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Diclofenac sodium oral

Updated 2 Feb 2023 | NSAIDs

Presentation

Enteric coated formulations of diclofenac sodium.

Drugs List

  • diclofenac sodium 25mg gastro-resistant tablets
  • diclofenac sodium 50mg gastro-resistant tablets
  • Therapeutic Indications

    Uses

    Acute musculoskeletal disorders
    Ankylosing spondylitis
    Gout - acute
    Juvenile chronic arthritis
    Low back pain
    Periarthritis
    Relief of pain and inflammation due to trauma
    Relief of pain and inflammation in osteoarthritis
    Relief of pain and inflammation in rheumatoid arthritis

    Dosage

    Adults

    75mg to 150mg a day, given in two or three divided doses.
    Maximum dose: 150mg a day.

    Children

    Children aged 12 to 18 years
    (See Dosage; Adult)

    Juvenile chronic arthritis(25mg tablet only)
    Children aged 1 to 12 years
    1mg/kg to 3mg/kg a day, given in divided doses.

    Fever and post-operative pain (25mg tablet only)
    Children aged 9 to 18 years with a bodyweight of 35kg or more
    Up to 2mg/kg a day in three divided doses, adjusted based on individual patient.

    Contraindications

    Children under 6 months
    Cerebrovascular disorder
    Galactosaemia
    Gastrointestinal haemorrhage
    Gastrointestinal perforation
    Gastrointestinal ulcer
    History of gastrointestinal haemorrhage
    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 aged 6 to 12 months
    Elderly
    Females attempting to conceive
    Risk factors for cardiovascular disorder
    Asthma
    Breastfeeding
    Connective tissue disorder
    Crohn's disease
    First trimester of pregnancy
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    History of gastrointestinal bleeding
    History of gastrointestinal ulceration
    Hypertension
    Lactose intolerance
    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 strengths are licensed for all indications
    Contains lactose
    Discontinue if signs of gastro-intestinal bleeding occur
    May inhibit platelet aggregation - observe for signs of bleeding
    Monitor hepatic function on long term therapy
    Monitor renal function in patients with cardiac impairment
    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 if hepatic function deteriorates
    Discontinue treatment if rash occurs
    Maintain treatment at the lowest effective dose

    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

    Pregnancy

    The manufacturer does not recommend this product in pregnancy.

    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.

    When an NSAID is considered essential, a more established drug such as ibuprofen may be considered. Diclofenac should be used with caution in the first and second trimesters. Schaefer (2007) considers that use of NSAIDs in early pregnancy does not require termination of pregnancy or invasive diagnostic procedures.

    Diclofenac is a prostaglandin synthetase inhibitor and may have the following effects during the second and third trimesters:
    - Pulmonary and cardiac toxicity in the foetus/newborn (pulmonary hypertension with preterm closing of the ductus arteriosus). The risk exists from the beginning of the sixth month and increases if administration is close to full term.
    - Functional renal injury in the foetus. From the twelfth week: oligohydramnios (usually reversible after the end of treatment) or anamnios (particularly with prolonged exposure). Following birth, renal failure may persist (especially with late and prolonged exposure).
    - Inhibition of uterine contractions with delayed onset and prolongation of labour.
    - Increased possibility of bleeding in mother and child.
    - Increased risk of maternal oedema formation.
    - When used in the peri-natal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.

    Use of any NSAID is considered contraindicated during the third trimester of pregnancy.

    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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. The manufacturer recommends avoiding the use of diclofenac when 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.

    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.

    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

    Side Effects

    Abdominal pain
    Abnormal liver function
    Acute renal insufficiency
    Aggravation of existing asthma
    Agranulocytosis
    Anaphylactoid reaction
    Anaphylaxis
    Anorexia
    Anxiety
    Aphthous stomatitis
    Aplastic anaemia
    Arterial thrombosis
    Aseptic meningitis
    Asthma
    Bronchospasm
    Cerebrovascular accident
    Chest pain
    Colonic stricture
    Confusion
    Congestive cardiac failure
    Constipation
    Convulsions
    Depression
    Diarrhoea
    Diarrhoea - bloody
    Disorientation
    Disturbances of sensation
    Dizziness
    Drowsiness
    Dyspepsia
    Dyspnoea
    Eczema
    Exacerbation of colitis or Crohn's proctocolitis
    Fatigue
    Flatulence
    Gastritis
    Gastro-intestinal perforation
    Gastro-intestinal ulceration
    Gastrointestinal bleeding
    Glossitis
    Haematemesis
    Haematuria
    Haemolytic anaemia
    Hair loss
    Hallucinations
    Headache
    Hearing disturbances
    Hepatic failure
    Hepatic impairment
    Hepatic necrosis
    Hepatitis
    Hypersensitivity reactions
    Hypertension
    Hypotension
    Impotence
    Increases in hepatic enzymes
    Insomnia
    Interstitial nephritis
    Irritability
    Jaundice
    Leucopenia
    Lyell's syndrome
    Malaise
    Melaena
    Memory disturbances
    Myocardial infarction
    Nausea
    Nephrotic syndrome
    Neutropenia
    Nightmares
    Non-specific allergic reactions
    Non-specific haemorrhagic colitis
    Oedema
    Oesophageal lesions
    Palpitations
    Pancreatitis
    Papillary necrosis
    Paraesthesia
    Photosensitivity
    Pneumonitis
    Proteinuria
    Pruritus
    Psychotic symptoms
    Purpura
    Renal failure
    Shock
    Skin disorder
    Stevens-Johnson syndrome
    Taste disturbances
    Thrombocytopenia
    Tinnitus
    Tiredness
    Tremor
    Ulcerative stomatitis
    Vasculitis
    Vertigo
    Visual disturbances
    Vomiting

    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 ).

    Further Information

    Last Full Review Date: July 2013

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Diclofenac Sodium 25mg Gastro-Resistant Tablets. Dexcel Pharma Ltd. Revised March 2017.
    Summary of Product Characteristics: Diclofenac Sodium 50mg Gastro-Resistant Tablets. Dexcel Pharma Ltd. Revised March 2017.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

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

    MHRA Drug Safety Update June 2013
    Available at: https://www.mhra.gov.uk
    Last accessed: July 11, 2013

    NICE - Evidence Services
    Available at: www.nice.org.uk
    Last accessed: 28 June 2017.

    The drug database for acute porphyria (NAPOS)
    Available at: https://www.drugs-porphyria.org/monograph.php?id=3175
    Diclofenac Last revised: June 30, 2010
    Last accessed: July 11, 2013

    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
    Diclofenac Last revised: March 1, 2012
    Last accessed: July 11,2013

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