- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder for solution for injection/infusion containing temocillin
Lower respiratory tract infections
Urinary tract infection
In mixed infections where gram-positive or anaerobic bacteria may be the causative organisms, concurrent administration with other appropriate antibacterial products should be considered.
4g per day divided into 2 doses (2g every 12 hours) or 4g as a continuous infusion.
Critically ill patients may require a higher dose of 6g per day divided into 3 doses (2g every 8 hours) or 6g as a continuous infusion.
For doses given as continuous infusions, give patient a loading dose of 2g.
Patients with Renal Impairment
Temocillin is mainly excreted unchanged renally. Therefore, excretion is reduced in patients with renal impairment and half-life is increased according to the severity of renal failure. The following dose adjustments are necessary in patients with creatinine clearance less than 60 ml/minute:
Creatinine clearance 30 to 60ml/minute: 1g every 12 hours
Creatinine clearance 10 to 30ml/minute: 1g every 24 hours
Creatinine clearance less than 10ml/minute: 1g every 48 hours or 500mg every 24 hours
Intramuscular route should be avoided because of the patient's treatment with heparin. Intravenous injection of temocillin is recommended, using water for injection as solvent.
The suggested dose is 1g per 24 hours of interdialytic session, preferably given at the end of haemodialysis.
Continuous peritoneal dialysis
1g temocillin by intramuscular injection every 48 hours.
May be administered by intravenous injection, intermittent or continuous intravenous infusion, or intramuscular injection after reconstitution.
Administer by slow injection into the vein (3 to 4 minutes) or by intravenous infusion over 30 to 40 minutes.
Continuous intravenous infusion can be considered. For doses given as continuous infusions, give patient a loading dose of 2g.
If pain is experienced at the injection site, lidocaine hydrochloride solution for injection 0.5 to 1% may be used for reconstitution instead of Water for Injections.
Children under 18 years
Precautions and Warnings
Renal impairment - creatinine clearance below 60ml/minute
Reduce dose in patients with creatinine clearance below 60ml/min
Sodium content of formulation may be significant
Consult national/regional policy on the use of anti-infectives
Monitor for signs of superinfection with non-susceptible organisms
Monitor potassium in patients with low potassium reserve
Consider pseudomembranous colitis if patient presents with diarrhoea
May affect urinary glucose test for reducing substances
Discontinue drug if bleeding abnormalities occur
Discontinue if allergic reaction occurs
Discontinue if severe and persistent diarrhoea develops
Bleeding manifestations have been reported in some patients receiving beta-lactam antibiotics. These reactions have included abnormal coagulation tests and are more likely to occur in patients with renal failure. If such bleeding manifestations do occur, discontinue the antibiotic and initiate appropriate therapy.
There have been reports of serious and occasionally fatal anaphylactic reactions in patients receiving therapy with penicillins. In the event of such an allergic reaction occurring, discontinue the temocillin therapy.
During treatment with temocillin, there is a possibility of the emergence of resistant organisms which might cause superinfections. Microbiological follow-up may be required to detect any important superinfection. If this occurs, appropriate measures should be taken.
Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.
Pregnancy and Lactation
Temocillin is contraindicated during pregnancy.
At the time of writing there is little experience of temocillin administration during human pregnancy. Animal studies have not shown any teratogenic effects.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Temocillin is contraindicated during breastfeeding.
Trace quantities of penicillins can be detected in human breast milk and therefore, due to the lack of data, mothers are advised against breastfeeding their infants while receiving temocillin.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Local pain (injection site)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: May 2017
Summary of Product Characteristics: Negaban 1 g, powder for solution for injection/infusion. EUMEDICA SA. Revised April 2018.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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