Tobramycin 80mg/2ml Inj, 2ml

Manufacturer MYLAN INSTITUTIONAL Active Ingredient Tobramycin (Systemic)(toe bra MYE sin) Pronunciation toe-bra-MYE-sin
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.
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Drug Class
Antibiotic
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Pharmacologic Class
Aminoglycoside
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Pregnancy Category
Category D
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FDA Approved
Mar 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tobramycin is an antibiotic medication given by injection to treat serious bacterial infections in different parts of the body, such as the lungs, skin, bones, and urinary tract. It works by stopping the growth of bacteria.
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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.

In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Stay well-hydrated by drinking plenty of fluids, unless otherwise instructed by your doctor.
  • Report any changes in hearing (ringing in ears, difficulty hearing), balance (dizziness, unsteadiness), or urination (less urine than usual) immediately.
  • Avoid taking other medications that can harm your kidneys or ears without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 3-5 mg/kg/day IV/IM divided every 8 hours OR 5-7 mg/kg once daily (extended-interval dosing)
Dose Range: 3 - 7 mg

Condition-Specific Dosing:

severeInfections: 5 mg/kg/day divided every 8 hours
lifeThreateningInfections: Up to 7 mg/kg/day once daily (extended-interval)
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Pediatric Dosing

Neonatal: Premature or full-term <1 week: 2.5-4 mg/kg/dose IV/IM every 12-24 hours (adjust based on post-natal age and renal function).
Infant: 1 week to 1 year: 2.5 mg/kg/dose IV/IM every 8 hours OR 5-7 mg/kg once daily (extended-interval).
Child: 1 year to 12 years: 2.5 mg/kg/dose IV/IM every 8 hours OR 5-7 mg/kg once daily (extended-interval).
Adolescent: 12 years to 18 years: 2.5 mg/kg/dose IV/IM every 8 hours OR 5-7 mg/kg once daily (extended-interval).
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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 9-12 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 12-24 hours).
Severe: Adjust dose or extend interval based on creatinine clearance (CrCl <30 mL/min: administer 20-30% of dose or extend interval to 24-48 hours).
Dialysis: Administer dose after dialysis. Hemodialysis removes 30-70% of dose. Peritoneal dialysis removes less. Monitor levels closely.

Hepatic Impairment:

Mild: No specific adjustment needed, but monitor for signs of toxicity.
Moderate: No specific adjustment needed, but monitor for signs of toxicity.
Severe: No specific adjustment needed, but monitor for signs of toxicity.

Pharmacology

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Mechanism of Action

Tobramycin is an aminoglycoside antibiotic that binds irreversibly to the 30S ribosomal subunit of susceptible bacteria, inhibiting bacterial protein synthesis. This leads to misreading of the mRNA code, premature termination of protein synthesis, and incorporation of incorrect amino acids, ultimately resulting in a defective bacterial cell membrane and cell death.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM)
Tmax: IV: immediate; IM: 30-90 minutes
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 clearance, proportional to creatinine clearance
ExcretionRoute: Renal (glomerular filtration)
Unchanged: >90%
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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 (PAE), allowing for extended-interval dosing.

Safety & Warnings

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BLACK BOX WARNING

WARNING: NEPHROTOXICITY, OTOTOXICITY, AND NEUROMUSCULAR BLOCKADE. Patients receiving tobramycin injection should be under close clinical observation because of the potential toxicity associated with the use of aminoglycosides. NEPHROTOXICITY: Aminoglycosides are associated with nephrotoxicity, which is usually reversible. The risk is greater in patients with impaired renal function, those receiving concomitant nephrotoxic drugs, and those receiving prolonged therapy. OTOTOXICITY: Aminoglycosides are associated with ototoxicity (both auditory and vestibular), which can be irreversible. The risk is greater in patients with impaired renal function, those receiving concomitant ototoxic drugs, and those receiving prolonged therapy. NEUROMUSCULAR BLOCKADE: Aminoglycosides can cause neuromuscular blockade and respiratory paralysis, especially when given rapidly intravenously to patients with pre-existing neuromuscular disorders (e.g., myasthenia gravis) or those receiving neuromuscular blocking agents.
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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
+ 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

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:

Headache
Diarrhea
Upset stomach or vomiting
Feeling tired or weak
Pain at the injection site

If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Ringing in the ears (tinnitus)
  • Hearing loss or difficulty hearing
  • Dizziness or vertigo
  • Unsteadiness or difficulty with balance
  • Decreased urine output
  • Unusual tiredness or weakness
  • Swelling in the ankles, feet, or hands
  • Muscle weakness or difficulty breathing
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is crucial 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.
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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 tests, hearing assessments, 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 experiencing side effects.
If you are breastfeeding, discuss the potential risks to your baby with your doctor to determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Severe kidney damage (decreased urine, swelling)
  • Severe hearing loss or deafness
  • Severe dizziness or vertigo
  • Muscle weakness or paralysis
  • Respiratory depression or arrest

What to Do:

Seek immediate medical attention. Treatment may involve hemodialysis to remove the drug from the body, supportive care, and administration of calcium salts or anticholinesterases for neuromuscular blockade. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, vancomycin, loop diuretics, NSAIDs, contrast media): Increased risk of nephrotoxicity.
  • Ototoxic drugs (e.g., loop diuretics, vancomycin, cisplatin): Increased risk of ototoxicity.
  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression or paralysis.
  • Botulinum toxin: Increased risk of neuromuscular blockade.
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Moderate Interactions

  • Cephalosporins (especially cephalothin): May increase risk of nephrotoxicity.
  • Penicillins (e.g., piperacillin, ticarcillin): In vitro inactivation of tobramycin when mixed in the same IV solution; administer separately. In vivo, synergistic effect is often observed.
  • Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect (rare, possibly due to vitamin K-producing gut flora reduction).
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Minor Interactions

  • Magnesium salts: May enhance neuromuscular blockade.

Monitoring

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Baseline Monitoring

Renal function (serum creatinine, BUN, creatinine clearance)

Rationale: Tobramycin is renally eliminated and nephrotoxic; baseline function is crucial for dosing.

Timing: Prior to first dose

Electrolytes (magnesium, potassium, calcium)

Rationale: Aminoglycosides can cause electrolyte disturbances, especially hypomagnesemia.

Timing: Prior to first dose

Audiometry (hearing assessment)

Rationale: Baseline assessment is recommended, especially for patients at high risk of ototoxicity or prolonged therapy.

Timing: Prior to first dose (if indicated)

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Routine Monitoring

Serum Tobramycin Levels (Peak and Trough)

Frequency: After 2-3 doses (for traditional dosing) or after first dose (for extended-interval dosing), then as clinically indicated or with dose changes.

Target: Traditional: Peak 4-10 mcg/mL, Trough <2 mcg/mL. Extended-interval: Peak 15-20 mcg/mL, Trough undetectable or <1 mcg/mL.

Action Threshold: Levels outside target range require dose adjustment to optimize efficacy and minimize toxicity.

Renal function (serum creatinine, BUN, urine output)

Frequency: Daily or every 2-3 days during therapy.

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 (magnesium, potassium, calcium)

Frequency: Weekly or as clinically indicated.

Target: Normal ranges.

Action Threshold: Significant abnormalities require supplementation or re-evaluation of therapy.

Audiometry/Vestibular function

Frequency: Periodically, especially with prolonged therapy (>10 days), high doses, or in patients with pre-existing hearing/balance issues.

Target: Stable hearing and balance.

Action Threshold: New or worsening hearing loss, tinnitus, vertigo, or ataxia warrants discontinuation or re-evaluation.

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Symptom Monitoring

  • Hearing loss (difficulty hearing, ringing in ears/tinnitus)
  • Balance problems (dizziness, vertigo, unsteadiness, ataxia)
  • Kidney problems (decreased urine output, swelling in legs/feet, unusual tiredness)
  • Muscle weakness or difficulty breathing (signs of neuromuscular blockade)
  • Numbness or tingling (peripheral neuropathy, rare)

Special Patient Groups

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Pregnancy

Category D. Tobramycin can cause fetal harm when administered to a pregnant woman. Aminoglycosides can cross the placenta and have been associated with reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. While not specifically reported for tobramycin, the risk is considered similar for all aminoglycosides.

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 (auditory and vestibular) due to development of fetal inner ear.
Third Trimester: Increased risk of fetal ototoxicity. Use only if the potential benefit justifies the potential risk to the fetus.
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Lactation

Excreted into breast milk in small amounts. Oral absorption by the infant is poor, so systemic effects on the infant are unlikely. However, theoretical risks include disruption of infant gut flora, diarrhea, or candidiasis. Monitor breastfed infant for adverse effects.

Infant Risk: Low risk, but monitor for gastrointestinal disturbances (e.g., diarrhea, thrush) or rash.
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Pediatric Use

Dosing must be carefully calculated based on weight, age, and renal function. Neonates and young infants have immature renal function, requiring longer dosing intervals. Close monitoring of serum levels and renal function is crucial due to increased susceptibility to toxicity.

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Geriatric Use

Elderly patients are at increased risk for nephrotoxicity and ototoxicity due to age-related decline in renal function and pre-existing hearing impairment. Dosing should be based on estimated creatinine clearance, and close monitoring of renal function and serum drug levels is essential.

Clinical Information

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Clinical Pearls

  • Therapeutic drug monitoring (TDM) with peak and trough levels is essential for optimizing efficacy and minimizing toxicity, especially with traditional dosing.
  • Extended-interval (once-daily) dosing is often preferred due to reduced nephrotoxicity and comparable efficacy, but requires specific patient selection and monitoring protocols.
  • Ensure adequate hydration to minimize the risk of nephrotoxicity.
  • Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible.
  • Patients should be counseled on the importance of reporting any changes in hearing, balance, or urination immediately.
  • Tobramycin is often used in combination with beta-lactam antibiotics for synergistic effect against severe Gram-negative infections, but they should not be mixed in the same IV bag due to in vitro inactivation.
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Alternative Therapies

  • Other aminoglycosides (e.g., gentamicin, amikacin)
  • Beta-lactam antibiotics (e.g., piperacillin/tazobactam, ceftazidime, meropenem) for Gram-negative infections
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections
  • Colistin (for multi-drug resistant Gram-negative infections)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 80mg/2ml vial per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance, as some communities have drug take-back programs. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain. If you have questions about disposing of medications, consult your pharmacist. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately 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.