Jiantuo Tobramycin Inhalation Solution

1. Indications and Usage
Cystic Fibrosis: Treatment of adults and pediatric patients 6 years of age and older with cystic fibrosis who have Pseudomonas aeruginosa infections.
Bronchiectasis: Treatment of adults with bronchiectasis who have Pseudomonas aeruginosainfections in the lungs.
Administration Restriction: For oral inhalation ONLY. Do not administer subcutaneously or intravenously.
2. Dosage and Administration
Standard Dosage: 300 mg (one single-dose vial) administered twice daily.
Cycle Regimen: Treatment is administered for 28 days followed by 28 days off (off-cycle) in a continuous alternating cycle.
Administration Timing: Doses should be given approximately every 12 hours, with a minimum interval of 6 hours.
Missed Dose: If a dose is missed, it may be taken as soon as possible on the same day, provided it is at least 6 hours before the next scheduled dose. Do not double the dose.
Nebulizer Use: Do not dilute or mix with other drugs in the nebulizer. Use a nebulizer with a mesh or jet system as instructed.
3. Mechanism of Action
Bactericidal Activity: Tobramycin is an aminoglycoside antibiotic that binds irreversibly to the 30S ribosomal subunit of bacteria.
Protein Synthesis Inhibition: This binding inhibits bacterial protein synthesis and causes misreading of the mRNA, leading to cell death. It is highly effective against Pseudomonas aeruginosa.
4. Safety and Warnings
Bronchospasm: May cause bronchospasm; immediate treatment is required if this occurs.
Nephrotoxicity: Aminoglycosides can cause nephrotoxicity. Monitor renal function, especially in patients with pre-existing renal impairment or those on systemic aminoglycosides.
Ototoxicity: May cause hearing loss, tinnitus, and vestibular damage. Monitor audiological function and serum tobramycin levels.
Neuromuscular Blockade: May exacerbate neuromuscular disorders (e.g., myasthenia gravis) and potentiate the effects of neuromuscular blocking agents.
Sensitivity/Allergy: Contraindicated in patients with known hypersensitivity to other aminoglycosides.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Cough, voice disorders, increased sputum, hemoptysis, dyspnea, wheezing, chest pain, and pharyngolaryngeal pain.
Serious Adverse Reactions: Bronchospasm, ototoxicity, and nephrotoxicity.
Clinical Research Highlights: Clinical trials have demonstrated improved lung function and reduced pulmonary exacerbations in patients with cystic fibrosis or bronchiectasis.
6. Drug Interactions
Systemic Aminoglycosides: Concomitant use with systemic aminoglycosides increases the risk of nephrotoxicity and ototoxicity; serum levels should be monitored.
Polymyxins: Concomitant use may increase toxicity.
Loop Diuretics: Drugs like furosemide can increase the risk of ototoxicity.
Neuromuscular Blockers: May enhance neuromuscular blockade, leading to respiratory paralysis.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Tobramycin.
Appearance: Clear, pale yellow solution.
Packaging: Single-dose vials (e.g., 300 mg/5 mL).
Storage: Store between 2°C and 8°C. Do not freeze.