Intravesical gentamicin protocol - Royal Devon & Exeter Hospital

Intravesical gentamicin protocol - Royal Devon & Exeter Hospital Intravesical gentamicin protocol - Royal Devon & Exeter Hospital

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3.4 Therapeutic drug monitoring3.4.1 A serum sample taken at 9am for measurement of gentamicin concentration shouldbe sent within 7 days of starting intravesical gentamicin. If there are any otherconcerns the gentamicin level could be checked after 3 days, at the discretion of theclinicians involved.3.4.2 If serum gentamicin concentration is > 1 mg/L, intravesical gentamicin should bestopped and not restarted.4. AUDIT AND GOVENANCE4.1 Patients will be followed up regularly and clinical progress will be documented. Auditof outcomes including readmissions, treatment failure and patient satisfaction will beconducted. Adverse incidents will be recorded. The patients will be the clinicalresponsibility of the Urology Consultants.5. REFERENCESNieuwkopp et al (2010). Intravesical gentamicin for recurrent urinary tract infections inpatients with intermittent bladder catheterisation. International Journal of AntimicrobialAgents 36: 485-490.INTRAVESICAL GENTAMICIN GUIDELINEApproved by the Drug and Therapeutics Committee: 21 st June 2011Review date: June 2012Page 4 of 7

Patient information sheetGentamicin 80mg/2mls for intravesical administrationRead this entire leaflet carefully before you start using this medicine.• Keep this leaflet. You may need to read it again.• If you have any further questions, ask your doctor or pharmacist.• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,even if their symptoms are the same as yours.• If you experience serious side effects, or if you notice side effects not listed in this leaflet,please tell your doctor or pharmacist.1. WHAT INTRAVESICAL GENTAMICIN IS AND WHAT IT IS USED FORGentamicin is an antibiotic that has been prescribed for the prevention of infection in the urinary system.The normal dose is gentamicin 80mg diluted with 50mls sterile sodium chloride 0.9% (instilled into thebladder each night). This therapy is novel and there is limited evidence to support its use – yourconsultant will have discussed the therapy with you before you start this treatment.2. BEFORE YOU USE INTRAVESICAL GENTAMICINThis treatment is not a first-line therapy and other conventional measures should be testedbefore this therapy is introduced including: a trial of long-term low dose antibiotic prophylaxis,use of cranberry juice or capsules, high fluid intake and frequent voiding, and a check ofintermittent self-catheterisation technique (before you can use intravesical gentamicin you willhave to be able to perform intermittent self-catheterisation).Do not use gentamicin if you are allergic (hypersensitive) to gentamicin or any of the other ingredientsof gentamicin injection (see “further information” for a list of all ingredients).Taking other medicines: In order to avoid possible interactions with other medicinal products, youmust always inform your doctor or pharmacist of any other current treatment.Pregnancy/Breastfeeding: Caution may be needed – discuss this with your urologist.3. HOW TO USE INTRAVESICAL GENTAMICINDosage: Gentamicin 80mg diluted with 50mls sterile sodium chloride 0.9% should be instilled in thebladder nightly, after completion of a conventional bladder washout, and the catheter withdrawn, leavingthe solution in the bladder overnight. The solution will be voided spontaneously in the morning, or beremoved by routine self catheterisation. Therapy is intended to be life-long in the absence ofcomplications of a change in circumstances.4. POSSIBLE SIDE EFFECTS OF INTRAVESICAL GENTAMICINAlong with their useful effects, most medicines can cause unwanted side-effects although not everyoneexperiences them. Gentamicin may cause local irritation in the bladder - If you experience discomfort orhave any blood in your urine contact your urologist. Gentamicin should not spread from the bladder intothe body but blood tests will be taken intermittently to check for this. If you experience any dizziness orringing in the ears (tinnitus) seek medical attention as this may mean gentamicin is accumulating in theblood stream. INFORM YOUR DOCTOR OR PHARMACIST OF ANY UNDESIRABLE/ UNPLEASANTEFFECT EVEN IF NOT MENTIONED IN THIS LEAFLET.5. HOW TO STORE GENTAMICINKeep out of the sight and reach of children. Store in a cool dry place – do not store above 25°C and donot refrigerate or freeze. Do not use gentamicin after the expiry date (which is stated on the outerpackaging – the expiry date refers to the last day of that month). Once diluted with sodium chloride0.9% use immediately.Ask your pharmacist how to dispose of medicines no longer required.6. FURTHER INFORMATIONThe active substance is: Gentamicin sulphateOther ingredients are: Methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),disodium edetate, water for Injections, 2M Sodium Hydroxide, 1M Sulphuric Acid7. CONTACT NUMBERS AT THE ROYAL DEVON AND EXETER HOSPITALMain switchboard, 01392 411 611Urology Department, 01392 402 539 Clinical Measurement, 01392 402 136

Patient information sheetGentamicin 80mg/2mls for intravesical administrationRead this entire leaflet carefully before you start using this medicine.• Keep this leaflet. You may need to read it again.• If you have any further questions, ask your doctor or pharmacist.• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,even if their symptoms are the same as yours.• If you experience serious side effects, or if you notice side effects not listed in this leaflet,please tell your doctor or pharmacist.1. WHAT INTRAVESICAL GENTAMICIN IS AND WHAT IT IS USED FORGentamicin is an antibiotic that has been prescribed for the prevention of infection in the urinary system.The normal dose is <strong>gentamicin</strong> 80mg diluted with 50mls sterile sodium chloride 0.9% (instilled into thebladder each night). This therapy is novel and there is limited evidence to support its use – yourconsultant will have discussed the therapy with you before you start this treatment.2. BEFORE YOU USE INTRAVESICAL GENTAMICINThis treatment is not a first-line therapy and other conventional measures should be testedbefore this therapy is introduced including: a trial of long-term low dose antibiotic prophylaxis,use of cranberry juice or capsules, high fluid intake and frequent voiding, and a check ofintermittent self-catheterisation technique (before you can use intravesical <strong>gentamicin</strong> you willhave to be able to perform intermittent self-catheterisation).Do not use <strong>gentamicin</strong> if you are allergic (hypersensitive) to <strong>gentamicin</strong> or any of the other ingredientsof <strong>gentamicin</strong> injection (see “further information” for a list of all ingredients).Taking other medicines: In order to avoid possible interactions with other medicinal products, youmust always inform your doctor or pharmacist of any other current treatment.Pregnancy/Breastfeeding: Caution may be needed – discuss this with your urologist.3. HOW TO USE INTRAVESICAL GENTAMICINDosage: Gentamicin 80mg diluted with 50mls sterile sodium chloride 0.9% should be instilled in thebladder nightly, after completion of a conventional bladder washout, and the catheter withdrawn, leavingthe solution in the bladder overnight. The solution will be voided spontaneously in the morning, or beremoved by routine self catheterisation. Therapy is intended to be life-long in the absence ofcomplications of a change in circumstances.4. POSSIBLE SIDE EFFECTS OF INTRAVESICAL GENTAMICINAlong with their useful effects, most medicines can cause unwanted side-effects although not everyoneexperiences them. Gentamicin may cause local irritation in the bladder - If you experience discomfort orhave any blood in your urine contact your urologist. Gentamicin should not spread from the bladder intothe body but blood tests will be taken intermittently to check for this. If you experience any dizziness orringing in the ears (tinnitus) seek medical attention as this may mean <strong>gentamicin</strong> is accumulating in theblood stream. INFORM YOUR DOCTOR OR PHARMACIST OF ANY UNDESIRABLE/ UNPLEASANTEFFECT EVEN IF NOT MENTIONED IN THIS LEAFLET.5. HOW TO STORE GENTAMICINKeep out of the sight and reach of children. Store in a cool dry place – do not store above 25°C and donot refrigerate or freeze. Do not use <strong>gentamicin</strong> after the expiry date (which is stated on the outerpackaging – the expiry date refers to the last day of that month). Once diluted with sodium chloride0.9% use immediately.Ask your pharmacist how to dispose of medicines no longer required.6. FURTHER INFORMATIONThe active substance is: Gentamicin sulphateOther ingredients are: Methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),disodium edetate, water for Injections, 2M Sodium Hydroxide, 1M Sulphuric Acid7. CONTACT NUMBERS AT THE ROYAL DEVON AND EXETER HOSPITALMain switchboard, 01392 411 611Urology Department, 01392 402 539 Clinical Measurement, 01392 402 136

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