Dabigatran Etexilate with Orlistat Interaction Details
Brand Names Associated with Dabigatran Etexilate
- Dabigatran
- Pradaxa®
Brand Names Associated with Orlistat
- Alli®
- Orlistat
- Xenical®
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Jan 08, 2024
Interaction Effect
An increased risk of bleeding
Interaction Summary
Changes in hemostatic parameters, increased INR, and decreased prothrombin have been reported in patients receiving orlistat with an anticoagulant. Orlistat may reduce the absorption of fat-soluble vitamins including vitamin K, with the result that a lower dose of warfarin is required . The pharmacokinetics and pharmacodynamics of a single dose of warfarin were not altered by a 10-day pretreatment of orlistat . Even though undercarboxylated osteocalcin (a nutritional status marker for vitamin K) was unaltered, vitamin K levels had a tendency to decline in patients administered orlistat. Closely monitor patients on chronic stable doses of warfarin or other anticoagulants for changes in coagulation parameters if coadministered .
Severity
Major
Onset
Unspecified
Evidence
Theoretical
How To Manage Interaction
Changes in hemostatic parameters, increased INR, and decreased prothrombin have been reported in patients receiving orlistat with an anticoagulant. Vitamin K absorption may be decreased with the use of orlistat. Closely monitor for changes in coagulation parameters if orlistat is coadministered with chronic stable doses of warfarin or other anticoagulants.
Mechanism Of Interaction
Decreased vitamin K absorption
Literature Reports
A) In a randomized, crossover study, 12 healthy male volunteers received 30 mg of warfarin on the eleventh day of orlistat (120 mg 3 times daily for 16 days) or placebo therapy. Warfarin was administered on day 11 with the morning orlistat or placebo dose, following an overnight fast. Participants were studied in a controlled environment for 144 hours following the warfarin dose. There were no differences between the pharmacokinetic parameters of R- and S- warfarin with respect to the AUC, Cmax, or Tmax for either the orlistat or placebo dosing. In addition, prothrombin time (PT) and Factor VII values were no different for either orlistat or placebo dosing .
B) Orlistat may reduce the absorption of fat-soluble vitamins including vitamin K, with the result that a lower dose of warfarin is required. A 66-year-old white male with a 3-year history of chronic atrial fibrillation, for which he had been taking warfarin for 2.5 years was seen for follow-up. He was taking amlodipine and perindopril for hypertension, and his type 2 diabetes mellitus was diet-controlled. Orlistat 120 mg 3 times daily was initiated for weight reduction. Eighteen days after the introduction of orlistat his INR was increased at 4.7. His INR had been previously stable for greater than 1 year. The amount of fatty foods was reduced but no other changes were made. His warfarin was withheld for 2 days and restarted at 5 mg/day. His International Normalized Ration (INR) remained elevated (4.4). Warfarin was withheld for another 2 days and subsequently restarted at 3 mg/day. Satisfactory control of INR was eventually obtained. The Naranjo score indicated that this suspected adverse reaction was probable .
Dabigatran Etexilate Overview
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Dabigatran is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults and children 3 months of age and older who have been treated with an injectable anticoagulant ('blood thinner'). It is also used to reduce the risk of a DVT and PE from happening again after initial treatment is completed in adults and children 3 months of age and older. Dabigatran is used to help prevent DVT and PE in adults who have had hip replacement surgery. Dabigatran is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
Orlistat Overview
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Orlistat (prescription and nonprescription) is used with an individualized low-calorie, low-fat diet and exercise program to help people lose weight. Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease. Orlistat is also used after weight-loss to help people keep from gaining back that weight. Orlistat is in a class of medications called lipase inhibitors. It works by preventing some of the fat in foods eaten from being absorbed in the intestines. This unabsorbed fat is then removed from the body in the stool.
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Definitions
Severity Categories
Contraindicated
These drugs, generally, should not be used together simultaneously due to the high risk of severe adverse effects. Combining these medications can lead to dangerous health outcomes and should be strictly avoided unless otherwise instructed by your provider.
Major
This interaction could result in very serious and potentially life-threatening consequences. If you are taking this drug combination, it is very important to be under close medical supervision to minimize severe side effects and ensure your safety. It may be necessary to change a medication or dosage to prevent harm.
Moderate
This interaction has the potential to worsen your medical condition or alter the effectiveness of your treatment. It's important that you are monitored closely and you potentially may need to make adjustments in your treatment plan or drug dosage to maintain optimal health.
Minor
While this interaction is unlikely to cause significant problems, it could intensify side effects or reduce the effectiveness of one or both medications. Monitoring for changes in symptoms and your condition is recommended, and adjustments may be made if needed to manage any increased or more pronounced side effects.
Onset
Rapid: Onset of drug interaction typically occurs within 24 hours of co-administration.
Delayed: Onset of drug interaction typically occurs more than 24 hours after co-administration.
Evidence
Level of documentation of the interaction.
Established: The interaction is documented and substantiated in peer-reviewed medical literature.
Theoretical: This interaction is not fully supported by current medical evidence or well-documented sources, but it is based on known drug mechanisms, drug effects, and other relevant information.
How To Manage The Interaction
Provides a detailed discussion on how patients and clinicians can approach the identified drug interaction as well as offers guidance on what to expect and strategies to potentially mitigate the effects of the interaction. This may include recommendations on adjusting medication dosages, altering the timing of drug administration, or closely monitoring for specific symptoms.
It's important to note that all medical situations are unique, and management approaches should be tailored to individual circumstances. Patients should always consult their healthcare provider for personalized advice and guidance on managing drug interactions effectively.
Mechanism Of Interaction
The theorized or clinically determined reason (i.e., mechanism) why the drug-drug interaction occurs.
Disclaimer: The information provided on this page is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional regarding your specific circumstances and medical conditions.
Where Does Our Information Come From?
Information for our drug interactions is compiled from several drug compendia, including:
The prescribing information for each drug, as published on DailyMED, is also used.
Individual drug-drug interaction detail pages contain references specific to that interaction. You can click on the reference number within brackets '[]' to see what reference was utilized.
The information posted is fact-checked by HelloPharmacist clinicians and reviewed quarterly.