Tobramycin Injection

IMPORTANT WARNING:

Tobramycin may cause serious kidney problems. Kidney problems may occur more often in older people or in people that are dehydrated. Tell your doctor if you have or have ever had kidney disease. If you experience any of the following symptoms, call your doctor immediately: decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.

Tobramycin may cause serious hearing problems. Hearing problems may occur more often in older people or in people who are dehydrated. Hearing loss may be permanent in some cases. Tell your doctor if you or a family member have hearing loss not related to normal aging or have a history of hearing loss due to use of any medication, or if you have or have ever had dizziness, vertigo, hearing loss, or ringing in the ears. If you experience any of the following symptoms, call your doctor immediately: hearing loss, ringing in the ears, or dizziness.

Tobramycin may cause nerve problems. Tell your doctor if you have or have ever had burning or tingling in the hands, arms, feet, or legs; muscle twitching or weakness; or seizures.

The risk that you will develop serious kidney, hearing, or other problems is greater if you are taking certain medications. Tell your doctor and pharmacist what other prescription and nonprescription medications you are taking, including diuretics ('water pills') such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), or torsemide (Soaanz). Your doctor may not want you to receive tobramycin injection or will monitor you carefully for side effects.

Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using tobramycin injection, call your doctor immediately. Tobramycin may harm the fetus.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, including hearing tests, before and during treatment to check your body's response to tobramycin.

WHY is this medicine prescribed?

Tobramycin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract. Tobramycin injection is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria.

Antibiotics such as tobramycin injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Tobramycin injection comes as a liquid to be injected intravenously (into a vein) or intramuscularly (into a muscle). When tobramycin is injected intravenously, it is usually infused (injected slowly) over a period of 20 to 60 minutes as frequently as every 6 hours but may be given less often depending on your age or other factors. Your doctor will decide how often you should receive tobramycin, The length of your treatment depends on the type of infection you have.

You may receive tobramycin injection in a hospital or you may administer the medication at home. If you will be receiving tobramycin injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

You should begin to feel better during the first few days of treatment with tobramycin injection. If your symptoms do not improve or get worse, call your doctor.

Use tobramycin injection until you finish the prescription, even if you feel better. If you stop using tobramycin injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using tobramycin,

• tell your doctor and pharmacist if you are allergic to tobramycin injection; other aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, neomycin, plazomicin (Zemdri), or streptomycin; sulfites; any other medications; or any of the ingredients in tobramycin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are or have or have ever had cystic fibrosis (an inherited condition that affects the lungs and digestive system), problems with your muscles such as myasthenia gravis, or Parkinson's disease.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Tobramycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• pain at the injection site
• headache
• fever
• tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash
• peeling or blistering of the skin
• itching
• hives
• swelling of the eyes, face, throat, tongue, or lips
• difficulty breathing or swallowing
• hoarseness
• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)

Tobramycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• hearing loss
• ringing in the ears
• dizziness
• decreased urination

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.