Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: IM/IV Bone and joint infections; Central nervous system infections; Gastrointestinal infections; Skin and soft tissue infections; Lower respiratory tract infections Usual dose: Serious infections: 3 mg/kg daily in 3 equally divided doses 8 hourly. Life-threatening infections: Increased up to 5 mg/kg daily in 3 or 4 divided doses, then reduce back to 3 mg/kg daily as clinically indicated. Max: 5 mg/kg daily. Usual treatment duration: 7-10 days. Cystic fibrosis Recommended dose: Up to 8-10 mg/kg daily in equally divided doses. IM Mild to moderate urinary tract infections 2-3 mg/kg as a single dose. Inhalation Cystic fibrosis As nebuliser solution: 300 mg 12 hourly or 170 mg 12 hourly via suitable nebuliser for 28 days, then stop treatment for the next 28 days. As inhalation powder cap: 112 mg 12 hourly via suitable inhaler device for 28 days, then stop treatment for the next 28 days. Repeat in cycles of 28 days on treatment, followed by 28 days off treatment. Ophth Ocular infections As 0.3% eye drop solution: Mild to moderate infection: Instill 1-2 drop(s) into the affected eye(s) 4 hourly. Severe infection: Instill 2 drops into the affected eye(s) hourly until improvement, then treatment should be reduced prior to discontinuation. As 0.3% ointment: Mild to moderate infection: Apply a half-inch ribbon into the affected eye(s) 2 or 3 times daily. Severe infection: Apply half-inch ribbon into the affected eye(s) 3-4 hourly until improvement, then treatment should be reduced prior to discontinuation.
Hypersensitivity to tobramycin and other aminoglycosides.
Special Precautions
Patient with hearing impairment, hypocalcaemia, neuromuscular disorder (e.g. myasthenia gravis, Parkinson's disease), dehydration; severe and active haemoptysis (inhalation). Renal impairment. Children. Pregnancy and lactation. Patient Counselling Ophthalmic: This drug may cause temporary blurred vision, if affected, do not drive or operate machinery. Wearing of contact lens is not recommended during treatment. Monitoring Parameters Monitor serum Ca, Mg and Na; BUN, serum creatinine, urinalysis, urine output, peak and trough plasma tobramycin levels. Assess hearing level prior to, during, and following treatment. Perform culture and sensitivity tests; consult local recommendations before treatment initiation due to antibiotic resistance risks.
Adverse Reactions
Significant: Nephrotoxicity, ototoxicity (e.g. tinnitus, hearing loss, vertigo), neurotoxicity, bronchospasm (inhalation), neuromuscular blockade, respiratory failure, prolonged respiratory paralysis. Cardiac disorders: Dyspnoea. Eye disorders: Lid itching, swelling and conjunctival erythema (ophthalmic). Gastrointestinal disorders: Nausea, oropharyngeal pain, vomiting, diarrhoea, dysgeusia. General disorders and administration site conditions: Malaise, pyrexia. Investigations: Decreased pulmonary function test. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Dizziness, headache. Respiratory, thoracic and mediastinal disorders: Laryngitis (inhalation), rhinitis, dysphonia, discoloured sputum, respiratory disorder, cough, wheezing, rales, nasal congestion, epistaxis. Skin and subcutaneous tissue disorders: Pruritus, urticaria, rash. Vascular disorders: Haemoptysis (inhalation).
Potentially Fatal: Superinfection, including C. difficile-associated diarrhoea and pseudomembranous colitis (prolonged use). Rarely, anaphylaxis, dermatologic reactions (e.g. exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome).
ROUTE(S) : Ophth: B
ROUTE(S) : Inhalation / IM / IV / Parenteral: D
Drug Interactions
Enhanced of neurotoxic or nephrotoxic effects with other aminoglycosides (e.g. amikacin, streptomycin, gentamicin), amphotericin B, viomycin, polymyxin B, cisplatin, vancomycin. May increase risk of nephrotoxicity with other antibacterials (e.g. cephalosporins), ciclosporin, mannitol. Enhanced blockade of respiratory paralysis with skeletal muscle relaxants. May increase risk of nephrotoxicity and ototoxicity with platinum compounds, potent diuretics (e.g. ethacrynic acid, furosemide). Antagonistic effect with neostigmine and pyridostigmine. May potentiate the effects of warfarin and phenindione.
ATC Classification
S01AA12 - tobramycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
J01GB01 - tobramycin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by CIMS based on tobramycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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