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gentamicin sulfate (ped) (PF) injection

WARNINGS:

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 immediately 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.

Who should not take gentamicin sulfate (ped) (PF) injection?
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Uses

This medication is used to prevent or treat a wide variety of bacterial infections. Gentamicin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria.

How to use gentamicin sulfate (ped) (PF) injection

This medication is given by injection into a vein or muscle as directed by your doctor, usually every 8 hours. The dosage is based on your medical condition, weight, and response to treatment. Laboratory tests (such as kidney function, levels of drug in the blood) may be performed to help find the best dose for your condition.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Side Effects

See also Warning section.

Nausea, vomiting, stomach upset, or loss of appetite may occur. Pain/irritation/redness at the injection site may infrequently occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

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: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

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.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications that may affect the kidneys or hearing may increase the risk of kidney damage or hearing loss if taken with gentamicin. Some affected drugs include: amikacin, tobramycin, amphotericin B, cidofovir, cisplatin, polymyxin B, cephalosporins such as cephaloridine, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, among others.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as kidney function, levels of drug in your blood) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Images

GENTAMICIN PED 20 MG/2 ML VIAL
GENTAMICIN PED 20 MG/2 ML VIAL
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GENTAMICIN PED 20 MG/2 ML VIAL
GENTAMICIN PED 20 MG/2 ML VIAL

Identification

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This medicine is a colorless, clear vial.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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