Gentamicin Sulfate (Ped-PF)

Warning

This 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 older, already have kidney disease, or if you have a severe loss of body water (dehydration). Your risk is also increased if you 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.

Careful monitoring by your doctor will reduce the risk of these side effects. Monitoring may include hearing, kidney, urine, and drug blood level tests.

Avoid other medications that may increase your risk for these serious side effects if taken together with gentamicin. See also Drug Interactions section.

Precautions

Before using gentamicin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as tobramycin, amikacin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), 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: cystic fibrosis, hearing problems (including deafness, decreased hearing), kidney problems, low blood minerals (including potassium, magnesium, calcium), myasthenia gravis, Parkinson's disease.

Gentamicin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using gentamicin 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.

This medication is not recommended for use during pregnancy. Although there have been reports of harm in babies born to women using similar drugs, the risk for harm may not be the same with this drug. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in small amounts. However, many doctors consider breastfeeding safe while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Nausea, vomiting, stomach upset, or loss of appetite may occur. 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: numbness/tingling, muscle twitching or weakness, seizure.

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 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.

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