Rifampin, isoniazid, and pyrazinamide (Oral route)
rif-AM-pin, eye-soe-NYE-a-zid, pir-a-ZIN-a-mide
Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Monthly clinical evaluation and liver function tests should be performed and therapy discontinued if symptoms of signs develop. Patients with tuberculosis should be given appropriate treatment with alternative drugs. If therapy must be reinstituted after resolution of hepatic symptoms, small and gradual dose increases should be employed and treatment should be withdrawn immediately if there is any indication of recurrent liver involvement .
Uses of This Medicine:
Rifampin, isoniazid, and pyrazinamide is a combination anti-infective medicine. This combination medicine is used to treat tuberculosis (TB). It may be taken alone or with one or more of other medicines for TB.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 rifampin, isoniazid, and pyrazinamide combination in children younger than 15 years of age. Safety and efficacy have not been established.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
- Cholera Vaccine, Live
- Dabigatran Etexilate
- Doxorubicin Hydrochloride Liposome
- Ethinyl Estradiol
- Irinotecan Liposome
- Mycophenolate Mofetil
- Mycophenolic Acid
- Tenofovir Alafenamide
- Vincristine Sulfate Liposome
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.
- Aminosalicylic Acid
- Aripiprazole Lauroxil
- Enalapril Maleate
- Morphine Sulfate Liposome
- Valproic Acid
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. 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 often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
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 doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Tyramine Containing Food
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:
- Alcohol abuse, or history of—Use with caution. There may be an increased chance of getting hepatitis if you take this medicine and drink alcohol daily.
- Diabetes, history of or
- Porphyria (an enzyme problem)—Use with caution. May make these conditions worse.
- Gout, acute or
- Liver disease, acute or severe—Should not be used in patients with these conditions.
Proper Use of This Medicine:
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) 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.
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.
- For the treatment of tuberculosis:
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.
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 While Using This Medicine:
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.
If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.
You should not use this medicine if you are also receiving certain medicines to treat HIV infection (eg, atazanavir, darunavir, fosamprenavir, ritonavir, saquinavir, tipranavir, Aptivus®, Fortovase®, Invirase®, Lexiva®, Norvir®, Prezista®, or Reyataz®).
Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Also, the regular use of alcohol may keep this medicine from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are taking this medicine.
Check with your doctor right away 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 be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).
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).
Check with 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 symptoms of an acute gout.
This medicine will cause urine, stool, saliva, sputum, sweat, and tears to turn reddish-orange to reddish-brown. 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. Therefore, it is best not to wear soft contact lenses while taking this medicine. Hard contact lenses are not discolored by this medicine. This condition will return to normal once you stop taking this medicine. If you have any questions about this, check with your doctor.
Check with your doctor right away if you feel very tired or very weak, or if you have clumsiness, unsteadiness, a loss of appetite, nausea, numbness, tingling, burning, or pain in the hands and feet, or vomiting. These may be early warning symptoms of more serious liver or nerve problems that could develop later.
Rifampin, isoniazid, and pyrazinamide combination may cause blood problems. These problems may result in 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 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.
If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Eating certain foods (eg, Cheshire cheese, Swiss cheese, skipjack, tuna, or Sardinella) or drinking red wine may cause reactions in some patients taking isoniazid-containing medicines. Check with your doctor if flushing, fast or pounding heartbeat, headache, redness or itching of the skin, sweating, dizziness, or lightheadedness occurs while you are taking this medicine.
Birth control pills may not work properly while you are taking this medicine. To keep from getting pregnant, 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 they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Clumsiness or unsteadiness
- coughing or spitting up blood
- dark urine
- fast, irregular, pounding, or racing heartbeat or pulse
- loss of appetite
- nausea and vomiting
- numbness, tingling, burning, or pain in the hands and feet
- pain in large and small joints
- tightness in the chest
- unusual tiredness or weakness
- yellow eyes or skin
- Less common
- difficulty in breathing
- hearing loss
- muscle and bone pain
- ringing or buzzing or other unexplained noise in ears
- skin rash, itching, or redness
- Black, tarry stools
- bleeding gums
- blistering, peeling, loosening of skin
- bloody or cloudy urine
- blurred vision or loss of vision, with or without eye pain
- greatly decreased frequency of urination or amount of urine
- mental depression
- mood or mental changes
- pinpoint red spots on skin
- sore throat
- unusual bleeding or bruising
- More common
- stomach pain
- Less common
- Sore mouth or tongue
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.
Last Updated: 9/4/2017