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Presentation

Solution for infusion containing 1mg bupivacaine hydrochloride and 2micrograms fentanyl (as citrate) per 1ml.

Solution for infusion containing 1.25mg bupivacaine hydrochloride and 2micrograms fentanyl (as citrate) per 1ml.

Drugs List

  • BUFYL 1.25mg/1ml (0.125%)+2microgram/1ml solution for infusion
  • BUFYL 1mg/1ml (0.1%)+2microgram/1ml solution for infusion
  • bupivacaine with fentanyl 1.25mg/1ml+2microgram/1ml solution for infusion
  • bupivacaine with fentanyl 1mg/1ml+2microgram/1ml solution for infusion
  • Therapeutic Indications

    Uses

    Local anaesthetic for lumbar epidural block to relieve pain during labour

    Maintaining analgesia post-operatively

    Dosage

    Bupivacaine and fentanyl infusion should only be used by those with the necessary training and experience.

    The dose administered should be tailored to the individual patient and procedure.

    To avoid excessive dosage in obese patients, dose may need to be calculated on the basis of ideal body weight.

    Adults

    Analgesia in Labour - Lumbar epidural:
    Bupivacaine 1mg/ml + fentanyl 2micrograms/ml solution for infusion - 10-15ml/hour (10-15mg/hour bupivacaine and 20-30micrograms/hour fentanyl).
    Bupivacaine 1.25mg/ml + fentanyl 2micrograms/ml solution for infusion - 8-15ml/hour (10-18.75mg/hour bupivacaine and 16-30micrograms/hour fentanyl).

    Control of post-operative pain - Thoracic, Upper/Lower abdominal epidural:
    The use of intra-operative bupivacaine and/or fentanyl should be taken into account.
    The maximum accumulated dosage should not exceed 400mg of bupivacaine and 720microgram of fentanyl for 24 hour period in a 70kg adult.
    The length of continuous epidural infusions given post-operatively should be minimized. Administration of bupivacaine with fentanyl epidural infusion has not been adequately studied for more than 72 hours.

    Bupivacaine 1mg/ml + fentanyl 2micrograms/ml solution for infusion - 4-15ml/hour (4-15mg/hour bupivacaine and 8-30micrograms/hour fentanyl).
    Bupivacaine 1.25mg/ml + fentanyl 2micrograms/ml solution for infusion - 6-15ml/hour (7.5-18.75mg/hour bupivacaine and 12-30micrograms/hour fentanyl).

    Elderly

    Elderly or debilitated patients especially those with advanced liver disease or severe renal impairment should be given a reduced dose.

    Children

    Not recommended for use in children since experience in paediatric patients is limited.

    Patients with Renal Impairment

    Reduced dose may be required in patients with renal impairment. Bupivacaine and fentanyl are excreted via the kidneys therefore there is the possibility of accumulation in patients with renal impairment.

    Patients with Hepatic Impairment

    Reduced dose may be required in patients with hepatic impairment. Bupivacaine and fentanyl are metabolised in the liver therefore there is the possibility of accumulation in patients with hepatic impairment.

    Additional Dosage Information

    Dosages should be reduced in debilitated patients.

    Administration

    For epidural infusion only.

    Careful aspiration before injection is recommended to prevent intravascular administration.

    The patient's vital signs should be observed closely during the injection and verbal contact maintained. If toxic symptoms occur, the injection should be stopped immediately.

    Handling

    For single use only - any unused solution should be discarded.

    Incompatibilities

    Bupivacaine and fentanyl infusion should not be mixed with other drugs.

    Contraindications

    Acute respiratory depression
    Acute asthma
    Chronic obstructive pulmonary disease
    Head trauma
    Raised intracranial pressure
    Coma
    Alcoholism
    Hypovolaemia
    Third degree atrioventricular block
    Within 2 weeks of discontinuing MAOIs
    Risk of paralytic ileus
    Children under 18 years

    Epidural anaesthesia is contraindicated in:
    Active central nervous system disease
    Meningitis
    Poliomyelitis
    Intracranial haemorrhage
    Subacute degeneration of the cord due to pernicious anaemia
    Spina bifida
    Meningomyelocele
    CNS tumours
    Tuberculosis of spine
    Cardiogenic shock
    Hypovolaemic shock
    Coagulation abnormalities
    Concurrent anticoagulant therapy
    Expanding cerebral lesion, a tumour, cyst or abscess which may obstruct cerebrospinal fluid or blood circulation if the intracranial pressure is suddenly altered.
    Arteriovenous malformation in the vertebral column

    Precautions and Warnings

    Bupivacaine should only be used by those with the necessary training and experience.

    Resuscitation facilities should be available. Intravenous access for resuscitation purposes should be established before bupivacaine and fentanyl is administered.

    Not to be injected into inflamed or infected tissues.

    The patients vital signs should be observed closely during the injection and verbal contact maintained. If toxic symptoms occur, the injection should be stopped immediately.

    Bupivacaine must not be used for intravenous regional anaesthesia (Bier's block) as passage of local anaesthetic into systemic circulation may cause systemic toxic reactions.

    Tolerance varies with the status of the patient. Young, debilitated, elderly or acutely ill patients should be given reduced doses depending on their physical status.

    Repeated use of opioid analgesics is associated with development of psychological and physical dependence, although this is rarely a problem with therapeutic use, caution is advised if prescribing for patients with a history of drug dependence.

    Allergic reactions, including anaphylactic shock, have occurred rarely.

    Caution should be used in patients with:
    Hypotension
    Hypertension
    Hypothyroidism
    Hyperthyroidism
    Asthma
    Decreased respiratory reserve - monitor patients closely
    Prostatic hypertrophy
    Convulsive disorders
    Shock
    Adrenocortical insufficiency
    Cardiovascular disease
    Urethral stenosis
    Obstructive or inflammatory bowel disorders
    Biliary tract disorders

    Local anaesthetics should be given with great caution if at all to patients with pre-existing abnormal neurological conditions, e.g. myasthenia gravis.

    To avoid excessive dosage in obese patients, dose may need to be calculated on the basis of ideal body weight.

    Patients on concurrent thrombolytics have a greater risk of bleeding when receiving epidural anaesthesia.

    Extrapyramidal symptoms have been observed up to 24 hours postoperatively when fentanyl is used with a neuroleptic, they can usually be controlled with antiparkinson agents.

    Hepatic impairment ( see dosage Hepatic Impairment section )

    Renal impairment ( See dosage Renal Impairment section )

    Breastfeeding ( See Lactation section )

    This product contains sodium which should be taken into account when treating patients on a controlled sodium diet.

    Pregnancy and Lactation

    Pregnancy

    There is no evidence of untoward effects when used during pregnancy.
    However fentanyl has been shown to have an umbilical cord to maternal vein ratio of 0.06 to 0.44. Therefore if used during childbirth an opioid antagonist should be available for use in the unlikely event that respiratory depression occurs in the neonate.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Both bupivacaine and fentanyl are excreted into breast milk in such small quantities that there is considered to be no risk to a healthy full term breastfeeding infant.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Effects on Ability to Drive and Operate Machinery

    This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.

    Side Effects

    Allergic reaction
    Bronchospasm
    Anaphylactic reaction
    Shock
    Nervousness
    Paraesthesia
    Dizziness
    CNS effects
    Euphoria
    Disorientation
    Seizures
    Localised areas of paraesthesia
    Tongue numbness
    Hyperacusis
    Visual disturbances
    Impaired consciousness
    Tremor
    Light-headedness
    Tinnitus
    Pruritus
    Diaphoresis
    Dysarthria
    Muscle twitch
    Muscle weakness
    Loss of sphincter control
    Peripheral neuropathy
    Neurological damage
    Arachnoiditis
    Paresis
    Paraplegia
    Diplopia
    Miosis
    Bradycardia
    Cardiovascular collapse
    Cardiac arrest
    Cardiac arrhythmias
    Hypotension
    Hypertension
    Laryngospasm
    Respiratory arrest
    Nausea
    Vomiting
    Urinary retention
    Urticaria
    Agitation
    Mood changes
    Hallucinations
    Muscle rigidity
    Dyskinesia
    Sedation
    Drowsiness
    Confusion
    Headache
    Facial flushing
    Vertigo
    Restlessness
    Raised intracranial pressure
    Tachycardia
    Palpitations
    Phlebitis
    Apnoea
    Hyperventilation
    Hiccups
    Dry mouth
    Constipation
    Allergic dermatitis
    Chills
    Hypothermia
    Sweating
    Micturition disorders
    Biliary spasm
    Oedema
    Dependence
    Ureteric spasm
    Sexual dysfunction
    Sleep disturbances
    Respiratory depression
    Orthostatic hypotension

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Reference Sources

    British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

    BNF for Children (2011-2012) Pharmaceutical Press, London.

    Summary of Product Characteristics: Bufyl 1mg/ml & 2micrograms/ml solution for infusion. Goldshield. Revised September 2011
    Summary of Product Characteristics: Bufyl 1.25mg/ml & 2micrograms/ml solution for infusion. Goldshield. Revised September 2011

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Bupivacaine Last revised: February 28, 2011
    Last accessed: February 13, 2012
    Fentanyl Last revised: January 3, 2012
    Last accessed: February 14, 2012

    Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015

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