Tobramycin 40mg/ml Inj, 2ml
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
Aug 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin is an antibiotic given by injection to treat serious bacterial infections, especially those caused by certain types of bacteria that are hard to kill. It works by stopping the bacteria from making the proteins they need to grow.
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
- Report any changes in hearing (ringing in ears, dizziness, difficulty hearing) or balance immediately.
- Report any signs of kidney problems (decreased urination, swelling in legs/feet, unusual tiredness).
- Stay well-hydrated unless otherwise instructed by your doctor.
- Inform your healthcare provider about all medications you are taking, including over-the-counter drugs and herbal supplements.
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 mg/kg/day IV/IM divided into 3 equal doses every 8 hours OR 5-7 mg/kg IV once daily
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
severeInfections:
Up to 5 mg/kg/day divided into 3-4 equal doses (for traditional dosing)
cysticFibrosis:
10 mg/kg/day IV once daily or divided every 8 hours (higher doses often used due to increased clearance)
Pediatric Dosing
Neonatal:
Premature (<1200g, <4 weeks): 2.5 mg/kg every 18-24 hours. Term (0-4 weeks): 2.5 mg/kg every 12 hours. (Adjust based on gestational/postnatal age and weight)
Infant:
1 month to 1 year: 2.5 mg/kg every 8 hours
Child:
1 year to 12 years: 2.5 mg/kg every 8 hours
Adolescent:
12 years to 18 years: 2.5 mg/kg every 8 hours OR 5-7 mg/kg IV once daily
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: Administer 60-90% of usual dose or extend interval to 8-12 hours.
Moderate:
CrCl 30-59 mL/min: Administer 30-50% of usual dose or extend interval to 12-24 hours.
Severe:
CrCl <30 mL/min: Administer 20-30% of usual dose or extend interval to 24-48 hours.
Dialysis:
Hemodialysis: Administer 1-1.5 mg/kg after each dialysis session. Peritoneal Dialysis: 0.625 mg/kg every 24 hours or 2.5 mg/L in dialysate. Monitor levels closely.
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 inhibits bacterial protein synthesis by irreversibly binding to the 30S ribosomal subunit. This binding leads to misreading of the mRNA code, resulting in the production of non-functional proteins and ultimately bacterial cell death. It is bactericidal.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (poor oral absorption, administered IV/IM)
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 edematous states, decreases in dehydration)
ProteinBinding:
<10%
CnssPenetration:
Limited (increases with inflamed meninges)
Elimination:
HalfLife:
2-3 hours (normal renal function); significantly prolonged in renal impairment
Clearance:
Primarily renal clearance, 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
DurationOfAction:
Dose-dependent, typically 8-24 hours depending on dosing strategy (traditional vs. extended-interval)
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
NEPHROTOXICITY: Aminoglycosides can cause irreversible 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 drugs. OTOTOXICITY: Aminoglycosides can cause irreversible ototoxicity (vestibular and cochlear), leading to dizziness, vertigo, tinnitus, and hearing loss. The risk is greater in patients with impaired renal function, those receiving high doses or prolonged therapy, the elderly, and those receiving concomitant ototoxic drugs. NEUROMUSCULAR BLOCKADE: Aminoglycosides can cause neuromuscular blockade and respiratory paralysis, especially when administered rapidly or to patients with neuromuscular disorders (e.g., myasthenia gravis).
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 or seek medical attention immediately:
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
Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea
Upset stomach or nausea
Feeling tired or weak
Pain at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. 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 or seek medical attention immediately:
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
Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea
Upset stomach or nausea
Feeling tired or weak
Pain at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. 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
- Dizziness or vertigo
- Unsteadiness or difficulty with balance
- Decreased urine output
- Swelling in the ankles or feet
- Unusual tiredness or weakness
- Muscle weakness or difficulty breathing
- Rash, itching, or hives
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 is crucial to avoid 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 vital 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.
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 is crucial to avoid 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 vital 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
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. As directed by your doctor, regularly undergo blood tests, hearing assessments, and other laboratory tests 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, as some formulations of this medication may contain sulfites. Individuals 65 years or 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 or vertigo
- Profound hearing loss
- Kidney failure (oliguria, anuria)
- Neuromuscular paralysis (respiratory depression, apnea)
- Hypotension
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is supportive and may include hemodialysis to remove the drug from the body, calcium salts for neuromuscular blockade, and respiratory support.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Potentiation of neuromuscular blockade, leading to respiratory depression/paralysis.
- Loop diuretics (e.g., furosemide, ethacrynic acid): Increased risk of ototoxicity.
- Other nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, NSAIDs, vancomycin): Increased risk of nephrotoxicity.
- Other ototoxic drugs (e.g., cisplatin, vancomycin, loop diuretics): Increased risk of ototoxicity.
Moderate Interactions
- Cephalosporins (e.g., cephalothin): May increase risk of nephrotoxicity (controversial, but caution advised).
- Penicillins (e.g., piperacillin): Inactivation of tobramycin in vitro when mixed in the same IV solution; administer separately. May also reduce tobramycin levels in vivo in patients with severe renal impairment.
- Oral anticoagulants (e.g., warfarin): Potential for increased anticoagulant effect (rare, mechanism unclear).
Minor Interactions
- Indomethacin: May increase tobramycin plasma concentrations in neonates.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, BUN)
Rationale: Tobramycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing.
Timing: Prior to initiation of therapy.
Audiometry/Vestibular function
Rationale: Baseline assessment for ototoxicity, especially in patients with pre-existing hearing/balance issues or prolonged therapy.
Timing: Prior to initiation, if clinically indicated or for high-risk patients.
Electrolytes (Potassium, Magnesium, Calcium)
Rationale: Aminoglycosides can cause electrolyte disturbances.
Timing: Prior to initiation.
Routine Monitoring
Tobramycin serum concentrations (peak and trough)
Frequency: After 2-3 doses (traditional dosing) or 1-2 doses (extended-interval dosing), then every 3-7 days or as clinically indicated.
Target: Traditional: Peak 4-10 mcg/mL, Trough <2 mcg/mL. Extended-interval: Trough <1 mcg/mL (or undetectable before next dose).
Action Threshold: Adjust dose/interval if levels are outside target range to optimize efficacy and minimize toxicity.
Renal function (Serum Creatinine, BUN, Urine output)
Frequency: Daily or every 1-3 days, depending on patient stability and risk factors.
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.
Electrolytes (Potassium, Magnesium, Calcium)
Frequency: Every 3-7 days or as clinically indicated.
Target: Within normal limits.
Action Threshold: Correct deficiencies as needed.
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)
- Neuromuscular blockade (muscle weakness, respiratory depression)
- Hypersensitivity reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Tobramycin is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Aminoglycosides can cause total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. While not definitively proven for tobramycin, the risk of ototoxicity to the fetus cannot be excluded.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data are limited. Risk of ototoxicity is a concern throughout pregnancy.
Second Trimester:
Risk of fetal ototoxicity (auditory and vestibular damage) due to drug crossing the placenta.
Third Trimester:
Highest risk of fetal ototoxicity and nephrotoxicity due to increased fetal renal function and drug accumulation.
Lactation
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. Use with caution; monitor infant for diarrhea, candidiasis, or signs of ototoxicity/nephrotoxicity.
Infant Risk:
L3 (Moderate risk - use with caution)
Pediatric Use
Dosing requires careful calculation based on weight, age, and renal function. Neonates and young infants have immature renal function, requiring longer dosing intervals. Close monitoring of serum concentrations 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. Lower doses or extended dosing intervals may be necessary. Close monitoring of renal function and serum drug levels is crucial.
Clinical Information
Clinical Pearls
- Tobramycin is often preferred over gentamicin for Pseudomonas aeruginosa infections due to slightly better activity and potentially lower nephrotoxicity.
- Extended-interval (once-daily) dosing is often preferred over traditional multiple-daily dosing due to similar efficacy, potentially reduced nephrotoxicity, and improved patient adherence.
- Therapeutic drug monitoring (TDM) of peak and trough levels is critical for optimizing efficacy and minimizing toxicity, especially with traditional dosing.
- 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 due to increased volume of distribution and clearance.
Alternative Therapies
- Other aminoglycosides (e.g., gentamicin, amikacin)
- Antipseudomonal beta-lactams (e.g., piperacillin/tazobactam, ceftazidime, cefepime, meropenem, imipenem/cilastatin)
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible organisms
- Polymyxins (e.g., colistin, polymyxin B) for multi-drug resistant Gram-negative infections
Cost & Coverage
Average Cost:
Not available Not available
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. Instead, consult with your pharmacist to determine the best disposal method, as some communities have designated drug take-back programs.
Additionally, some medications may have a separate patient information leaflet; your pharmacist can provide this information if available. If you have any questions or concerns about your medication, it is crucial to 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, as this will aid healthcare professionals in providing appropriate treatment.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. Instead, consult with your pharmacist to determine the best disposal method, as some communities have designated drug take-back programs.
Additionally, some medications may have a separate patient information leaflet; your pharmacist can provide this information if available. If you have any questions or concerns about your medication, it is crucial to 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, as this will aid healthcare professionals in providing appropriate treatment.