Dabigatran etexilate STADA
Direct oral anticoagulant (DOAC) — Thrombin inhibitor for stroke prevention and blood clot treatment
Quick Facts About Dabigatran etexilate STADA
Key Takeaways About Dabigatran etexilate STADA
- Direct thrombin inhibitor: Dabigatran directly blocks thrombin (Factor IIa), preventing blood clot formation without requiring regular blood monitoring like warfarin
- Specific reversal agent available: Idarucizumab (Praxbind) can rapidly reverse dabigatran's effect in emergencies, making it one of the safest DOACs for urgent situations
- Renal function matters: Dabigatran is primarily eliminated by the kidneys; dose adjustment or avoidance is necessary in patients with impaired renal function
- Do not open capsules: Capsules must be swallowed whole — opening, chewing or breaking them increases absorption by up to 75%, significantly raising bleeding risk
- Proven clinical efficacy: The landmark RE-LY trial demonstrated dabigatran 150 mg twice daily was superior to warfarin in preventing stroke with a lower rate of intracranial haemorrhage
What Is Dabigatran etexilate STADA and What Is It Used For?
Dabigatran etexilate STADA is a direct oral anticoagulant (DOAC) that prevents blood clots by directly inhibiting thrombin. It is prescribed for stroke prevention in atrial fibrillation, treatment and prevention of deep vein thrombosis and pulmonary embolism, and thromboprophylaxis after joint replacement surgery.
Dabigatran etexilate is a prodrug — an inactive compound that is rapidly converted to its active form, dabigatran, after oral administration. Once activated, dabigatran acts as a potent, competitive, and reversible direct thrombin inhibitor. Thrombin (also known as Factor IIa) is a serine protease that plays a central role in the coagulation cascade by converting fibrinogen to fibrin, the structural protein that forms the mesh of a blood clot. By blocking thrombin's active site, dabigatran effectively prevents the final step of clot formation.
Unlike traditional anticoagulants such as warfarin, which work indirectly by inhibiting vitamin K-dependent clotting factor synthesis, dabigatran provides a more targeted and predictable anticoagulant effect. This means patients do not require routine coagulation monitoring (such as INR testing) — a significant advantage in terms of convenience and quality of life. Dabigatran etexilate STADA is a generic formulation that contains the same active substance as the originator product and meets the same regulatory standards for quality, safety, and efficacy as established by the European Medicines Agency (EMA).
The 75 mg hard capsule formulation of Dabigatran etexilate STADA is primarily intended for patients who require a lower dose, including certain elderly patients, those with moderate renal impairment, or patients receiving concomitant medications that increase dabigatran exposure. The standard therapeutic dose for most indications is 150 mg twice daily, with the 75 mg capsule used in specific clinical scenarios as determined by the prescribing physician.
Approved Indications
Dabigatran etexilate STADA is approved for the following clinical indications, in line with EMA-approved labelling:
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors, such as prior stroke or transient ischaemic attack, age 75 years or older, heart failure, diabetes mellitus, or hypertension
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, following initial treatment with a parenteral anticoagulant for at least 5 days
- Prevention of recurrent DVT and PE in adults who have completed at least 6 months of anticoagulant treatment
- Prevention of venous thromboembolic events (VTE) in adults who have undergone elective total hip replacement surgery or total knee replacement surgery
The choice between dabigatran and other anticoagulants should be individualised based on patient-specific factors including renal function, bleeding risk, concomitant medications, patient preference, and clinical context. Current European Society of Cardiology (ESC) guidelines recommend DOACs, including dabigatran, as first-line therapy over warfarin for stroke prevention in non-valvular atrial fibrillation.
What Should You Know Before Taking Dabigatran etexilate STADA?
Before starting Dabigatran etexilate STADA, your doctor must assess your kidney function, bleeding risk, and current medications. This medicine is not suitable for patients with mechanical heart valves, severe kidney impairment, or active significant bleeding.
Contraindications
Dabigatran etexilate STADA must not be used in the following situations:
- Known hypersensitivity to dabigatran etexilate, dabigatran, or any of the excipients
- Severe renal impairment (creatinine clearance < 30 mL/min) — dabigatran is predominantly cleared by the kidneys and accumulates to dangerous levels in severe renal failure
- Active clinically significant bleeding or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding, or recent brain or spinal injury
- Mechanical prosthetic heart valves — the RE-ALIGN trial was terminated early due to excess thromboembolic and bleeding events with dabigatran in this population
- Hepatic impairment or liver disease expected to have any impact on survival
- Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, dronedarone, or other strong P-glycoprotein (P-gp) inhibitors
- Lesions or conditions considered a significant risk factor for major bleeding, including current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury or surgery, or oesophageal varices
Warnings and Precautions
Special care and close monitoring are required in the following situations:
- Renal function monitoring: Renal function must be assessed before initiating therapy and should be reassessed at least annually, or more frequently in clinical situations where renal function may decline (e.g., hypovolaemia, dehydration, concomitant nephrotoxic drugs). In patients older than 75 years, or those with known renal impairment, renal function should be checked at least every 6 months
- Bleeding risk: As with all anticoagulants, dabigatran should be used with caution in conditions associated with an increased risk of bleeding. Any unexplained fall in haemoglobin or blood pressure should be investigated for a bleeding site. Factors that may increase bleeding risk include age 75 years or older, moderate renal impairment, concomitant use of antiplatelet agents or NSAIDs, and conditions such as thrombocytopenia or platelet function defects
- Surgical procedures: Dabigatran should be temporarily discontinued before invasive procedures. The timing depends on renal function and the bleeding risk of the procedure. For standard-risk procedures, discontinue 24 hours before surgery; for high-risk procedures or patients with moderate renal impairment, discontinue 48–96 hours before surgery
- Spinal/epidural anaesthesia: Patients receiving neuraxial anaesthesia or spinal puncture are at risk of developing an epidural or spinal haematoma, which can result in long-term or permanent paralysis
- Gastrointestinal effects: Dabigatran has been associated with gastrointestinal bleeding and may cause dyspepsia. The capsules contain tartaric acid, which may contribute to gastrointestinal symptoms
Do not stop taking Dabigatran etexilate STADA without consulting your doctor. Premature discontinuation of any anticoagulant, including dabigatran, increases the risk of thrombotic events such as stroke. If dabigatran must be discontinued for a reason other than pathological bleeding or completion of therapy, consider covering the patient with an alternative anticoagulant.
Pregnancy and Breastfeeding
There are limited data on the use of dabigatran etexilate in pregnant women. Animal studies have shown reproductive toxicity, and dabigatran should not be used during pregnancy unless the potential benefit clearly outweighs the potential risk to the foetus. Women of childbearing potential should use effective contraception during treatment.
It is not known whether dabigatran is excreted in human breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. As a precaution, breastfeeding should be discontinued during treatment with dabigatran.
How Does Dabigatran etexilate STADA Interact with Other Drugs?
Dabigatran etexilate is a substrate of the P-glycoprotein (P-gp) transporter. Drugs that strongly inhibit or induce P-gp can significantly alter dabigatran blood levels, leading to increased bleeding risk or reduced efficacy. Some combinations are contraindicated, while others require dose adjustments.
Unlike warfarin, dabigatran is not metabolised by cytochrome P450 enzymes, which reduces the potential for drug-drug interactions. However, as a substrate of the P-glycoprotein (P-gp) efflux transporter, dabigatran levels can be significantly affected by drugs that modulate P-gp activity. Understanding these interactions is essential for safe prescribing and optimal patient outcomes.
The P-glycoprotein transporter is an ATP-dependent efflux pump expressed in the intestinal epithelium, renal tubular cells, and hepatocytes. Drugs that inhibit P-gp reduce the efflux of dabigatran, increasing its absorption and reducing its renal clearance, thereby raising plasma levels and bleeding risk. Conversely, P-gp inducers increase efflux, reducing dabigatran absorption and efficacy.
Major Interactions — Contraindicated or Requires Special Precautions
| Drug | Mechanism | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole (systemic) | Strong P-gp inhibitor | Increases dabigatran levels by 140–150% | Contraindicated |
| Dronedarone | Strong P-gp inhibitor | Increases dabigatran levels by ~70–100% | Contraindicated |
| Itraconazole | Strong P-gp inhibitor | Significant increase in dabigatran exposure | Contraindicated |
| Cyclosporine | Strong P-gp inhibitor | Significant increase in dabigatran exposure | Contraindicated |
| Rifampicin | Potent P-gp inducer | Reduces dabigatran levels by ~65% | Avoid concomitant use |
| St John’s Wort | P-gp inducer | May reduce dabigatran efficacy | Avoid concomitant use |
| Carbamazepine | P-gp inducer | May reduce dabigatran levels | Avoid concomitant use |
Moderate Interactions — Dose Adjustment May Be Required
| Drug | Mechanism | Effect | Recommendation |
|---|---|---|---|
| Amiodarone | Moderate P-gp inhibitor | Increases dabigatran levels by ~50–60% | Consider dose reduction; close monitoring |
| Verapamil | Moderate P-gp inhibitor | Increases dabigatran levels by 12–180% (timing dependent) | Reduce dose to 220 mg/day; take simultaneously |
| Quinidine | Moderate P-gp inhibitor | Increases dabigatran levels by ~50% | Consider dose reduction |
| Clarithromycin | Moderate P-gp inhibitor | May increase dabigatran exposure | Close clinical monitoring |
| Aspirin / Clopidogrel | Antiplatelet effect | Additive bleeding risk | Use with caution; assess risk-benefit |
| NSAIDs (e.g., ibuprofen) | Antiplatelet + GI mucosal effect | Increased bleeding risk, especially GI | Avoid long-term use; short-term with caution |
| SSRIs / SNRIs | Antiplatelet effect on serotonin | May increase bleeding risk | Monitor for signs of bleeding |
Unlike warfarin, dabigatran does not interact with vitamin K-rich foods such as leafy green vegetables. Patients do not need to restrict their diet while taking Dabigatran etexilate STADA. The capsules can be taken with or without food. However, taking the capsule with food may delay the time to peak concentration by approximately 2 hours without affecting overall absorption.
What Is the Correct Dosage of Dabigatran etexilate STADA?
The standard dose of dabigatran for stroke prevention in atrial fibrillation is 150 mg twice daily. The 75 mg capsule is used for specific patient populations requiring dose reduction, including certain elderly patients and those with moderate renal impairment or receiving interacting medications.
Dosing of Dabigatran etexilate STADA must be individualised based on the clinical indication, patient age, renal function, body weight, and concomitant medications. The capsules should be swallowed whole with a full glass of water and must not be opened, chewed, or broken, as this dramatically increases bioavailability and bleeding risk. Dabigatran can be taken with or without food.
Adults — Dosage by Indication
| Indication | Standard Dose | Reduced Dose | Duration |
|---|---|---|---|
| Stroke prevention in AF | 150 mg twice daily | 110 mg twice daily | Long-term |
| Treatment of DVT/PE | 150 mg twice daily | 110 mg twice daily | Min 3–6 months |
| Prevention of recurrent DVT/PE | 150 mg twice daily | 110 mg twice daily | As determined by physician |
| VTE prophylaxis — hip replacement | 220 mg once daily (2×110 mg) | 150 mg once daily (2×75 mg) | 28–35 days |
| VTE prophylaxis — knee replacement | 220 mg once daily (2×110 mg) | 150 mg once daily (2×75 mg) | 10 days |
For VTE prophylaxis after orthopaedic surgery, treatment should begin with a single capsule (110 mg or 75 mg) taken 1–4 hours after completion of surgery, provided haemostasis has been achieved. From the following day, the full daily dose (two capsules) should be taken once daily.
Elderly Patients (Age 75 Years and Older)
Dose Recommendation for Elderly Patients
For stroke prevention in atrial fibrillation, a dose of 110 mg twice daily is recommended for patients aged 80 years and older. For patients aged 75–79 years, either 150 mg or 110 mg twice daily may be used, depending on individual assessment of thromboembolic and bleeding risks. For VTE prophylaxis after surgery, a reduced dose of 150 mg once daily (2 × 75 mg) should be used in patients aged 75 years and older.
Patients with Renal Impairment
Dose Adjustments for Renal Function
CrCl > 50 mL/min: Standard dose (no adjustment required).
CrCl 30–50 mL/min: Dose reduction to 110 mg twice daily (for AF) or 150 mg once daily (for VTE prophylaxis) should be considered, particularly in patients with additional bleeding risk factors.
CrCl < 30 mL/min: Dabigatran is contraindicated. Dabigatran is approximately 80% renally eliminated, and accumulation in severe renal impairment leads to unacceptably high bleeding risk.
Children
Dabigatran etexilate STADA is not recommended for use in children and adolescents under 18 years of age for most indications, as safety and efficacy have not been established in this population. Specific paediatric formulations and dosing regimens exist for the treatment of venous thromboembolism in children, but these use different formulations and dosing approaches.
Missed Dose
If you miss a dose, take it as soon as you remember, provided there are at least 6 hours before the next scheduled dose. If less than 6 hours remain until the next dose, skip the missed dose and continue with the regular dosing schedule. Never take a double dose to make up for a missed one. If you frequently forget doses, discuss this with your doctor, as consistent dosing is essential for adequate anticoagulation and protection against blood clots.
Overdose
Doses of dabigatran exceeding those recommended place the patient at increased risk of bleeding. If overdose is suspected, emergency coagulation testing (such as ecarin clotting time, diluted thrombin time, or activated partial thromboplastin time) should be performed. The specific reversal agent idarucizumab (Praxbind) is approved for rapid reversal of dabigatran's anticoagulant effect. Additionally, because dabigatran has relatively low protein binding (~35%), it can be removed by haemodialysis, though clinical experience with this approach is limited. Activated charcoal may be considered if ingestion occurred within the previous 2 hours.
What Are the Side Effects of Dabigatran etexilate STADA?
The most significant side effect of dabigatran is bleeding, which can range from minor nosebleeds and bruising to serious gastrointestinal or intracranial haemorrhage. Gastrointestinal symptoms such as dyspepsia and abdominal discomfort are the most commonly reported non-bleeding side effects.
As with all anticoagulant medications, bleeding is the principal safety concern with dabigatran. The risk of bleeding increases with dose, age, degree of renal impairment, and concomitant use of other medications that affect haemostasis. In the landmark RE-LY clinical trial involving over 18,000 patients, the overall safety profile of dabigatran was favourable compared with warfarin, with significantly lower rates of intracranial haemorrhage and haemorrhagic stroke. However, gastrointestinal bleeding rates were somewhat higher with dabigatran 150 mg twice daily compared with warfarin.
The following side effects have been reported in clinical trials and post-marketing surveillance. They are categorised by frequency according to the European convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (<1/1,000).
Common Side Effects
- Gastrointestinal bleeding (rectal, gingival, or other GI tract bleeding)
- Abdominal pain and dyspepsia (indigestion, stomach discomfort)
- Diarrhoea and nausea
- Epistaxis (nosebleeds)
- Urogenital bleeding (including haematuria)
- Skin bleeding (bruising, ecchymosis)
- Haemoglobin decrease
- Abnormal liver function tests / elevated transaminases
Uncommon Side Effects
- Thrombocytopenia (low platelet count)
- Hypersensitivity reactions (rash, pruritus, urticaria)
- Intracranial haemorrhage (bleeding in the brain)
- Haemarthrosis (bleeding into joints)
- Wound bleeding post-surgery
- Haemoptysis (coughing up blood)
- Gastrointestinal ulceration
- Gastro-oesophagitis
- Gastro-oesophageal reflux disease
- Dysphagia (difficulty swallowing)
Rare Side Effects
- Anaphylactic reaction (severe allergic reaction)
- Angioedema (swelling of face, lips, tongue, or throat)
- Hepatic function abnormal / hepatobiliary disorders
- Retroperitoneal haemorrhage
- Pericardial bleeding
- Alopecia (hair loss)
Contact your doctor or go to the nearest emergency department immediately if you experience: blood in your urine (pink, red or brown colour), black or tarry stools, coughing up blood, vomiting blood or material that looks like coffee grounds, unexplained bruising or bruising that grows in size, prolonged bleeding from cuts, sudden severe headache or confusion, weakness on one side of the body, or any signs of a severe allergic reaction such as swelling of the face or difficulty breathing.
How Should You Store Dabigatran etexilate STADA?
Dabigatran etexilate STADA capsules must be stored in their original packaging to protect them from moisture. Do not store above 30°C. Once a blister strip has been opened, capsules should be used within 30 days.
Proper storage of dabigatran is particularly important because the capsules are sensitive to moisture. Exposure to moisture can degrade the active ingredient and reduce the effectiveness of the medication. The following storage guidelines should be observed:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze
- Moisture protection: Keep capsules in the original blister packaging at all times. Do not transfer capsules to a pill organiser or other container, as this removes the moisture barrier
- Blister integrity: Only remove a capsule from the blister immediately before taking it. Peel back the aluminium foil backing rather than pushing the capsule through the blister
- Opened blisters: Once a blister strip has been opened, use the remaining capsules within 30 days
- Bottle packaging (if applicable): If supplied in a bottle, close the bottle tightly after each use and use the capsules within 4 months of first opening
- Keep out of reach of children
- Expiry date: Do not use after the expiry date printed on the packaging. Dispose of expired medicines according to local guidelines — do not flush or throw in household waste
If capsules appear discoloured, cracked, or damaged, do not take them. Contact your pharmacist for a replacement supply. The capsule shell is hygroscopic (absorbs moisture), and any visible damage may indicate compromised product integrity and reduced therapeutic effectiveness.
What Does Dabigatran etexilate STADA Contain?
Each hard capsule of Dabigatran etexilate STADA 75 mg contains 75 mg of dabigatran etexilate (as mesilate) as the active substance, along with tartaric acid and other excipients.
Active Substance
Each capsule contains 75 mg dabigatran etexilate (as dabigatran etexilate mesilate). Dabigatran etexilate mesilate is the salt form used in the formulation, which is converted in the body to the active compound dabigatran. The molecular formula of dabigatran etexilate mesilate is C34H41N7O5 · CH4O3S, with a molecular weight of approximately 723.86 g/mol.
Excipients (Inactive Ingredients)
The capsule contents and shell contain the following inactive ingredients:
- Tartaric acid — creates an acidic microenvironment that enhances absorption of dabigatran etexilate; may contribute to gastrointestinal side effects in some patients
- Hypromellose — a cellulose derivative used as a binding agent
- Talc — used as a glidant to improve powder flow during manufacturing
- Hydroxypropylcellulose — a binding and film-forming agent
- Croscarmellose sodium — a disintegrant that helps the capsule contents break apart in the stomach
- Magnesium stearate — a lubricant used in capsule manufacturing
- Capsule shell components: Hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) and/or other colourants depending on the capsule strength and manufacturer specifications
Patients with known allergies to any of these excipients should inform their doctor or pharmacist before taking this medication. The capsule formulation is free from lactose, gluten, and sucrose.
Frequently Asked Questions About Dabigatran etexilate STADA
Medical References
This article is based on the following peer-reviewed sources and international guidelines:
- Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation (RE-LY trial). N Engl J Med. 2009;361(12):1139-1151. doi:10.1056/NEJMoa0905561
- European Medicines Agency (EMA). Summary of Product Characteristics: Dabigatran etexilate. EMA/SmPC. Last updated 2024.
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. Eur Heart J. 2021;42(5):373-498. doi:10.1093/eurheartj/ehaa612
- Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism (RE-COVER trial). N Engl J Med. 2009;361(24):2342-2352. doi:10.1056/NEJMoa0906598
- Pollack CV Jr, Reilly PA, van Ryn J, et al. Idarucizumab for dabigatran reversal — full cohort analysis (RE-VERSE AD trial). N Engl J Med. 2017;377(5):431-441. doi:10.1056/NEJMoa1707278
- World Health Organization. WHO Model List of Essential Medicines — 23rd list. Geneva: WHO; 2023.
- Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation. Circulation. 2011;123(21):2363-2372.
- British National Formulary (BNF). Dabigatran etexilate. National Institute for Health and Care Excellence (NICE). Updated 2025.
- Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2020;41(4):543-603.
- Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in patients with mechanical heart valves (RE-ALIGN trial). N Engl J Med. 2013;369(13):1206-1214.
About Our Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, consisting of licensed specialist physicians in cardiology, haematology, and clinical pharmacology. Our team follows international medical guidelines (ESC, EMA, WHO) and uses the GRADE evidence framework to ensure the highest quality of medical information.
All medical claims are supported by systematic reviews, randomised controlled trials, and official drug monographs (EMA SmPC, BNF). Evidence level 1A.
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