Pretomanid - Oral

Pronunciation: pre-TOE-ma-nid

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used in combination with certain other medications (such as bedaquiline, linezolid) to treat active multi-drug-resistant tuberculosis (TB) of the lungs in certain people. Pretomanid belongs to a class of drugs known as antibiotics. It works by stopping the growth of the bacteria that causes TB.

This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking pretomanid and each time you get a refill. This medication must be used with certain other TB medications. Also read the Medication Guide and drug information that comes with your other medications. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food exactly as directed by your doctor, usually once daily for 26 weeks. The dosage is based on your medical condition and response to treatment.

The manufacturer directs to swallow this medication whole. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's direction on how to take this medication.

For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time every day.

Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early or skipping doses may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Nausea, upset stomach, diarrhea, cough, muscle/joint pain, acne, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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 right away if you have any serious side effects, including:

  • symptoms of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
  • symptoms of lactic acidosis (such as deep/fast breathing, unusual drowsiness, nausea/vomiting that doesn't stop)
  • numbness/tingling of the arms/hands/legs/feet
  • easy bruising/bleeding
  • unusual tiredness

Get medical help right away if you have any very serious side effects, including:

  • coughing up blood
  • chest pain
  • fast/irregular heartbeat
  • severe dizziness
  • fainting
  • vision changes (such as blurred vision, decreased vision)

This medication, taken with certain other TB medications, can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

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 pretomanid, tell your doctor or pharmacist if you are allergic to it; or to bedaquiline; or to linezolid; 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:

  • kidney problems
  • liver problems

This medication, taken with certain other TB medications, may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using pretomanid, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

  • certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
  • family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication combination safely.

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

Pretomanid may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of pretomanid from your body, which may affect how pretomanid works. Examples include efavirenz, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Lab and/or medical tests (such as complete blood counts, liver function, EKG, potassium/calcium/magnesium levels, eye exams) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Your doctor may direct you to keep taking this medication with other TB medications for a longer time (longer than 26 weeks) if you miss doses. Carefully follow your doctor's directions.

Storage

Store tightly closed in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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