Composition: Tobramycin 300mg/5ml.
Presentation: Ampoules of preservative-free, aqueous nebuliser solution.
Storage and stability: Store at 2-8C. The contents of the whole ampoule should be used immediately after opening and any remaining solution should be discarded.
Action: Aminoglycoside antibiotic.
Indications: Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients aged six years and older.
Contraindications: Any patient with known hypersensitivity to any aminoglycoside.
Dosage and administration: Adults and children (above 6 years of age), recommended dose is one ampoule twice daily for 28 days. The dose interval should be as close as possible to 12 hours and not less than six hours. A cycle of 28 days of active therapy followed by 28 days of rest from treatment should be maintained. Dosage is not adjusted for weight. Tobi is administered by inhalation over approximately a 15 minute period, using a hand-held Pari LC Plus reusable nebuliser with a suitable compressor.
Pregnancy, the product should not be used during pregnancy or lactation, unless the benefits to the mother outweigh the risks to the foetus or baby.
Overdosage: Symptoms may include severe hoarseness. Toxicity is unlikely with accidental ingestion. Acute toxicity should be treated with immediate withdrawal and baseline tests of renal function should be undertaken.
Precautions: The first dose should be given under supervision in case bronchospasm occurs - see SPC for details. Use with caution in patients with known or suspected renal, auditory, vestibular or neuromuscular dysfunction, or patients with severe, active haemoptysis.
Drug interactions: Avoid concurrent or sequential use with drugs with nephrotoxic or ototoxic potential. Do not administer concomitantly with ethacrynic acid, frusemide, urea or mannitol.
Side effects: In placebo-controlled trials the majority of adverse effects were reported with similar frequency in patients treated with Tobi and the aerosolised placebo control. Voice alteration was more common in patients treated with Tobi compared with control patients. Tinnitus was reported rarely but was more common in the Tobi- treated patients.
Net price: 56 ampoules £1,540.
Supplier: Pathogenesis Ltd, Pathogenesis House, Park Lane, Cranford, Hounslow TW5 9RR (tel 0181 580 4000).
Legal class: POM.