NITROFURANTOIN v01 1/12 NITROFURANTOIN PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner (Nurse) Medicines Management Group Date issued 01/02/2013 Review date 31/01/2015 Clinical Publication Category Mandatory (RED) - No deviation from document permissible Clinical Requirements Competencies Continuing education Successful completion of a competency assessment in the use of this medicine for the indications stated; Completion of education in both the legal and professional aspects of PGD administration and the supply of medicines; Registered paramedics must have successfully completed a recognised Emergency Care Practitioner course; Registered nurses must be employed as Nurse Practitioners or have successfully completed a recognised Emergency Care Practitioner course. The clinician is responsible for keeping him/herself aware of any changes to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their own individual scope of practice.
NITROFURANTOIN v01 2/12 Clinical Situation Clinical situation Inclusion criteria Acute lower urinary tract infection; Treatment of suspected catheter-related acute lower urinary tract infection. Adults 16 years and over; Pregnant women; Patients with indwelling urethral or suprapubic catheter who present with a suspected acute lower urinary tract infection; Patients who have recently had their catheter replaced and a catheter specimen of urine (CSU sample) has already been taken and sent for microbiological analysis before treatment is initiated; Patients who have completed a course of antibiotics within the past 72 hours and present with persistent and unresolved urinary symptoms. These patients must have a further MSU sample taken and sent for microbiological analysis before treatment is initiated; Patients unable to take trimethoprim because they are taking one of the following medicines: Methotrexate; Pyrimethamine; Amiodarone; Phenytoin; Lamivudine; Digoxin; Azathioprine; Mercaptopurine; Ciclosporin; Dapsone; Procainamide; Eplenerone; Repaglinide.
NITROFURANTOIN v01 3/12 Exclusion criteria Cautions Children under 16 years of age; Fever and loin pain suggesting upper urinary tract infection / pyelonephritis (nitrofurantoin will not reach concentrations in blood plasma); Breast-feeding if the infant has a known glucose-6- phosphate dihydrogenase deficiency (G6PD); Patients with known glucose-6-phosphate dihydrogenase deficiency (G6PD); Women with vaginal discharge or itch (STD or candida infection); Renal impairment (nitrofurantoin will not reach concentration in urine but may reach toxic levels in blood plasma); Known sensitivity to nitrofurantoin; Patients with haematuria when ketamine abuse is known or suspected; Patients taking quinolone antibacterials. Care is required in patients with pre-existing pulmonary, hepatic, neurological or allergic disorders and those with conditions (such as anaemia, diabetes mellitus, electrolyte imbalance, debility or Vitamin B and folate deficiency) which may predispose to peripheral neuropathy; May cause false positives for urinary glucose if patient tested for reducing substances; Patients with haematuria (macroscopic or microscopic) All definite haematuria, whether macroscopic or microscopic, requires investigation to exclude serious underlying conditions, especially urinary tract neoplasm. The clinician must refer these patients to their own GP for further investigation; Patients taking anticoagulants with haematuria should be investigated. Anticoagulants are more likely to provoke, rather than be the cause of, haematuria.
NITROFURANTOIN v01 4/12 Side effects Action if excluded Action if patient declines Gastrointestinal anorexia, vomiting, nausea and diarrhoea; Acute and chronic pulmonary reactions; Peripheral neuropathy; Hypersensitivity reactions angioedema, anaphylaxis, sialadentis, urticaria, rash and pruritus; Rarely cholestatic jaundice, hepatitis, exfoliative dermatitis, erythema multiforma, pancreatitis, arthralgia and blood disorders. Transient alopecia. If patient meets exclusion criteria refer to medical practitioner; Record in patient clinical record the reason for exclusion and any action taken. If patient declines treatment or advice, ensure the patient clinical record details: The advice given by the clinician; Details of any referral made; The intended actions of the patient (including parent or guardian).
NITROFURANTOIN v01 5/12 Description of Treatment Generic name Presentation Route Nitrofurantoin. Capsules 50mg immediate release or 100mg modified release. Oral. Method Administration Supply Dose Frequency Duration of treatment Quantity to supply Adult dose: One capsule (50mg) or one modified release capsule 100mg. Adult dose: Four times a day (50mg capsules) or twice a day (100mg MR capsules). Women with uncomplicated lower urinary tract infection 3 days; Pregnant women 7 days; Men with uncomplicated lower urinary tract infection 7 days; Catheter-associated infection 7 days. 1 x 30 capsules; Ensure that each pack of medicine supplied is labelled with the patient s name, the date and the Trust s contact details.
NITROFURANTOIN v01 6/12 Follow Up Referral arrangements and safety netting Referral to patient s own GP for further assessment must always be arranged for patients with haematuria whether macroscopic or microscopic and pregnant women, and male patients with UTI; Patients with a catheter-related infection must have their catheter changed and a CSU sample sent for microbiological analysis; Take MSU sample before treatment and send for microscopy (for use in case of treatment failure) in men, pregnant women and children; Patients who have already received trimethoprim and are still symptomatic must have an MSU sample taken and sent for microbiological analysis prior to the commencement of nitrofurantoin; Ensure that there is a communication to the patient s registered GP to inform him/her about the consultation, the outcomes of that consultation and any treatment given using local mechanisms. This information must also be available to other healthcare professionals who may be required to administer care to the patient following the consultation; Patients should be told to seek further medical advice if they become generally unwell, if there is no improvement within 48 hours or if there is deterioration in their condition.
NITROFURANTOIN v01 7/12 Advice to patients Records References Advise patient not to take alkalinising agents such as potassium citrate mixture (or other OTC cystitis preparations) at the same time as nitrofurantoin; Nitrofurantoin may discolour the urine either yellow or brown; Paracetamol may be used to relieve pain/discomfort; If condition becomes a recurring problem, consult a doctor; Consideration of sexual history may indicate investigation for STD. Advise attendance at GUM clinic if appropriate; Take with or after food; Complete the course; Latest recommendations are that no additional contraceptive precautions are required when combined oral contraceptives are used with antibacterials that do not induce liver enzymes, unless diarrhoea and vomiting occur. Complete patient clinical record. British National Formulary (BNF) 64, September 2012; Electronic Medicines Compendium http://www.emc.org. uk accessed 12-08-2010; Health Protection Agency s guidance for primary care prescribing http://hqweb. xwcas-tr.swest.nhs.uk/swast/clinical/pgd/ HPAmanagementofinfectionguidanceforprimarycare.pdf.
NITROFURANTOIN v01 8/12 Authorisation Chief Executive Officer Medical Director Pharmaceutical Advisor Name Ken Wenman Signature Date 01/02/2013 Name Dr Andy Smith Signature Date 01/02/2013 Name Sue Oakley Signature Date 01/02/2013 This must be signed by the Chief Executive Officer, Medical Director and Pharmaceutical Advisor to be legally valid.
NITROFURANTOIN v01 9/12 Individual Authorisation (Staff Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this document. PGDs do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.
NITROFURANTOIN v01 10/12 Individual Authorisation (Trust Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this document. PGDs do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.