Bedaquiline

Generic name: Bedaquiline
Brand names: Sirturo
Dosage form: oral tablet (100 mg; 20 mg)
Drug class: Diarylquinolines

Usage of Bedaquiline

Bedaquiline is an antibiotic that is used together with other medications to treat tuberculosis of the lungs that has been resistant to other antibacterial medications.

Bedaquiline is for use in adults and children at least 5 years old and weighing at least 33 pounds (15 kilograms).

Bedaquiline can cause serious and sometimes fatal side effects. bedaquiline should be used only if you have no other treatment options.

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

Bedaquiline side effects

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

Bedaquiline may cause serious side effects. Call your doctor at once if you have:

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

chest pain;

coughing up blood or vomit that looks like coffee grounds; or

liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of bedaquiline may include:

coughing up blood;

chest pain;

nausea, stomach pain;

headache;

joint pain; or

abnormal liver function tests.

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.

Before taking Bedaquiline

Tell your doctor if you have ever had:

heart problems or a heart rhythm disorder;

underactive thyroid;

long QT syndrome (in you or a family member);

human immunodeficiency virus (HIV);

liver or kidney disease; or

an electrolyte imbalance (such as low blood levels of calcium, potassium, or magnesium in your blood).

Follow your doctor's instructions about using this medicine if you are pregnant. Having tuberculosis during pregnancy could harm both mother and baby.

If you are breastfeeding, tell your doctor if you notice decreased appetite, sleepiness, nausea, stomach pain or swelling, dark urine, clay-colored-stools, or yellowing of the skin or eyes in the nursing baby.

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How to use Bedaquiline

Usual Adult Dose for Tuberculosis -- Resistant:

Weeks 1 and 2: 400 mg orally once a dayWeeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between dosesDuration of therapy: 24 weeksComments:-Alcohol should be avoided during treatment.-Treatment should be given by directly observed therapy (DOT).-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in cOnfirmatory trials.-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.-Treatment should be used with at least 3 other drugs to which the in-vitro multidrug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by Mycobacterium tuberculosis

Usual Pediatric Dose for Tuberculosis -- Resistant:

12 years and older:30 kg and over:-Weeks 1 and 2: 400 mg orally once a day-Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses-Duration of therapy: 24 weeksComments:-Alcohol should be avoided during treatment.-Treatment should be given by DOT, and should be given in combination with other antimycobacterial agents.-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.-Treatment should be used with at least 3 other drugs to which the in-vitro MDR-TB isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by M tuberculosis

Warnings

Bedaquiline can cause serious and sometimes fatal side effects. bedaquiline should be used only if you have no other treatment options. Use only the prescribed dose of this medication, and follow all patient instructions for safe use.

Bedaquiline can cause a serious side effect on your heart. Tell your doctor if you have fast or irregular heartbeats and sudden dizziness, like you might pass out.

What other drugs will affect Bedaquiline

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Bedaquiline can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect bedaquiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Disclaimer

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