Tobramycin 80mg/2ml Inj Mdv
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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
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)
Moderate Interactions
- Penicillins (in vitro inactivation, administer separately)
- Cephalosporins (potential for additive nephrotoxicity, monitor renal function)
- Oral anticoagulants (potential for increased INR, monitor)
Monitoring
Baseline Monitoring
Rationale: Tobramycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing and monitoring.
Timing: Prior to initiation of therapy
Rationale: To establish baseline hearing function due to risk of ototoxicity.
Timing: Prior to initiation of therapy
Rationale: Aminoglycosides can cause electrolyte wasting.
Timing: Prior to initiation of therapy
Routine Monitoring
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.
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.
Frequency: Weekly or as clinically indicated.
Target: Normal ranges.
Action Threshold: Hypokalemia, hypomagnesemia, or hypocalcemia may require supplementation.
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
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:
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.
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.
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
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.
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