Tobramycin Sulf 40mg/ml Inj, 30ml
WARNING: This drug may cause kidney, nerve, and hearing problems (like long-lasting hearing loss), even at normal doses. The risk may be higher if you already have kidney or hearing problems, you take higher doses, or you use this drug for a long time. The risk may be higher in older people, infants, or with dehydration. Hearing loss can happen even after this drug is stopped. If you already have kidney problems or hearing problems, tell your doctor. You may need to have hearing and kidney tests.Do not use this drug if you are taking or have recently taken any drugs that can cause nerve, kidney, or hearing problems. This may be drugs like amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, cyclosporine, ethacrynic acid, furosemide, paromomycin, polymyxin B, vancomycin, viomycin, or other drugs like this one. There are many other drugs that can do this. Ask your doctor or pharmacist if you are not sure.Muscle problems (muscle weakness) and severe breathing problems have happened with drugs like this one. The risk is higher in people who already have nerve or muscle problems like myasthenia gravis. The risk is also higher in people who are getting other drugs like those that are used to put you to sleep or to relax muscles. If you have questions, talk with the doctor.This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Aminoglycoside Antibiotic
Pregnancy Category
Category D
FDA Approved
Mar 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin is an antibiotic given by injection to treat serious bacterial infections, especially those affecting the lungs, blood, or urinary tract. It works by killing the bacteria that cause the infection.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
Lifestyle & Tips
- Stay well-hydrated unless otherwise instructed by your doctor.
- Report any changes in hearing, balance, or urination 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
Standard Dose:
3-5 mg/kg/day IV or IM, divided into 3-4 doses (q8h or q6h) or as a single daily dose
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
severeInfections:
5-7 mg/kg/day IV or IM, once daily or divided q8h
cysticFibrosis:
10 mg/kg/day IV, once daily or divided q8h
Pediatric Dosing
Neonatal:
Premature or full-term <1 week: 4 mg/kg/day IV/IM divided q12h. Full-term >1 week: 6 mg/kg/day IV/IM divided q8h.
Infant:
6-7.5 mg/kg/day IV/IM divided q8h.
Child:
6-7.5 mg/kg/day IV/IM divided q8h.
Adolescent:
6-7.5 mg/kg/day IV/IM divided q8h.
Dose Adjustments
Renal Impairment:
Mild:
Adjust dose interval or reduce dose based on creatinine clearance (CrCl).
Moderate:
Adjust dose interval or reduce dose based on CrCl (e.g., CrCl 30-50 mL/min: q12-24h; CrCl 10-30 mL/min: q24-48h).
Severe:
Adjust dose interval or reduce dose based on CrCl (e.g., CrCl <10 mL/min: q48-72h).
Dialysis:
Hemodialysis: Administer dose after dialysis. Peritoneal dialysis: Supplemental dosing may be required.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Tobramycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit of susceptible bacteria, inhibiting bacterial protein synthesis. This leads to the production of non-functional proteins and ultimately bacterial cell death. It is bactericidal.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (poor oral absorption for systemic effect); 100% (IV/IM)
Tmax:
IV: 30-60 minutes after infusion; IM: 30-90 minutes
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
0.2-0.3 L/kg (increases in ascites, edema, burns; decreases in dehydration)
ProteinBinding:
0-10%
CnssPenetration:
Limited (poor penetration into CSF, even with inflamed meninges)
Elimination:
HalfLife:
2-3 hours (normal renal function); significantly prolonged in renal impairment
Clearance:
Primarily renal clearance, directly proportional to creatinine clearance
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
90-95%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes for IV)
PeakEffect:
Within 30-90 minutes (post-infusion/injection)
DurationOfAction:
Dose-dependent, typically 8-24 hours for bactericidal effect (post-antibiotic effect)
Safety & Warnings
BLACK BOX WARNING
Aminoglycosides can cause irreversible ototoxicity (vestibular and bilateral auditory) and nephrotoxicity. The risk is greater in patients with impaired renal function, those receiving high doses or prolonged therapy, the elderly, and those receiving concomitant nephrotoxic or ototoxic drugs. Neuromuscular blockade and respiratory paralysis have been reported, especially after rapid IV administration or in patients with neuromuscular disorders. Serum concentrations should be monitored to minimize risk.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarsiness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain, cramps, or spasms
+ Weakness, shakiness, or balance changes
+ Abnormal heartbeat or seizures
+ Loss of appetite or severe nausea and vomiting
Dizziness or fainting
Changes in balance
Fever, chills, or sore throat
Unexplained bruising or bleeding, or 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, bloody, or accompanied by stomach pain or cramps (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
Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following:
Headache
Diarrhea, upset stomach, or nausea and vomiting
Fatigue or weakness
Pain at the injection site
If you experience any of these side effects or have concerns about other symptoms, consult your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns, contact your doctor or report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarsiness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain, cramps, or spasms
+ Weakness, shakiness, or balance changes
+ Abnormal heartbeat or seizures
+ Loss of appetite or severe nausea and vomiting
Dizziness or fainting
Changes in balance
Fever, chills, or sore throat
Unexplained bruising or bleeding, or 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, bloody, or accompanied by stomach pain or cramps (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
Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following:
Headache
Diarrhea, upset stomach, or nausea and vomiting
Fatigue or weakness
Pain at the injection site
If you experience any of these side effects or have concerns about other symptoms, consult your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns, contact your doctor or report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Ringing in the ears (tinnitus)
- Hearing loss
- Dizziness or spinning sensation (vertigo)
- Difficulty with balance
- Decreased urine output
- Unusual tiredness or weakness
- Muscle weakness
- Numbness or tingling
- Difficulty breathing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood work, hearing tests, 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 second infection. If you have a known allergy to sulfites, consult your doctor before taking this medication, as some formulations may contain sulfites. Individuals aged 65 and older should exercise caution when using this drug, as they may be more susceptible to side effects. Additionally, 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 dizziness
- Vertigo
- Tinnitus
- Hearing loss
- Kidney failure (decreased urine, swelling)
- Respiratory depression or paralysis
- Neuromuscular blockade
What to Do:
Seek immediate medical attention. Management includes supportive care, maintaining hydration, and potentially hemodialysis to remove the drug from the blood. Calcium salts may reverse neuromuscular blockade. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, loop diuretics, NSAIDs, vancomycin): Increased risk of nephrotoxicity.
- Ototoxic drugs (e.g., loop diuretics, ethacrynic acid, cisplatin, vancomycin): 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 cephaloridine, cephalothin): May increase risk of nephrotoxicity.
- Penicillins (e.g., carbenicillin, ticarcillin, piperacillin): Inactivation of tobramycin in vitro when mixed directly; administer separately.
- Oral anticoagulants (e.g., warfarin): Potential for increased anticoagulant effect (rare, mechanism unclear).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Renal function (serum creatinine, BUN, CrCl)
Rationale: Tobramycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing and monitoring.
Timing: Prior to initiation of therapy.
Audiometric testing (if prolonged therapy or high risk)
Rationale: Aminoglycosides can cause irreversible ototoxicity (auditory and vestibular).
Timing: Prior to initiation of therapy, especially in high-risk patients or for prolonged courses.
Electrolytes (magnesium, potassium, calcium)
Rationale: Aminoglycosides can cause electrolyte disturbances, particularly hypomagnesemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Tobramycin Peak Level
Frequency: After 3rd or 4th dose (for multiple daily dosing) or 24 hours after first dose (for once-daily dosing), then as clinically indicated.
Target: Conventional dosing: 4-10 mcg/mL (for serious infections); Once-daily dosing: 15-20 mcg/mL (for serious infections)
Action Threshold: Levels consistently above target may indicate toxicity risk; adjust dose or interval.
Serum Tobramycin Trough Level
Frequency: Before 4th dose (for multiple daily dosing) or 18-24 hours after first dose (for once-daily dosing), then as clinically indicated.
Target: Conventional dosing: <2 mcg/mL; Once-daily dosing: <1 mcg/mL (ideally undetectable)
Action Threshold: Levels >2 mcg/mL (conventional) or >1 mcg/mL (once-daily) indicate accumulation and increased risk of toxicity; hold dose, extend interval, or reduce dose.
Renal function (serum creatinine, BUN)
Frequency: Daily or every 2-3 days during therapy, more frequently in unstable patients or those with renal impairment.
Target: Stable or improving from baseline.
Action Threshold: Significant increase in serum creatinine (>0.5 mg/dL or >50% increase from baseline) may indicate nephrotoxicity; consider dose adjustment or discontinuation.
Urinalysis (proteinuria, casts)
Frequency: Weekly or as clinically indicated.
Target: Normal or stable.
Action Threshold: New onset or worsening proteinuria/casts may indicate renal tubular damage.
Audiometric testing/Vestibular function tests
Frequency: Periodically during prolonged therapy or if symptoms of ototoxicity develop.
Target: Stable hearing/balance.
Action Threshold: New onset hearing loss, tinnitus, vertigo, or nystagmus; discontinue drug if possible.
Symptom Monitoring
- Hearing loss
- Tinnitus (ringing in ears)
- Vertigo (dizziness)
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Decreased urine output
- Increased thirst
- Muscle weakness
- Difficulty breathing
- Numbness or tingling
Special Patient Groups
Pregnancy
Category D. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Cases of congenital deafness have been reported in children whose mothers received streptomycin during pregnancy. While not definitively linked to tobramycin, the risk of ototoxicity to the fetus cannot be excluded. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data are limited for tobramycin specifically.
Second Trimester:
Risk of fetal ototoxicity (auditory and vestibular damage) increases.
Third Trimester:
Risk of fetal ototoxicity (auditory and vestibular damage) increases; potential for neuromuscular blockade in the neonate if administered close to delivery.
Lactation
L3 (Moderately Safe). Tobramycin is excreted into breast milk in small amounts. While systemic absorption by the infant is poor, potential risks include alteration of bowel flora, direct effects on the infant (e.g., ototoxicity, nephrotoxicity), or masking of infection. Use with caution; monitor infant for diarrhea, candidiasis, or signs of toxicity.
Infant Risk:
Low risk of systemic effects due to poor oral absorption, but theoretical risk of ototoxicity/nephrotoxicity and disruption of gut flora.
Pediatric Use
Dosing must be carefully calculated based on weight and age, especially in neonates and infants due to immature renal function and higher volume of distribution. Close monitoring of serum levels and renal function is essential 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 serum levels and renal function is crucial.
Clinical Information
Clinical Pearls
- Tobramycin is often used for Pseudomonas aeruginosa infections, especially in cystic fibrosis patients.
- Once-daily dosing (extended-interval dosing) is often preferred over multiple daily dosing due to reduced nephrotoxicity and ototoxicity, while maintaining efficacy, by leveraging the post-antibiotic effect and concentration-dependent killing.
- Therapeutic drug monitoring (TDM) of peak and trough levels is critical to optimize efficacy and minimize toxicity.
- Ensure adequate hydration to minimize nephrotoxicity.
- Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible.
Alternative Therapies
- Other aminoglycosides (e.g., gentamicin, amikacin)
- Beta-lactam antibiotics (e.g., piperacillin/tazobactam, ceftazidime, cefepime, meropenem) for susceptible Gram-negative infections
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 40mg/ml 30ml vial per 30ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.