Individual generic drug information

tobramycin

Reference monograph

Part of registered formulation

DEXAMETHASON E + TOBRAMYCIN

Reference record: Tobramycin
Source: BNF 80 (2020–2021)
Printed source pages: 568, 569, 570
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Tobramycin only.

Indications And Dose

Septicaemia | Meningitis and other CNS infections | Biliary- tract infection | Acute pyelonephritis or prostatitis | Pneumonia in hospital patients ▶BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult: 3 mg/kg daily in 3 divided doses; increased if necessary up to 5 mg/kg daily in 3–4 divided doses, increased dose used in severe infection; dose to be reduced back to 3 mg/kg daily as soon as clinically indicated Urinary-tract infection ▶BY INTRAMUSCULAR INJECTION ▶Adult: 2–3 mg/kg for 1 dose Chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis ▶BY INHALATION OF NEBULISED SOLUTION ▶Adult: 300 mg every 12 hours for 28 days, subsequent courses repeated after 28-day interval without tobramycin nebuliser solution ▶BY INHALATION OF POWDER ▶Adult: 112 mg every 12 hours for 28 days, subsequent courses repeated after 28-day interval without tobramycin inhalation powder DOSES AT EXTREMES OF BODY-WEIGHT ▶With intramuscular use or intravenous use To avoid excessive dosage in obese patients, use ideal weight for height to calculate parenteral dose and monitor serum-tobramycin concentration closely. VANTOBRA ® NEBULISER SOLUTION Chronic pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis ▶BY INHALATION OF NEBULISED SOLUTION ▶Adult: 170 mg every 12 hours for 28 days, subsequent courses repeated after 28-day interval without tobramycin nebuliser solution

Source page 568

Cautions

▶When used by inhalation Auditory disorder. conditions characterised by muscular weakness (may impair neuromuscular transmission). history of prolonged previous or concomitant intravenous aminoglycosides (increased risk of ototoxicity). renal impairment (limited information available). severe haemoptysis (risk of further haemorrhage). vestibular disorder

Source pages 568, 569

National Funding Access Decisions

NICE decisions ▶Tobramycin by dry powder inhalation for pseudomonal lung infection in cystic fibrosis (March 2013) NICE TA276 ▶When used by inhalation Tobramycin dry powder for inhalation is recommended for chronic pulmonary infection caused by Pseudomonas aeruginosa in patients with cystic ﬁbrosis only if there is an inadequate response to colistimethate sodium, or if colistimethate sodium cannot be used because of contra-indications or intolerance. The manufacturer must provide tobramycin dry powder for inhalation at the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS. Patients currently receiving tobramycin dry powder for inhalation can continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta276

Source page 569

Safety

Extracted information for Tobramycin only.

Interactions

→Appendix 1: aminoglycosides

Source page 569

Side Effects

GENERAL SIDE-EFFECTS ▶Rare or very rare Diarrhoea. dizziness SPECIFIC SIDE-EFFECTS ▶Common or very common ▶When used by inhalation Dysphonia. malaise. respiratory disorder. sputum discolouration ▶Uncommon ▶When used by inhalation Cough ▶Rare or very rare ▶When used by inhalation Abdominal pain. aphonia. appetite decreased. asthenia. asthma. chest discomfort. drowsiness. ear disorder. ear pain. haemorrhage. hypoxia . increased risk of infection. lymphadenopathy. oral ulceration. pain. taste altered ▶Frequency not known ▶When used by inhalation Oropharyngeal pain ▶With parenteral use Granulocytopenia. leucocytosis. nerve disorders. urine abnormalities SIDE-EFFECTS, FURTHER INFORMATION Manufacturer advises to monitor serum-tobramycin concentration in patients with known or suspected signs of auditory dysfunction; if ototoxicity develops — discontinue treatment until serum concentration falls below 2 mg/litre.

Source page 569

Renal Impairment

▶When used by inhalation Manufacturer advises monitor serum-tobramycin concentration; if nephrotoxicity develops—discontinue treatment until serum concentration falls below 2 mg/litre.

Source page 569

Monitoring Requirements

▶With intramuscular use or intravenous use One-hour (‘peak’) serum concentration should not exceed 10 mg/litre; pre- dose (‘trough’) concentration should be less than 2 mg/litre. ▶When used by inhalation Measure lung function before and after initial dose of tobramycin and monitor for bronchospasm; if bronchospasm occurs in a patient not using a bronchodilator, repeat test using bronchodilator. Manufacturer advises monitor renal function before treatment and then annually.

Source page 569

Dose and formulations

Extracted information for Tobramycin only.

Directions For Administration

▶With intravenous use For intravenous infusion (Nebcin ®); intermittent or via drip tubing in Glucose 5% or Sodium chloride 0.9%. For adult intermittent infusion suggested volume 50–100 mL given over 20–60 minutes. ▶When used by inhalation Other inhaled drugs should be administered before tobramycin.

Source page 569

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Infection Solution for injection ▶Tobramycin (Non-proprietary) Tobramycin 40 mg per 1 ml Tobramycin 80mg/2ml solution for injection vials | 1 vial P £5.37 DT = £5.37 | 5 vial P £20.80 DT = £20.80 Tobramycin 240mg/6ml solution for injection vials | 1 vial P £19.20 DT = £19.20 ▶Nebcin (Flynn Pharma Ltd) Tobramycin 40 mg per 1 ml Nebcin 80mg/2ml solution for injection vials | 1 vial P £5.37 DT = £5.37 Inhalation powder ▶Tobi Podhaler (Mylan) Tobramycin 28 mg Tobi Podhaler 28mg inhalation powder capsules with device | 224 capsule P £1,790.00 DT = £1,790.00 Nebuliser liquid ▶Tobramycin (Non-proprietary) Tobramycin 60 mg per 1 ml Tobramycin 300mg/5ml nebuliser liquid ampoules | 56 ampoule P £1,187.00–£1,305.92 DT = £780.00 Munuza 300mg/5ml nebuliser solution 5ml ampoules | 56 ampoule P £779.99 DT = £780.00 ▶Bramitob (Chiesi Ltd) Tobramycin 75 mg per 1 ml Bramitob 300mg/4ml nebuliser solution 4ml ampoules | 56 ampoule P £1,187.00 DT = £1,187.00 ▶TOBI (Mylan) Tobramycin 60 mg per 1 ml Tobi 300mg/5ml nebuliser solution 5ml ampoules | 56 ampoule P £1,305.92 DT = £780.00 ▶Tymbrineb (Teva UK Ltd) Tobramycin 60 mg per 1 ml Tymbrineb 300mg/5ml nebuliser solution 5ml ampoules | 56 ampoule P £780.00 DT = £780.00 ▶Vantobra (Pari Medical Ltd) Tobramycin 100 mg per 1 ml Vantobra 170mg/1.7ml nebuliser solution 1.7ml ampoules | 56 ampoule P £1,305.00 ANTIBACTERIALS › CARBAPENEMS Carbapenems Overview The carbapenems are beta-lactam antibacterials with a broad-spectrum of activity which includes many Gram- positive and Gram-negative bacteria, and anaerobes; imipenem (imipenem with cilastatin p. 548) and meropenem p. 549 have good activity against Pseudomonas aeruginosa. The carbapenems are not active against meticillin-resistant Staphylococcus aureus and Enterococcus faecium. Imipenem (imipenem with cilastatin) and meropenem are used for the treatment of severe hospital-acquired infections and polymicrobial infections including septicaemia, hospital-acquired pneumonia, intra-abdominal infections, skin and soft-tissue infections, and complicated urinary- tract infections. Ertapenem p. 548 is licensed for treating abdominal and gynaecological infections and for community-acquired pneumonia, but it is not active against atypical respiratory pathogens and it has limited activity against penicillin- resistant pneumococci. It is also licensed for treating foot infections of the skin and soft tissue in patients with diabetes. Unlike the other carbapenems, ertapenem is not active against Pseudomonas or against Acinetobacter spp. Imipenem is partially inactivated in the kidney by enzymatic activity and is therefore administered in combination with cilastatin (imipenem with cilastatin), a speciﬁc enzyme inhibitor, which blocks its renal metabolism. Meropenem and ertapenem are stable to the renal enzyme which inactivates imipenem and therefore can be given without cilastatin. Side-effects of imipenem with cilastatin are similar to those of other beta-lactam antibiotics. Meropenem has less seizure-inducing potential and can be used to treat central nervous system infection.

Source pages 569, 570

Clinical care

Extracted information for Tobramycin only.

Patient And Carer Advice

▶When used by inhalation Patient counselling is advised for Tobramycin dry powder for inhalation (administration). VANTOBRA ® NEBULISER SOLUTION Missed doses ▶When used by inhalation Manufacturer advises if a dose is more than 6 hours late, the missed dose should not be taken and the next dose should be taken at the normal time.

Source page 569

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

3 mg/kg daily in 3 divided doses; increased if

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

2–3 mg/kg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

300 mg every 12 hours for 28 days, subsequent

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

112 mg every 12 hours for 28 days, subsequent

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

170 mg every 12 hours for 28 days, subsequent

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

tobramycin

Reference monograph

Part of registered formulation

DEXAMETHASON E + TOBRAMYCIN

Reference record: Tobramycin
Source: BNF 80 (2020–2021)
Printed source pages: 568, 569, 570
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Tobramycin only.

Indications And Dose

Source page 568

Cautions

Source pages 568, 569

National Funding Access Decisions

Source page 569

Safety

Extracted information for Tobramycin only.

Interactions

→Appendix 1: aminoglycosides

Source page 569

Side Effects

Source page 569

Renal Impairment

▶When used by inhalation Manufacturer advises monitor serum-tobramycin concentration; if nephrotoxicity develops—discontinue treatment until serum concentration falls below 2 mg/litre.

Source page 569

Monitoring Requirements

Source page 569

Dose and formulations

Extracted information for Tobramycin only.

Directions For Administration

Source page 569

Medicinal Forms

Source pages 569, 570

Clinical care

Extracted information for Tobramycin only.

Patient And Carer Advice

Source page 569

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

3 mg/kg daily in 3 divided doses; increased if

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

2–3 mg/kg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

300 mg every 12 hours for 28 days, subsequent

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

112 mg every 12 hours for 28 days, subsequent

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Adults

First line only; read the complete Indications and dose section above.

170 mg every 12 hours for 28 days, subsequent

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 568

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.