Tobramycin


Thông tin kê toa tóm tắt
Chỉ định/Công dụng
Listed in Dosage.
Liều dùng/Hướng dẫn sử dụng
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.
Dosage Details
Inhalation/Respiratory
Cystic fibrosis
Adult: For management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with 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.
Child: ≥6 years As nebuliser solution/inhalation powder cap: Same as adult dose.

Intramuscular
Mild to moderate urinary tract infections
Adult: 2-3 mg/kg as a single dose.

Ophthalmic
Ocular infections
Adult: 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.
Child: >1 year As 0.3% eye drop solution/ointment: Same as adult dose.

Parenteral
Bone and joint infections, Central nervous system infections, Gastrointestinal infections, Lower respiratory tract infections, Skin and soft tissue infections
Adult: Usual dose: Serious infections: 3 mg/kg daily in 3 equally divided doses 8 hourly via IM inj or IV infusion over 20-60 minutes. 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.
Child: ≤1 week Premature or full-term neonates: Up to 4 mg/kg daily in 2 equal doses 12 hourly. >1 week 6-7.5 mg/kg daily in 3 or 4 equally divided doses. Usual treatment duration: 7-10 days.

Parenteral
Cystic fibrosis
Adult: Recommended dose: Up to 8-10 mg/kg daily in equally divided doses. Monitor serum tobramycin levels during treatment due to wide interpatient variability.
Renal Impairment
Parenteral/Intramuscular:
Dosage adjustment needed.
Hướng dẫn pha thuốc
IV infusion: Add the calculated dose in 50-100 mL of NaCl 0.9% or dextrose inj 5%.
Chống chỉ định
Hypersensitivity to tobramycin and other aminoglycosides.
Thận trọng
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.
Phản ứng phụ
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).
IM/Inhalation/Respiratory/IV/Parenteral: D; Ophth: B
Thông tin tư vấn bệnh nhân
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.
MonitoringParameters
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.
Quá liều
Symptoms: Parenteral: Dizziness, tinnitus, vertigo, loss of high tone hearing acuity, respiratory failure, neuromuscular blockade, renal impairment. Management: Parenteral: Establish airway and ensure oxygenation and ventilation. Initiate resuscitative measures immediately if respiratory paralysis occurs. Monitor fluid balance, creatinine clearance and tobramycin plasma levels. Ca salts may be given to reverse neuromuscular blockade. Haemodialysis or peritoneal dialysis may help remove drug serum levels.
Tương tác
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.
Tác dụng
Description: Tobramycin is an aminoglycoside antibiotic that interferes with bacterial protein synthesis by binding to 30S and 50S ribosomal subunits, resulting in a defective bacterial cell membrane.
Pharmacokinetics:
Absorption: Poorly absorbed from the gastrointestinal tract. Rapidly and completely absorbed (IM). Time to peak plasma concentration: 30-60 minutes (IM); approx 30 minutes (IV); 60 minutes (powder for inhalation).
Distribution: Distributed into most body tissues and fluids. Crosses the placenta and enters breast milk. Volume of distribution: 0.2-0.3 L/kg (systemic); 85.1 L (powder for inhalation). Plasma protein binding: <30%.
Excretion: Via urine (approx 90-95%). Elimination half-life: 2-3 hours (IV); approx 3 hours (powder for inhalation); approx 3-4.4 hours (solution for inhalation).
Đặc tính

Chemical Structure Image
Tobramycin

Source: National Center for Biotechnology Information. PubChem Database. Tobramycin, CID=36294, https://pubchem.ncbi.nlm.nih.gov/compound/Tobramycin (accessed on Jan. 23, 2020)

Bảo quản
Parenteral: Store between 20-25°C. Reconstituted solution: Store at room temperature (stable for 24 hours) or between 2-8°C (stable for 96 hours). Powder for inhalation: Store at 25°C. Protect from moisture. Solution for inhalation: Store between 2-8°C or at 25°C (intact or opened foil pouch) for up to 28 days. Protect from light. Ophthalmic solution/ointment: Store between 2-25°C.
Phân loại ATC
J01GB01 - tobramycin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
S01AA12 - tobramycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
References
Anon. Tobramycin (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/11/2019.

Anon. Tobramycin (Oral Inhalation). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/11/2019.

Anon. Tobramycin (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/11/2019.

Buckingham R (ed). Tobramycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2019.

Joint Formulary Committee. Tobramycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2019.

Novartis New Zealand Limited. Tobrex Eye Drops and Eye Ointment 0.3% data sheet May 2019. Medsafe. http://www.medsafe.govt.nz/. Accessed 07/11/2019.

Tobramycin Inhalation Solution Inhalant (Dr. Reddy’s Laboratories Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/11/2019.

Tobramycin Ophthalmic Solution/Drops (Alembic Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/11/2019.

Tobramycin Sulfate Injection, Powder, For Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/11/2019.

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