Tobramycin

Registered South African indications:

• Potentially life-threatening infections in complicated or recurrent urinary tract infections; respiratory tract infections and various nosocomial infections (inj)
• Long-term management  of chronic pulmonary colonisation by Pseudomonas aeruginosa in cystic fibrosis patients aged 6 years and older (neb)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Hypersensitivity to other aminoglycosides 
• Pregnancy
• Breastfeeding
• Myasthenia gravis, parkinsonism and other conditions characterised by muscular weakness (80mg/2ml solution for injection)

Cautions

• Renal impairment 
• High doses
• Prolonged use 
• Asthma 
• Burns 
• Intraocular or subconjunctival use 
• Neuromuscular disorders 
• Premature infants
• Neonates 

Forms avail. in SA and covered in this monograph: inj, neb

Infections caused by: Most Gram-negative aerobic bacilli (excluding H. influenza and extended spectrum beta-lactamase Klebsiella)

General dosing range

• Serious infections: IV/IM: 3mg/kg/day, as a single daily dose or in 3 divided doses
• Life-threatening infections: IV/IM: 5mg/kg/day, as a single daily dose or in 3-4 divided doses

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See additional prescribing points for administration directions 

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Dosing schedule guide

Weight (kg)	Usual dose for serious infections (3mg/kg/day)		Maximum dose for life-threatening infections (5mg/kg/day)
	mg/dose	ml/dose	mg/dose	ml/dose
120	120	3.0	200	5.0
100	100	2.5	155	4.0
80	80	2.0	133	3.0
60	60	1.5	100	2.5
40	40	1.0	66	1.6

 

Specific doses based on individual indications

Please note that the doses below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Long-term management of chronic pulmonary colonisation by Pseudomonas aeruginosa in cystic fibrosis patients aged 6 years and older

• Inhaled (neb): 300mg, 12hrly; Treatment duration: 28 days

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After 28 days of therapy, patients should stop therapy for the next 28 days

A cycle of 28 days of active therapy and 28 days of rest from treatment should be maintained

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To achieve therapeutic serum levels in patients with cystic fibrosis, it may be necessary to administer up to 8 to 10mg/kg/day in equally divided doses

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Brucellosis

• IV: 5mg/kg, dly; Treatment duration: 7 days; in combination with doxycycline
  OR
  IM: 240mg, dly; Treatment duration: 7 days; in combination with doxycycline

Hospital-acquired pneumonia
Ventilator-assisted pneumonia 

• IV: 5-7mg/kg/day, as a single daily dose; Treatment duration: 7 days 

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Aminoglycosides are not recommended as monotherapy in patients with hospital-acquired or ventilator-associated pneumonia due to Pseudomonas aeruginosa

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Cholangitis

• IV/IM: 4-6mg/kg, as a single daily dose, in combination with ampicillin 

 Complicated diverticulitis

• IV/IM: 1.5-2 mg/kg, 8hrly, in combination with ampicillin and metronidazole 

Meningitis
- Enterococcus
- Pseudomonas aeruginosa 

• IV: 5mg/kg/day, in 3 divided doses, in combination with another bacteriocidal drug 

Pelvic inflammatory disease

• IV/IM: Loading dose: 2mg/kg, Maintenance: 1.5mg/kg, 8hrly OR 4.5mg/kg, as a single daily dose 

Urinary tract infection

• IV/IM: 1.5 mg/kg, 8hrly

Prevention of endocarditis
- Dental, oral, upper respiratory, gastrointestinal and genitourinary procedures 

• IV/IM: 1.5mg/kg, 30min prior to procedure 

Tularemia

• IV/IM: 5mg/kg/day, in 3 divided doses; Treatment duration: 1-2 weeks 

Plague

• IV/IM: 5mg/kg/day, followed by post-exposure prophylaxis with doxycycline 

Paed. forms avail. in SA and covered in this monograph: inj, neb

Infections caused by: Most Gram-negative aerobic bacilli (excluding Streptococcus pyogenes, Streptococcus pneumonia, Enterococci)

General dosing range

• Children: IV/IM: 6-7.5mg/kg/day, in 3-4 divided doses 
• Premature and full term neonates (1.5-2.5kg): IV/IM: 4mg/kg/day, in 2 divided doses 

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See additional prescribing points for administration directions 

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Specific doses based on individual indications

Please note that the doses below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Long-term management of chronic pulmonary colonisation by Pseudomonas aeruginosa in cystic fibrosis patients aged 6 years and older

• Inhaled (neb): 300mg, 12hrly; Treatment duration: 28 days

---

After 28 days of therapy, patients should stop therapy for the next 28 days

A cycle of 28 days of active therapy and 28 days of rest from treatment should be maintained

---

To achieve therapeutic serum levels in patients with cystic fibrosis, it may be necessary to administer up to 8-10mg/kg/day in equally divided doses

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Cystic fibrosis

• IV/IM: 2.5-3.3mg/kg, 6-8hrly 

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment 

• No dose adjustment recommended 

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Vertigo
• Confusion
• Headache 
• Lethargy 
• Disorientation

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea 

Hepatobiliary Disorders

• Increased serum transaminases 
• Increased serum bilirubin

Genitourinary Disorders

• Increased urea and creatinine 
• Oliguria
• Cylinduria
• Proteinuria 

Endocrine and Metabolic Disorders

• Decreased serum calcium
• Decreased serum magnesium
• Decreased serum sodium
• Decreased serum potassium

Skin and Subcutaneous Tissue Disorders

• Rash
• Exfoliative dermatitis
• Pruritis
• Urticaria 
• Pain at injection site 

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Granulocytopenia
• Thrombocytopenia
• Leucopenia
• Leucocytosis
• Eosinophilia
• Fever 

Sensory Disorders

• Tinnitus
• Hearing loss
• Roaring in the ears  

• Other aminoglycosides 
• Amphotericin B 
• Cephaloridine
• Viomycin
• Polymyxin B (neb)
• Colistin
• Cisplatin
• Diuretics
• Cephalosporins
• Muscle relaxants
• General anaesthetics 
• Cytotoxics
• Cyclosporins
• Wafarin
• Phenindione
• Cholinergics
• Platinum compounds (neb)

• Peak and trough levels (see additional prescribing points)  
• Renal function
• Electrolytes
• Hearing/ cranial nerve VIII function  

Method of administration 

• For intravenous administration infuse over 20-60 minutes in 50-100ml sterile sodium chloride or glucose solution
• For inhalation administration the contents of one ampoule should be emptied in the nebuliser and administered over 15 minutes

Monitoring

• To measure the peak level, a serum sample should be drawn 30 minutes following intravenous infusion or at one hour after intramuscular injection
• Trough levels are measured by obtaining serum samples at eight hours or just prior to the next dose of tobramycin
• Perform serum level assays after two or three doses, so that the dosage could be adjusted if necessary
• Prolonged serum concentrations above 12mg/l should be avoided

Interferes with bacterial protein synthesis by binding to 30S ribosomal subunit, resulting in a defective cell membrane. 

Spectrum of activity: Most Gram-negative aerobic bacilli (excluding H. influenza and extended spectrum beta-lactamase Klebsiella)

Injection (per 2ml) 80mg

• Micro-Tobramicin (Micro Healthcare)
• Nebcin (Pharmacare)
• Tobramycin Fresenius (Fresenius)

Nebuliser solution (per 4ml) 300mg

• Bramitob Nebuliser Solution 300mg/4ml (Safeline Pharmaceuticals)

Nebuliser solution (per 5ml) 300mg

• Tobi ampoules (Mylan) originator

Also available in the following forms: Eye drop and eye ointment.