(bed AK wi leen) Brand: Sirturo
• Bedaquiline can reason serious and sometimes fatal side effects. This medication must be used only if you have no another treatment options. Use only the predesigned doze of this medicine, and do not use it for longer than your doctor recommends. Follow all patient instructions for safety use. Talk with your doctor about your individual risks and benefits of using bedaquiline.
• Bedaquiline can affect your heart rhythm, especially if you also take determined another medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with bedaquiline, especially an antibiotic, anti-malaria medicine, migraine headache medicine, medication for depression or mental diseases, heart rhythm medication, cancer medication, or medication to prevent or treat nausea and vomiting.
• Bedaquiline is an antibiotic that fights bacteria.
• Bedaquiline is used together with another medications to treat tuberculosis that has been resistant to another antibacterial medications.
• Bedaquiline can reason serious and sometimes fatal side effects. This medication must be used only if you have no another treatment options.
• Bedaquiline may also be used for purposes not listed in this medicine guide.
• You must not use bedaquiline if you are allergic to it.
• To create certain bedaquiline is safety for you, speak your doctor if you have:
· human immunodeficiency virus (HIV);
· liver disease;
· kidney disease;
· a private or family history of long QT syndrome;
· a history of heart failure, or slow heartbeats caused by underactive thyroid;
· an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood); or
· if you have ever had an emergency electrocardiogram or ECG (sometimes called an EKG).
• FDA pregnancy category B. Bedaquiline is not expected to harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant during treatment.
• It is not known whether bedaquiline passes into breast milk or if it could harm a nursing child. You must not breast-feed while using this medicine.
• Do not give this medicine to anyone under 18 years old without medical advice.
• Follow all directions on your prescription label. Use only the predesigned doze of this medicine, and do not use it for longer than your doctor recommends. Follow all patient instructions for safety use.
• Take with food.
• Take this medication with a full glass of water. Swallow the tablet intact. Do not break.
• Bedaquiline is generally taken each day for 2 weeks, and then only 3 times for week for the following 22 weeks.
• Bedaquiline should be given in combination with at least 3 another tuberculosis medications and it must not be used alone. Use all medications as directed by your doctor. Read the medicine manual or patient instructions provided with every medicine. Do not change your doses or medicine schedule without your doctor's advice.
• Follow your doctor's dosing instructions very carefully.
• Use this medicine for the full predesigned length of time. Your symptoms may improve till the infection is completely cleared. Skipping doses may also magnify your risk of further infection that is resistant to antibiotics.
• While using bedaquiline, you may need frequent blood trials. Your heart function may also need to be checked with an electrocardiograph or ECG (sometimes called an EKG).
• Store this medication in the original container at room temperature away from moisture and heat.
• If you miss a doze during the first 2 weeks of treatment: Skip the missed doze and do not take extra medication to create up the missed dose.
• If you miss a doze during week 3 or later: Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Avoid drinking alcohol. It may magnify your risk of liver hurt while you are taking bedaquiline.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.
• Call your doctor at once if you have:
· headache and severe dizziness, fainting, quick or pounding heartbeats;
· chest pain;
· coughing up blood; or
· upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• General side effects may include:
· nausea;
· mild headache;
· skin rash; or
· joint pain.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Many drugs can interact with bedaquiline, and some must not be used at the same time. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with bedaquiline, especially:
· bosentan;
· droperidol;
· imatinib;
· isoniazid;
· methadone;
· St. John's wort;
· other antibiotic--azithromycin, clarithromycin, erythromycin, moxifloxacin, pentamidine, telithromycin;
· an antidepressant--citalopram, escitalopram, nefazodone;
· antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
· anti-malaria medication--chloroquine, halofantrine;
· cancer medicine--arsenic trioxide, vandetanib;
· heart medication--amiodarone, disopyramide, dofetilide, flecainide, ibutilide, nicardipine, procainamide, quinidine, sotalol;
· hepatitis C medications--boceprevir, telaprevir;
· HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir;
· medication to treat a psychiatric disorder--chlorpromazine, haloperidol, mesoridazine, pimozide, thioridazine;
· seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or
· tuberculosis medication--rifabutin, rifampin, rifapentine.
• This list is not complete and much another drugs can interact with bedaquiline. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.
• Your pharmacist can provide more information about bedaquiline.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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