Rifater

DRUG DESCRIPTION

RIFATER (rifampin, isoniazid and pyrazinamide) (rifampin/isoniazid/pyrazinamide) tablets are combination tablets containing 120 mg rifampin, 50 mg isoniazid, and 300 mg pyrazinamide for use in antibacterial therapy. The tablets also contain as inactive ingredients: povidone, carboxymethylcellulose sodium, calcium stearate, sodium lauryl sulfate, sucrose, talc, acacia, titanium dioxide, kaolin, magnesium carbonate, colloidal silicon dioxide, dried aluminum hydroxide gel, ferric oxide, black iron oxide, carnauba wax, white beeswax, colophony, hard paraffin, lecithin, shellac, and propylene glycol. The RIFATER (rifampin, isoniazid and pyrazinamide) triple therapy combination was developed for dosing convenience.

Rifampin

Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and methanol. Its molecular weight is 822.95 and its chemical formula is C43H5gN4Oi2. The chemical name for rifampin is either:

3 - [ [(4-methyl-1 -piperazinyl) imino] -methyl] -rifamycin; or 5,6,9,17,19,21 -hexahydroxy-23methoxy-2,4,12,16,18,20,22 heptamethyl-8-[N-(4-methyl-l-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,1 l,13]trienimino)naphtho[2,l-b]furan-l, 1 l(2H)-dione 21-acetate. Its structural formula is:

Rifampin Structural Formula Illustration

Isoniazid

Isoniazid is the hydrazide of isonicotinic acid. It is a colorless or white crystalline powder or white crystals. It is odorless and slowly affected by exposure to air and light. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Its molecular weight is 137.14 and its chemical formula is C6H7N3O.

The chemical name for isoniazid is 4-pyridinecarboxylic acid, hydrazide and its structural formula is:

Pyrazinamide

Pyrazinamide, the pyrazine analogue of nicotinamide, is a white, crystalline powder, stable at room temperature, and sparingly soluble in water. The chemical name for pyrazinamide is pyrazinecarboxamide and its molecular weight is 123.11. Its chemical formula is C5H5N3O and its structural formula is:

What are the possible side effects of isoniazid, pyrazinamide, and rifampin (Rifater)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Isoniazid, pyrazinamide, and rifampin can cause severe liver symptoms. Stop taking this medication and call your doctor at once if you have any of these liver symptoms:

  • low fever;
  • nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Rifater

What are the precautions when taking rifampin, isoniazid and pyrazinamide (Rifater)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to rifampin, isoniazid, or pyrazinamide; 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, gout, high uric acid level in the blood, numbness/tingling of arms/legs (peripheral neuropathy), recent childbirth, a certain blood disorder (porphyria).

Before...

Read All Potential Precautions of Rifater


Rifater Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, upset stomach, heartburn, mild muscle/joint pain, 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, fast heartbeat, 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, isoniazid, or pyrazinamide; 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, gout, high uric acid level in the blood, 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 medication passes into breast milk but the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.


Rifater Patient Information Including Side Effects

Brand Names: Rifater

Generic Name: isoniazid, pyrazinamide, and rifampin (Pronunciation: EYE soe NYE a zid, PIR a ZIN a mide, and rif AM pin)

  • What is isoniazid, pyrazinamide, and rifampin (Rifater)?
  • What are the possible side effects of isoniazid, pyrazinamide, and rifampin (Rifater)?
  • What is the most important information I should know about isoniazid, pyrazinamide, and rifampin (Rifater)?
  • What should I discuss with my healthcare provider before taking isoniazid, pyrazinamide, and rifampin (Rifater)?
  • How should I take isoniazid, pyrazinamide, and rifampin (Rifater)?
  • What happens if I miss a dose (Rifater)?
  • What happens if I overdose (Rifater)?
  • What should I avoid while taking isoniazid, pyrazinamide, and rifampin (Rifater)?
  • What other drugs will affect isoniazid, pyrazinamide, and rifampin (Rifater)?
  • Where can I get more information?

What is isoniazid, pyrazinamide, and rifampin (Rifater)?

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

The combination of isoniazid, pyrazinamide, and rifampin is used to treat tuberculosis (TB).

Isoniazid, pyrazinamide, and rifampin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of isoniazid, pyrazinamide, and rifampin (Rifater)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Isoniazid, pyrazinamide, and rifampin can cause severe liver symptoms. Stop taking this medication and call your doctor at once if you have any of these liver symptoms:

  • low fever;
  • nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have any other serious side effects such as:

  • fever, chills, body aches, flu symptoms, weakness, sores in your mouth and throat;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • feeling short of breath, feeling like you might pass out;
  • cough, chest pain or tightness;
  • diarrhea that is watery or bloody;
  • vision problems;
  • urinating less than usual or not at all; or
  • drowsiness, mood changes, increased thirst, swelling, weight gain.

Less serious side effects may include:

  • mild stomach pain, heartburn, diarrhea;
  • mild rash or itching;
  • muscle or joint pain;
  • drowsiness, dizziness, spinning sensation;
  • ringing in your ears; or
  • numbness or tingling in your legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Take this medication for the full prescribed length of time. Your symptoms may get better before your infection is completely cleared. Isoniazid, pyrazinamide, and rifampin will not treat a viral infection such as the common cold or flu.

Avoid drinking alcohol while taking isoniazid, pyrazinamide, and rifampin. Alcohol may increase your risk of liver damage.

Isoniazid, pyrazinamide, and rifampin can make birth control pills less effective. Ask your doctor about using a different method of birth control while taking isoniazid, pyrazinamide, and rifampin.

Avoid foods that are high in tyramine, listed in the "What should I avoid while taking isoniazid, pyrazinamide, and rifampin?" section of this leaflet. Tyramine can interact with this medication and cause unpleasant side effects.

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