Tobramycin 80mg/2ml Inj Mdv

Manufacturer HOSPIRA 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
Jan 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tobramycin is an antibiotic given by injection to treat serious bacterial infections. It works by killing the bacteria that cause the infection. It's very important to take this medicine exactly as prescribed and to report any side effects to your doctor or nurse.
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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 via injection into a muscle or as an intravenous infusion over a specified period.

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 promptly 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, balance, or urination immediately.
  • Complete the full course of treatment, even if you start feeling better.

Dosing & Administration

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Adult Dosing

Standard Dose: Traditional dosing: 1 mg/kg IV/IM every 8 hours. Extended-interval dosing: 5-7 mg/kg IV/IM once daily.
Dose Range: 3 - 7 mg

Condition-Specific Dosing:

severeInfections: Initial dose 1.5 mg/kg IV/IM every 8 hours, then adjust based on levels.
cysticFibrosis: Higher doses may be required due to altered pharmacokinetics, e.g., 10 mg/kg/day in 1-2 divided doses.
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Pediatric Dosing

Neonatal: Premature neonates (<1200 g): 2.5 mg/kg IV every 18-24 hours. Term neonates (0-4 weeks): 2.5 mg/kg IV every 12 hours.
Infant: 1-6 months: 2.5 mg/kg IV every 8 hours.
Child: 6 months-12 years: 2-2.5 mg/kg IV/IM every 8 hours.
Adolescent: 12-18 years: 2-2.5 mg/kg IV/IM every 8 hours or 5-7 mg/kg IV/IM once daily.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 60-90 mL/min: Administer 60-90% of normal dose or extend interval to 9-12 hours.
Moderate: CrCl 30-59 mL/min: Administer 30-70% of normal dose or extend interval to 12-24 hours.
Severe: CrCl <30 mL/min: Administer 20-30% of normal dose or extend interval to 24-48 hours.
Dialysis: Hemodialysis: Administer dose after dialysis session. Peritoneal Dialysis: Dose adjustment required, often 2-3 mg/kg every 48-72 hours or 0.625 mg/kg after each exchange.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed. Monitor renal function closely as hepatic impairment can indirectly affect renal perfusion.

Pharmacology

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Mechanism of Action

Tobramycin is an aminoglycoside antibiotic that binds irreversibly to the 30S ribosomal subunit of susceptible bacteria, leading to misreading of mRNA and inhibition of protein synthesis. This results in the production of non-functional proteins and ultimately bacterial cell death (bactericidal effect).
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (poor oral absorption, ~100% IV/IM)
Tmax: 0.5-1 hour (IV), 0.5-1.5 hours (IM)
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 glomerular filtration
ExcretionRoute: Renal
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV administration)
PeakEffect: Within 30-60 minutes post-infusion (IV)
DurationOfAction: Concentration-dependent killing with a significant post-antibiotic effect (PAE) lasting several hours, allowing for extended-interval dosing.

Safety & Warnings

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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.
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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 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
Note: In rare cases, allergic reactions can be fatal.
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 or accompanied by stomach pain, cramps, or bloody stools (see below for more information on C. diff-associated diarrhea)

C. diff-associated Diarrhea (CDAD)

Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called CDAD. This may occur during or after treatment with antibiotics. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Severe Skin Reaction

A rare but potentially life-threatening skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. If you notice any of the following symptoms, seek medical help right away:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they persist or bother you, contact your doctor:

Headache
Diarrhea, upset stomach, or nausea and vomiting
Feeling tired or weak
* Pain at the injection site

Reporting Side Effects

This is not an exhaustive list of possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Ringing in the ears (tinnitus)
  • Hearing loss or muffled sounds
  • Dizziness or feeling off balance (vertigo)
  • Numbness or tingling in hands or feet
  • Muscle weakness
  • Decreased amount of urine
  • Unusual thirst
  • Swelling in ankles or feet
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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 assess potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain 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.
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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 directed 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. Individuals aged 65 and 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.
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Overdose Information

Overdose Symptoms:

  • Nephrotoxicity (renal failure)
  • Ototoxicity (hearing loss, vertigo)
  • Neuromuscular blockade (respiratory depression, paralysis)
  • Electrolyte disturbances (hypocalcemia, hypomagnesemia, hypokalemia)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is supportive. Hemodialysis may be effective in removing tobramycin from the blood, especially in patients with renal impairment.

Drug Interactions

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Major Interactions

  • Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, NSAIDs, vancomycin, loop diuretics)
  • Ototoxic drugs (e.g., loop diuretics, vancomycin, ethacrynic acid)
  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)
  • Botulinum toxin (increased risk of neuromuscular blockade)
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Moderate Interactions

  • Penicillins (in vitro inactivation, administer separately)
  • Cephalosporins (potential for additive nephrotoxicity, monitor renal function)
  • Oral anticoagulants (potential for increased INR, monitor)

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN, Creatinine Clearance)

Rationale: Tobramycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing and monitoring.

Timing: Prior to initiation of therapy

Audiometry (if prolonged therapy or high risk)

Rationale: To establish baseline hearing function due to risk of ototoxicity.

Timing: Prior to initiation of therapy

Electrolytes (Potassium, Magnesium, Calcium)

Rationale: Aminoglycosides can cause electrolyte wasting.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Tobramycin Peak and Trough levels

Frequency: Traditional dosing: Trough before 3rd or 4th dose, Peak 30-60 min after end of infusion. Extended-interval dosing: Random level 6-14 hours after dose, or trough before 2nd dose.

Target: Traditional: Peak 4-10 mcg/mL, Trough <2 mcg/mL. Extended-interval: Nomogram-based or target trough <1 mcg/mL.

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

Renal function (Serum Creatinine, BUN, Urine Output)

Frequency: Daily or every 2-3 days, depending on patient stability and risk factors.

Target: Stable or improving renal function.

Action Threshold: Increase in SCr by >0.5 mg/dL or 50% from baseline, or significant decrease in urine output, warrants dose adjustment or discontinuation.

Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Weekly or as clinically indicated.

Target: Normal ranges.

Action Threshold: Hypokalemia, hypomagnesemia, or hypocalcemia may require supplementation.

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Symptom Monitoring

  • Hearing loss (difficulty hearing, muffled sounds)
  • Tinnitus (ringing in ears)
  • Vertigo (spinning sensation)
  • Dizziness
  • Ataxia (loss of coordination)
  • Numbness or tingling
  • Muscle weakness
  • Decreased urine output
  • Increased thirst
  • Fatigue
  • Nausea, vomiting

Special Patient Groups

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Pregnancy

Category D. Tobramycin can cause fetal harm when administered to a pregnant woman. Aminoglycosides can cause congenital deafness. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, particularly ototoxicity.
Second Trimester: Risk of fetal ototoxicity (irreversible bilateral congenital deafness) increases with exposure.
Third Trimester: Risk of fetal ototoxicity (irreversible bilateral congenital deafness) increases with exposure.
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Lactation

Excreted in breast milk in low concentrations. While systemic absorption by the infant is poor, monitor breastfed infants for diarrhea, candidiasis (thrush), and potential interference with gut flora. Use with caution.

Infant Risk: Low to moderate risk. Potential for altered gut flora, diarrhea, or sensitization. Ototoxicity and nephrotoxicity are unlikely due to poor oral absorption by the infant.
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Pediatric Use

Dosing must be carefully calculated based on weight and age, with close monitoring of serum levels and renal function due to varying pharmacokinetics in different pediatric age groups, especially neonates and infants. Higher doses per kg may be needed in cystic fibrosis patients.

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Geriatric Use

Increased risk of nephrotoxicity and ototoxicity due to age-related decline in renal function and pre-existing hearing impairment. Dose adjustment based on renal function is crucial. Close monitoring of serum levels and renal function 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 dosing (once-daily) is often preferred for its potential to reduce nephrotoxicity and simplify administration, while maintaining efficacy due to tobramycin's concentration-dependent killing and post-antibiotic effect.
  • Ensure adequate hydration to minimize the risk of nephrotoxicity.
  • Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible. If unavoidable, monitor renal function and hearing even more closely.
  • Patients with cystic fibrosis often require higher doses and more frequent monitoring due to increased clearance.
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Alternative Therapies

  • Other aminoglycosides (e.g., Gentamicin, Amikacin)
  • Beta-lactam antibiotics (e.g., Piperacillin/Tazobactam, Ceftazidime) for Gram-negative infections
  • Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin) for susceptible Gram-negative infections
  • Carbapenems (e.g., Meropenem, Imipenem/Cilastatin) for broad-spectrum coverage
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Cost & Coverage

Average Cost: Check current market prices per 80mg/2ml 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 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. 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, as this will help healthcare professionals provide the best possible care.