Rifamate

DRUG DESCRIPTION

RIFAMATE (rifampin and isoniazid) is a combination capsule containing 300 mg rifampin and 150 mg isoniazid. The capsules also contain as inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, sodium starch glycolate, and titanium dioxide.

Rifampin is a semisynthetic antibiotic derivative of rifamycin B. The chemical name for rifampin is 3-(4-methyl-1-piperazinyliminomethyl) rifamycin SV.

Isoniazid is the hydrazide of isonicotinic acid. It exists as colorless or white crystals or as a white, crystalline powder that is water soluble, odorless, and slowly affected by exposure to air and light.

What are the possible side effects of isoniazid and rifampin (Rifamate)?

If you experience any of the following serious side effects, stop taking isoniazid and rifampin and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • excessive tiredness or weakness;
  • nausea, vomiting, diarrhea, or loss of appetite;
  • yellow skin or eyes;
  • unusual bruising or bleeding;
  • dark urine;
  • little or no...

Read All Potential Side Effects and See Pictures of Rifamate

What are the precautions when taking rifampin and isoniazid (Rifamate)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to rifampin or isoniazid; or to other rifamycins (such as rifabutin, rifapentine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe reaction from isoniazid (such as liver disease), liver disease, kidney disease, alcohol use, HIV infection, diabetes, numbness/tingling of arms/legs (peripheral neuropathy), recent childbirth, a certain blood disorder (porphyria).

Before having surgery, tell your doctor or dentist about all the...

Read All Potential Precautions of Rifamate


Rifamate Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, upset stomach, heartburn, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn reddish. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may become permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, painful/swollen joints.

Tell your doctor immediately if any of these rare but serious side effects occur: change in the amount of urine, increased thirst/urination, bloody urine, vision changes, easy bruising/bleeding, signs of a new infection (such as fever, persistent sore throat), mental/mood changes (such as confusion, psychosis), seizures.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to rifampin or isoniazid; or to other rifamycins (such as rifabutin, rifapentine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe reaction from isoniazid (such as liver disease), liver disease, kidney disease, alcohol use, HIV infection, diabetes, numbness/tingling of arms/legs (peripheral neuropathy), recent childbirth, a certain blood disorder (porphyria).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

This product may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

During pregnancy, this product should be used only when clearly needed. When rifampin is taken during the last few weeks of pregnancy, the risk of bleeding in both mother and infant may be increased. Tell your doctor immediately if you notice any bleeding in your newborn. Discuss the risks and benefits with your doctor.

This product passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Rifamate Patient Information Including Side Effects

Brand Names: Rifamate

Generic Name: isoniazid and rifampin (Pronunciation: eye so NYE a zid and RIF am pin)

  • What is isoniazid and rifampin (Rifamate)?
  • What are the possible side effects of isoniazid and rifampin (Rifamate)?
  • What is the most important information I should know about isoniazid and rifampin (Rifamate)?
  • Who should not take isoniazid and rifampin (Rifamate)?
  • How should I take isoniazid and rifampin (Rifamate)?
  • What happens if I miss a dose (Rifamate)?
  • What happens if I overdose (Rifamate)?
  • What should I avoid while taking isoniazid and rifampin (Rifamate)?
  • What other drugs will affect isoniazid and rifampin (Rifamate)?
  • Where can I get more information?

What is isoniazid and rifampin (Rifamate)?

Isoniazid and rifampin are antibiotics. They prevent tuberculous bacteria from multiplying in your body.

Isoniazid and rifampin are used together to treat tuberculosis (TB).

Isoniazid and rifampin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of isoniazid and rifampin (Rifamate)?

If you experience any of the following serious side effects, stop taking isoniazid and rifampin and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • excessive tiredness or weakness;
  • nausea, vomiting, diarrhea, or loss of appetite;
  • yellow skin or eyes;
  • unusual bruising or bleeding;
  • dark urine;
  • little or no urine;
  • numbness or tingling in your hands or feet;
  • muscle or bone pain;
  • seizures;
  • blurred vision;
  • fever, chills, or a sore throat;
  • a headache;
  • a rash or itching; or
  • confusion or abnormal behavior.

Other, less serious side effects may be more likely to occur. Continue to take isoniazid and rifampin and talk to your doctor if you experience

  • red-orange coloration of tears, sweat, saliva, urine, or feces; or
  • mild tiredness or weakness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about isoniazid and rifampin (Rifamate)?

Take all of the isoniazid and rifampin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Avoid alcohol while taking isoniazid and rifampin. Alcohol will increase the risk of damage to your liver during treatment with this medication.

Call your doctor immediately if you experience a fever, chills, a sore throat, muscle and bone pain, a headache, excessive tiredness or weakness, numbness or tingling in your hands or feet, loss of appetite, nausea and vomiting, yellowing of your skin or eyes, darkening of your urine, unusual bleeding or bruising, a rash, or itching.

Take isoniazid and rifampin on an empty stomach 1 hour before or 2 hours after a meal.

This medication may decrease the effectiveness of birth control pills. Talk to your doctor about using another form of birth control during treatment.

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