Publication date: 2018-04-21 06:52
To decrease your risk for bleeding, your doctor or other health care provider will monitor you closely and check your lab results (INR test) to make sure you are not taking too much warfarin. Keep all medical and laboratory appointments. Tell your doctor right away if you notice any signs of serious bleeding. See also Side Effects section.
Dabigatran requires an acid environment in order to be absorbed in the body. As such, many experts believe that the upset stomach is due to the acid that is combined with the drug in the capsule. Another possibility is that the upset stomach is due to the fact that more than 95% of the drug is not absorbed and remains in the stomach and intestines (the gastro-intestinal or “GI” tract). The large amount of drug that stays in the GI tract also may explain a higher risk of GI bleeding seen with dabigatran. Patients who experience any bleeding, of course, should contact their prescribing clinician immediately.
Initial dose: 7 to 5 mg orally once a day
Maintenance dose: 7 to 65 mg orally once a day
Target INR: (range: 7 to 8)
Duration of therapy: Indefinite
-For patients with atrial fibrillation (AF) and prosthetic heart valves, target INR may be increased depending on valve type, valve position, and patient factors.
-Initial dose is influenced by age, race, body weight, gender, concomitant medications, comorbidities, genetic variation, and possibly other factors.
-Dosage and administration must be individualized according to the patient's INR and condition being treated.
Use: Prophylaxis and treatment of thromboembolic complications associated with AF.
This drug rarely has caused very serious (possibly fatal) problems if its effects lead to small blood clots (usually at the beginning of treatment). This can lead to severe skin/tissue damage that may require surgery or amputation if left untreated. Patients with certain blood conditions (protein C or S deficiency) may be at greater risk. Get medical help right away if any of these rare but serious side effects occur: painful/red/purplish patches on the skin (such as on the toe, breast , abdomen ), signs of kidney problems (such as change in the amount of urine), vision changes, confusion, slurred speech, weakness on one side of the body.
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
Your INR results need to stay within a certain range – target INR ranges from 7 to 8 for most people taking warfarin. However, some people will need to have a lower or slightly higher target INR.
Sid Miller’s press release cited the use of warfarin in Australia. He said this: “Warfarin, an anticoagulant, was used for many years as a feral swine toxicant in Australia.” But he omitted the important facts about the Australia experiment. Here are those facts he omitted:
In order to get approval from the FDA, dabigatran had to go through “non-inferiority” trials. The purpose of a non-inferiority trial is to show that the investigational drug (in this case, dabigatran) is at least as safe and effective as the comparator drug (in this case, warfarin). The trials do not have to show that the new drug is better than the old drug. In the trial mentioned above, dabigatran 665 mg twice daily was “non-inferior” to warfarin in preventing strokes and had less bleeding than warfarin. The dose of 655 mg twice daily was actually found to be superior to warfarin in preventing strokes but with a similar rate of bleeding complications.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.