CLARITHROMYCIN v01 1/13 CLARITHROMYCIN 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.
CLARITHROMYCIN v01 2/13 Clinical Situation Clinical situation Inclusion criteria Second-line agent when the recommended first-line drug, a penicillin, is contraindicated, as penicillin hypersensitivity is known or suspected in the treatment of: Acute exacerbation of COPD; Otitis Media; Cellulitis; Impetigo; Sore throat; Bacterial community-acquired pneumonia (if CRB65=0 so suitable for home treatment but allergic to penicillin); Leg ulcers (active infection cellulitis, increased pain, pyrexia, purulent exudate, odour); Human bites (with metronidazole) when patient is allergic to penicillin. Adults and children aged over 1 year with: Cellulitis; Impetigo; Sore throat (see Penicillin PGD for making a decision to treat sore throat); Bacterial community-acquired pneumonia if CRB65=0 (i.e, Suitable for home treatment); Sinusitis in whom penicillin is contraindicated; A human bite (in conjunction with metronidazole), when doxycycline is otherwise contraindicated.
CLARITHROMYCIN v01 3/13 Exclusion criteria Cautions Children aged 1 year and under; Patient with a sensitivity to clarithromycin or other macrolide antibiotics; Patients taking colchicine (for gout) as may increase patient exposure to colchicine; Patients taking ergot derivatives (ergotamine or dihydroergotamine) for migraine may cause toxicity characterised by vasospasm and ischaemia of extremities and other tissues including the CNS; Patients with severe renal (may require dose reduction) or hepatic impairment as clarithromycin is principally excreted by the liver and kidney; Pregnancy and breastfeeding; Patients taking: cisapride, pimoziode or terfenadine; Patients taking: cilostazol, methylprednisolone, oral anticoagulants, quinine, sildenafil (Viagra), alprazolam, triazolam, midazolam, disopyramide, rifabutin, phenytoin, ciclosporin, valproate, vinblastine or tacrolimus. These drugs may have their metabolism inhibited by the clarithromycin and their plasma levels may increase. Clostridium difficile infection; Clostridium difficile (C. difficile) is the major cause of antibiotic-associated diarrhoea and colitis, a healthcareassociated intestinal infection that mostly affects elderly patients with underlying diseases. It is a sporeforming gram-positive anaerobic bacterium found in the environment and in a minority of the healthy adult population (less than 5%). It is kept in check by the normal bacterial population of the intestine. Some are able to produce toxins which may cause diarrhoea when the faecal flora is disturbed in some way, i.e. by giving antibiotics, and in debilitated and /or elderly patients. In most cases the disease develops as a result of crossinfection from symptomatic patients, either by patient to patient spread or from the environment. Transmission is via the faecal-oral route; The antibiotics with the greatest risk of causing C. difficile-associated diarrhoea (CDAD) are Clindamycin, Co-amoxiclav and cephalosporins such as Cefalexin. Recent evidence also suggests strong association of CDAD with Clarithromycin;
CLARITHROMYCIN v01 4/13 High levels of antibiotic use are the main risk factor in the development of Clostridium difficile infection. All antibiotic prescriptions should be reviewed regularly to ensure patients receive the most appropriate agent, and that therapy is monitored and discontinued as soon as possible; Any patient who has received antibiotic therapy in the preceding three months may be at increased risk of CDAD, and this risk increases significantly if they have been exposed to other patients with CDAD during the episode of care. Bites Hepatitis B/C and HIV risk should be considered in any person with a human bite. Discuss with GP if necessary; Consider rabies if the person was bitten by an animal whilst abroad; Consider tetanus prophylaxis; The majority of bites to the face will require referral to the emergency department; some very superficial, low risk bites may be treated using this PGD but ALL cases must be discussed with a medical practitioner in the emergency department before treating; Immuno-suppressed patients should be urgently referred to their GP/Emergency Department if active infection present.
CLARITHROMYCIN v01 5/13 Side effects Action if excluded Action if patient declines Nausea, dyspepsia, diarrhoea, vomiting and abdominal pain; Paraesthesia; Stomatitis; Headache, arthralgia, myalgia; Allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis; Stevens-Johnson syndrome, toxic epidermal necrosis; Altered sense of taste and smell; Tooth discolouration (usually reversible); Transient CNS effects including: dizziness, vertigo, anxiety, insomnia, bad dreams, tinnitus, confusion, disorientation, hallucination, psychosis, depersonalisation; Reversible hearing loss; Pseudomembranous colitis (rare) ranging from mild to life-threatening; Hypoglycaemia (rare); Uveitis (very rare) in patients on rifabutin; Isolated cases of leucopenia and thrombocytopenia; Reversible hepatic dysfunction, altered liver function tests, hepatitis and cholestatis; Rarely - increased serum creatinine, interstitial nephritis, renal failure, pancreatitis and convulsions; Rarely - QT prolongation, VT and Torsades de Pointes. 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).
CLARITHROMYCIN v01 6/13 Description of Treatment Generic name Presentation Route Clarithromycin Tablets 250mg or 500mg; Suspension 125mg in 5ml or 250mg in 5ml. Oral Method Administration Supply Cellulitis, Impetigo, Sore throat, human bites Every twelve hours for 7 days (5 days for sore throat): Adults (18 years and over): 250mg increased in severe infections to 500mg; Child (12 to 18 years): 250mg increased in severe infections to 500mg; Child 12 yrs and under: Approx. age (Yrs) Weight (Kg) Dose (ml) Dosage per 5ml teaspoonful (125mg/5ml) 1-2 8-11 2.5 A half 3-6 12-19 5.0 One 7-9 20-29 7.5 One and a half 10-12 30-40 10.0 Two NB. Doses from Klaricid summary of product characteristics (Accessed at http://www.emc.medicines.org.uk ) Dose Leg ulcer - Every twelve hours for 7 days: Adults (18 years and over): 500mg COPD - Every twelve hours for 5 days: Adults (18 years and over): 500mg Bacterial Community-acquired Pneumonia (Every twelve hours for 7 days): Adults (18 years and over): 500mg; Child (12 to 18 years): 500mg. Approx. age (Yrs) Weight (Kg) Dose (ml) Dosage per 5ml teaspoonful (125mg/5ml) 1-2 8-11 2.5 A half 3-6 12-19 5.0 One 7-9 20-29 7.5 One and a half 10-12 30-40 10.0 Two Children with wheeze and any high risk features admit immediately (see CKS). Accessed at http://www.cks.library. nhs.uk/cough_acute_with_chest_signs_in_children
CLARITHROMYCIN v01 7/13 Frequency Duration of treatment Quantity to supply Every twelve hours. Seven days (five days sore throat/copd). 1or 2 x 14 tablets or multiples of 70ml reconstituted suspension sufficient to supply seven days of treatment (depending on diagnosis and strength of presentation); Ensure that each pack of medicine supplied is labelled with the patient s name, the date and the Trust s contact details.
CLARITHROMYCIN v01 8/13 Follow Up 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. Referral arrangements and safety netting Bites If adult bites have been inflicted on a child, consider child protection issues and follow Trust policy for referral of children considered at risk; Refer penetrating wounds involving arteries, joints, nerves, muscles, tendons, bones or the central nervous system; Refer facial wounds (except very minor) and bites to poorly vascularised areas such as ear/nose cartilage; Refer people with severe cellulitis, or with infected bite wounds that are not responding to treatment, or who are systemically unwell; Refer devitalised wounds requiring debridement; Refer if the severity of the injury is difficult to assess or a foreign body may be present in the wound; Human bites; send pus or deep wound swab for culture before cleaning wound. Admit anyone who has a severe infection or who is systemically unwell; Immuno-suppressed patients should be urgently referred to their GP/Emergency Department if active infection present; All bites to be reviewed at 24 and 48 hours by patient s GP; Advise patient that if a rash or other signs of hypersensitivity occur, they should stop taking the medicine and contact their GP for advice; Complete the course even if feeling better;
CLARITHROMYCIN v01 9/13 Patients should be told to seek further medical advice if they become generally unwell; they suffer new symptoms, if there is no improvement within 48 hours or if there is a deterioration in their condition; Take with at least a half a glass of water; May be taken without regard to meals as food does not affect the bioavailability of clarithromycin; It is no longer necessary to use an extra method of contraception with the pill, patch or vaginal ring while you have clarithromycin unless you experience diarrhoea and vomiting. This change in advice comes because to date there is no evidence to prove that antibiotics (other than rifampicin or rifabutin) affect these contraceptives. This is the latest guidance from the Faculty of Sexual & Reproductive Healthcare. Advice to patients Treating self-limiting conditions NICE has issued guidance on the treatment of selflimiting respiratory infections in primary care based on systematic reviews of best evidence; Adults and children over 3 months should be offered a clinical assessment that includes an assessment of any evidence of complications or the risk of developing complications. Address patients concerns, perspectives and expectations about treatment before negotiating the use of antibiotics; In suspected Acute otitis media (AOM) a red or bulging tympanic membrane on examination will help to confirm a positive diagnosis. If a child has a red tympanic membrane he/she is 8.4 times more likely to have AOM than someone who hasn t and if it is bulging he/she is 34 times more likely to have AOM; Before supplying an antibiotic for AOM or sinusitis discuss options with patient or parents. Explain benefits and drawbacks of antibiotic use;
CLARITHROMYCIN v01 10/13 Benefits of treating AOM with Clarithromycin - some evidence that they can reduce the duration and severity of symptoms in some people (usually children). 8 out of 10 children with AOM will recover in 3 days without antibiotics. One patient gains benefit for every 14 treated with antibiotics (NNT=14). For under 2 years slightly better (NNT= 9). Greater benefit in children if they have a high temperature and vomiting (NNT=3); Drawbacks of treating AOM with Clarithromycin - may promote antibiotic resistance in the individual and in the community, and may cause adverse effects. Health Protection Agency points out that many cases of AOM are viral, and poor outcomes (without antibiotics) are unlikely if there are no systemic symptoms. One patient is harmed (diarrhoea, vomiting or rash) for every 17 treated with antibiotics (NNH=17); Symptoms improve in 80% of untreated children after 2-3 days and in 87% of children who are treated in 2-3 days; Mastoiditis - NNT=4,064 to prevent one case of mastoiditis; Patient decision aid to help illustrate these risks vs. benefits available at http://www.npci.org. uk?therapeutics/infect/commonresp/resources/pda_ common_infect_rti.pdf; Sinusitis - avoid antibiotics as 80% resolve in 14 days without and they only offer marginal benefit after 7 days. NNT=15; Sore throat avoid antibiotics as 90% resolve in 7 days without and pain only reduced by 16 hours. The National Institute for Health and Clinical Excellence recommends antibiotics in the following situations: Features of marked systemic upset secondary to the acute sore throat; Unilateral peritonsillitis; A history of rheumatic fever; An increased risk of infection (such as a child with diabetes or immunodeficiency).
CLARITHROMYCIN v01 11/13 Offer advice instead: Get plenty of rest and continue to eat and drink as becoming hungry and dehydrated can make other symptoms such as headache and tiredness worse; Over the counter pain killers such as paracetamol or ibuprofen taken regularly for 48 hours are usually recommended; It helps to avoid food or drink that is too hot because this can irritate your throat; Eating cool, soft food or warm liquids may help to relieve symptoms; Adults and older children may find that sucking lozenges, hard sweets or ice cubes can bring additional relief; Avoid smoking and smoky environments; Regularly using a mouthwash of warm salty water may help to reduce any pain or swelling; Consider desloughing food stuffs- i.e. Dry toast, dried cornflakes; If a decision is made with the patient or carer not to supply antibiotics, reassure them that antibiotics are not needed. Offer the option of returning to clinician if the condition worsens in the out-of-hours period. Records References Complete patient clinical record. British National Formulary 64, September 2012; Klaricid summary of product characteristics. Accessed at http://www.emc.medicines.org.uk; Health Protection Agency s guidance for primary care prescribing. Accessed at http://hqweb. xwcas-tr.swest.nhs.uk/swast/clinical/pgd/ HPAmanagementofinfectionguidanceforprimarycare.pdf.
CLARITHROMYCIN v01 12/13 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.
CLARITHROMYCIN v01 13/13 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.
CLARITHROMYCIN v01 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.