Tobramycin 300mg/5ml Inh Sol 5ml
It is used in people with cystic fibrosis to treat a certain type of bacterial infection.
Drug Class
Anti-infective, Aminoglycoside
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 that you breathe in through a nebulizer. It's used to treat lung infections, especially those caused by a germ called Pseudomonas aeruginosa, in people with cystic fibrosis. It helps to kill the bacteria in your lungs and improve your breathing.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication properly, 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 correctly. Be sure to use only the type of nebulizer recommended by your doctor. If you're unsure about the type of nebulizer to use, consult with your doctor.
Continue taking 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 instructions for cleaning the nebulizer carefully.
Storing and Disposing of Your Medication
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 properly, 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 correctly. Be sure to use only the type of nebulizer recommended by your doctor. If you're unsure about the type of nebulizer to use, consult with your doctor.
Continue taking 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 instructions for cleaning the nebulizer carefully.
Storing and Disposing of Your Medication
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
- Administer doses approximately 12 hours apart, but no less than 6 hours apart.
- Follow the 28-day on, 28-day off cycle strictly.
- Use a clean, appropriate nebulizer system as instructed by your healthcare provider.
- Do not mix tobramycin inhalation solution with other medications in the nebulizer.
- Continue other prescribed cystic fibrosis treatments (e.g., bronchodilators, mucolytics) as directed. Administer bronchodilators first, then mucolytics, then tobramycin.
- Store ampules in the refrigerator or at room temperature for a limited time as specified by the manufacturer.
- Protect ampules from light.
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) inhaled twice daily, administered over approximately 15 minutes, using a nebulizer. Doses should be administered as close to 12 hours apart as possible, but not less than 6 hours apart. Administer in alternating 28-day cycles (28 days on drug, 28 days off drug).
Dose Range:
300 - 300 mg
Condition-Specific Dosing:
cysticFibrosis:
300 mg inhaled twice daily in alternating 28-day cycles.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy in patients <6 years of age have not been established).
Child:
For patients 6 years of age and older with cystic fibrosis: 300 mg (one 5 mL ampule) inhaled twice daily, administered over approximately 15 minutes, using a nebulizer. Doses should be administered as close to 12 hours apart as possible, but not less than 6 hours apart. Administer in alternating 28-day cycles (28 days on drug, 28 days off drug).
Adolescent:
300 mg (one 5 mL ampule) inhaled twice daily, administered over approximately 15 minutes, using a nebulizer. Doses should be administered as close to 12 hours apart as possible, but not less than 6 hours apart. Administer in alternating 28-day cycles (28 days on drug, 28 days off drug).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended for inhaled tobramycin due to minimal systemic absorption. Monitor renal function if systemic exposure is a concern.
Moderate:
No specific dose adjustment recommended for inhaled tobramycin due to minimal systemic absorption. Monitor renal function if systemic exposure is a concern.
Severe:
No specific dose adjustment recommended for inhaled tobramycin due to minimal systemic absorption. Monitor renal function if systemic exposure is a concern.
Dialysis:
No specific dose adjustment recommended for inhaled tobramycin due to minimal systemic absorption. Monitor renal function if systemic exposure is a concern.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
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 abnormal proteins and disruption of the bacterial cell membrane, ultimately resulting in bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability (typically <10% of the inhaled dose is absorbed systemically).
Tmax:
Approximately 1 hour (for systemic absorption after inhalation). Peak sputum concentrations are achieved within 10 minutes.
FoodEffect:
Not applicable for inhaled formulation.
Distribution:
Vd:
Not readily quantifiable for inhaled route; primarily distributed locally in the airways and lungs. Systemic Vd is approximately 0.26 L/kg.
ProteinBinding:
Low (<10% for systemic tobramycin).
CnssPenetration:
Limited (poor penetration into CNS from systemic circulation; not relevant for primary action of inhaled form).
Elimination:
HalfLife:
Approximately 2-3 hours (systemic). Sputum half-life is longer, around 3-6 hours.
Clearance:
Primarily renal (systemically absorbed portion).
ExcretionRoute:
Renal (glomerular filtration).
Unchanged:
>90% (systemically absorbed portion).
Pharmacodynamics
OnsetOfAction:
Rapid (local effect in airways within minutes of inhalation).
PeakEffect:
Peak sputum concentrations within 10 minutes.
DurationOfAction:
Sustained concentrations in sputum for several hours (up to 12 hours).
Safety & Warnings
BLACK BOX WARNING
Aminoglycosides, including tobramycin, have been associated with nephrotoxicity and ototoxicity. Nephrotoxicity is dose-dependent and usually reversible. Ototoxicity (vestibular and auditory) can be irreversible and may be delayed. Concurrent use with other neurotoxic or nephrotoxic drugs should be avoided. Neuromuscular blockade and respiratory paralysis have been reported following administration of aminoglycosides. These effects are more likely to occur in patients with impaired renal function or those receiving concurrent neuromuscular blocking agents. Tobramycin can cause fetal harm when administered to a pregnant woman.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 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 breathing difficulties
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
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 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 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 breathing difficulties
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
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 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:
- New or worsening cough, shortness of breath, or wheezing
- Hoarseness or voice changes
- Chest tightness or pain
- Ringing in your ears (tinnitus)
- Hearing loss or muffled hearing
- Dizziness or feeling unsteady
- Changes in how much you urinate
- Swelling in your hands, ankles, or feet
- Rash or itching
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 allergic reaction you experienced, including any symptoms that occurred.
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 recently taken any medications that may cause nerve, kidney, or hearing problems, such as:
+ Amphotericin B
+ Bacitracin
+ Cephaloridine
+ Cisplatin
+ Colistin
+ Cyclosporine
+ Paromomycin
+ Polymyxin B
+ Vancomycin
+ Viomycin
+ Other similar medications
Please note that this is not an exhaustive list of medications that may interact with this drug. If you are unsure about any medications, consult your doctor or pharmacist.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
Any health problems you have
Carefully review your medications and health problems with your doctor to confirm that it is safe to take this medication. Do not start, stop, or change the dose of any medication without first consulting 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 allergic reaction you experienced, including any symptoms that occurred.
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 recently taken any medications that may cause nerve, kidney, or hearing problems, such as:
+ Amphotericin B
+ Bacitracin
+ Cephaloridine
+ Cisplatin
+ Colistin
+ Cyclosporine
+ Paromomycin
+ Polymyxin B
+ Vancomycin
+ Viomycin
+ Other similar medications
Please note that this is not an exhaustive list of medications that may interact with this drug. If you are unsure about any medications, consult your doctor or pharmacist.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
Any health problems you have
Carefully review your medications and health problems with your doctor to confirm that it is safe to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 are pregnant or become pregnant while taking this medication, you should immediately contact your doctor, as it may cause harm to the unborn baby.
If you are breastfeeding, consult your doctor to discuss the potential risks to your baby and determine the best course of action.
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 are pregnant or become pregnant while taking this medication, you should immediately contact your doctor, as it may cause harm to the unborn baby.
If you are breastfeeding, consult your doctor to discuss the potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe dizziness or vertigo
- Ringing in ears or hearing loss
- Kidney problems (e.g., decreased urine output)
- Muscle weakness or difficulty breathing (rare with inhaled form)
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Hemodialysis may be considered in cases of significant systemic overdose.
Drug Interactions
Major Interactions
- Other aminoglycosides (e.g., amikacin, gentamicin, streptomycin, neomycin): Increased risk of nephrotoxicity and ototoxicity.
- Amphotericin B, cisplatin, cyclosporine, tacrolimus, polymyxins, vancomycin: Increased risk of nephrotoxicity.
- Loop diuretics (e.g., furosemide, ethacrynic acid): Increased risk of ototoxicity.
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Potentiation of neuromuscular blockade, leading to respiratory depression or paralysis.
Moderate Interactions
- Cephalosporins (especially cephaloridine): May increase risk of nephrotoxicity.
- Digoxin: Aminoglycosides may increase digoxin levels by altering gut flora.
- Oral anticoagulants (e.g., warfarin): May potentiate anticoagulant effect by altering gut flora.
Monitoring
Baseline Monitoring
Renal function (serum creatinine, BUN)
Rationale: To establish baseline kidney function, especially important if there's any systemic absorption or concurrent nephrotoxic drugs.
Timing: Prior to initiation of therapy.
Audiometry (hearing assessment)
Rationale: To establish baseline hearing, as ototoxicity is a known side effect of aminoglycosides, though less common with inhaled forms.
Timing: Prior to initiation of therapy.
Sputum culture and sensitivity
Rationale: To confirm susceptibility of Pseudomonas aeruginosa.
Timing: Prior to initiation and periodically during therapy.
Routine Monitoring
Pulmonary function tests (e.g., FEV1)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Improvement or stabilization of lung function.
Action Threshold: Significant decline may indicate treatment failure or worsening disease.
Signs/symptoms of ototoxicity (e.g., hearing loss, tinnitus, vertigo)
Frequency: Regularly (e.g., at each clinic visit).
Target: Absence of symptoms.
Action Threshold: New or worsening symptoms warrant audiometry and consideration of drug discontinuation.
Signs/symptoms of nephrotoxicity (e.g., changes in urine output, edema)
Frequency: Regularly (e.g., at each clinic visit).
Target: Absence of symptoms.
Action Threshold: New or worsening symptoms warrant renal function tests.
Sputum culture and sensitivity
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Reduction in bacterial load or eradication of Pseudomonas aeruginosa.
Action Threshold: Persistent or increasing bacterial load, or emergence of resistant strains.
Symptom Monitoring
- Worsening cough
- Increased sputum production or change in sputum color/consistency
- Increased shortness of breath or wheezing
- Fever
- Chest pain or tightness
- Hoarseness or voice changes
- Hearing changes (e.g., ringing in ears, muffled hearing)
- Dizziness or vertigo
- Changes in urine output
- Swelling in ankles or feet
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:
First Trimester:
Potential for fetal harm, including ototoxicity.
Second Trimester:
Potential for fetal harm, including ototoxicity.
Third Trimester:
Potential for fetal harm, including ototoxicity.
Lactation
L3 (Moderately safe). Tobramycin is excreted in human milk in small amounts after systemic administration. Systemic absorption from inhaled tobramycin is minimal, making infant exposure low. Monitor breastfed infants for diarrhea, candidiasis, and potential effects on gut flora. Weigh the benefits of breastfeeding against the potential risks.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption and poor oral absorption by the infant. Monitor for gastrointestinal disturbances.
Pediatric Use
Approved for use in patients 6 years of age and older with cystic fibrosis. Safety and efficacy in patients younger than 6 years have not been established. Dosing is the same as for adults for patients 6 years and older.
Geriatric Use
No specific dose adjustments are recommended for elderly patients. However, elderly patients are more likely to have decreased renal function, which could increase systemic exposure if significant absorption occurs. Monitor renal function and hearing if concerns arise.
Clinical Information
Clinical Pearls
- Tobramycin inhalation solution is specifically formulated for inhalation and should NOT be administered parenterally.
- Patients should be instructed on proper nebulizer technique and maintenance to ensure effective drug delivery.
- Administer bronchodilators before tobramycin inhalation solution to optimize drug delivery and minimize bronchospasm.
- The alternating 28-day on/28-day off cycle is crucial for maintaining efficacy and reducing the development of resistance.
- While systemic side effects (nephrotoxicity, ototoxicity) are less common with inhaled tobramycin due to minimal systemic absorption, patients should still be monitored, especially if they have pre-existing renal impairment or are on other nephrotoxic/ototoxic medications.
- Hoarseness and voice changes are common local side effects; rinsing the mouth after inhalation may help.
Alternative Therapies
- Aztreonam for inhalation solution (Cayston)
- Colistimethate sodium for inhalation (Colistin)
- Oral azithromycin (for anti-inflammatory effects in CF, not direct anti-pseudomonal)
- Systemic antibiotics (e.g., IV aminoglycosides, beta-lactams, fluoroquinolones) for acute exacerbations.
Cost & Coverage
Average Cost:
Varies widely, typically $1,000 - $3,000+ per 28-day supply (56 ampules)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization for most plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.