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Introduction About DABIGO 75MG CAPSULE
DABIGO 75MG CAPSULE contains Dabigatran etexilate which belongs to the group of medicines called Anticoagulants. It is used to manage stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation and venous thromboembolic events in patients who have undergone orthopaedic surgery.
It is also used to manage acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and manages recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE). This medicine is also used in children to manage blood clots and to manage blood clots from reoccurring.
Avoid taking DABIGO 75MG CAPSULE, if you currently have bleeding disorders, organ disease of the body that increases the risk of serious bleeding such as stomach ulcer, injury or bleeding in the brain, severely reduced kidney or liver function.
Before taking DABIGO 75MG CAPSULE, inform your doctor if you have increased bleeding risks such as s bone fracture, head injury or any injury requiring surgical management, lung or heart problems.
DABIGO 75MG CAPSULE is not recommended for use in pregnant and breastfeeding women. Consult your doctor before taking DABIGO 75MG CAPSULE.
Your doctor will prescribe the right dose depends on your child’s age body weight and disease condition. Consult your doctor before taking DABIGO 75MG CAPSULE.
The most common side effects of taking DABIGO 75MG CAPSULE are stomachache, indigestion, frequent loose or liquid bowel movements and or nausea. Consult your doctor if any of these above side effects gets worse.
Uses Of DABIGO 75MG CAPSULE
It is used to:
- prevent stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation
- prevent venous thromboembolic events in patients who have undergone orthopaedic surgery
- manage acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
- prevent recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE)
- manage blood clots and to manage blood clots from reoccurring (in children)
How DABIGO 75MG CAPSULE Works
DABIGO 75MG CAPSULE works by blocking thrombin (blood central clotting agent) that results in the management of blood clots thereby managing the occurrence of stroke, heart attack, deep vein thrombosis and pulmonary embolism.
How to use DABIGO 75MG CAPSULE
Take DABIGO 75MG CAPSULE as advised by your physician. Swallow DABIGO 75MG CAPSULE with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects Of DABIGO 75MG CAPSULE
Common
- bleeding (nose, stomach or bowel, from penis/vagina or urinary tract)
- stomachache
- indigestion
- frequent loose or liquid bowel movements
- nausea
Uncommon
- bleeding (joint, from or after an injury or after an operation, from piles, from the rectum or in the brain)
- haematoma, formation or bruising occurring after an operation
- coughing of blood or blood stained sputum
- allergic reactions
- sudden change in color and appearance of the skin
- itching
- ulcer in the stomach or bowel
- inflammation of the gullet and stomach
- reflux of gastric juice into the gullet
- vomiting
- wound secretion (liquid exuding from the surgical wound)
- yellowing of the skin or whites of the eyes (liver or blood problems)
- difficulty in swallowing
Rare
- sign of allergic skin reaction such as skin rash notable for dark red, raised, itchy bumps
Stop taking DABIGO 75MG CAPSULE and contact your doctor if you experience any of the following side effects:
- signs of excessive bleeding such as exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling
- serious allergic reaction which causes difficulty in breathing or dizziness
How To Manage Side Effects
Dizziness:
Try to rest and relax and get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Limit your consumption of alcohol, as it can aggravate your dizziness. Consult and inform your doctor if the symptom does not improve.
Nausea and Vomiting:
Try to take DABIGO 75MG CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.
Indigestion:
Try to have smaller and more frequent meals and eat slowly. Try to reduce consumption of tea, coffee, cola or alcohol and lose weight if you are obese. Consult and inform your doctor if the symptom does not improve.
Warning & Precautions
Pregnancy
DABIGO 75MG CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking DABIGO 75MG CAPSULE.
Breastfeeding
DABIGO 75MG CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking DABIGO 75MG CAPSULE.
Driving and Using Machines
DABIGO 75MG CAPSULE has no known effects to affect the ability to drive or use machines. Consult your doctor before taking DABIGO 75MG CAPSULE.
Alcohol
Avoid Consumption of alcohol while taking DABIGO 75MG CAPSULE. Consult your doctor for advice.
Kidney
DABIGO 75MG CAPSULE is not recommended for use in patients with severely reduced kidney function. Consult your doctor before taking DABIGO 75MG CAPSULE.
Liver
DABIGO 75MG CAPSULE is not recommended for use in patients with severe liver disease or reduced liver function. Consult your doctor for advice before taking DABIGO 75MG CAPSULE.
Allergy
Do not take DABIGO 75MG CAPSULE if you are allergic to Dabigatran etexilate or any of the other ingredients of this medicine.
Lungs
DABIGO 75MG CAPSULE should be used with caution in patients with lung problems such as pulmonary embolism (blood clot in lungs). Consult your doctor before taking DABIGO 75MG CAPSULE.
Heart Disease
DABIGO 75MG CAPSULE is not recommended for use if you have received an artificial heart valve that requires permanent blood thinning. It should be used with caution in patients with heart problems such as heart attack, bacterial endocarditis (infection in the heart). Consult your doctor before taking DABIGO 75MG CAPSULE.
Others
DABIGO 75MG CAPSULE is not recommended for use if you:
- have bleeding problems
Before taking DABIGO 75MG CAPSULE, inform your doctor if you:
- have increased bleeding risk such as surgical tissue removal (biopsy), serious injury (bone fracture, head injury or any injury requiring surgical management), inflammation of the gullet or stomach, reflux of gastric juice into the gullet
- have symptoms of dehydration such as feeling thirsty and passing reduced amounts of dark-coloured (concentrated) or foaming urine
Use in pediatrics:
DABIGO 75MG CAPSULE is recommended for use in children and adolescents (from 8 to 18 years of age) to manage and reduce the risk of recurrence of blood clot disorder. Your doctor will prescribe the right dose depends on your child’s age, body weight and disease condition. Consult your doctor before taking DABIGO 75MG CAPSULE.
Use in geriatrics:
DABIGO 75MG CAPSULE is used with caution in elderly patients (aged 75 years or above). Consult your doctor before taking DABIGO 75MG CAPSULE.
Interactions
A. Drug-Drug Interactions:
Before taking DABIGO 75MG CAPSULE, inform your doctor, if you are taking any of the following medicine:
- aspirin (medicines used to reduce fever and relieves mild to moderate pain)
- ibuprofen, naproxen, diclofenac (medicines used to reduce fever and relieve mild to moderate pain)
- warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid (medicines used to reduce blood clotting)
- medicines to manage fungal infections (Ex. ketoconazole, itraconazole)
- medicines to manage abnormal heart beats (Ex. amiodarone, dronedarone, quinidine, verapamil)
- medicines used to manage organ rejection after transplantation (Ex. tacrolimus, cyclosporine)
- glecaprevir and pibrentasvir (used to manage hepatitis C)
- citalopram, dapoxetine, escitalopram fluoxetine, St. John’s wort, desvenlafaxine, duloxetine, levomilnacipran (used for depression)
- rifampicin or clarithromycin (used for bacterial infection)
- ritonavir (used for AIDS)
- medicines used for epilepsy (Ex. carbamazepine, phenytoin)
Overdosage:
If you or anyone else accidentally takes too much of DABIGO 75MG CAPSULE, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Dabigatran etexilate |
| Pharmacological Category | : | Anticoagulants |
| Therapeutic Indication | : | Prevent stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation, Venous thromboembolic events in patients who have undergone orthopaedic surgery, Blood clot disorders |
| Dosage Forms | : | Capsule, Tablet |
More Information
- Keep the medicine out of reach in children
- Store DABIGO 75MG CAPSULE at room temperature
FAQs About DABIGO 75MG CAPSULE
What DABIGO 75MG CAPSULE is used for?
DABIGO 75MG CAPSULE is used to manage stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation and venous thromboembolic events in patients who have undergone orthopaedic surgery.
How should DABIGO 75MG CAPSULE be taken?
Take DABIGO 75MG CAPSULE as advised by your physician. Swallow DABIGO 75MG CAPSULE with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
What are the side effects of DABIGO 75MG CAPSULE?
The most common symptoms of taking DABIGO 75MG CAPSULE are stomachache, indigestion , frequent loose or liquid bowel movements and nausea. Consult your doctor if any of these above side effects gets worse.
What happens if you stop taking DABIGO 75MG CAPSULE?
Do not stop taking DABIGO 75MG CAPSULE without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop management too early. Consult your doctor if you have any queries regarding stopping the medicine.
Is DABIGO 75MG CAPSULE safe to use in children?
DABIGO 75MG CAPSULE is recommended for use in children and adolescents (from 8 to 18 years of age) to manage and reduce the risk of recurrence of blood clot disorder. Your doctor will prescribe the right dose depends on your child’s age, body weight and disease condition. Consult your doctor before taking DABIGO 75MG CAPSULE.
References
1. KD. Tripathi. Drugs Affecting Coagulation, Bleeding and Thrombosis. Seventh edition. 2013. Page – 623.
2. Boehringer Ingelheim. Safety of Dabigatran Etexilate in Blood Clot Prevention in Children. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in June 2020] [Accessed on 30th May 2022] https://clinicaltrials.gov/ct2/show/NCT02197416
3. Eline A Dubois and Adam F Cohen. Dabigatran etexilate. NIH National Library of Medicine, National center for biotechnology information. PMC PubMed Central. July 2010. [Accessed on 30th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2909802/
4. Teerapat Nantsupawat, Suthipong Soontrapa, Nopakoon Nantsupawat, David Sotello, Saranapoom Klomjit, Selcuk Adabag and Alejandro Perez-Verdia. Risk factors and prevention of dabigatran-related gastrointestinal bleeding in patients with atrial fibrillation. NIH National Library of Medicine, National center for biotechnology information. PMC PubMed Central. February 2018. [Accessed on 30th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5828263/
5. Boehringer Ingelheim Pharmaceuticals, Inc. PRADAXA. [Revised in June 2021] [Accessed on 30th May 2022] https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf
6. Boehringer Ingelheim International GmbH. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.6228.pdf
7. Boehringer Ingelheim International GmbH. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.6229.pdf
8. Boehringer Ingelheim International GmbH. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.4703.pdf
9. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration (EMC). [Revised in November 2015] [Accessed on 30th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf
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