IsonaRif (Oral)

Rifampin and isoniazid combination is used to treat tuberculosis (TB) infection. You can take it alone or with one or more other medicines for TB. Rifampin is an antibiotic that kills or stops the growth of bacteria. However, it will not work for colds, flu, or other virus infections.

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

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

If your or your child's 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 the last dose of praziquantel.

Liver problems may happen more often if you drink alcohol regularly while taking this medicine. Also, regular alcohol use may stop this medicine from working properly. Therefore, you should strictly limit how much alcohol you drink while using this medicine.

Contact your doctor right away if you or your child have a fever, chills, cough, sore throat, swollen, painful, or tender lymph nodes in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be signs of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

Serious skin reactions can happen with this medicine. Contact 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 while using this medicine.

Contact your doctor right away if you notice blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want you or your child to see an ophthalmologist (eye doctor).

Do not stop using this medicine suddenly without asking your doctor. You may need to gradually reduce your dose before stopping it completely.

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

This medicine will cause 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. It is best not to wear soft contact lenses while using this medicine. Hard contact lenses are not discolored by this medicine. This condition will return to normal once you stop using this medicine. If you have any questions about this, contact your doctor.

Contact your doctor right away 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 more serious liver or nerve problems that could develop later.

Rifampin and isoniazid combination may cause blood problems. These problems may lead to a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be postponed until your blood counts are back to normal. Contact your medical doctor or dentist if you have any questions about proper oral hygiene during treatment.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests 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 taking isoniazid-containing medicines. Contact your doctor if you experience flushing, fast or pounding heartbeat, headache, red or itchy 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 medicine, the risks of taking the medication must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other drugs. As well 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 and isoniazid 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 and isoniazid combination in the elderly.

Breast Feeding

Studies in women suggest that this drug poses minimal chance to the infant when used during breastfeeding.

Interactions with Drugs

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 clinician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially critical that your healthcare professional know if you are using 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 drug or change some of the other medicines 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 medicine with any of the following medicines is typically not recommended, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the medications.

• 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
• Zolpidem
• Zuranolone

Using this medicine with any of the following medications may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the medications.

• 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 medications 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 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 medication with any of the following is normally not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medication with any of the following may cause an increased chance of certain side effects but may be unavoidable in some cases. If used together, your doctor 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 Issues

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

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

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

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

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the drug from the body.

• Liver disease, chronic or
• Patients with poor nutrition status—Use with caution. May raise 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

• Clumsiness or unsteadiness
• Dark urine
• Loss of appetite
• Nausea and vomiting
• Numbness, tingling, burning, or pain in the hands and feet
• Unusual tiredness or weakness
• Yellow eyes or skin

Less common

• Chills
• Difficult breathing
• Dizziness
• Fever
• Headache
• Itching, skin rash and redness
• Muscle and bone pain
• Shivering

Rare

• Bloody or cloudy urine
• Blurred vision or loss of vision, with or without eye pain
• Convulsions (seizures)
• Depression
• Greatly decreased frequency of urination or amount of urine
• Mood or mental changes
• Sore throat
• Unusual bleeding or bruising

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 ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• Stomach pain or upset

Less common

• Sore mouth or tongue

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.

• IsonaRif
• Rifamate

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 and isoniazid 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) every day 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 and isoniazid 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 the oral dosage form (capsules): For the treatment of tuberculosis: Adults and children 15 years of age and older weighing 55 kilograms (kg)—2 capsules (containing 600 milligrams (mg) of rifampin and 300 mg of isoniazid) once a 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 and isoniazid 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.