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Fentanyl lozenge with applicator (all strengths)

Updated 2 Feb 2023 | Opioid analgesics


Buccal/sublingual formulations containing fentanyl

Drugs List

  • ACTIQ 1.2mg lozenge with applicator
  • ACTIQ 1.6mg lozenge with applicator
  • ACTIQ 200microgram lozenge with applicator
  • ACTIQ 400microgram lozenge with applicator
  • ACTIQ 600microgram lozenge with applicator
  • ACTIQ 800microgram lozenge with applicator
  • CYNRIL 1.2mg lozenge with applicator
  • CYNRIL 1.6mg lozenge with applicator
  • CYNRIL 200microgram lozenge with applicator
  • CYNRIL 400microgram lozenge with applicator
  • CYNRIL 600microgram lozenge with applicator
  • CYNRIL 800microgram lozenge with applicator
  • fentanyl 1.2mg lozenge with applicator
  • fentanyl 1.6mg lozenge with applicator
  • fentanyl 200microgram lozenge with applicator
  • fentanyl 400microgram lozenge with applicator
  • fentanyl 600microgram lozenge with applicator
  • fentanyl 800microgram lozenge with applicator
  • Therapeutic Indications


    Management of breakthrough cancer pain in patients receiving opiates


    Lozenges should be titrated to provide adequate analgesia and minimise side effects for the individual.


    Prior to titration, background persistent pain should be controlled by opioid therapy and patients should not be experiencing more than 4 episodes of breakthrough pain per day.

    Initial titration dose: 200micrograms, increasing if necessary by 200micrograms to 400micrograms until a single dose provides adequate analgesia.
    If adequate analgesia is not obtained within 30 minutes (15 minutes after completing consumption) a second lozenge of the same strength may be administered. Maximum of two lozenges to treat any individual pain episode.
    An increase to the next strength of the dose should be considered if several consecutive breakthrough pain episodes require more than one lozenge per episode.

    Maintenance dose: Once an adequate titration dose is reached, patients should be maintained on this dose. Maximum of four lozenges per day.
    A health professional should monitor the patient to ensure the maximum dosage is not exceeded.

    Dose re-adjustment:
    If more than four episodes of breakthrough pain are experienced per day, the long acting opioid dose used for persistent pain should be re-evaluated. Once the patient's persistent pain has been re-stabilised, the dose of fentanyl lozenge to treat breakthrough pain may need to be reviewed. It is imperative that any dose re-titration of any analgesic is monitored by a health professional.

    In the absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.

    Patients with Renal Impairment

    The Renal Drug Handbook recommends the following

    GFR 20 to 50ml/min: 75% of normal dose, titrate according to response.
    GFR 10 to 20ml/min: 75% of normal dose, titrate according to response.
    GFR less than 10ml/min: 50% of normal dose, titrate according to response.


    Children under 16 years
    Opioid-naive patients
    Within 2 weeks of discontinuing MAOIs
    Hereditary fructose intolerance
    Severe obstructive pulmonary disease
    Severe respiratory depression

    Precautions and Warnings

    Family history of alcohol abuse
    Family history of drug misuse
    Impaired consciousness
    Tobacco smoking
    Adrenal insufficiency
    Chronic obstructive pulmonary disease
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Head trauma
    Hepatic impairment
    History of alcohol abuse
    History of drug misuse
    History of psychiatric disorder
    Raised intracranial pressure
    Renal impairment
    Respiratory depression

    Diabetes: Some products may contain dextrates
    Advise patient ability to drive or operate machinery may be impaired
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine may be subject to driving restrictions
    Contains glucose
    Contains propylene glycol: may cause irritation
    Preparation contains sucrose
    Dental check-ups advisable during long-term treatment
    Diabetic control may need adjustment
    May cause adrenal suppression
    Monitor at regular intervals as withdrawal symptoms & dependence may occur
    Monitor patient closely during titration of dose
    Monitor patient for signs and symptoms of respiratory depression
    Monitor patients with a history of alcoholism and drug abuse
    Potential for drug abuse
    Tolerance and dependence may occur
    When used with SSRIs, risk of Serotonin syndrome
    Consider dose reduction if sleep-related breathing disorders occur
    Consider dose reduction or change in opioid if evidence of hyperalgesia
    Increased risk of central sleep apnoea and sleep-related hypoxemia
    Mucositis: absorption may be increased, consider during dose titration
    Prolonged treatment may lead to dental caries
    Prolonged use at high doses may result in hyperalgesia
    Avoid abrupt withdrawal
    Discontinue if serotonin syndrome develops
    Reduce dose in elderly
    Advise patient not to take St John's wort concurrently
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Advise patient grapefruit products may increase plasma level
    Advise patient of need for high oral hygiene standards

    Fentanyl lozenges are not interchangeable on a microgram to microgram basis with other short-acting fentanyl products that are indicated for the use of breakthrough cancer pain.

    To reduce the risk of respiratory depression and death, the product should only be given to patients stabilised on maintenance opioid therapy and this maintenance therapy must continue while the patient is taking fentanyl lozenges.

    All patients require careful monitoring for signs of abuse and addiction. Monitor for signs of drug-seeking behaviours such as early prescription requests.

    Repeated use may lead to Opioid Use Disorder (OUD). The risk of developing OUD is increased in patients with a personal or family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders such as depression, anxiety and personality disorders. Consider consultation with addiction specialist in patients with signs or symptoms of OUD.

    Adrenal insufficiency has been reported with opioid use, as opioid may influence the gonadal or the hypothalamic-pituitary-adrenal axes. Changes in serum prolactin, plasma cortisol and testosterone levels have been shown with the use of opioids. If adrenal insufficiency is suspected, gradually wean patient off opioid treatment until adrenal function is recovered. Continue with corticosteroid treatment until adrenal function has recovered and opioid treatment can commence.

    Central sleep apnoea and sleep-related hypoxemia has been reported with opioid use in a dose-dependent fashion. Consider dose reduction in patients presenting with central sleep apnoea.

    Pregnancy and Lactation


    Use fentanyl lozenges with caution during pregnancy.

    The manufacturer recommends only using fentanyl lozenges if necessary. At the time of writing, human data is limited but animal studies have shown reproductive toxicity. Risks are currently unknown.


    Use fentanyl lozenges with caution during breastfeeding.

    The manufacturer suggests fentanyl lozenges should not be used when breastfeeding and not to restart treatment until 5 days after the last administration of fentanyl. Lactmed suggests limiting maternal intake of fentanyl by providing pain relief via non narcotic analgesics.

    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). This medicine may be subject to police testing and has specified maximum blood levels for driving.
    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.


    Advise patients that the fentanyl lozenge should be placed in the mouth against the cheek and moved around the mouth using the applicator.

    Advise patients that the fentanyl lozenge should be sucked not chewed and consumed over a 15 minute period.

    Patients and their carers must be instructed that fentanyl lozenges contain an active substance in an amount that can be fatal to a child. Patients and their carers must be instructed to keep all units out of the reach of children and to discard of open units and fentanyl products no longer required, appropriately.

    Advise patients that fentanyl may impair their ability to perform hazardous tasks. They should be advised not to drive or operate machinery if they experience somnolence, dizziness, blurred or double vision during treatment.

    Advise patients of the need to maintain high oral hygiene standards. Dental check-ups are advisable during long-term treatment as prolonged treatment may lead to dental caries.

    Advise patients grapefruit products may increase plasma levels.

    Advise patients the effects are potentiated by CNS depressants (including alcohol).

    Side Effects

    Abdominal pain
    Abnormal thinking
    Abnormal vision
    Accidental injury
    Adrenal insufficiency
    Anaphylactic reaction
    Bleeding (application site)
    Bleeding gums
    Circulatory depression
    Circumoral paraesthesia
    Dream abnormalities
    Dry mouth
    Emotional lability
    Enlarged abdomen
    Gait abnormality
    Hot flushes
    Hypersensitivity reactions
    Increase in dental caries
    Irritation at application site
    Loss of consciousness (transient)
    Mouth ulcers
    Muscle rigidity
    Opioid use disorder
    Peripheral oedema
    Pharyngeal oedema
    Psychological dependence
    Respiratory depression
    Sleep apnoea
    Slurred speech
    Taste disturbances
    Tongue disorder
    Urinary retention
    Weight loss


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last full review date: May 2019

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Actiq 200 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.

    Summary of Product Characteristics: Actiq 400 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.

    Summary of Product Characteristics: Actiq 600 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.

    Summary of Product Characteristics: Actiq 800 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.

    Summary of Product Characteristics: Actiq 1200 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.

    Summary of Product Characteristics: Actiq 1600 micrograms Lozenges. Teva Pharma B.V. Revised May 2022.

    Summary of Product Characteristics: Cynril Lozenges. Fontus Health Ltd. Revised March 2019.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London. 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: Last accessed: 10 May 2019
    New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 10 May 2019

    NICE Evidence Services Available at: Last accessed: 10 May 2019

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