Rifabutin is used to help prevent Mycobacterium avium complex (MAC) disease from causing disease throughout the body in patients with advanced human immunodeficiency virus (HIV) infection. MAC is an infection caused by two similar bacteria, Mycobacterium avium and Mycobacterium intracellulare. Mycobacterium avium is more common in patients with HIV infection. MAC also may occur in other patients whose immune system is not working properly. Symptoms of MAC in people with acquired immunodeficiency syndrome (AIDS) include fever, night sweats, chills, weight loss, and weakness. Rifabutin is an antibiotic and works to kill or prevent the growth of certain bacteria. It will not help against viruses.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, rifabutin is used in certain patients with the following medical condition:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of rifabutin in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifabutin in the elderly. However, elderly patients are more likely to have kidney, liver, or heart disease which may require caution and an adjustment in the dose for patients receiving rifabutin.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.
This medicine should not be given to patients with active tuberculosis (TB). If you know you have TB or think you may have active TB, tell your doctor.
Rifabutin may be taken on an empty stomach (either 1 hour before or 2 hours after a meal). However, if this medicine upsets your stomach, you may want to take it with food.
If you cannot swallow the capsule, you may open it and the contents of the capsules may be mixed with applesauce. Be sure to take all the food to get the full dose of medicine.
To help prevent MAC disease, it is very important that you keep using this medicine for the full time of treatment. You may have to take it every day for many months. It is important that you do not miss any doses.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits. Blood and urine tests may be needed to check for unwanted effects.
Rifabutin will cause your urine, stools, saliva, skin, sputum, sweat, and tears to turn reddish-orange to brown-orange. This is to be expected while you are taking this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. It is best not to wear soft contact lenses while taking this medicine. Hard contact lenses are not discolored by rifabutin. If you have any questions about this, check with your doctor.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.
Rifabutin can lower the number of white blood cells in your blood temporarily, increasing the chance of getting infection. It can also lower the number of platelets, which are necessary for proper blood clotting. These problems may result in a greater chance of getting certain infections, slow healing, and bleeding of the gums. Be careful when using a regular toothbrush, dental floss, or toothpick. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
Birth control pills may not work properly if you take them while you are taking rifabutin. Unplanned pregnancies may occur. Use a different means of birth control while you are taking rifabutin. If you have any questions about this, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.