Apo-Dabigatran

Brand Name

Apo-Dabigatran

Common Name

dabigatran

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Dabigatran belongs to the family of medications called anticoagulants. Anticoagulants prevent harmful blood clots from forming in the blood vessels by reducing the ability of the blood to clot. Dabigatran is used to prevent blood clots for people who have had total hip replacement or knee replacement surgery.

Dabigatran is also used to treat blood clots for people who have had a deep vein thrombosis (DVT; a blood clot in the major arteries, particularly the leg), pulmonary embolism (blood clot in the lung), and to prevent these clots from happening again.

Dabigatran is also used to prevent stroke or blood clots for people with atrial fibrillation.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For knee replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 10 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily. For people over the age of 75, the doctor may recommend a lower dose of 150 mg taken once daily.

For hip replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 28 to 35 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily.

To treat or prevent blood clots in the lungs or veins of your legs the usual dose is 300 mg taken as one 150 mg capsule twice daily following 5-10 days of treatment with an injectable blood thinner. For people over the age of 80, or those with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.

For stroke and clot prevention in people with atrial fibrillation, the usual dose is 300 mg taken as one 150 mg capsule twice daily. For people over the age of 80, or those with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.

Dabigatran may be taken with food or on an empty stomach, with a full glass of water. If you experience heartburn or upset stomach, take dabigatran with food. Swallow the capsules whole. Do not open, break, or chew the capsules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you stop this medication before your doctor advises you to, your risk of developing blood clots may increase.

• For hip or knee replacement surgery: if you miss a dose, skip the missed dose and continue with your regular dosing schedule.
• For treatment or prevention of blood clots in the lungs or veins of your legs: if you miss a dose, and there are more than 6 hours before your next dose, take the missed dose and continue with your regular dosing schedule. If there are less than 6 hours before your next dose, skip the missed dose and continue with your regular dosing schedule.
• For treatment of atrial fibrillation: if you miss a dose, and there are more than 6 hours before your next dose, take the missed dose and continue with your regular dosing schedule. If there are less than 6 hours before your next dose, skip the missed dose and continue with your regular dosing schedule.

Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in its original package, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

75 mg
Each light blue and buff opaque capsule, filled with light yellow-to-yellow powder, imprinted "APO" with black ink on the cap and "D75" with black ink on the body, contains 75 mg of dabigatran. Nonmedicinal ingredients: fumaric acid, magnesium stearate, and mannitol; HPMC capsule shell: black printing ink SW-9008/SW9009, FDA/E172 red iron oxide, FDA/E172 yellow iron oxide, FD&C Blue No. 1, hypromellose, titanium dioxide; printing ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.

110 mg
Each light blue and buff opaque capsule, filled with light yellow-to-yellow powder, imprinted "APO" with black ink on the cap and "D110" with black ink on the body, contains 110 mg of dabigatran. Nonmedicinal ingredients: fumaric acid, magnesium stearate, and mannitol; HPMC capsule shell: black printing ink SW-9008/SW9009, FDA/E172 red iron oxide, FDA/E172 yellow iron oxide, FD&C Blue No. 1, hypromellose, titanium dioxide; printing ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.

150 mg
Each light blue and buff opaque capsule, filled with light yellow-to-yellow powder, imprinted "APO" with black ink on the cap and "D150" with black ink on the body, contains 150 mg of dabigatran. Nonmedicinal ingredients: fumaric acid, magnesium stearate, and mannitol; HPMC capsule shell: black printing ink SW-9008/SW9009, FDA/E172 red iron oxide, FDA/E172 yellow iron oxide, FD&C Blue No. 1, hypromellose, titanium dioxide; printing ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.

Who should NOT take this medication?

Do not take dabigatran if you:

• are allergic to dabigatran or any ingredients of this medication
• are taking certain other medications such as ketoconazole or glecaprevir-pibrentasvir that may increase the amount of this medication in the body
• are taking any other medications to reduce blood clotting (e.g., warfarin, heparin, enoxaparin)
• have active bleeding
• have any condition that is associated with an increased risk of bleeding (e.g., bleeding problems)
• have or have had a body lesion at risk of bleeding, such as a stroke within the past 6 months
• have severely reduced kidney function
• have a prosthetic heart valve and require other medication to reduce blood clotting
• are breast-feeding

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bruising (mild)
• diarrhea
• difficulty swallowing
• hair loss
• heartburn/reflux
• nausea
• stomach pain
• upset stomach
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• oozing from the surgical wound
• joint pain or swelling
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding, bleeding in the rectum or from hemorrhoids, bleeding from where a catheter enters a vein)
• signs of infection (e.g., fever, chills, cough, difficulty breathing, unusual fatigue)
• skin rash
• symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching)
• symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• bleeding (severe) from a surgical wound
• signs of a serious allergic reaction (i.e., hives, difficulty breathing, or swelling of the face and throat)
• signs of bleeding in the stomach or digestive system (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Heart valves: Bleeding events, such as strokes, have been reported to occur when dabigatran is used by someone who has a replacement heart valve. If you have had surgery to replace or repair a heart valve, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Increased bleeding risk: If you have an increased risk of bleeding (e.g., recent biopsy; major trauma; brain, spinal, or eye surgery; taking medications that increase the risk of bleeding; bleeding disorders; stomach or intestinal ulcers; stroke; or inflammation of certain parts of the heart), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people who are at a high risk of bleeding.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with severely decreased kidney function.

Liver function: Dabigatran may cause liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Spinal or epidural catheters: This medication should not be taken by people who have spinal or epidural catheters in place (or for 2 hours after their removal) or by people receiving pain medications through an epidural catheter.

Surgery: Your doctor may want to stop dabigatran for a few days prior to any planned surgery to prevent any unnecessary bleeding, so it is important to tell all of your doctors that you are taking dabigatran.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dabigatran passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

Seniors: Seniors are more likely to have age-related reductions in kidney function. Your doctor may adjust your dose based on your kidney function.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-Dabigatran