Pretomanid (pre-TOE-ma-nid)

Treats tuberculosis (TB).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Pretomanid is used together with other medicines (bedaquiline and linezolid) to treat tuberculosis. Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not stop using your medicine unless your doctor tells you to.
• Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
• It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how pretomanid works. Tell your doctor if you are using efavirenz, methotrexate, or rifampin.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, anemia, or seizures. Tell your doctor if you have a history of underactive thyroid, or if you or anyone in your family has a history of a heart problem (including slow heartbeat, QT prolongation, heart attack, or heart failure).
• This medicine may cause the following problems:
  • Serious liver problem
  • Nerve problems, especially in the eyes
  • Heart rhythm problems
  • Lactic acidosis (too much lactic acid in the blood)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor may also need to check your heart.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme weakness, tiredness, or confusion
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, and body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Acne
• Diarrhea, constipation, upset stomach
• Headache
• Muscle or joint pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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