Tobramycin 300mg/5ml Inh Sol 56x5ml
It is used in people with cystic fibrosis to treat a certain type of bacterial infection.
Drug Class
Anti-infective
Pharmacologic Class
Aminoglycoside antibiotic
Pregnancy Category
Category D
FDA Approved
Mar 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin inhalation solution is an antibiotic medicine used to treat lung infections caused by a specific type of bacteria (Pseudomonas aeruginosa) in people with cystic fibrosis. It helps to improve lung function and reduce flare-ups of lung infections. You breathe it in using a nebulizer.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You will inhale this medication through your mouth using a special machine called a nebulizer. Your doctor will show you how to use the nebulizer properly. Be sure to use only the type of nebulizer recommended by your doctor. If you're unsure about the correct nebulizer to use, consult with your doctor.
Continue using this medication as directed by your doctor or healthcare provider, even if you're feeling well. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not mix other medications in the nebulizer. If you're taking multiple inhaled medications, discuss the best order for taking them with your doctor.
It's essential to follow the cleaning instructions for the nebulizer carefully.
Storage and Disposal
Store this medication in a refrigerator or at room temperature. If stored at room temperature, discard any unused portion after 28 days. Keep unused containers in their foil pouches until you're ready to use them. Do not freeze the medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's less than 6 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You will inhale this medication through your mouth using a special machine called a nebulizer. Your doctor will show you how to use the nebulizer properly. Be sure to use only the type of nebulizer recommended by your doctor. If you're unsure about the correct nebulizer to use, consult with your doctor.
Continue using this medication as directed by your doctor or healthcare provider, even if you're feeling well. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not mix other medications in the nebulizer. If you're taking multiple inhaled medications, discuss the best order for taking them with your doctor.
It's essential to follow the cleaning instructions for the nebulizer carefully.
Storage and Disposal
Store this medication in a refrigerator or at room temperature. If stored at room temperature, discard any unused portion after 28 days. Keep unused containers in their foil pouches until you're ready to use them. Do not freeze the medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's less than 6 hours until your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Always use your bronchodilator (if prescribed) before using tobramycin inhalation solution.
- Use a nebulizer that is compatible with the medication (e.g., PARI LC PLUS® nebulizer with a DeVilbiss Pulmo-Aide® compressor or equivalent).
- Follow the instructions for preparing and administering the dose carefully.
- Do not mix tobramycin inhalation solution with other medications in the nebulizer.
- Complete the full 28-day course of treatment, even if you feel better, to prevent antibiotic resistance.
- Maintain good oral hygiene to reduce the risk of oral candidiasis.
- Store ampules in the refrigerator or at room temperature for a limited time as directed.
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:
300 mg (one 5 mL ampule) administered twice daily via nebulizer, for 28 days on, followed by 28 days off therapy.
Dose Range:
300 - 300 mg
Condition-Specific Dosing:
cysticFibrosis_pseudomonasAeruginosa:
300 mg (one 5 mL ampule) administered twice daily via nebulizer, for 28 days on, followed by 28 days off therapy. Doses should be administered as close to 12 hours apart as possible, but not less than 6 hours apart.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 6 years of age and older: 300 mg (one 5 mL ampule) administered twice daily via nebulizer, for 28 days on, followed by 28 days off therapy.
Adolescent:
300 mg (one 5 mL ampule) administered twice daily via nebulizer, for 28 days on, followed by 28 days off therapy.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended for inhaled tobramycin due to low systemic absorption, but monitor renal function if systemic exposure is a concern or if concomitant nephrotoxic drugs are used.
Moderate:
Use with caution. Monitor renal function (serum creatinine, BUN) and consider audiometry. Systemic exposure is low, but accumulation can occur.
Severe:
Use with extreme caution. Monitor renal function and drug levels if possible. Consider alternative therapies if appropriate. Risk of systemic toxicity (nephrotoxicity, ototoxicity) is increased.
Dialysis:
Not specifically studied for inhaled tobramycin. Systemic tobramycin is dialyzable. For inhaled form, monitor for systemic accumulation if used.
Hepatic Impairment:
Mild:
No specific dose adjustment needed as tobramycin is not significantly metabolized by the liver.
Moderate:
No specific dose adjustment needed.
Severe:
No specific dose adjustment needed.
Pharmacology
Mechanism of Action
Tobramycin is an aminoglycoside antibiotic. It exerts its bactericidal effect by irreversibly binding to the 30S ribosomal subunit of susceptible bacteria, thereby inhibiting bacterial protein synthesis. This leads to the production of non-functional proteins and disruption of the bacterial cell membrane integrity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10-20% (systemic bioavailability after inhalation)
Tmax:
Plasma Tmax: Approximately 1 hour after inhalation
FoodEffect:
Not applicable (inhalation solution)
Distribution:
Vd:
Not well-defined for inhaled administration; for IV, approximately 0.26 L/kg
ProteinBinding:
Less than 10%
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life: Approximately 2-3 hours (after inhalation, similar to IV)
Clearance:
Primarily renal clearance
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
Greater than 90% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of inhalation, local effect)
PeakEffect:
Peak sputum concentrations within 10 minutes to 1 hour post-dose. Clinical effect observed over weeks of therapy.
DurationOfAction:
Local effect persists for several hours; systemic half-life is 2-3 hours.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Changes in balance
Dizziness or fainting
Fever
Muscle weakness
Ringing in the ears, hearing loss, or other changes in hearing
Wheezing
Persistent cough
Coughing up blood
New or worsening trouble breathing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Cough
Increased sputum production
Mouth pain
Throat pain
Sore throat
Changes in taste
Noisy breathing
Changes in voice
Stuffy nose
Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Changes in balance
Dizziness or fainting
Fever
Muscle weakness
Ringing in the ears, hearing loss, or other changes in hearing
Wheezing
Persistent cough
Coughing up blood
New or worsening trouble breathing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Cough
Increased sputum production
Mouth pain
Throat pain
Sore throat
Changes in taste
Noisy breathing
Changes in voice
Stuffy nose
Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- New or worsening cough or shortness of breath
- Wheezing or chest tightness after inhalation
- Hoarseness or changes in voice
- Sore throat or mouth sores
- Ringing in the ears (tinnitus)
- Hearing loss or difficulty hearing
- Dizziness or feeling off balance
- Muscle weakness
- Signs of kidney problems (e.g., decreased urination, swelling in legs/feet)
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.
If you are currently taking or have recently taken any of the following medications: Ethacrynic acid, furosemide, mannitol, or urea.
If you are taking or have taken medications that can cause nerve, kidney, or hearing problems, such as amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, cyclosporine, paromomycin, polymyxin B, vancomycin, or viomycin. There are many other medications with similar potential side effects; consult your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure your safety while taking this medication.
Remember, before starting, stopping, or changing the dosage of any medication, you must consult with your doctor to confirm it is safe to do so in conjunction with this medication and your individual health profile.
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.
If you are currently taking or have recently taken any of the following medications: Ethacrynic acid, furosemide, mannitol, or urea.
If you are taking or have taken medications that can cause nerve, kidney, or hearing problems, such as amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, cyclosporine, paromomycin, polymyxin B, vancomycin, or viomycin. There are many other medications with similar potential side effects; consult your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure your safety while taking this medication.
Remember, before starting, stopping, or changing the dosage of any medication, you must consult with your doctor to confirm it is safe to do so in conjunction with this medication and your individual health profile.
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 ensure safe treatment. Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. If you are pregnant or become pregnant while taking this drug, immediately notify your doctor, as it may cause harm to the unborn baby. Additionally, if you are breast-feeding, consult your doctor to discuss potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe dizziness or vertigo
- Ringing in the ears or hearing loss
- Kidney problems (e.g., decreased urine output)
- Muscle weakness or paralysis
- Difficulty breathing
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include monitoring of serum tobramycin levels, renal function, and audiometry. Hemodialysis may be considered in severe systemic toxicity.
Drug Interactions
Major Interactions
- Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, polymyxins, vancomycin, other aminoglycosides, loop diuretics): Increased risk of nephrotoxicity.
- Ototoxic drugs (e.g., loop diuretics, cisplatin, ethacrynic acid): Increased risk of ototoxicity.
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression or paralysis.
Moderate Interactions
- Cholinergic drugs (e.g., neostigmine, pyridostigmine): Aminoglycosides may antagonize the effects of these drugs.
- Oral anticoagulants (e.g., warfarin): Potential for increased anticoagulant effect (rare, but reported with systemic aminoglycosides).
Monitoring
Baseline Monitoring
Pulmonary Function Tests (PFTs), specifically FEV1
Rationale: To establish baseline lung function and monitor therapeutic response and potential for bronchospasm.
Timing: Prior to initiating therapy
Renal Function (Serum Creatinine, BUN)
Rationale: Although systemic absorption is low, baseline assessment is important, especially in patients with pre-existing renal impairment or those receiving concomitant nephrotoxic drugs.
Timing: Prior to initiating therapy
Audiometry
Rationale: To establish baseline hearing function, as ototoxicity is a known class effect of aminoglycosides, even with low systemic exposure.
Timing: Prior to initiating therapy
Routine Monitoring
Pulmonary Function Tests (FEV1)
Frequency: Every 3-6 months, or as clinically indicated
Target: Improvement or stabilization of FEV1
Action Threshold: Significant decline in FEV1 may indicate lack of efficacy, worsening disease, or adverse effect (e.g., bronchospasm).
Renal Function (Serum Creatinine, BUN)
Frequency: Periodically, especially if concomitant nephrotoxic drugs are used or if there are signs of systemic toxicity.
Target: Within normal limits for patient's age and baseline.
Action Threshold: Significant increase in creatinine or BUN may indicate renal impairment; consider drug discontinuation or alternative.
Audiometry
Frequency: Periodically (e.g., annually) or if symptoms of ototoxicity develop.
Target: Stable hearing thresholds.
Action Threshold: Significant hearing loss (especially high-frequency) or onset of tinnitus; consider drug discontinuation or alternative.
Symptom Monitoring
- Increased cough
- Bronchospasm (wheezing, shortness of breath)
- Voice alteration (hoarseness)
- Sore throat
- Oral candidiasis
- Hearing changes (decreased hearing, difficulty understanding speech)
- Tinnitus (ringing in the ears)
- Vertigo or dizziness
- Changes in urine output (decreased)
- Muscle weakness
Special Patient Groups
Pregnancy
Tobramycin is classified as Pregnancy Category D. There are no adequate and well-controlled studies of inhaled tobramycin in pregnant women. Aminoglycosides can cause fetal harm (e.g., ototoxicity) when administered systemically to pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic exposure from inhaled route is low.
Second Trimester:
Potential for fetal harm, particularly ototoxicity.
Third Trimester:
Potential for fetal harm, particularly ototoxicity.
Lactation
Tobramycin is excreted in human milk following systemic administration. While systemic absorption from inhaled tobramycin is low, caution should be exercised when administered to a nursing mother. The amount transferred to breast milk is likely small, and oral absorption by the infant is poor, minimizing risk.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to poor oral absorption of tobramycin.
Pediatric Use
Approved for use in patients 6 years of age and older. Safety and effectiveness in patients younger than 6 years have not been established. Dosing is the same for pediatric patients ≥6 years as for adults.
Geriatric Use
No specific dose adjustment is required based on age alone. However, geriatric patients are more likely to have decreased renal function, which should be monitored. Monitor for signs of ototoxicity and nephrotoxicity.
Clinical Information
Clinical Pearls
- Always administer a bronchodilator (if prescribed) before tobramycin inhalation solution to maximize drug delivery and minimize bronchospasm.
- The 28-day on, 28-day off cycling regimen is crucial for efficacy and to minimize the development of resistance and adverse effects.
- Proper nebulizer technique is essential for effective drug delivery to the lungs. Patients should be trained and periodically re-evaluated.
- Patients should be advised to rinse their mouth after each dose to reduce the risk of oral candidiasis and voice changes.
- Monitor for signs of ototoxicity (hearing loss, tinnitus, vertigo) and nephrotoxicity, especially if patients are on concomitant systemic aminoglycosides or other nephrotoxic/ototoxic drugs.
Alternative Therapies
- Aztreonam for inhalation solution (Cayston)
- Colistimethate sodium for inhalation (Colistin)
- Oral or intravenous antibiotics (e.g., ciprofloxacin, ceftazidime, meropenem) for acute exacerbations or different bacterial pathogens.
- Dornase alfa (Pulmozyme) - mucolytic, often used concomitantly in CF.
- Hypertonic saline - mucolytic, often used concomitantly in CF.
Cost & Coverage
Average Cost:
Varies widely, typically several thousand USD per 28-day cycle per 56x5ml ampules (28-day supply)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered for CF patients)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. 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, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.