PROMIXIN®INJECTION
Gram-negative infections resistant to other
antibacterials, including those caused byPseudomonas
aeruginosa,Acinetobacter baumanii,Klebsiella
pneumoniae
▶BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS
INFUSION
▶Child (body-weight up to 40 kg):75 000–150 000units/kg
daily in 3 divided doses, to be administered into a
totally implantable venous access device when giving
via slow intravenous injection
▶Child (body-weight 40 kg and above): 9 million units daily
in 2 – 3 divided doses, to be administered into a totally
implantable venous access device when giving via slow
intravenous injection
PROMIXIN®NEBULISER SOLUTION
Management of chronic pulmonary infections due to
Pseudomonas aeruginosain patients with cystic fibrosis
▶BY INHALATION OF NEBULISED SOLUTION
▶Child 1 month–1 year: 0. 5 – 1 million units twice daily, for
specific advice on administration using nebulisers—
consult product literature; maximum 2 million units
per day
▶Child 2–17 years: 1 – 2 million units 2 – 3 times a day, for
specific advice on administration using nebulisers—
consult product literature; maximum 6 million units
per daylCONTRA-INDICATIONSMyasthenia gravis
lCAUTIONS
▶When used by inhalationSevere haemoptysis—risk of further
haemorrhage
lINTERACTIONS→Appendix 1 : colistimethate
lSIDE-EFFECTS
▶Common or very common
▶When used by inhalationArthralgia.asthenia.asthma.
balance impaired.chest discomfort.cough.dysphonia.
dyspnoea.fever.haemorrhage.headache.lower
respiratory tract infection.nausea.respiratory disorders.
taste altered.throat complaints.tinnitus.vomiting
▶Uncommon
▶When used by inhalationAnxiety.appetite decreased.
diarrhoea.drowsiness.ear congestion.flatulence.oral
disorders.proteinuria.seizure.sputum purulent.thirst.
weight change
▶Rare or very rare
▶With parenteral useConfusion.nephrotoxicity.presyncope
.psychosis.speech slurred.visual impairment
▶Frequency not known
▶With parenteral useApnoea.neurological effects.
neurotoxicity.renal disorder.sensory disorder
SIDE-EFFECTS, FURTHER INFORMATIONNeurotoxicity and
nephrotoxicity are dose-related.
lPREGNANCY
▶When used by inhalationClinical use suggests probably safe.
▶With intravenous useUse only if potential benefit outweighs
risk.
lBREAST FEEDINGPresent in milk but poorly absorbed from
gut; manufacturers advise avoid (or use only if potential
benefit outweighs risk).
lRENAL IMPAIRMENT
Dose adjustments▶With intravenous useReduce dose.
Monitoring▶With intravenous useIn renal impairment,
monitor plasma colistimethate sodium concentration
during parenteral treatment—consult product literature.
Recommended‘peak’plasma colistimethate sodium
concentration (approx. 1 hour after intravenous injection
or infusion) 5 – 15 mg/litre; pre-dose (‘trough’)
concentration 2 – 6 mg/litre.
lMONITORING REQUIREMENTS
▶With intravenous useMonitor renal function.
▶When used by inhalationMeasure lung function before and
after initial dose of colistimethate sodium and monitor for
bronchospasm; if bronchospasm occurs in a patient not
using a bronchodilator, repeat test using a bronchodilator
before the dose of colistimethate sodium.
lDIRECTIONS FOR ADMINISTRATION
▶When used by inhalationOther inhaled drugs should be
administered before colistimethate sodium. For
nebulisationadminister required dose in 2 – 4 mL of sodium
chloride 0. 9 % (or water for injections) or a 1 : 1 mixture of
sodium chloride 0. 9 % and water for injection.
▶With intravenous useForintravenous infusion, dilute to a
concentration of40 000units/mL with Sodium Chloride
0. 9 %; give over 30 minutes. Forslow intravenous injection
into a totally implantable venous access device, dilute to a
concentration of90 000units/mL with Sodium Chloride
0. 9 % for child under 12 years (200 000units/mL for child
over 12 years).
COLOMYCIN®Colomycin®Injection may be used for
nebulisation; administer required dose in 2 – 4 mL of
sodium chloride 0. 9 %, (or water for injections) or a
1 : 1 mixture of sodium chloride 0. 9 % and water for
injection.
lPRESCRIBING AND DISPENSING INFORMATION
Colistimethate sodium is included in some preparations
for topical application.
lPATIENT AND CARER ADVICE
▶When used by inhalationPatient should be advised to rinse
mouth with water after each dose of dry powder
inhalation. Patients or carers should be given advice on
how to administer colistimethate sodium;first dose should
be given under medical supervision.
Driving and skilled tasksManufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness,
confusion and visual disturbances.
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Colistimethate sodium by dry powder inhalation for
pseudomonal lung infection in cystic fibrosis (March 2013 )
NICE TA276
Colistimethate sodium dry powder for inhalation is
recommended for chronic pulmonary infection caused by
Pseudomonas aeruginosain patients with cysticfibrosis
who would benefit from continued treatment, but do not
tolerate the drug in its nebulised form. The manufacturer
must provide colistimethate sodium 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 colistimethate
sodium dry powder for inhalation can continue treatment
until they and their clinician consider it appropriate to
stop.
http://www.nice.org.uk/TA276lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for solution for injection
ELECTROLYTES:May contain Sodium
▶Colistimethate sodium (Non-proprietary)
Colistimethate sodium 1000000 unitColistimethate 1 million unit
powder for solution for injection vials| 10 vialP£ 18. 00 DT =
£ 18. 00 | 10 vialP£ 18. 00 DT = £ 18. 00 (Hospital only)
▶Colomycin(Teva UK Ltd)
Colistimethate sodium 1000000 unitColomycin 1 million unit
powder for solution for injection vials| 10 vialP£ 18. 00 DT =
£ 18. 00
Colistimethate sodium 2000000 unitColomycin 2 million unit
powder for solution for injection vials| 10 vialP£ 32. 40 DT =
£ 32. 40BNFC 2018 – 2019 Bacterial infection 347
Infection5