Tobramycin (Injection route)
- Powder for Solution
Patients treated with tobramycin injection should be under close clinical observation because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity. Auditory changes are irreversible, are usually bilateral, and may be partial or total. The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued. Neurotoxicity can occur and may include numbness, skin tingling, muscle twitching, and convulsions. Renal and eighth-nerve toxicities should be closely monitored in patients with known or suspected renal impairment. Peak and trough serum concentrations of aminoglycosides should be monitored periodically during therapy to assure adequate levels and to avoid potentially toxic levels. Drug accumulation, excessive peak concentrations, advanced age, and cumulative dose may contribute to ototoxicity and nephrotoxicity. Evidence of impairment of renal, vestibular, or auditory function requires discontinuation of the drug or dosage adjustment. Tobramycin should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug. Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics, particularly other aminoglycosides, should be avoided. Aminoglycosides should not be given concurrently with potent diuretics, such as ethacrynic acid and furosemide. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including tobramycin and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after administration of antibacterial agents .Injection route(Solution;Powder for Solution)
Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity. Aminoglycoside-induced ototoxicity is usually irreversible. Serum concentrations of aminoglycosides should be monitored periodically to assure adequate levels and to avoid potentially toxic levels. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided. Tobramycin should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug. Aminoglycosides can cause fetal harm when administered to a pregnant woman .
Uses of This Medicine:
Tobramycin injection is used to treat serious bacterial infections in many different parts of the body.
Tobramycin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
Tobramycin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your hearing, sense of balance, and kidneys. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefits of this medicine as well as the risks.
This medicine is to be administered only by or under the immediate supervision of your doctor.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tobramycin injection in children. However, this medicine should be used with caution in premature and newborn infants.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tobramycin injection in the elderly. However, elderly patients are more likely to develop unwanted effects and to have kidney problems, which may require caution and an adjustment in the dose for patients receiving tobramycin injection.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Colistimethate Sodium
- Ethacrynic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma or
- Sulfite allergy, history of—This medicine contains sodium bisulfite which may cause an allergic reaction in patients with these conditions.
- Burns, extensive or
- Cystic fibrosis—Use with caution. Your doctor may need to change your dose if you have these conditions.
- Kidney disease—Higher blood levels of tobramycin may result, which increases the risk of serious side effects.
- Kidney disease, severe or
- Muscle problems or
- Myasthenia gravis (severe muscle weakness) or
- Nerve problems or
- Parkinson's disease—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle or into a vein. This medicine should not be given into the eyes.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must receive this medicine on a regular schedule.
To keep your kidneys working well and help prevent kidney problems, drink extra fluids so you will pass more urine while you are receiving this medicine.
Precautions While Using This Medicine:
Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects. Electrolytes (e.g., calcium, magnesium, and potassium) in the blood should also be monitored by your doctor.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have blistering, peeling, or loosening of the skin; itching; hives; hoarseness; shortness of breath; sores, ulcers, or white spots in the mouth or on the lips; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.
Stop using this medicine and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of damage to your hearing or sense of balance.
Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.
This medicine may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.
Make sure your doctor knows that you or your child are using this medicine before having a surgery or other procedures that require you to receive a numbing medicine (e.g., anesthetics, neuromuscular blocking agents). Using tobramycin injection together with numbing medicines may increase your risk of having difficulty in breathing, drowsiness, inability to breathe without assistance, or unusual tiredness or weakness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- cloudy urine
- continuing ringing or buzzing or other unexplained noise in the ears
- cracks in the skin
- decrease in the amount of urine
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- feeling of fullness in the ears
- loss of balance
- loss of heat from the body
- loss or change in hearing
- pale skin
- pinpoint red spots on the skin
- red, swollen skin
- scaly skin
- sensation of spinning
- shortness of breath
- sore throat
- trouble in hearing
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- Symptoms of overdose
- Inability to breath without assistance
- Incidence not known
- Confusion about identity, place, and time
- hives or welts
- pain at the injection site
- redness of the skin
- skin rash
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014