Description
Rifapentine is used in combination with other medicines (eg, ethambutol, isoniazid, pyrazinamide) to treat active or inactive (latent) tuberculosis. Rifapentine is an antibiotic and works to kill or prevent the growth of bacteria. It will not help against viruses.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rifapentine to treat active tuberculosis in children younger than 12 years of age or to treat inactive tuberculosis in children younger than 2 years of age. Safety and efficacy have not been established in these age groups.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifapentine in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Artemether
- Cabotegravir
- Delamanid
- Doravirine
- Isavuconazonium Sulfate
- Lonafarnib
- Lurasidone
- Mavacamten
- Nirmatrelvir
- Praziquantel
- Ranolazine
- Rilpivirine
- Ritonavir
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Adagrasib
- Alfentanil
- Alpelisib
- Amprenavir
- Apremilast
- Aprepitant
- Aripiprazole
- Atogepant
- Avacopan
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Bictegravir
- Bosutinib
- Buprenorphine
- Capivasertib
- Ceritinib
- Cholera Vaccine, Live
- Clarithromycin
- Cobicistat
- Codeine
- Crizotinib
- Cyclosporine
- Daridorexant
- Darunavir
- Dasatinib
- Desogestrel
- Dienogest
- Dihydrocodeine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Drospirenone
- Elacestrant
- Elexacaftor
- Elvitegravir
- Entrectinib
- Enzalutamide
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.
- Acetyldigoxin
- Adinazolam
- Alprazolam
- Amiodarone
- Amitriptyline
- Amlodipine
- Aranidipine
- Bentazepam
- Bepridil Hydrochloride
- Betamethasone
- Bisoprolol
- Bromazepam
- Brotizolam
- Carteolol
- Carvedilol
- Chloramphenicol
- Chlordiazepoxide
- Chlorpropamide
- Cilnidipine
- Ciprofloxacin
- Clevidipine
- Clobazam
- Clofibrate
- Clonazepam
- Clorazepate
- Dapsone
- Delavirdine
- Delorazepam
- Deslanoside
- Dexamethasone
- Diazepam
- Digitoxin
- Digoxin
- Diltiazem
- Disopyramide
- Doxycycline
- Estazolam
- Felodipine
- Fluconazole
- Fludrocortisone
Other Interactions
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:
- HIV infection—Use is not recommended to treat active tuberculosis in patients with this condition.
- Liver disease or
- Porphyria (an enzyme problem)—Use with caution. May make these conditions worse.
Proper Use
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 come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food.
Swallow the tablet whole. If you cannot swallow it whole, you may crush it and add it to a small amount of semi-solid food. Take all of it right away and do not store it for later use.
To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if you begin to feel better after a few weeks. If you have TB, you might have to take rifapentine for several months. It is important that you not miss any doses.
Dosing
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.
- For oral dosage form (tablets):
- For the treatment of active tuberculosis:
- Adults and children 12 years of age and older—600 milligrams (mg) 2 times a week with an interval of not less than 3 days (72 hours) between doses. Then, 600 mg once a week taken for 4 months with isoniazid or other medicines.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For the treatment of latent tuberculosis:
- Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually up to 900 milligrams (mg) once a week taken with isoniazid for 12 weeks.
- Children 2 to 11 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually taken with isoniazid for 12 weeks.
- Weighing more than 50 kilograms (kg)—900 mg (6 tablets) once a week.
- Weighing 32.1 to 50 kg—750 mg (5 tablets) once a week.
- Weighing 25.1 to 32 kg—600 mg (4 tablets) once a week.
- Weighing 14.1 to 25 kg—450 mg (3 tablets) once a week.
- Weighing 10 to 14 kg—300 mg (2 tablets) once a week.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For the treatment of active tuberculosis:
Missed Dose
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.
Storage
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.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills after using this medicine.
Check with your doctor right away if you or your child have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are using this medicine. Also, the regular use of alcohol may keep this medicine from working properly. You should not drink alcoholic beverages while you are using this medicine.
Rifapentine will cause the urine, stools, saliva, sputum, sweat, and tears to turn reddish-orange to reddish-brown. This is to be expected while you are using this medicine. This effect may also cause soft contact lenses and dentures to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. It is best not to wear soft contact lenses or dentures while using this medicine. Hard contact lenses are not discolored by rifapentine. If you have any questions about this, check with your 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.
Rifapentine 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 a 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.
Before you have any medical tests, tell the doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
Birth control pills may not work properly if you take them while you are using rifapentine. Use a non-hormonal form of birth control (eg, condoms, spermicide) while you are using rifapentine. 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.
Side Effects
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:
More common
- Black, tarry stools
- chills
- cough
- coughing up blood
- fever
- hoarseness
- lower back or side pain
- painful or difficult urination
- pale skin
- skin rash
- sore throat
- trouble breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Bleeding gums
- blood in the urine or stools
- burning, dry, or itching eyes
- excessive tearing of the eye
- eye pain
- fast heartbeat
- general feeling of illness
- headache
- hives, itching
- irritation
- joint pain, stiffness, or swelling
- loss of appetite
- pinpoint red spots on the skin
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- trouble breathing or swallowing
- weight loss
Rare
- Anxiety
- bloating
- blue or pale skin
- burning feeling in the chest or stomach
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- chest pain, possibly moving to the left arm, neck, or shoulder
- cloudy or dark urine
- cold sweat
- collection of blood under the skin
- confusion
- constipation
- deep, dark purple bruise
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fast, pounding, or irregular heartbeat or pulse
- heartburn
- indigestion
- itching in the genital or other skin areas
- lack or loss of strength
- light-colored stools
- muscle pain
- nausea
- noisy breathing
- pain in the lower back or side
- pain or burning in the throat
- pains in the stomach, side, or abdomen, possibly radiating to the back
- right upper stomach pain and fullness
- scaling of the skin
- seizures
- stabbing pain
- stomach upset
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- thick, white vaginal discharge with mild or no odor
- thickening of bronchial secretions
- thirst
- vaginal bleeding
- voice changes
- vomiting
- yellow skin or eyes
Incidence not known
- Blistering, peeling, or loosening of the skin
- diarrhea
- red skin lesions, often with a purple center
- sensitivity of the skin to the sun
- thinning of the skin
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:
More common
- Increased sweating
Less common
- Belching
- difficulty in moving
Rare
- Discoloration of the skin
- drowsiness
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.
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