Tobramycin 80mg/2ml Inj, 2ml
Overview
What is this medicine?
How to Use This Medicine
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Stay well-hydrated by drinking plenty of fluids, unless otherwise instructed by your doctor.
- Report any changes in hearing (ringing in ears, difficulty hearing), balance (dizziness, unsteadiness), or urination (less urine than usual) immediately.
- Avoid taking other medications that can harm your kidneys or ears without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
- Tobramycin 0.3% Oph Sol 5ml
- Tobramycin 40mg/ml Injection 25x2ml
- Tobramycin 80mg/2ml Inj Mdv
- Tobramycin Sulf 40mg/ml Inj, 30ml
- Tobramycin 10mg/ml Inj, 2ml
- Tobramycin 300mg/5ml Inh Sol 5ml
- Tobramycin 80mg/2ml Inj, 2ml
- Tobramycin 1.2/30ml Inj, 30ml
- Tobramycin 300mg/5ml Inh Sol 56x5ml
- Tobramycin 300mg/4ml Neb Sol 4ml
- Tobramycin 40mg/ml Inj, 50ml
- Tobramycin 40mg/ml Inj, 2ml
- Tobramycin 1.2gm Inj, 1 Vial
- Tobramycin 1.2gm Inj 1 Vial
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Balance problems
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe nausea or vomiting
Dizziness or fainting
Changes in balance
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Muscle weakness
New or worsening breathing difficulties
Abnormal sensations, such as burning, numbness, or tingling
Twitching
Ringing in the ears, hearing loss, or other changes in hearing
Seizures
Confusion
Diarrhea, especially if it is severe or accompanied by stomach pain, cramps, or bloody stools (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:
Headache
Diarrhea
Upset stomach or vomiting
Feeling tired or weak
Pain at the injection site
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns, consult your doctor.
Reporting Side Effects
You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Ringing in the ears (tinnitus)
- Hearing loss or difficulty hearing
- Dizziness or vertigo
- Unsteadiness or difficulty with balance
- Decreased urine output
- Unusual tiredness or weakness
- Swelling in the ankles, feet, or hands
- Muscle weakness or difficulty breathing
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
Regularly undergo blood tests, hearing assessments, and other laboratory tests as instructed by your doctor to monitor your condition.
Do not exceed the prescribed duration of treatment, as this may increase the risk of a secondary infection.
If you have a known allergy to sulfites, consult your doctor before taking this medication, as some formulations may contain sulfites.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to experiencing side effects.
If you are breastfeeding, discuss the potential risks to your baby with your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe kidney damage (decreased urine, swelling)
- Severe hearing loss or deafness
- Severe dizziness or vertigo
- Muscle weakness or paralysis
- Respiratory depression or arrest
What to Do:
Seek immediate medical attention. Treatment may involve hemodialysis to remove the drug from the body, supportive care, and administration of calcium salts or anticholinesterases for neuromuscular blockade. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, vancomycin, loop diuretics, NSAIDs, contrast media): Increased risk of nephrotoxicity.
- Ototoxic drugs (e.g., loop diuretics, vancomycin, cisplatin): Increased risk of ototoxicity.
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression or paralysis.
- Botulinum toxin: Increased risk of neuromuscular blockade.
Moderate Interactions
- Cephalosporins (especially cephalothin): May increase risk of nephrotoxicity.
- Penicillins (e.g., piperacillin, ticarcillin): In vitro inactivation of tobramycin when mixed in the same IV solution; administer separately. In vivo, synergistic effect is often observed.
- Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect (rare, possibly due to vitamin K-producing gut flora reduction).
Minor Interactions
- Magnesium salts: May enhance neuromuscular blockade.
Monitoring
Baseline Monitoring
Rationale: Tobramycin is renally eliminated and nephrotoxic; baseline function is crucial for dosing.
Timing: Prior to first dose
Rationale: Aminoglycosides can cause electrolyte disturbances, especially hypomagnesemia.
Timing: Prior to first dose
Rationale: Baseline assessment is recommended, especially for patients at high risk of ototoxicity or prolonged therapy.
Timing: Prior to first dose (if indicated)
Routine Monitoring
Frequency: After 2-3 doses (for traditional dosing) or after first dose (for extended-interval dosing), then as clinically indicated or with dose changes.
Target: Traditional: Peak 4-10 mcg/mL, Trough <2 mcg/mL. Extended-interval: Peak 15-20 mcg/mL, Trough undetectable or <1 mcg/mL.
Action Threshold: Levels outside target range require dose adjustment to optimize efficacy and minimize toxicity.
Frequency: Daily or every 2-3 days during therapy.
Target: Stable or improving renal function.
Action Threshold: Increase in serum creatinine by >0.5 mg/dL or >50% from baseline, or significant decrease in urine output, warrants dose adjustment or discontinuation.
Frequency: Weekly or as clinically indicated.
Target: Normal ranges.
Action Threshold: Significant abnormalities require supplementation or re-evaluation of therapy.
Frequency: Periodically, especially with prolonged therapy (>10 days), high doses, or in patients with pre-existing hearing/balance issues.
Target: Stable hearing and balance.
Action Threshold: New or worsening hearing loss, tinnitus, vertigo, or ataxia warrants discontinuation or re-evaluation.
Symptom Monitoring
- Hearing loss (difficulty hearing, ringing in ears/tinnitus)
- Balance problems (dizziness, vertigo, unsteadiness, ataxia)
- Kidney problems (decreased urine output, swelling in legs/feet, unusual tiredness)
- Muscle weakness or difficulty breathing (signs of neuromuscular blockade)
- Numbness or tingling (peripheral neuropathy, rare)
Special Patient Groups
Pregnancy
Category D. Tobramycin can cause fetal harm when administered to a pregnant woman. Aminoglycosides can cross the placenta and have been associated with reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. While not specifically reported for tobramycin, the risk is considered similar for all aminoglycosides.
Trimester-Specific Risks:
Lactation
Excreted into breast milk in small amounts. Oral absorption by the infant is poor, so systemic effects on the infant are unlikely. However, theoretical risks include disruption of infant gut flora, diarrhea, or candidiasis. Monitor breastfed infant for adverse effects.
Pediatric Use
Dosing must be carefully calculated based on weight, age, and renal function. Neonates and young infants have immature renal function, requiring longer dosing intervals. Close monitoring of serum levels and renal function is crucial due to increased susceptibility to toxicity.
Geriatric Use
Elderly patients are at increased risk for nephrotoxicity and ototoxicity due to age-related decline in renal function and pre-existing hearing impairment. Dosing should be based on estimated creatinine clearance, and close monitoring of renal function and serum drug levels is essential.
Clinical Information
Clinical Pearls
- Therapeutic drug monitoring (TDM) with peak and trough levels is essential for optimizing efficacy and minimizing toxicity, especially with traditional dosing.
- Extended-interval (once-daily) dosing is often preferred due to reduced nephrotoxicity and comparable efficacy, but requires specific patient selection and monitoring protocols.
- Ensure adequate hydration to minimize the risk of nephrotoxicity.
- Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible.
- Patients should be counseled on the importance of reporting any changes in hearing, balance, or urination immediately.
- Tobramycin is often used in combination with beta-lactam antibiotics for synergistic effect against severe Gram-negative infections, but they should not be mixed in the same IV bag due to in vitro inactivation.
Alternative Therapies
- Other aminoglycosides (e.g., gentamicin, amikacin)
- Beta-lactam antibiotics (e.g., piperacillin/tazobactam, ceftazidime, meropenem) for Gram-negative infections
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections
- Colistin (for multi-drug resistant Gram-negative infections)