Product Information
Trespin 300 mg Respules deliver Tobramycin, an aminoglycoside antibiotic, directly to the lungs through inhalation. This targeted approach ensures high local concentrations of the antibiotic at the site of infection while minimizing systemic exposure. By inhibiting bacterial protein synthesis, Tobramycin effectively combats Pseudomonas aeruginosa, a common and persistent pathogen in cystic fibrosis patients. Regular use of Trespin can lead to improved respiratory function and a decrease in the frequency of pulmonary exacerbations.
Indications
Trespin 300 mg Respules are indicated for:
- Management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older.
Composition
Each 5 mL respule contains:
- Active Ingredient: 300 mg of Tobramycin.
- Inactive Ingredients: Sodium chloride, water for injection, sulfuric acid, and sodium hydroxide (to adjust pH).
Dosage and Administration
- Recommended Dose: One 300 mg/5 mL respule inhaled twice daily for 28 days, followed by a 28-day off period. This 28-day on/off cycle is repeated continuously.
- Administration:
- Use with a hand-held nebulizer connected to an air compressor.
- Administer each dose over approximately 15 minutes.
- Doses should be spaced at least 6 hours apart.
Note: It’s essential to follow the prescribed dosing schedule and use the nebulizer system recommended by the healthcare provider.
Precautions
- Hypersensitivity: Contraindicated in patients with known hypersensitivity to Tobramycin or other aminoglycosides.
- Bronchospasm: Inhalation may induce bronchospasm; monitor lung function before and after the first dose.
- Ototoxicity: Aminoglycosides can cause hearing loss, dizziness, or vertigo; assess auditory function periodically.
- Nephrotoxicity: Use cautiously in patients with renal impairment; monitor renal function regularly.
- Neuromuscular Disorders: Patients with conditions like myasthenia gravis or Parkinson’s disease should be closely observed due to potential exacerbation of muscle weakness.
- Pregnancy and Lactation: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when administered to nursing mothers.
Storage
- Refrigeration: Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Room Temperature: If refrigeration is unavailable, unopened pouches may be stored at room temperature (up to 25°C/77°F) for up to 28 days.
- Light Protection: Protect from intense light.
- Appearance: The solution may darken if not refrigerated; however, this does not indicate a loss of quality if stored as recommended.
Note
- Baseline Assessments: Conduct baseline renal and auditory function tests before initiating therapy.
- Monitoring: Regularly monitor renal function, auditory function, and lung function during treatment.
- Concomitant Medications: Avoid concurrent use with other drugs that have neurotoxic, nephrotoxic, or ototoxic potential.
- Patient Education: Instruct patients on proper nebulizer use and the importance of adhering to the dosing schedule.
