary disease, exertional dyspnea, aspiration pneumonia, atrial flutter, angina pectoris, acute myocardial infarction, congestive heart failure, coronary artery disease, pericardial effusion, cardiac dysfunction, unstable angina, cardiac arrest, acute heart failure, heart failure, mixed mitral valve disease, back pain, limb pain, arthralgia, arthritis, bursitis, soft tissue necrosis, pneumonia, respiratory tuberculosis, upper respiratory infection, liver fluke infection, encephalitis, influenza, sepsis, dental abscess, acute kidney injury, hypotension, aneurysm, arterial rupture, hyperkalemia, hyponatremia, fracture, radiational proctitis, spinal compression fracture, subdural hematoma, subarachnoid hemorrhage, cataract, thrombocytopenia, cholestatic jaundice, melena, cerebral infarction, cerebrovascular accident, dyspnea, atrial fibrillation, soft tissue inflammation, hematuria, flushing, facial edema, depressed mood, hallucinations, visual hallucinations, somatoform disorder, insomnia, anxiety, hyperlipidemia, decreased appetite, contusion, increased serum creatinine, increased blood urea nitrogen, blepharospasm, limbal dermoid, eye itching, eyelid edema, strabismus, dizziness, sensorineural hearing loss, acute hearing loss, tinnitus, positional vertigo, erectile dysfunction, gynecomastia, hemorrhoids, anal polyp, ischemic colitis, duodenal ulcer bleeding, hematemesis, paralytic ileus, colon polyp, constipation, epigastric discomfort, gastric dysfunction, odynophagia, periodontal disease, ataxia, syncope, burning sensation, epilepsy, sensory loss, lumbosacral radiculopathy, migraine, drowsiness, tension headache, central nervous system-originated vertigo, heat sensation, chest pain, peripheral edema, facial edema, oropharyngeal pain, wet cough, oropharyngeal discomfort, congestive heart failure, palpitations, limb discomfort, musculoskeletal pain, myalgia, osteoarthritis, spinal stenosis, spinal pain, bursitis, costochondritis, lumbar spinal stenosis, osteoporosis, plantar fasciitis, nasopharyngitis, bronchitis, onychomycosis, medical device-related infection, herpes zoster, onychomycosis, periodontitis, pharyngitis, tinea pedis, urinary tract infection, dysuria, polyuria, colored urine, overactive bladder, incontinence, urgency, nephrotic syndrome, proteinuria, renal dysfunction, ureteral stones, flushing, facial edema, anxiety disorder, anxiety, decreased appetite, contusion

This medication should be stored at room temperature between 1 and 30 degrees Celsius in a tightly closed container that is well-ventilated. Additionally, it should be stored away from humid areas to maintain its effectiveness.

Appearance

A hard capsule with yellow pellets, with a bright blue upper part and white lower part

Package unit

60 capsules (10 capsules/PTP x 6)