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Canagliflozin oral

Updated 2 Feb 2023 | SGLT 2 inhibitors


Oral formulations of canagliflozin.

Drugs List

  • canagliflozin 100mg tablets
  • canagliflozin 300mg tablets
  • INVOKANA 100mg tablets
  • INVOKANA 300mg tablets
  • Therapeutic Indications


    Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone

    Indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control.

    As monotherapy when diet and exercise do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate.

    In combination with other glucose lowering medication including insulin where the existing regimen with diet and exercise does not provide adequate glycaemic control.



    The recommended starting dose is 100mg once daily.

    In patients tolerating canagliflozin 100mg once daily who have creatinine clearance equal to or more than 60ml/minute and need tighter glycaemic control, the dose can be increased to 300mg once daily.

    Patients with Renal Impairment

    Creatinine clearance 30 to 60ml/minute:
    The dose should be adjusted to or maintained at 100mg once daily.

    Creatinine clearance less than 30ml/minute:
    Initiation should be avoided.
    Maintain the dose of 100mg daily if well tolerated.


    Children under 18 years
    Diabetic ketoacidosis
    Renal impairment - creatinine clearance below 30ml/minute at baseline
    Severe hepatic impairment

    Precautions and Warnings

    Acute illness
    Major surgery
    Patients over 65 years
    Predisposition to hypotension
    Cardiovascular disorder
    Glucose-galactose malabsorption syndrome
    History of alcohol abuse
    Lactose intolerance
    New York Heart Association class III failure
    New York Heart Association class IV failure
    Renal impairment - creatinine clearance below 60ml/minute

    Correct electrolyte disorders before treatment
    Reduce dose in patients with creatinine clearance below 60ml/min
    Advise ability to drive/operate machinery may be affected by side effects
    Correct hypovolaemia prior to administration
    Contains lactose
    Monitor renal function prior to initiating treatment
    Electrolyte & volume depletion may occur - interrupt treatment as necessary
    Hospitalised patients: Monitor blood ketones before restart treatment
    Monitor blood pressure
    Monitor renal function 2-4 times a year in renal impairment
    Monitor renal function annually in patients with normal renal function
    Monitor renal function if concomitant drugs that impair renal function
    Advise patient to report genital/perineal symptoms with fever or malaise
    Advise patient to report symptoms of diabetic ketoacidosis immediately
    Discontinue SGLT2 inhibitor if Fournier's gangrene is suspected
    Increased risk of genital mycotic infection
    Increased risk of urinary tract infection
    Interrupt treatment temporarily in complicated urinary tract infections
    Test results for urinary glucose will be positive
    Advise patient to seek advice at first indications of pregnancy
    Interrupt therapy if acute serious illness requiring hospitalisation occurs
    Interrupt treatment in patients undergoing major surgery
    Discontinue if diabetic ketoacidosis is suspected
    Discontinue if foot infection, ulcer or gangrene occurs
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid excess of alcohol
    Advise patient on the need for adequate foot hygiene
    Advise patient on the need for adequate hydration
    Advise patient to report symptoms of volume depletion
    Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

    Clinical trials suggest there is an increased risk of lower limb amputation (primarily of the toe) in patients treated with canagliflozin. This risk is independent of predisposing factors, however the absolute risk is higher in patients with previous amputations, existing peripheral vascular disease or neuropathy. Patients with these risk factors should be carefully monitored and discontinuation or interruption of treatment can be considered in the event of any significant complication such as lower-extremity skin ulcer, osteomyelitis or gangrene.

    Cases of diabetic ketoacidosis (DKA), including rare life-threatening and fatal cases, have been reported in patients taking SGLT2 inhibitors. The signs and symptoms of DKA are rapid weight loss; feeling or being sick; stomach pain; fast and deep breathing; sleepiness; a sweet smell to the breath; a sweet or metallic taste in the mouth; or a different odour to urine or sweat. Patients with moderate to severe renal impairment who require insulin appear to be at a greater risk of developing DKA. Other risk factors for DKA include low beta cell function reserve; conditions leading to restricted food intake or severe dehydration; sudden reduction in insulin; increased insulin requirements due to acute illness; surgery and alcohol abuse.

    Cases of necrotising fasciitis of the perineum (Fournier's gangrene) have been reported in patients taking SGLT2 inhibitors. This a rare but serious event that requires urgent intervention and may be preceded by genital infection or penineal abscess. Patients should be advised to report a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.

    Patients with diabetic kidney disease with albuminuria using canagliflozin may have additional benefit from treatment.

    Pregnancy and Lactation


    Canagliflozin is contraindicated in pregnancy.

    At the time of writing there are no data from the use of canagliflozin in pregnant women. Animal studies have shown reproductive toxicity at high doses. The potential risk for humans is unknown.

    Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at .

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


    Canagliflozin is contraindicated in breastfeeding.

    It is unknown whether canagliflozin and/or its metabolites are excreted in human milk. Animal studies have shown excretion of canagliflozin/metabolites in milk. Therefore a risk to the nursing infant cannot be excluded.

    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


    Advise the patient of the signs and symptoms of diabetic ketoacidosis (DKA) and to seek medical advice if they occur. The risk factors of DKA should be discussed with the patient.

    Patients should be advised to report symptoms of volume depletion.

    Advise patient on the need for adequate hydration.

    Advise patient to seek advice at first signs of pregnancy.

    Advise patient on the need for adequate foot hygiene.

    Advise patient to report symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.

    Advise patient not to take St John's wort concurrently.

    Advise patient to avoid excess consumption of alcohol.

    Advise patient that their ability to drive or operate machinery may be impaired.

    Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing website.

    Side Effects

    Anaphylactic reaction
    Elevated serum potassium
    Fournier's gangrene
    Increase in blood urea or creatinine
    Increase in haematocrit
    Increased risk of fractures
    Increased serum inorganic phosphate
    Lower limb amputation
    Orthostatic hypotension
    Osmotic diuresis
    Postural dizziness
    Renal impairment
    Urinary tract infections
    Vaginal candidiasis

    Effects on Laboratory Tests

    Due to its mechanism of action, patients taking canagliflozin will test positive for glucose in their urine.


    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: September 2018

    Reference Sources

    Summary of Product Characteristics: Invokana 100 mg and 300 mg film-coated tablets. Napp Pharmaceuticals Limited. Revised November 2021.

    MHRA Drug Safety Update April 2016
    Available at:
    Last accessed: 03 July 2018

    HPRA Safety Notice May 2016
    Available at:
    Last accessed: 03 July 2018

    MHRA Drug Safety Update February 2019
    Available at:
    Last accessed: 22 February 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Canagliflozin. Last revised: 02 April 2018
    Last accessed: 03 July 2018

    NICE Evidence Services Available at: Last accessed: 15 September 2022

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