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Instillagel® Staff Characteristics Clinical Details Registered Midwife Clinical Situation for which medicine is to be used Surface anaesthesia, lubrication and antisepsis for catheterisation. Clinical Criteria for inclusion Women ≥ 16 years requiring catheterisation. Clinical Criteria for exclusion • • • • • • • Management of excluded women and those not wishing to receive care Use in pregnancy or lactation • • Known hypersensitivity to any component of the medicine. Individuals < 16 years of age. Instillagel® is contraindicated in women with known or suspected hypersensitivity to local anaesthetics of the amide type, to chlorhexidine or to any ingredient in the formulation. The woman is suffering from a urine infection. The woman has damaged or bleeding mucous membranes. The woman has heart, liver or kidney problems, or malignant hyperthermia (a hereditary condition). The woman suffers from epilepsy. Refer to medical staff as appropriate. Document action / refusal in woman’s maternity handheldrecord. Pregnancy – During the first 3 months of pregnancy, lidocaine should be used only if absolutely necessary. Lactation – can be used during breastfeeding. Cautions and/or reasons for seeking further advice from a doctor • • • • Woman fits exclusion criteria. Woman suffers an adverse drug reaction. Chronic dosing is required. Woman declines medication. Cautions and action that will be taken if a caution applies • • Check for and document any allergies. Check and document past medical and drug history and current medication to ascertain potential for overdose. If a caution applies consult with a doctor. Document consultation in woman’s maternity handheld record. Refer to current BNF for latest information on interactions. • • • Description of Treatment Name / Form / Strength of Medicine Instillagel® / Gel / lidocaine hydrochloride 2%&chlorhexidinegluconate 0.05% Dosage Fill the urethra with 6mls of Instillagel® using the needle-less, pre-filled syringe. Route of administration Intraurethrally Frequency of administration Once only prior to catheterisation Duration of treatment n/a Legal Status • P –midwife may supply. Storage requirements • Store the unopened blister packs below 25°C. Warnings • Lidocaine should be used with caution in women receiving antiarrhythmic drugs. Follow –up • Refer if woman develops side/adverse effects or if there is an inadequate response. Refer immediately in case of overdose. • Undesirable effects Some women may experience a slight stinging after the gel is inserted. In spite of the proven wide safety range of Instillagel®, undesirable effects of the localanaesthetic Iidocaine are possible where there is severe injury to the mucosa and absorption may occur. Examples are anaphylaxis, fall in blood pressure, bradycardia or convulsions. • If a serious adverse reaction is suspected please report to the MHRA Yellow Card Scheme http://yellowcard.mhra.gov.uk/ Overdose Signs include drowsiness, numbness of the tongue, light-headedness, ringing in ears, blurred vision, vomiting, dizziness, unusually slow heartbeat, fainting, nervousness, unusual sweating, trembling and/or seizures. • Immediate assessment / treatment is essential – refer to medical staff. • Manage in accordance with established treatment guidelines or see BNF overdose section. • For further advice contact National Poisons Centres 0844 892 0111. Advice to be given to the woman Monitoring arrangements during and after treatment and follow-up required. Records to be kept References • • • • Explain treatment and course of action. Side effects explained. Verbal consent obtained before administration. It is good practice to offer the woman the manufacturer’s Patient Information Leaflet to support any verbal advice provided. If the woman suffers a serious adverse drug reaction, seek immediate medical assistance. • Monitor for side effects and effectiveness. • To be reviewed by doctor if inadequate response. Must be written in the once only medicines and pre-medications section of the medicine kardex. The person who writes up the medication must write their designation after their signature e.g. Midwife Band (*). Also record the administration, date, time and name of practitioner in the relevant section of the woman’s maternity handheld record. • • • Instillagel SPC 28th February 2010www.clinimed.co.uk www.instillagel.ca accessed 10th September 2014.