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PlazomicinWarningThis medication can cause serious kidney problems and nerve damage, resulting in permanent hearing loss (including deafness or decreased hearing) and balance problems. The risk is increased if you are an older adult, already have kidney disease, or if you are taking other drugs that can affect the kidneys or nerves. Your risk is also increased if you have a family history of hearing loss, or receive high doses, or with longer use of this medication. Tell your doctor right away if you notice ringing/roaring sounds in the ears, hearing loss, dizziness, or an unusual decrease in the amount of your urine. These symptoms can occur even after treatment has finished. Careful monitoring by your doctor may lessen the risk of these side effects. Monitoring may include hearing, kidney, urine, and drug blood level tests. PrecautionsBefore using plazomicin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin, tobramycin); 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: hearing problems (including deafness, decreased hearing), kidney problems, myasthenia gravis. Plazomicin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using plazomicin before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the effects of this drug, especially kidney damage. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using plazomicin. Plazomicin may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Side EffectsSee also Warning section. Pain/irritation/redness at the injection site may rarely occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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: muscle weakness. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following 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. |