Tobramycin 10mg/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, Aminoglycoside
Pharmacologic Class
Bactericidal protein synthesis inhibitor
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 that affect the lungs, blood, or urinary tract. It works by stopping the growth of bacteria. It's very important to take this medicine exactly as prescribed and to have regular blood tests to ensure it's working safely.
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.
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 unless otherwise instructed by your doctor.
- Report any changes in hearing (ringing in ears, dizziness, feeling off balance) or changes in urination (less urine, swelling) 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/IM, divided into 3-4 doses (traditional dosing) or 5-7 mg/kg once daily (extended-interval dosing)
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
Cystic Fibrosis:
10 mg/kg/day IV/IM, divided into 2-3 doses or 10-12 mg/kg once daily (extended-interval dosing)
Urinary Tract Infections (uncomplicated):
2-3 mg/kg/day IV/IM, divided into 2-3 doses
Pediatric Dosing
Neonatal:
Premature or full-term <1 week: 4 mg/kg/day IV/IM divided q12-24h. Full-term >1 week: 4.5-5 mg/kg/day IV/IM divided q8h.
Infant:
6-7.5 mg/kg/day IV/IM divided q8h (traditional dosing) or 7-10 mg/kg once daily (extended-interval dosing).
Child:
6-7.5 mg/kg/day IV/IM divided q8h (traditional dosing) or 7-10 mg/kg once daily (extended-interval dosing).
Adolescent:
6-7.5 mg/kg/day IV/IM divided q8h (traditional dosing) or 7-10 mg/kg once daily (extended-interval dosing).
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: Administer 60-90% of usual dose or extend interval to q12-18h.
Moderate:
CrCl 30-59 mL/min: Administer 30-50% of usual dose or extend interval to q24-36h.
Severe:
CrCl <30 mL/min: Administer 20-30% of usual dose or extend interval to q48h or longer.
Dialysis:
Hemodialysis: Administer dose after dialysis; 2-3 mg/kg post-dialysis. Peritoneal Dialysis: 0.625 mg/kg q12h or 2.5 mg/L in dialysate.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
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 (poor oral absorption, administered IV/IM)
Tmax:
IV: 30-90 minutes; 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:
<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 of IV/IM administration
DurationOfAction:
Concentration-dependent killing with post-antibiotic effect, allowing for extended-interval dosing.
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.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 right away:
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 changes
+ 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 severe skin reactions, seek medical help immediately:
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 do not experience significant side effects, but some may occur. 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 vomiting
Feeling tired or weak
Pain at the injection site
Reporting Side Effects
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 right away:
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 changes
+ 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 severe skin reactions, seek medical help immediately:
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 do not experience significant side effects, but some may occur. 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 vomiting
Feeling tired or weak
Pain at the injection site
Reporting Side Effects
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 or difficulty hearing
- Dizziness, vertigo, or feeling off balance
- Numbness or tingling
- Muscle weakness
- Difficulty breathing
- Decreased urine output or swelling in legs/feet
- Severe diarrhea or abdominal cramps
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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* 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. 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, 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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* 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. 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 directed by your doctor to monitor your condition.
Do not exceed the recommended duration of treatment, as this may increase the risk of a secondary infection.
If you have a known allergy to sulfites, consult your doctor before taking this medication, as some formulations may contain sulfites.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects due to age-related factors.
If you are breastfeeding, discuss the potential risks to your baby with your doctor to determine the best course of action.
Regularly undergo blood work, hearing tests, and other laboratory tests as directed by your doctor to monitor your condition.
Do not exceed the recommended duration of treatment, as this may increase the risk of a secondary infection.
If you have a known allergy to sulfites, consult your doctor before taking this medication, as some formulations may contain sulfites.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects due to age-related factors.
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 (decreased urine, swelling)
- Neuromuscular blockade (muscle weakness, respiratory depression, paralysis)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve hemodialysis to remove the drug from the blood, and supportive care for respiratory depression (e.g., mechanical ventilation) and electrolyte imbalances.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Potentiates neuromuscular blockade, leading to respiratory depression/paralysis.
- Loop diuretics (e.g., furosemide, ethacrynic acid): Increases risk of ototoxicity.
- Other nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, NSAIDs, vancomycin): Increases risk of nephrotoxicity.
- Methoxyflurane: Increases risk of nephrotoxicity.
Moderate Interactions
- Cephalosporins (e.g., cephalothin): May increase risk of nephrotoxicity (controversial).
- Penicillins (e.g., carbenicillin, ticarcillin, piperacillin): Inactivation of tobramycin in vitro when mixed; administer separately. May also occur in vivo in patients with severe renal impairment.
- Oral anticoagulants (e.g., warfarin): May potentiate anticoagulant effect by reducing vitamin K-producing bacteria.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, BUN)
Rationale: Tobramycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing and monitoring.
Timing: Prior to first dose
Audiometry and Vestibular function tests
Rationale: Aminoglycosides are ototoxic (cochlear and vestibular). Baseline assessment is recommended, especially for prolonged therapy or high-risk patients.
Timing: Prior to first dose (if prolonged therapy anticipated or high risk)
Electrolytes (Potassium, Magnesium, Calcium)
Rationale: Aminoglycosides can cause electrolyte disturbances.
Timing: Prior to first dose
Routine Monitoring
Tobramycin Peak and Trough levels
Frequency: After 3rd or 4th dose (for traditional dosing); 12-18 hours post-dose (for extended-interval dosing)
Target: Traditional: 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 or interval change to prevent toxicity or ensure efficacy.
Renal function (Serum Creatinine, BUN)
Frequency: Daily or every 2-3 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 hydration and renal function
Action Threshold: Oliguria or anuria may indicate nephrotoxicity.
Electrolytes (Potassium, Magnesium, Calcium)
Frequency: Weekly or as clinically indicated
Target: Within normal limits
Action Threshold: Hypokalemia, hypomagnesemia, or hypocalcemia may require supplementation.
Symptom Monitoring
- Hearing loss (tinnitus, high-frequency hearing loss)
- Vertigo, dizziness, ataxia, nystagmus (vestibular toxicity)
- Muscle weakness, respiratory depression (neuromuscular blockade)
- Decreased urine output, swelling (nephrotoxicity)
- Nausea, vomiting, diarrhea
- Rash, itching
Special Patient Groups
Pregnancy
Tobramycin is classified as Pregnancy Category D. Aminoglycosides can cause fetal harm when administered to a pregnant woman. There have been reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although not reported with tobramycin, the potential for ototoxicity exists.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data are limited. Avoid if possible.
Second Trimester:
Risk of fetal ototoxicity (irreversible bilateral congenital deafness) increases, especially with prolonged exposure.
Third Trimester:
Highest risk of fetal ototoxicity and nephrotoxicity due to increased fetal renal function and drug accumulation. Use only if clearly needed and benefits outweigh risks.
Lactation
Tobramycin is excreted into breast milk in small amounts. Oral absorption by the infant is poor, so systemic effects on the infant are unlikely. However, theoretical concerns include alteration of infant gut flora, direct effects on the infant, or interference with culture results if fever workup is needed. Monitor infant for diarrhea or candidiasis.
Infant Risk:
Low risk, but monitor for gastrointestinal disturbances (diarrhea, candidiasis) or potential for ototoxicity/nephrotoxicity (though absorption is minimal).
Pediatric Use
Dosing is weight-based and adjusted for age, especially in neonates due to immature renal function. Close monitoring of serum concentrations and renal function is crucial due to increased susceptibility to toxicity.
Geriatric Use
Elderly patients are at increased risk for nephrotoxicity and ototoxicity due to age-related decline in renal function and pre-existing hearing impairment. Dosing should be carefully adjusted based on renal function, and close monitoring of serum levels, renal function, and auditory/vestibular function is essential.
Clinical Information
Clinical Pearls
- Tobramycin is a concentration-dependent killer; higher peak concentrations are associated with greater bactericidal activity.
- Extended-interval dosing (once daily) is often preferred for its potential to reduce nephrotoxicity and simplify administration, while maintaining efficacy due to the post-antibiotic effect.
- Therapeutic drug monitoring (TDM) of peak and trough levels is critical to optimize efficacy and minimize toxicity, especially in patients with fluctuating renal function, severe infections, or those receiving prolonged therapy.
- Hydration is important to minimize the risk of nephrotoxicity.
- Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible.
- Patients should be counseled on the signs and symptoms of ototoxicity and nephrotoxicity and instructed to report them immediately.
Alternative Therapies
- Other aminoglycosides (e.g., gentamicin, amikacin)
- Cephalosporins (e.g., ceftazidime, cefepime)
- Carbapenems (e.g., meropenem, imipenem/cilastatin)
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin)
- Polymyxins (e.g., colistin, polymyxin B) for multi-drug resistant Gram-negative infections
Cost & Coverage
Average Cost:
Not available (highly variable by supplier and contract) per 2ml vial
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 evaluation and guidance. To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication that has been prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. 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 pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Additionally, some medications may have a separate 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, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.
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, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. 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 pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Additionally, some medications may have a separate 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, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.
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, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.