Plazomicin is an antibiotic medicine used to treat serious infections of the bladder or kidneys.

plazomicin can cause serious or disabling side effects that may not be reversible. Plazomicin should be used only for infections that cannot be treated with a safer antibiotic.

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

Plazomicin can harm your kidneys, and may also cause nerve damage or hearing loss, especially if you have kidney disease or use certain other medicines.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Plazomicin is given as an infusion into a vein, every 24 to 48 hours. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use plazomicin if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Plazomicin is usually given for 4 to 7 days. Follow your doctor's dosing instructions very carefully.

Drink plenty of liquids while you are using plazomicin.

You may need frequent blood or urine tests. Your hearing, kidney function, and nerve function may also need to be checked.

Store in the refrigerator, do not freeze.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Pyelonephritis:

15 mg/kg IV infusion (given over 30 minutes) every 24 hours
-Duration of therapy: 4 to 7 days

Comment: Appropriate oral therapy should be considered after 4 to 7 days of treatment to complete a total (IV and oral) treatment duration of 7 to 10 days.

Use: Treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae

Usual Adult Dose for Urinary Tract Infection:

15 mg/kg IV infusion (given over 30 minutes) every 24 hours
-Duration of therapy: 4 to 7 days

Comment: Appropriate oral therapy should be considered after 4 to 7 days of treatment to complete a total (IV and oral) treatment duration of 7 to 10 days.

Use: Treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae

You should not use plazomicin if you are allergic to plazomicin or similar antibiotics such as amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin.

Plazomicin is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• kidney disease; or

• nerve-muscle disorder such as myasthenia gravis.

Do not use plazomicin if you are pregnant. This medicine may cause hearing loss in the newborn baby. Use effective birth control, and tell your doctor if you become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

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

Plazomicin can harm your kidneys, and may also cause nerve damage or hearing loss.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• dizziness, spinning sensation;

• a light-headed feeling, like you might pass out;

• hearing loss, a buzzing or roaring sound in your ears (during or after treatment with plazomicin);

• muscle weakness; or

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Serious side effects may be more likely in older adults.

Common side effects of plazomicin may include:

• nausea, vomiting, diarrhea;

• headache; or

• feeling light-headed.

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.

Plazomicin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect plazomicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.