Tobramycin 40mg/ml Injection 25x2ml
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 injection used to treat serious bacterial infections, especially those affecting the lungs, skin, bones, or blood. It works by stopping the growth of bacteria. Because it can have serious side effects, your doctor will monitor you closely with blood tests and may check your hearing and kidney function.
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 adhere to all provided guidelines. 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.
If 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.
If 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 (e.g., ringing in ears, dizziness, difficulty hearing), changes in urination, or muscle weakness immediately.
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 (conventional) or 4-7 mg/kg IV once daily (extended-interval)
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
conventional_dosing:
1 mg/kg every 8 hours
extended_interval_dosing:
4-7 mg/kg every 24 hours (or longer based on nomogram)
Pediatric Dosing
Neonatal:
Premature or full-term <1 week: 2.5-4 mg/kg/dose IV/IM every 12-24 hours; Full-term >1 week: 2.5 mg/kg/dose IV/IM every 8 hours
Infant:
2.5 mg/kg/dose IV/IM every 8 hours or 5-7 mg/kg IV once daily (extended-interval)
Child:
2.5 mg/kg/dose IV/IM every 8 hours or 5-7 mg/kg IV once daily (extended-interval)
Adolescent:
2.5 mg/kg/dose IV/IM every 8 hours or 5-7 mg/kg IV once daily (extended-interval)
Dose Adjustments
Renal Impairment:
Mild:
Adjust dose or extend interval based on creatinine clearance (CrCl 60-90 mL/min: administer 60-90% of dose or extend interval to 12-18 hours)
Moderate:
Adjust dose or extend interval based on creatinine clearance (CrCl 30-59 mL/min: administer 30-50% of dose or extend interval to 18-24 hours)
Severe:
Adjust dose or extend interval based on creatinine clearance (CrCl <30 mL/min: administer 20-30% of dose or extend interval to >24 hours)
Dialysis:
Hemodialysis: Administer dose after dialysis; Peritoneal Dialysis: Administer 2.5 mg/kg every 36-48 hours or add 0.625 mg/L to dialysate
Confidence:
High
Hepatic Impairment:
Mild:
No specific adjustment recommended, monitor renal function closely
Moderate:
No specific adjustment recommended, monitor renal function closely
Severe:
No specific adjustment recommended, monitor renal function closely
Confidence:
High
Pharmacology
Mechanism of Action
Tobramycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit of susceptible bacteria, inhibiting bacterial protein synthesis and leading to the production of non-functional proteins. This results in increased permeability of the bacterial cell membrane and ultimately cell death.
Pharmacokinetics
Absorption:
Bioavailability:
90-100% (IM), 100% (IV)
Tmax:
30-90 minutes (IM)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
0.2-0.3 L/kg (increases in ascites, edema; decreases in dehydration)
ProteinBinding:
<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 (glomerular filtration)
ExcretionRoute:
Renal
Unchanged:
90-95%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of IV administration)
PeakEffect:
Within 30-60 minutes after IV infusion; 30-90 minutes after IM injection
DurationOfAction:
Concentration-dependent killing with a significant post-antibiotic effect, allowing for extended-interval dosing
Confidence:
High
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 following administration of aminoglycosides, especially in patients with neuromuscular disorders (e.g., myasthenia gravis) or those receiving neuromuscular blocking agents. Serum concentrations should be monitored to minimize the risk of toxicity.
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 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 or 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 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
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)
Important: If you experience any of the following severe skin reactions, seek medical help immediately:
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 nausea and vomiting
Feeling tired or weak
Pain at the injection site
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. 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 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 or 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 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
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)
Important: If you experience any of the following severe skin reactions, seek medical help immediately:
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 nausea and vomiting
Feeling tired or weak
Pain at the injection site
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. 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)
- Dizziness or vertigo
- Hearing loss
- Decreased urine output
- Swelling in the ankles, feet, or hands
- Unusual tiredness or weakness
- Nausea or vomiting
- 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any health problems you have, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any health problems you have, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 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 (e.g., no urine output)
- Severe muscle weakness or paralysis
- Respiratory depression or apnea
What to Do:
Seek immediate medical attention. Treatment may involve hemodialysis to remove the drug from the blood, 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, NSAIDs, vancomycin, loop diuretics): 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.
- Methoxyflurane: Increased risk of renal toxicity.
Moderate Interactions
- Cephalosporins (especially cephaloridine): May increase risk of nephrotoxicity (less common with newer cephalosporins).
- Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect by altering gut flora (rare).
Confidence Interactions
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine, CrCl)
Rationale: To establish baseline kidney function and guide initial dosing, as tobramycin is primarily renally eliminated and nephrotoxic.
Timing: Prior to initiation of therapy
Audiometry (if prolonged therapy or pre-existing hearing impairment)
Rationale: To establish baseline hearing function due to the risk of ototoxicity.
Timing: Prior to initiation of therapy
Electrolytes (e.g., magnesium, potassium, calcium)
Rationale: To assess baseline electrolyte status, as imbalances can exacerbate toxicity or be caused by therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Tobramycin serum concentrations (peak and trough)
Frequency: After 2-3 doses (conventional dosing) or 1-2 doses (extended-interval dosing), then as clinically indicated (e.g., every 3-7 days, with dose changes, or changes in renal function)
Target: Conventional: Peak 4-10 mcg/mL, Trough <2 mcg/mL; Extended-interval: Trough <1 mcg/mL (or undetectable)
Action Threshold: Levels outside target range require dose adjustment to optimize efficacy and minimize toxicity.
Renal function (BUN, serum creatinine, urine output)
Frequency: Daily or every 2-3 days during therapy, more frequently in patients with impaired renal function or concurrent nephrotoxic drugs
Target: Stable or improving renal function
Action Threshold: Significant increase in BUN/creatinine or decrease in urine output warrants dose adjustment or discontinuation.
Audiometric testing (if prolonged therapy or symptoms of ototoxicity)
Frequency: Periodically during prolonged therapy or if symptoms develop
Target: Stable hearing
Action Threshold: Evidence of hearing loss or vestibular dysfunction warrants discontinuation or re-evaluation.
Electrolytes (magnesium, potassium, calcium)
Frequency: Periodically during therapy
Target: Within normal limits
Action Threshold: Significant abnormalities may require supplementation or dose adjustment.
Symptom Monitoring
- Hearing loss (e.g., difficulty hearing, tinnitus, feeling of fullness in ears)
- Vestibular dysfunction (e.g., dizziness, vertigo, ataxia, nystagmus)
- Nephrotoxicity (e.g., decreased urine output, swelling in ankles/feet, unusual tiredness, nausea, vomiting)
- Neuromuscular blockade (e.g., muscle weakness, respiratory depression, apnea)
- Hypersensitivity reactions (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
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 linked to tobramycin, the risk of ototoxicity to the fetus cannot be excluded.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though specific data for tobramycin is limited. Risk of ototoxicity is theoretical.
Second Trimester:
Increased risk of fetal ototoxicity (irreversible bilateral congenital deafness) due to development of fetal auditory system.
Third Trimester:
Continued risk of fetal ototoxicity and potential for neuromuscular blockade in the neonate if administered close to delivery.
Lactation
L3 (Moderate concern). Tobramycin is excreted in breast milk in low concentrations. While systemic absorption by the infant is poor, there is a theoretical risk of altering gut flora or direct effects on the infant. Monitor breastfed infants for diarrhea, candidiasis, or rash. Use with caution, or consider an alternative drug.
Infant Risk:
Low systemic absorption, but potential for gastrointestinal disturbances (e.g., diarrhea, candidiasis) or theoretical ototoxicity/nephrotoxicity if absorbed.
Pediatric Use
Use with caution, especially in neonates and young infants, due to immature renal function which can lead to prolonged half-life and increased risk of toxicity. Close monitoring of serum concentrations and renal function is essential. Dosing must be carefully adjusted based on age, weight, and renal function.
Geriatric Use
Increased risk of nephrotoxicity and ototoxicity due to age-related decline in renal function and potential for pre-existing hearing impairment. Dosing should be carefully adjusted based on renal function (CrCl), and close monitoring of serum concentrations, renal function, and hearing is crucial.
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 (once-daily) dosing is often preferred as it may reduce nephrotoxicity and ototoxicity while maintaining efficacy, particularly for Gram-negative infections.
- Adequate hydration is important to help prevent nephrotoxicity.
- Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible. If co-administration is necessary, monitor patients very closely.
- Patients with cystic fibrosis may have increased tobramycin clearance and may require higher doses or more frequent administration.
- Tobramycin is ineffective against anaerobic bacteria.
Alternative Therapies
- Beta-lactam antibiotics (e.g., piperacillin/tazobactam, meropenem, ceftazidime) for susceptible Gram-negative infections
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections
- Colistin (for multi-drug resistant Gram-negative infections, often as a last resort)
- Polymyxin B (for multi-drug resistant Gram-negative infections)
Cost & Coverage
Average Cost:
Varies widely by supplier and quantity per 2ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (depending on insurance plan and formulary)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. 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, 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 advice. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, do not hesitate 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.