Diclofenac sodium oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Enteric coated formulations of diclofenac sodium.
Acute musculoskeletal disorders
Gout - acute
Juvenile chronic arthritis
Low back pain
Relief of pain and inflammation due to trauma
Relief of pain and inflammation in osteoarthritis
Relief of pain and inflammation in rheumatoid arthritis
75mg to 150mg a day, given in two or three divided doses.
Maximum dose: 150mg a day.
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.
Children under 6 months
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
Children aged 6 to 12 months
Females attempting to conceive
Risk factors for cardiovascular disorder
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
History of gastrointestinal bleeding
History of gastrointestinal ulceration
Renal impairment - glomerular filtration rate 10-20ml/minute
Second trimester of pregnancy
Systemic lupus erythematosus
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
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
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 ).
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
Abnormal liver function
Acute renal insufficiency
Aggravation of existing asthma
Congestive cardiac failure
Diarrhoea - bloody
Disturbances of sensation
Exacerbation of colitis or Crohn's proctocolitis
Increases in hepatic enzymes
Non-specific allergic reactions
Non-specific haemorrhagic colitis
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 ).
Last Full Review Date: July 2013
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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