Rifater (Oral)

Rifampin, isoniazid, and pyrazinamide combination is used to treat tuberculosis (TB) infection. It can be taken by itself or with other TB medicines. Rifampin is an antibiotic that kills or stops the growth of bacteria. However, it will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your or your child's progress during regular visits. Blood and urine tests may be needed to check for side effects.

If your symptoms do not improve within 2 to 3 weeks, or if they get worse, contact your doctor.

Do not use this medicine if you are also taking certain medicines for HIV infection (for example, atazanavir, darunavir, fosamprenavir, ritonavir, saquinavir, tipranavir, Aptivus®, Fortovase®, Invirase®, Lexiva®, Norvir®, Prezista®, or Reyataz®).

Do not use this medicine with praziquantel. If you need to take praziquantel, stop using this medicine 4 weeks before starting praziquantel. You can restart this medicine one day after your last dose of praziquantel.

Liver problems may be more likely if you regularly drink alcohol while using this medicine. Also, drinking alcohol regularly may prevent this medicine from working properly. Therefore, you should strictly limit alcoholic beverages while using this medicine.

Contact your doctor immediately if you 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 indicate a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

Serious skin reactions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis) can happen with this medicine. Contact your doctor immediately if you experience 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 while using this medicine.

Inform your doctor right away if you have chest pain, cough, coughing or spitting up blood, difficulty breathing, sore throat, muscle aches, night sweats, sudden high fever, or unusual tiredness. These could be signs of a paradoxical drug reaction to this medicine. If your symptoms do not improve within a few days or worsen, consult your doctor.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any change in vision during or after treatment. Your doctor may want an ophthalmologist (eye doctor) to check your eyes.

See your doctor right away if you have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling in your feet or lower legs. These could be symptoms of acute gout.

This medicine may cause problems with blood clotting, which can lead to bleeding. Check with your doctor immediately if you cough up blood, have bleeding gums, difficulty breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools after using this medicine.

This medicine will cause your urine, stool, saliva, sputum, sweat, teeth, and tears to turn reddish-orange to reddish-brown. This is normal while using this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not remove all the discoloration. Therefore, it is best not to wear soft contact lenses while using this medicine. Hard contact lenses are not affected by this medicine. This condition will return to normal once you stop using the medicine. If you have questions about this, consult your doctor.

This medicine may cause lung or breathing problems (for example, interstitial lung disease, pneumonitis, pneumonia, respiratory failure, pulmonary fibrosis, acute respiratory distress syndrome), which can be life-threatening and require immediate medical attention. Contact your doctor right away if you have chest pain, chills, dry cough, fever, a general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Contact your doctor immediately if you feel very tired or weak, or if you have clumsiness, unsteadiness, loss of appetite, nausea, numbness, tingling, burning, or pain in your hands and feet, or vomiting. These may be early warning signs of serious liver or nerve problems that could develop later.

Rifampin, isoniazid, and pyrazinamide combination may cause blood problems. These issues may increase the risk of certain infections, slow healing, and bleeding gums. Therefore, be cautious when using regular toothbrushes, dental floss, and toothpicks. Delay dental work until your blood counts return to normal. Consult your medical doctor or dentist if you have questions about proper oral hygiene during treatment.

This medicine may cause thrombotic microangiopathy (damage in the smallest blood vessels), including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura. Inform your doctor immediately if you notice a change in mental status, dark or bloody urine, decreased urine output, difficulty speaking, fever, pale skin, pinpoint red spots on the skin, seizures, severe chest pain, sudden weakness in your arms or legs, unusual bleeding or bruising, or yellow eyes or skin.

If you develop a skin rash, hives, or any allergic reaction to this medicine, contact your doctor right away.

Before any medical tests, inform the medical doctor in charge that you are using this medicine. Some test results may be affected by this medicine.

Eating certain foods (for example, Cheshire cheese, Swiss cheese, skipjack, tuna, or Sardinella) or drinking red wine may cause reactions in some patients using isoniazid-containing medicines. Check with your doctor if you experience flushing, fast or pounding heartbeat, headache, redness or itching of the skin, sweating, dizziness, or lightheadedness while using this medicine.

Birth control pills may not work properly while you are using this medicine. To prevent pregnancy, use another form of birth control along with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the chances of taking the medicine must be weighed against the good it will do. This is a decision you and your clinician will make. For this medication, 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 drugs. Also inform 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 rifampin, isoniazid, and pyrazinamide combination in children younger than 15 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifampin, isoniazid, and pyrazinamide combination in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this drug while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially important that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medicines is not advised. Your physician may decide not to treat you with this medicine or change some of the other drugs you take.

• Artemether
• Atazanavir
• Bictegravir
• Boceprevir
• Cabotegravir
• Cobicistat
• Daclatasvir
• Darunavir
• Dasabuvir
• Delamanid
• Doravirine
• Elbasvir
• Elvitegravir
• Fosamprenavir
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Isavuconazonium
• Lenacapavir
• Lopinavir
• Lorlatinib
• Lurasidone
• Maraviroc
• Mavacamten
• Nelfinavir
• Nirmatrelvir
• Ombitasvir
• Pacritinib
• Paritaprevir
• Pibrentasvir
• Praziquantel
• Ranolazine
• Rilpivirine
• Ritonavir
• Saquinavir
• Sofosbuvir
• Telaprevir
• Tenofovir Alafenamide
• Tipranavir
• Velpatasvir
• Voriconazole
• Voxilaprevir

Using this drug with any of the following drugs is normally not advised, but may be required in some cases. If both drugs are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Abemaciclib
• Abiraterone Acetate
• Abrocitinib
• Acalabrutinib
• Acetaminophen
• Adagrasib
• Afatinib
• Alfentanil
• Alpelisib
• Amifampridine
• Amiodarone
• Amlodipine
• Amprenavir
• Apixaban
• Apremilast
• Aprepitant
• Aripiprazole
• Atogepant
• Atovaquone
• Avacopan
• Avapritinib
• Avatrombopag
• Axitinib
• Bedaquiline
• Belumosudil
• Bendamustine
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Bortezomib
• Bosutinib
• Brexpiprazole
• Brigatinib
• Brivaracetam
• Buprenorphine
• Bupropion
• Cabozantinib
• Cannabidiol
• Capmatinib
• Carbamazepine
• Cariprazine
• Ceritinib
• Cholera Vaccine, Live
• Clopidogrel
• Clozapine
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclosporine
• Dabigatran Etexilate
• Daprodustat
• Daridorexant
• Darolutamide
• Dasatinib
• Deferasirox
• Deflazacort
• Delavirdine
• Desogestrel
• Dexamethasone
• Dienogest
• Digoxin
• Dihydrocodeine
• Dolutegravir
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Duvelisib
• Edoxaban
• Efavirenz
• Elacestrant
• Elagolix
• Elexacaftor
• Eliglustat
• Eluxadoline
• Encorafenib
• Entrectinib
• Enzalutamide
• Eravacycline
• Erdafitinib
• Erlotinib
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethionamide
• Ethynodiol
• Etonogestrel
• Etrasimod
• Etravirine
• Everolimus
• Exemestane
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Finerenone
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Futibatinib
• Gefitinib
• Gepirone
• Gestodene
• Gilteritinib
• Glasdegib
• Glimepiride
• Halothane
• Hemin
• Hydrocodone
• Hydroxychloroquine
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Ifosfamide
• Imatinib
• Indinavir
• Infigratinib
• Irinotecan
• Irinotecan Liposome
• Isoniazid
• Istradefylline
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ixazomib
• Ketoconazole
• Lamotrigine
• Lapatinib
• Larotrectinib
• Ledipasvir
• Lefamulin
• Lemborexant
• Leniolisib
• Letermovir
• Levodopa
• Levoketoconazole
• Levonorgestrel
• Linagliptin
• Lorcainide
• Lumateperone
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Maribavir
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methadone
• Methotrexate
• Metoprolol
• Midostaurin
• Mifepristone
• Mirtazapine
• Mitapivat
• Mobocertinib
• Momelotinib
• Mycophenolate Mofetil
• Mycophenolic Acid
• Naloxegol
• Neratinib
• Netupitant
• Nevirapine
• Nifedipine
• Nilotinib
• Nimodipine
• Nintedanib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Olaparib
• Olutasidenib
• Omaveloxolone
• Omeprazole
• Osimertinib
• Oxcarbazepine
• Oxycodone
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Pazopanib
• Pemigatinib
• Pentazocine
• Perampanel
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Piperaquine
• Pirtobrutinib
• Pitavastatin
• Pitolisant
• Ponatinib
• Ponesimod
• Posaconazole
• Pralsetinib
• Pretomanid
• Primidone
• Pyrazinamide
• Quetiapine
• Quinine
• Quizartinib
• Regorafenib
• Relugolix
• Revefenacin
• Ribociclib
• Rifampin
• Rimegepant
• Ripretinib
• Risperidone
• Ritlecitinib
• Rivaroxaban
• Roflumilast
• Rolapitant
• Romidepsin
• Ruxolitinib
• Samidorphan
• Segesterone
• Selexipag
• Selpercatinib
• Selumetinib
• Sildenafil
• Simeprevir
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sonidegib
• Sorafenib
• Sotagliflozin
• Sotorasib
• Sparsentan
• Stiripentol
• Sufentanil
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tasimelteon
• Tazemetostat
• Tegafur
• Telithromycin
• Temsirolimus
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tivozanib
• Tofacitinib
• Tolvaptan
• Trabectedin
• Tramadol
• Tucatinib
• Ubrogepant
• Ulipristal
• Upadacitinib
• Valbenazine
• Vandetanib
• Vemurafenib
• Venetoclax
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voclosporin
• Vonoprazan
• Vorapaxar
• Vortioxetine
• Voxelotor
• Zanubrutinib
• Zavegepant
• Zidovudine
• Zolpidem
• Zuranolone

Using this medication with any of the following medicines may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Acetyldigoxin
• Aliskiren
• Aminosalicylic Acid
• Anisindione
• Aripiprazole Lauroxil
• Atorvastatin
• Betamethasone
• Bexarotene
• Bosentan
• Buspirone
• Carbamazepine
• Carvedilol
• Caspofungin
• Chloramphenicol
• Chlorpropamide
• Citalopram
• Clarithromycin
• Clofibrate
• Cortisone
• Diazepam
• Dicumarol
• Diltiazem
• Disopyramide
• Disulfiram
• Doxycycline
• Eltrombopag
• Enalaprilat
• Enalapril Maleate
• Enflurane
• Etoricoxib
• Fluconazole
• Fludrocortisone
• Fosphenytoin
• Gliclazide
• Glyburide
• Haloperidol
• Isradipine
• Levomethadyl
• Levothyroxine
• Linezolid
• Losartan
• Mefloquine
• Meperidine
• Metformin
• Methylprednisolone
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nisoldipine
• Ospemifene
• Phenprocoumon
• Phenytoin
• Pioglitazone
• Pirmenol
• Prednisolone
• Prednisone
• Propafenone
• Raltegravir
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Sertraline
• Simvastatin
• Tadalafil
• Theophylline
• Tocainide
• Triazolam
• Trimetrexate
• Valproic Acid
• Warfarin
• Zaleplon
• Zidovudine

Interactions with Food/Tobacco/Alcohol

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 medications may as well cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• food
• Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medication. Make sure you inform your doctor if you have any other medical issues, especially:

• Adrenal gland problem or
• Blood clotting issues or
• Diabetes, history of or
• Porphyria (an enzyme issue) or
• Vitamin K deficiency—Use with caution. May make these conditions worse.

• Alcohol abuse, or history of—Use with caution. There may be an increased chance of getting liver problems (eg, hepatitis) if you take this medicine and drink alcohol daily.

• Gout, acute or
• Liver disease, acute or serious or
• Meningococcal disease (including infections of the lining of the brain and spinal cord [meningitis] and bloodstream [eg, bacteremia, septicemia)—Should not be used in patients with these conditions.

• Liver disease, chronic or
• Patients with poor nutrition status—Use with caution. May increase chance for vitamin K deficiency, which may lead to excessive bleeding.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain or tightness
• Clumsiness or unsteadiness
• Coughing or spitting up blood
• Dark urine
• Fast, irregular, pounding, or racing heartbeat or pulse
• Loss of appetite
• Nausea
• Numbness, tingling, burning, or pain in the hands and feet
• Pain in the large and small joints
• Sneezing
• Trouble breathing
• Unusual tiredness or weakness
• Vomiting
• Yellow eyes or skin

Less common

• Chills
• Difficulty in breathing
• Dizziness
• Fever
• Headache
• Hearing loss
• Muscle and bone pain
• Ringing, buzzing, or other unexplained noise in the ears
• Shivering
• Skin rash, itching, or redness

Rare

• Agitation
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Blood in the urine or stools
• Blurred vision or loss of vision, with or without eye pain
• Bruising
• Confusion
• Darkening of the skin
• Difficulty in swallowing
• Fainting
• Feeling that others are watching you or controlling your behavior
• Feeling that others can hear your thoughts
• Feeling, seeing, or hearing things that are not there
• Fever with or without chills
• General feeling of tiredness or weakness
• Heavier menstrual periods
• Hives
• Hoarseness
• Hostility
• Increased blood pressure
• Increased thirst
• Irritability
• Light-colored stools
• Lower back or side pain
• Mental depression
• Muscle tenderness, wasting, or weakness
• Persistent bleeding or oozing from puncture sites, mouth, or nose
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Seizures
• Severe mood or mental changes
• Swelling of the face, ankles, fingers, hands, or lower legs
• Unusual behavior
• Unusual drowsiness, dullness, or feeling of sluggishness
• Weight gain

Incidence not known

• Ankle, knee, or great toe pain
• Back pain
• Being forgetful
• Black, tarry stools
• Bleeding under the skin
• Blemishes on the skin
• Bloating
• Bloody, severe, or watery diarrhea
• Blue-yellow color blindness
• Bone pain
• Burning while urinating
• Cloudy urine
• Cold, clammy skin
• Constipation
• Cough
• Difficulty seeing at night
• Difficulty with speaking
• Double vision
• Dry mouth
• Fast, weak pulse
• Flushed, dry skin
• Fruit-like breath odor
• General feeling of discomfort or illness
• Greatly decreased frequency of urination or amount of urine
• Hair loss
• Inability to move the arms, legs, or facial muscles
• Inability to speak
• Increased hunger
• Increased menstrual flow or vaginal bleeding
• Increased sensitivity of the eyes to sunlight
• Increased urination
• Indigestion
• Joint pain, stiffness, or swelling
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Lightheadedness
• Muscle aches, pains, and tremors
• Night sweats
• Nosebleeds
• Painful or difficult urination
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Paralysis
• Pimple
• Prolonged bleeding from cuts
• Rapid, deep breathing
• Red or dark brown urine
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Restlessness
• Runny nose
• Slow speech
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stiff neck
• Stomach cramps or pain
• Sweating
• Swollen glands
• Trouble sleeping
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision
• Confusion
• Decreased awareness or responsiveness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fainting
• Fast, pounding, or irregular heartbeat or pulse
• Feeling of fullness in the upper abdomen or stomach
• Loss of consciousness
• Low blood pressure or slow pulse
• Pain in the upper abdomen or stomach
• Reddish-orange to reddish-brown color of the urine, stool, saliva, sputum, sweat, and tears
• Seeing, hearing, or feeling things that are not there
• Seizures
• Severe sleepiness
• Slurring of speech
• Swelling around the eyes and face
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Yellow eyes or 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:

Less common

• Sore mouth or tongue

Incidence not known

• Belching
• Bloated or full feeling
• Excess air or gas in the stomach or bowels
• Not able to concentrate
• Pain or discomfort in the chest, upper stomach, or throat
• Swelling of the breasts or breast soreness in both females and males
• Tooth discoloration

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.

In the U.S.

• Rifater

Chemical Class: Rifamycin

Take this medicine only 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 of side effects.

This medicine should be taken on an empty stomach, 1 hour before or 2 hours after a meal, with a full of glass of water. It is important to take this medicine on a regular schedule.

If this medicine upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids (eg, Maalox®, Mylanta®) within 1 hour of the time you take rifampin, isoniazid, and pyrazinamide combination. They may keep this medicine from working properly.

To help clear up your tuberculosis (TB) infection completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. It is important that you do not miss any doses.

Your doctor may also want you to take pyridoxine (eg, Hexa-Betalin, vitamin B6) everyday to help prevent or lessen some of the side effects of isoniazid. If it is needed, it is very important to take pyridoxine everyday along with this medicine. Do not miss any doses.

If you are taking itraconazole, do not use rifampin, isoniazid, and pyrazinamide combination 2 weeks before and during itraconazole treatment.

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 tuberculosis: Adults and children 15 years of age and older weighing 55 kilograms (kg) (121 pounds) or more—6 tablets per day. Adults and children 15 years of age and older weighing between 45 and 54 kg (99 and 119 pounds)—5 tablets per day. Adults and children 15 years of age and older weighing 44 kg (97 pounds) or less—4 tablets per day. Children younger than 15 years of age—Use and dose must be determined by your doctor.

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.

If rifampin, isoniazid, and pyrazinamide combination is taken on an irregular schedule, side effects may occur more often and may be more serious than usual. If you have any questions about this, check with your doctor.

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.