Generic Name: Isoniazid/Pyrazinamide/Rifampin (EYE-soe-NYE-a-zid/PIR-a-ZIN-a-mide/rif-AM-pin)Brand Name: Rifater

Rifater may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients more than 35 years old. It may also be increased by daily use of alcohol, long-term liver problems, or unsanitary injectable drug use. Women, especially those who are black or Hispanic, or who have just had a baby, may also be at increased risk. Hepatitis can develop at any time during treatment, but usually occurs during the first 3 months. Your doctor will monitor your liver function and discuss your progress every month.

Contact your doctor right away if you develop unusual fatigue, weakness or fever that lasts longer than 3 days, general feeling of discomfort, loss of appetite, nausea, vomiting, numbness or tingling of the hands or feet, dark urine, yellowing of the skin or eyes, or stomach pain or tenderness.

Patients with active liver problems should not use Rifater .

Rifater is used for:

Treating tuberculosis (TB) of the lungs.

Rifater is a combination of 3 antibacterial agents. It works by killing sensitive TB bacteria.

Do NOT use Rifater if:

  • you are allergic to any ingredient in Rifater or have had severe side effects from isoniazid, such as drug fever, chills, or arthritis
  • you have severe liver damage, active liver disease, or liver damage from previous use of Rifater
  • you have active gout or a history of hepatitis caused by any medicine
  • you are taking ranolazine, temsirolimus, a tyrosine kinase receptor inhibitor (eg, lapatinib), or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rifater :

Some medical conditions may interact with Rifater . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have diabetes, the blood disease porphyria, kidney problems, nerve problems (eg, neuropathy) or risk of nerve problems, HIV, severe diarrhea due to antibiotic use (pseudomembranous colitis), or a history of liver problems or gout
  • if you have a history of alcohol or other substance abuse, have unsanitary injectable drug habits, or drink alcohol daily
  • if you are more than 35 years old, you have recently given birth, or you have previously taken Rifater
  • if you wear contact lenses

Some MEDICINES MAY INTERACT with Rifater . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Ranolazine, temsirolimus, tyrosine kinase receptor inhibitors (eg, lapatinib), or voriconazole because their effectiveness may be decreased by Rifater
  • Many prescription and nonprescription medicines (eg, used for alcoholism, allergic reactions, anxiety, arthritis, asthma, birth control, blood pressure, blood thinning, cancer, cholesterol, depression, diabetes, Hansen disease, heart problems, HIV, hormone replacement, immune system suppression, infections, irregular heartbeat, mental or mood problems, nausea and vomiting, pain, Parkinson disease, seizures, sleep) may interact with Rifater , increasing the risk of side effects or decreasing effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rifater may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rifater :

Use Rifater as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Rifater by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
  • Take Rifater with a full glass of water (8 oz/240 mL).
  • If you also take an antacid, take Rifater at least 1 hour before you take the antacid.
  • If you also take aminosalicylic acid granules, do not take it within 8 to 12 hours of Rifater . Check with your doctor if you have questions.
  • Continue to take Rifater even if you feel well. Do not miss any doses.
  • Do not stop taking Rifater without checking with your doctor. Rarely, kidney problems have occurred when patients started taking Rifater again after stopping therapy.
  • If you miss a dose of Rifater , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rifater .

Important safety information:

  • Rifater may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rifater with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before drinking alcohol while taking Rifater . Alcohol may increase the risk of liver problems. If you have a history of alcohol abuse, you may also be at increased risk of developing nerve problems from Rifater . Notify your doctor if you notice any unusual tingling or numbness in your hands or feet.
  • If you have a history of diabetes, alcohol abuse, or poor nutrition, your doctor may recommend that you also take vitamin B6 while you are taking Rifater . This may help to decrease your risk of nerve problems. Discuss any questions with your doctor.
  • Rifater may cause a reddish orange color of urine, stools, saliva, tears, sweat, sputum, and skin. This is normal and not a cause for concern.
  • Rifater may cause a permanent reddish orange color of soft contact lenses.
  • Do not eat foods high in tyramine while you take Rifater . Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use Rifater may cause severe high blood pressure. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.
  • Do not eat foods high in histamine while you take Rifater . Eating foods high in histamine (eg, skipjack, tuna, tropical fish) while you use Rifater may cause low blood pressure, irregular heartbeat, headache, sweating, or flushing. Contact your doctor at once if any of these symptoms occur.
  • Ask your health care provider for a complete list of all foods you should avoid while you are taking Rifater .
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Rifater . To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Rifater only works against TB bacteria; it does not treat viral infections (eg, the common cold).
  • Be sure to take Rifater for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you take the antibiotic or within several months after you stop taking it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
  • Tell your doctor or dentist that you take Rifater before you receive any medical or dental care, emergency care, or surgery.
  • Rifater may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Rifater .
  • Diabetes patients - Rifater may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. You may also be at increased risk of developing nerve problems from Rifater . Contact your doctor if you notice any unusual tingling in your hands or feet.
  • Lab tests, including complete blood cell counts, uric acid levels, liver function, and eye exams, may be performed while you take Rifater . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Rifater with caution in black and hispanic women; they may have a greater risk of severe liver problems from Rifater .
  • Use Rifater with caution in patients more than 35 years old; they may have a greater risk of severe liver problems from Rifater .
  • Rifater should be used with extreme caution in CHILDREN younger than 15 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Rifater while you are pregnant. Rifater is found in breast milk. Do not breast-feed while taking Rifater .

Possible side effects of Rifater :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; gas; headache; heartburn; mild joint or muscle aches; mild stomach upset or cramps; nausea; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; change in the amount of urine produced; changes in vision; chest pain; coughing up blood; dark urine; fever, chills, or sore throat; general feeling of discomfort; increased thirst or urination; irregular heartbeat; joint pain or swelling; loss of appetite; memory problems; menstrual changes; mental or mood changes; nausea; ringing in the ears; seizures; severe diarrhea, nausea, or stomach cramps; severe or persistent muscle pain; severe pain or tenderness in the big toe; shortness of breath; stomach pain or tenderness; swelling of the hands or legs; swollen lymph nodes; symptoms of low B6 levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; hallucinations; loss of consciousness; seizures; severe dizziness or nausea; sluggishness; slurred speech; stomach pain or tenderness; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting; yellowing of the skin or eyes.

Proper storage of Rifater :

Store Rifater between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rifater out of the reach of children and away from pets.

General information:

  • If you have any questions about Rifater , please talk with your doctor, pharmacist, or other health care provider.
  • Rifater is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rifater . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Rifater Prescribing Information (FDA)
  • Rifater Detailed Consumer Information (PDR)
  • Rifater Concise Consumer Information (Cerner Multum)
  • Rifater Advanced Consumer (Micromedex) - Includes Dosage Information