Priftin

DRUG DESCRIPTION

PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet.

The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide.

Rifapentine is a rifamycin derivative antibiotic and has a similar profile of microbiological activity to rifampin (rifampicin). The molecular weight is 877.04.

The molecular formula is C₄₇H₆₄N₄O₁₂.

The chemical name for rifapentine is rifamycin, 3-[[(4-cyclopentyl-1-piperazinyl)imino]methyl]-or 3-[N-(4-Cyclopentyl - 1-piperazinyl)formimidoyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-cyclopentyl-l-piperazinyl)-formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. It has the following structure:

What are the possible side effects of rifapentine (Priftin)?

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

Call your doctor at once if you have any of these serious side effects:

• blood in your urine;


• pale skin, weakness, easy bruising or bleeding; or


• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or...

Read All Potential Side Effects and See Pictures of Priftin »

What are the precautions when taking rifapentine (Priftin)?

Before taking rifapentine, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); 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: HIV infection, a certain blood disorder (porphyria), liver disease, alcohol use.

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

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

Rifapentine may cause...

Read All Potential Precautions of Priftin »

Priftin Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, 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 be 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: symptoms of liver disease (such as persistent nausea/vomiting, unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), painful/swollen joints, dark/bloody urine, easy bleeding/bruising, unusual tiredness, signs of a new infection (such as fever, persistent sore throat).

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: Before taking rifapentine, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); 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: HIV infection, a certain blood disorder (porphyria), liver disease, alcohol use.

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

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

Rifapentine 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 medication should be used only when clearly needed. When this drug 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.

It is unknown if rifapentine passes into breast milk. However, similar drugs pass into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Priftin Patient Information Including Side Effects

Brand Names: Priftin

Generic Name: rifapentine (Pronunciation: RIF a PEN teen)

• What is rifapentine (Priftin)?


• What are the possible side effects of rifapentine (Priftin)?


• What is the most important information I should know about rifapentine (Priftin)?


• What should I discuss with my healthcare provider before taking rifapentine (Priftin)?


• How should I take rifapentine (Priftin)?


• What happens if I miss a dose (Priftin)?


• What happens if I overdose (Priftin)?


• What should I avoid while taking rifapentine (Priftin)?


• What other drugs will affect rifapentine (Priftin)?


• Where can I get more information?

What is rifapentine (Priftin)?

Rifapentine is an antibiotic. It prevents bacteria from multiplying in your body.

Rifapentine is used together with other antibiotics to treat tuberculosis.

Rifapentine must always be used in combination with other antibiotics.

Rifapentine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of rifapentine (Priftin)?

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

Call your doctor at once if you have any of these serious side effects:

• blood in your urine;


• pale skin, weakness, easy bruising or bleeding; or


• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;


• nausea, vomiting, diarrhea, loss of appetite;


• stomach pain;


• headache;


• joint pain; or


• mild skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rifapentine (Priftin)?

You should not take this medication if you are allergic to rifapentine, rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Before taking rifapentine, tell your doctor if you have porphyria.

Rifapentine should not be used without other antibiotics. Be sure to take all your medications as prescribed by your doctor.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Rifapentine can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifapentine.

Do not wear dentures or contact lenses while taking rifapentine. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain a pair of contact lenses.

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• Priftin