Description of treatment
Name, strength & formulation of drug
- Nitrofurantoin 50mg immediate release tablets or capsules
- Nitrofurantoin 100mg modified release capsules
Legal category & Route / method of administration
- POM
- Orally, swallowed whole taken with food or milk.
Off-label use
Temperature variations
Medicines should be stored according to the conditions detailed in the Storage section below. However, in the event of an inadvertent or unavoidable deviation of these conditions a pharmacist must ensure the medicine remains pharmaceutically stable and appropriate for use if it is to be issued.
Where medicines have been assessed by a pharmacist in accordance with national or specific product recommendations/manufacturer advice as appropriate for continued use this would constitute off-label administration under this PGD.
The responsibility for the decision to release the affected medicines for use lies with the pharmacist.
Where a drug is recommended off-label consider, as part of the consent process, informing the individual/carer that the drug is being offered in accordance with national guidance but that this is outside the product licence.
Dose and frequency of administration
Adults:
100mg modified release capsules twice a day (every 12 hours)
OR if unavailable:
50 mg immediate release tablets or capsules four times a day (every 6 hours)
Duration of treatment
3 days
Treatment should be started immediately and 3 days of treatment completed.
Quantity to be supplied
In line with the Pharmacy First service specification the best value product to meet the clinical need should be supplied from those listed within this PGD.
Adults:
Appropriately labelled pack of 6 x 100mg modified release capsules OR appropriately labelled pack of 12 x 50mg immediate release tablets or capsules.
Storage
Stock must be securely stored according to organisation medicines policy and in conditions in line with SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk
Drug interactions
Where it is known an individual is concurrently taking the following medicine, treatment should not be undertaken under this PGD and the individual referred to a prescriber:
- Typhoid vaccine (oral): see Criteria for exclusion [NHSE document link missing]
No other clinically significant interactions identified.
A detailed list of drug interactions is available in the SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk
Identification & management of adverse reactions
A detailed list of adverse reactions is available in the SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk and BNF www.bnf.org
The following side effects are listed in the product SPC/BNF as common with nitrofurantoin (but may not reflect all reported side effects):
- Nausea
- Vomiting
- Diarrhoea
- Loss of appetite
- Headaches
- Dizziness
- Drowsiness
- Discoloured dark yellow or brown urine
The following side effects are listed in the product SPC/BNF as rare but serious with nitrofurantoin:
- Respiratory reactions (including trouble breathing, shortness of breath, a lingering cough, coughing up blood or mucus, or pain or discomfort when breathing): advise to seek urgent medical advice if new or worsening breathing difficulties develop. Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Chronic pulmonary reactions can develop insidiously. Discontinue treatment with nitrofurantoin if pulmonary reactions occur.
- Hepatic reactions (including yellowing of the skin or eyes, upper right abdominal pain, dark urine and pale or grey coloured stools, itching or joint pain and swelling): advise to seek urgent medical advice if signs or symptoms of liver dysfunction develop.
- Neurological disorders: advise to seek urgent medical advice if peripheral neuropathy develops.
- For further information refer to MHRA Nitrofurantoin Drug Safety Update.
Severe adverse reactions are rare, but anaphylaxis (delayed or immediate) has been reported and requires immediate medical treatment.
In the event of a severe adverse reaction, the individual must be advised to stop treatment immediately and seek urgent medical advice.
Management of and reporting procedure for adverse reactions
- Healthcare professionals and individuals/carers are encouraged toreport suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: https://yellowcard.mhra.gov.uk
- Record all adverse drug reactions (ADRs) in the individual’s clinical record.
- Report via organisation incident policy.
- It is considered good practice to notify the individual’s GP in the event of an adverse reaction.
Written or other information to be given toindividual/carer/parent/guardian
Individual advice / follow up treatment
- Explain the dose, frequency and method of administration.
- The individual/carer/parent/guardian should be advised to read PIL.
- Advise individual/carer/parent/guardian to take the medication at regular intervals with food or milk and to finish the course.
- Symptoms should start to improve within 48 hours of taking nitrofurantoin – advise individual/carer/parent/guardian to seek medical advice if no improvement within this time.
- Inform individual/carer/parent/guardian of possible side effects and their management, including that the urine may become discoloured (brown/yellow) while taking nitrofurantoin but that this is not of concern and urine will return to normal colour when the course is complete.
- Advise that nitrofurantoin is not a penicillin related antibiotic.
- Medicines which make the urine less acidic such as OTC cystitis preparations containing potassium citrate, sodium bicarbonate or sodium citrate decreases the antibacterial action of nitrofurantoin and should not be taken during the course of nitrofurantoin.
- Antacids such as magnesium trisilicate can decrease the absorption of nitrofurantoin and should not be taken during the course of nitrofurantoin.
- If the individual is affected by dizziness or drowsiness advise them not to drive or operate machinery.
- The individual/carer/parent/guardian should be advised to seek medical advice in the event of an adverse reaction or if any other new symptoms develop.
- If dose is missed advise to refer to PIL supplied with the product.
- Advise individual/carer/parent/guardian to complete the full courseeven if symptoms improve.
- Advise individual/carer/parent/guardian to seek medical attention if symptoms worsen rapidly or significantly at any time.
- Advise individual/carer/parent/guardian to seek medical attention if symptoms do not improve after completion of antibiotic treatment course.
- Advise individual/carer/parent/guardian to seek immediate medical attention (by calling 999 or going to A&E) if the individual develops signs or symptoms of sepsis.
- Advise individual/carer/parent/guardian to return any used medicines to a pharmacy for disposal: do not dispose of medicines in the bin, down the sink or toilet.
Records
Appropriate records must include the following:
- That valid informed consent has been given
- Individual’s name, address and date of birth
- Name of GP individual is registered with or record where an individual is not registered with a GP
- Name and registration number of registered healthcare professional operating under this PGD
- Specify how the individual has/has not met the criteria of the PGD
- Relevant past and present medical history and medication history
- Any known allergies and nature of reaction(s)
- Name/dose/form/quantity of medicine supplied
- Date and time of supply
- Documentation of cautions as appropriate
- Advice given, including advice given if individual excluded or declines treatment
- Details of any adverse drug reactions and actions taken
- Advice given about the medication including side effects, benefits, and when and what to do if any concerns.
- Any follow up and/or referral arrangements made.
- Any supply outside the terms of the product marketing authorisation
- The supply must be entered in the Patient Medication Record (PMR)
- That supply was made under a PGD
- Any safety incidents, such as medication errors, near misses and suspected adverse events
- Any additional requirements in accordance with the service specification:
- The pharmacy contractor will ensure that a notification of the provision of the service is sent to the patient’s general practice on the day of provision or on the following working day. Where possible, this should be sent as a structured message in real-time via the NHS assured Pharmacy First IT system. In the absence of an automated digital solution or if there is a temporary problem with the system, this should be sent via NHSmail or hard copy.
- Where an action is required by the General Practice team (such as booking the patient in for a follow up or appointment) an action message or alternative form of an URGENT ACTION communication (rather than the standard post event message) must be sent to the practice.
- All records should be kept in line with national guidance. This includes individual data, master copies of the PGD and lists of authorised practitioners.
Records must be signed and dated (or a password controlled e-records).
All records must be clear, legible and contemporaneous.
A record of all individuals receiving treatment under this PGD must also be kept for audit purposes in accordance with the service specification.