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Diclofenac sodium parenteral

Updated 2 Feb 2023 | NSAIDs


Solution for injection formulation of diclofenac sodium.

Drugs List

  • AKIS 75mg/1ml injection solution
  • diclofenac sodium 75mg/1ml injection solution
  • diclofenac sodium 75mg/3ml injection
  • VOLTAROL 75mg/3ml injection
  • Therapeutic Indications


    Acute back pain
    Gout - acute
    Pain relief in fractures
    Prevention of post-operative pain
    Relief of acute pain
    Relief of pain and inflammation due to trauma
    Renal colic
    Short term symptomatic treatment of acute exacerbations of osteoarthritis
    Short term symptomatic treatment of exacerbations of rheumatoid arthritis
    Treatment of post-operative pain


    Diclofenac sodium parenteral should not be administered for more than 2 days. Treatment may be continued with other formulations of diclofenac sodium, if considered necessary.

    For detailed administration instructions consult product information.


    Intramuscular or subcutaneous only
    Severe pain including renal colic
    75 mg repeated if necessary. Maximum dose 150mg in 24 hours.

    Severe pain including renal colic
    75mg repeated if necessary. Maximum dose of 150mg in 24 hours.

    Intravenous infusion
    Moderate to severe post-operative pain
    75mg repeated if necessary. Maximum dose of 150mg in 24 hours.

    Prevention of post-operative pain
    25mg to 50mg loading dose after surgery followed by 5mg per hour. Maximum dose of 150mg in 24 hours.


    Voltarol (unlicensed)
    Postoperative pain by intravenous infusion or deep intramuscular injection into gluteal muscle
    Children aged 2 to 18 years
    0.3mg/kg to 1mg/kg once or twice daily, administered intramuscularly, for no longer than 2 days.
    Maximum dose of 150mg a day.

    Additional Dosage Information

    Diclofenac injection should not be given for more than 2 days. If necessary, treatment can be continued with diclofenac tablets or suppositories.


    Children under 2 years
    Haemorrhagic diathesis
    Surgical procedure with high risk of haemorrhage
    Cardiac impairment
    Cerebrovascular disorder
    Gastrointestinal haemorrhage
    Gastrointestinal perforation
    Gastrointestinal ulcer
    History of gastrointestinal haemorrhage
    History of gastrointestinal perforation
    History of peptic ulcer
    Ischaemic heart disease
    New York Heart Association class II failure
    Peripheral arterial circulatory disorder
    Renal impairment - glomerular filtration rate below 10ml/minute
    Severe hepatic impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Allergic disposition
    Children under 18 years
    Females attempting to conceive
    Predisposition to haemorrhage
    Risk factors for cardiovascular disorder
    Connective tissue disorder
    Crohn's disease
    First trimester of pregnancy
    Haematological disorder
    Hepatic impairment
    Renal impairment - glomerular filtration rate 10-20ml/minute
    Second trimester of pregnancy
    Systemic lupus erythematosus
    Ulcerative colitis

    May mask symptoms or signs of infections
    May precipitate bronchospasm in patients with asthma or allergy
    Advise patient dizziness may affect ability to drive or operate machinery
    Not all available brands are licensed for all routes of administration
    Not all available products are licensed for all uses
    Do not mix with other injections or infusions prior to administration
    Discontinue if signs of gastro-intestinal bleeding occur
    Haematological monitoring required in long term use
    May inhibit platelet aggregation - observe for signs of bleeding
    Monitor renal function in patients with hepatic impairment
    Monitor renal function on long term therapy
    High dose/long term use may increase risk of arterial thrombotic events
    Severe gastro-intestinal side effects may occur without warning
    Discontinue treatment if rash occurs
    Maintain treatment at the lowest effective dose
    May cause impaired fertility

    Elderly patients have increased frequency of adverse reactions, especially gastrointestinal bleeding and perforation which may be fatal. These patients should commence treatment on the lowest dose available and be monitored for gastrointestinal bleeding for 4 weeks following initiation of therapy.

    Patients with renal or hepatic impairment and the elderly should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored.

    If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (eosinophilia, rash, etc) treatment should be discontinued. Hepatitis may occur without prodromal symptoms.

    Diclofenac sodium may reversibly inhibit platelet aggregation. Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.

    Pregnancy and Lactation


    Diclofenac sodium is contraindicated in the third trimester of pregnancy.

    Use diclofenac sodium with caution in the first and second trimester of pregnancy.

    The manufacturer does not recommend diclofenac sodium in pregnancy.

    When an NSAID is considered essential, a more established drug such as ibuprofen may be considered.

    First trimester exposure to NSAIDs has been associated with an increased risk spontaneous abortions and of birth defects (notably cardiac septal defects). There is conflicting evidence, however, from various studies and the risk appears to be low.

    Diclofenac is a prostaglandin synthetase inhibitor and may have effects during the second and third trimesters, including pulmonary and cardiac toxicity in the foetus/newborn from the beginning of the sixth month and increases in risk if administration is close to full term. Other effects also include, functional renal injury in the foetus, inhibition of uterine contractions with delayed onset and prolongation of labour, increased possibility of bleeding in mother and child, and increased risk of maternal oedema formation. When used in the perinatal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.

    In animal studies prostaglandin synthetase inhibitors show pre and post implantation loss and embryo foetal lethality.

    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 ( ).


    Use diclofenac sodium with caution in breastfeeding.

    The manufacturer does not recommend the use in breastfeeding.

    There is limited published information regarding the use of diclofenac sodium in breastfeeding.

    NSAIDs can appear in breast milk in very low concentrations. The secretion in maternal milk following oral administration is minimal and probably too low to affect the infant. Diclofenac has a short half life of 1.1 hours and a number of active metabolites although the clinical significance of these is not known.

    Lactmed (2018) state that some sources consider diclofenac to be acceptable to use during breastfeeding.

    When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice although occasional use of diclofenac is permissible.

    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

    Side Effects

    Abdominal pain
    Acute renal insufficiency
    Aggravation of existing asthma
    Anaphylactic reaction
    Anaphylactoid reaction
    Arterial thrombosis
    Aseptic meningitis
    Blurred vision
    Cerebrovascular accident
    Chest pain
    Colonic damage
    Colonic stricture
    Congestive cardiac failure
    Disturbances of sensation
    Erythema multiforme
    Exacerbation of colitis
    Exacerbation of Crohn's disease
    Exfoliative dermatitis
    Eye disorder
    Gastro-intestinal disturbances
    Gastro-intestinal ulceration and bleeding
    Hair loss
    Hearing disturbances
    Hepatic disorders
    Hypersensitivity reactions
    Increase of liver transaminases
    Increases in hepatic enzymes
    Injection site reactions
    Interstitial nephritis
    Memory disturbances
    Mouth ulcers
    Myocardial infarction
    Nephrotic syndrome
    Non-specific haemorrhagic colitis
    Oesophageal lesions
    Papillary necrosis
    Renal failure
    Skin disorder
    Stevens-Johnson syndrome
    Taste disturbances
    Toxic epidermal necrolysis
    Urinary abnormalities
    Visual disturbances


    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: July 2013

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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: Voltarol Ampoules. Novartis Pharmaceuticals UK Ltd. Revised March 2017.

    Summary of Product Characteristics: Akis 75mg/ml solution for injection in prefilled syringe. Flynn Pharma Ltd. Revised October 2017.

    'PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors'
    European Medicines Agency (EMA) 14th June 2013
    Available at:
    Last accessed: July 11, 2013

    MHRA Drug Safety Update June 2013
    Available at:
    Last accessed: July 11, 2013

    NICE - Evidence Services
    Available at:
    Last accessed: 11 July 2018

    The drug database for acute porphyria (NAPOS)
    Available at:
    Diclofenac Last revised: 9 April 2014
    Last accessed: 11 July 2018

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Diclofenac Last revised: 9 January 2018
    Last accessed: 11 July 2018

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