Tobramycin 1.2/30ml 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
Pregnancy Category
Category D
FDA Approved
Mar 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin is an antibiotic used to treat serious bacterial infections, especially those caused by certain types of bacteria. It works by stopping the bacteria from making proteins they need to grow, which kills them. It is usually given by injection into a vein or muscle.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered either as an intramuscular injection or as an intravenous infusion, which is given over a specified period of time.
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.
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
- Report any changes in hearing (ringing in ears, dizziness, difficulty hearing) or balance immediately.
- Report any signs of kidney problems (less urine, swelling, unusual tiredness).
- Stay well-hydrated unless otherwise instructed by your doctor.
- Complete the full course of treatment, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
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/IM in 3 divided doses (q8h) or 4-7 mg/kg IV/IM once daily (extended interval dosing)
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
severeInfections:
5 mg/kg/day IV/IM in 3 divided doses (q8h)
cysticFibrosis:
10 mg/kg/day IV/IM in 3 divided doses (q8h) or 10-12 mg/kg IV/IM once daily
Pediatric Dosing
Neonatal:
Premature or full-term <1 week: 2 mg/kg/dose IV/IM q12-24h. Full-term >1 week to 4 weeks: 2.5 mg/kg/dose IV/IM q8-12h.
Infant:
1 month to 1 year: 2.5 mg/kg/dose IV/IM q8h.
Child:
1 year to 12 years: 2.5 mg/kg/dose IV/IM q8h.
Adolescent:
12 years to 18 years: 2.5 mg/kg/dose IV/IM q8h or 4-7 mg/kg IV/IM once daily.
Dose Adjustments
Renal Impairment:
Mild:
Adjust dosing interval or reduce dose based on creatinine clearance (CrCl). CrCl 60-90 mL/min: q8-12h or 80% of dose.
Moderate:
CrCl 30-59 mL/min: q12-24h or 50% of dose.
Severe:
CrCl 10-29 mL/min: q24-48h or 30% of dose.
Dialysis:
Hemodialysis: Administer dose after dialysis. Peritoneal dialysis: 2.5 mg/kg loading dose, then 2.5 mg/kg q72h or 0.625 mg/kg q24h. Monitor levels closely.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required. Monitor renal function closely as hepatic impairment can indirectly affect renal perfusion.
Pharmacology
Mechanism of Action
Tobramycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by irreversibly binding to the 30S ribosomal subunit. This binding leads to misreading of the mRNA code, premature termination of protein synthesis, and incorporation of incorrect amino acids, ultimately resulting in the production of non-functional proteins and bacterial cell death. It is bactericidal.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (IV/IM administration)
Tmax:
IV: 0.5-1 hour; IM: 0.5-1.5 hours
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
0.2-0.3 L/kg (increases in ascites, edema, burns; decreases in dehydration)
ProteinBinding:
<10%
CnssPenetration:
Limited (poor penetration into CSF unless meninges are inflamed)
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%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of IV administration)
PeakEffect:
Within 30-90 minutes post-infusion (IV)
DurationOfAction:
Dose-dependent, typically 8-24 hours depending on dosing regimen (conventional vs. extended-interval)
Safety & Warnings
BLACK BOX WARNING
Aminoglycosides can cause irreversible ototoxicity (vestibular and bilateral auditory) and nephrotoxicity. The risk of ototoxicity and nephrotoxicity 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. Serum concentrations of aminoglycosides should be monitored to assure adequate levels and to avoid potentially toxic levels. Neuromuscular blockade and respiratory paralysis have been reported following administration of aminoglycosides. These effects are more likely to occur in patients with neuromuscular diseases (e.g., myasthenia gravis) or in patients receiving concomitant neuromuscular blocking agents.
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
+ 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 or confusion
+ Muscle pain, cramps, or spasms
+ Weakness or shakiness
+ Changes in balance
+ 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)
Important: If you experience any of the following symptoms, seek medical help immediately:
A severe skin reaction (Stevens-Johnson syndrome or 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. You can also report side effects to the FDA at 1-800-332-1088 or online at 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
+ 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 or confusion
+ Muscle pain, cramps, or spasms
+ Weakness or shakiness
+ Changes in balance
+ 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)
Important: If you experience any of the following symptoms, seek medical help immediately:
A severe skin reaction (Stevens-Johnson syndrome or 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. You can also report 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 (ataxia)
- Decreased urine output
- Unusual tiredness or weakness
- Numbness or tingling
- Muscle weakness or 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, 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 this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 directed 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. Elderly patients (65 years 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:
- Nephrotoxicity (renal failure, oliguria)
- Ototoxicity (hearing loss, vertigo, tinnitus)
- Neuromuscular blockade (muscle weakness, respiratory depression, apnea)
- Electrolyte disturbances (hypomagnesemia, hypokalemia, hypocalcemia)
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is supportive. Hemodialysis may be effective in removing tobramycin from the blood, especially in patients with renal impairment. Calcium salts may reverse neuromuscular blockade.
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, cisplatin, vancomycin): Increased risk of ototoxicity.
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression or paralysis.
Moderate Interactions
- Cephalosporins (especially cephalothin): May increase risk of nephrotoxicity.
- Polymyxins (e.g., colistin): Increased risk of nephrotoxicity and neuromuscular blockade.
- 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 for toxicity.
Timing: Prior to initiation of therapy
Audiometry and Vestibular function tests
Rationale: Tobramycin is ototoxic (cochlear and vestibular). Baseline assessment is important, especially in patients with pre-existing hearing/balance issues or prolonged therapy.
Timing: Prior to initiation, especially for long-term therapy or high-risk patients
Electrolytes (Magnesium, Potassium, Calcium)
Rationale: Aminoglycosides can cause electrolyte disturbances, particularly hypomagnesemia.
Timing: Prior to initiation of therapy
Routine Monitoring
Serum Tobramycin levels (peak and trough)
Frequency: After 3-4 doses (conventional dosing) or 1-2 doses (extended-interval dosing), then every 3-7 days or as clinically indicated.
Target: Conventional: Peak 4-10 mcg/mL, Trough <2 mcg/mL. Extended-interval: Peak 15-20 mcg/mL, Trough undetectable or <1 mcg/mL.
Action Threshold: Trough levels >2 mcg/mL (conventional) or >1 mcg/mL (extended-interval) indicate accumulation and increased risk of toxicity; adjust dose/interval. Peak levels outside range may indicate subtherapeutic or toxic levels.
Renal function (serum creatinine, BUN)
Frequency: Daily or every 1-3 days, depending on patient stability and duration of therapy.
Target: Stable or improving from baseline.
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.
Urine output
Frequency: Daily
Target: Adequate for age/weight.
Action Threshold: Oliguria or anuria may indicate acute kidney injury.
Electrolytes (Magnesium, Potassium, Calcium)
Frequency: Weekly or as clinically indicated.
Target: Within normal limits.
Action Threshold: Hypomagnesemia, hypokalemia, or hypocalcemia may require supplementation.
Symptom Monitoring
- Hearing loss (tinnitus, high-frequency hearing loss, difficulty understanding speech)
- Vestibular dysfunction (dizziness, vertigo, ataxia, nystagmus)
- Nephrotoxicity (decreased urine output, edema, fatigue, nausea, vomiting)
- Neuromuscular blockade (muscle weakness, respiratory depression, apnea)
Special Patient Groups
Pregnancy
Category D. Tobramycin can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and have been associated with total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. While not definitively proven for tobramycin, the risk of ototoxicity 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. Risk of ototoxicity is theoretical but cannot be ruled out.
Second Trimester:
Risk of fetal ototoxicity (irreversible bilateral deafness) is highest during this period due to development of the fetal ear.
Third Trimester:
Continued risk of fetal ototoxicity. Also, 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 infant gut flora, direct effects on the infant (e.g., ototoxicity, nephrotoxicity), and interference with culture results if fever workup is needed. Monitor breastfed infant for diarrhea, candidiasis, and signs of ototoxicity/nephrotoxicity. Use with caution, or consider an alternative drug with better safety data.
Infant Risk:
Low systemic absorption, but theoretical risk of gut flora disruption, diarrhea, and very low risk of ototoxicity/nephrotoxicity.
Pediatric Use
Dosing must be carefully calculated based on weight and age, with close monitoring of serum levels and renal function due to varying pharmacokinetics in different pediatric age groups, especially neonates and infants. Neonates have prolonged half-lives and lower clearance. Risk of ototoxicity and nephrotoxicity is present across all pediatric ages.
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. Extended-interval dosing may be less suitable for some elderly patients.
Clinical Information
Clinical Pearls
- Therapeutic drug monitoring (TDM) with peak and trough levels is crucial for optimizing efficacy and minimizing toxicity, especially for conventional dosing.
- Extended-interval dosing (once-daily) is often preferred due to potential for reduced nephrotoxicity and comparable efficacy, but requires careful patient selection and monitoring.
- Ensure adequate hydration to minimize the risk of nephrotoxicity.
- Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible.
- Patients with cystic fibrosis often require higher doses and more frequent monitoring due to altered pharmacokinetics (increased clearance).
Alternative Therapies
- Other aminoglycosides (e.g., gentamicin, amikacin)
- Beta-lactam antibiotics (e.g., piperacillin/tazobactam, meropenem) for Gram-negative infections, often used in combination with aminoglycosides for synergy.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections.
- Polymyxins (e.g., colistin) for multi-drug resistant Gram-negative infections.
Cost & Coverage
Average Cost:
Varies widely per 30ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health problems 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 otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 call 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 timely and effective treatment.