Tobramycin 1.2gm Inj, 1 Vial
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
Feb 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin is an antibiotic given by injection to treat serious bacterial infections, especially those affecting the lungs, blood, or urinary tract. It works by killing the bacteria that cause the infection. Because it can have serious side effects, your doctor will monitor your blood levels and kidney function closely.
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 is essential to follow the 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 proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on the next steps to take.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the 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 proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on the next steps to take.
Lifestyle & Tips
- Report any changes in hearing or balance immediately.
- Report any decrease in urine output or unusual thirst.
- Stay well-hydrated unless otherwise instructed by your doctor.
- 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:
Traditional dosing: 3-5 mg/kg/day IV/IM divided into 3-4 doses (e.g., 1-1.7 mg/kg every 8 hours). Once-daily dosing: 5-7 mg/kg IV once daily.
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
cysticFibrosis:
10 mg/kg/day IV/IM divided into 2-3 doses or 10-12 mg/kg IV once daily.
severeInfections:
Up to 7 mg/kg/day IV/IM once daily or divided.
Pediatric Dosing
Neonatal:
Premature (<1200g): 2.5 mg/kg/dose IV every 18-24 hours. Term (0-4 weeks): 2.5 mg/kg/dose IV every 12-24 hours.
Infant:
1-6 months: 2.5 mg/kg/dose IV every 8 hours.
Child:
6 months-12 years: 2.5 mg/kg/dose IV every 8 hours (traditional) or 5-7 mg/kg IV once daily (extended interval).
Adolescent:
12-18 years: 2.5 mg/kg/dose IV every 8 hours (traditional) or 5-7 mg/kg IV once daily (extended interval).
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: Administer 60-90% of dose or extend interval to 8-12 hours.
Moderate:
CrCl 30-59 mL/min: Administer 30-50% of dose or extend interval to 12-24 hours.
Severe:
CrCl <30 mL/min: Administer 20-30% of dose or extend interval to 24-48 hours.
Dialysis:
Hemodialysis: Administer dose after dialysis; supplemental dose may be needed. Peritoneal Dialysis: Administer 2.5 mg/kg every 48-72 hours or add to dialysate.
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, leading to misreading of the mRNA code and premature termination of protein synthesis. This results in the production of non-functional proteins and ultimately bacterial cell death (bactericidal effect).
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 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:
Approximately 0.08-0.12 L/hr/kg (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:
Concentration-dependent killing with post-antibiotic effect (PAE) 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 to minimize 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 immediate 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)
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
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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 immediate 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)
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
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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 or difficulty hearing
- Dizziness or vertigo
- Unsteadiness or difficulty walking
- Muscle weakness
- Numbness or tingling
- Decreased urination
- Unusual tiredness or weakness
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. 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 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.
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 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 instructed 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.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
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 instructed 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.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
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:
- Ototoxicity (hearing loss, tinnitus, vertigo)
- Nephrotoxicity (decreased urine output, elevated BUN/creatinine)
- Neuromuscular blockade (muscle weakness, respiratory depression/paralysis)
- Hypocalcemia, hypomagnesemia, hypokalemia
What to Do:
Supportive care, including maintaining airway and ventilation if respiratory paralysis occurs. Hemodialysis or peritoneal dialysis can aid in the removal of tobramycin from the blood. Calcium salts may reverse neuromuscular blockade. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, loop diuretics, NSAIDs, vancomycin): Increased risk of nephrotoxicity.
- Ototoxic drugs (e.g., loop diuretics, cisplatin, vancomycin): Increased risk of ototoxicity.
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression/paralysis.
- Botulinum toxin: Increased risk of neuromuscular blockade.
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, monitor INR).
Minor Interactions
- Indomethacin (in neonates): May increase tobramycin levels due to decreased renal clearance.
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine, CrCl)
Rationale: Tobramycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing and monitoring.
Timing: Prior to initiation of therapy.
Audiometry/Vestibular function
Rationale: Baseline assessment for patients at high risk of ototoxicity (e.g., pre-existing hearing loss, prolonged therapy, concomitant ototoxic drugs).
Timing: Prior to initiation of therapy for high-risk patients.
Electrolytes (Magnesium, Potassium, Calcium)
Rationale: Aminoglycosides can cause electrolyte disturbances.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Tobramycin levels (peak and trough)
Frequency: Traditional dosing: Trough before 3rd or 4th dose, peak 30-60 min after end of infusion. Once-daily dosing: Random level 6-14 hours post-dose or trough before 2nd dose.
Target: Traditional: Peak 4-10 mcg/mL, Trough <2 mcg/mL. Once-daily: 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 (BUN, serum creatinine)
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 oliguria, indicates potential nephrotoxicity and requires dose adjustment or discontinuation.
Urinalysis
Frequency: Periodically during therapy.
Target: Normal.
Action Threshold: Presence of casts, proteinuria, or increased specific gravity may indicate renal damage.
Electrolytes (Magnesium, Potassium, Calcium)
Frequency: Weekly or as clinically indicated.
Target: Normal.
Action Threshold: Hypomagnesemia, hypokalemia, or hypocalcemia may require supplementation.
Audiometry/Vestibular function
Frequency: Periodically for prolonged therapy (>7-10 days) or in high-risk patients.
Target: Stable.
Action Threshold: New onset hearing loss, tinnitus, vertigo, or ataxia requires immediate evaluation and potential discontinuation.
Symptom Monitoring
- Hearing loss (difficulty hearing, tinnitus, feeling of fullness in ears)
- Balance problems (dizziness, vertigo, unsteadiness, ataxia)
- Muscle weakness or paralysis (especially in patients with neuromuscular disorders)
- Decreased urine output
- Unusual thirst
- Fatigue
- Numbness or tingling
- Rash or 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 fetal ototoxicity has not been reported with tobramycin, the potential exists.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though specific data for first trimester exposure is limited. Avoid if possible.
Second Trimester:
Risk of fetal ototoxicity (irreversible bilateral congenital deafness) due to development of fetal auditory system.
Third Trimester:
Risk of fetal ototoxicity and potential for neuromuscular blockade in the neonate if administered close to delivery.
Lactation
Tobramycin is excreted into breast milk in small amounts. Oral absorption by the infant is poor. While the risk of adverse effects in the infant is generally considered low, monitor for diarrhea, candidiasis (thrush, diaper rash), and potential effects on gut flora. Use with caution, especially in premature infants or those with impaired renal function.
Infant Risk:
L3 (Moderately Safe - likely compatible, but monitor infant for GI upset or candidiasis).
Pediatric Use
Dosing must be carefully calculated based on weight and age, with close monitoring of serum levels and renal function due to immature renal function in neonates and infants. Higher doses per kg may be needed in cystic fibrosis patients due to increased clearance.
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 adjusted based on creatinine clearance, and close monitoring of serum levels, renal function, and auditory/vestibular function is essential.
Clinical Information
Clinical Pearls
- Tobramycin is often preferred over gentamicin for Pseudomonas aeruginosa infections due to slightly better activity and less nephrotoxicity in some studies.
- Therapeutic drug monitoring (TDM) is crucial for tobramycin to optimize efficacy and minimize toxicity. Both peak and trough levels are important, especially with traditional dosing.
- Extended-interval (once-daily) dosing is often preferred for its convenience, potential for reduced nephrotoxicity, and exploitation of the post-antibiotic effect, but requires careful patient selection and monitoring.
- Ensure adequate hydration to minimize the risk of nephrotoxicity.
- Counsel patients on the importance of reporting any changes in hearing, balance, or urine output immediately.
- Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible. If unavoidable, increase monitoring frequency.
Alternative Therapies
- Other aminoglycosides (e.g., gentamicin, amikacin)
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections
- Cephalosporins (e.g., ceftazidime, cefepime) for susceptible Gram-negative infections
- Carbapenems (e.g., meropenem, imipenem/cilastatin) for broad-spectrum Gram-negative coverage
- Polymyxins (e.g., colistin) for multi-drug resistant Gram-negative infections
Cost & Coverage
Average Cost:
Highly variable per 1.2gm 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 guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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 prompt and effective treatment.