Diclofenac potassium oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of diclofenac potassium.
Pain and/or inflammation
Treatment of post-operative pain
Fever in ear, nose or throat infection
75mg to 150mg a day, in two or three divided doses.
Initial dose: 50mg at the first signs or symptoms of an impending attack.
If the first dose is not sufficient, a further 50mg may be administered after 2 hours.
50mg may be administered every 4 to 6 hours, if needed.
Maximum dose should not exceed 200mg a day.
Children aged 14 to 18 years
75mg to 100mg a day, in two or three divided doses.
Children aged 9 to 14 years with a bodyweight of 35kg or more (unlicensed)
In post-operative pain, up to 2mg/kg may be administered, in 3 divided doses, a day. Maximum dose of 100mg daily.
Pyrexia due to infection of ear, nose or throat (unlicensed)
Children aged 9 to 18 years with a bodyweight of 35kg or more
Up to 2mg/kg in 3 divided doses a day. Maximum dose of 100mg daily.
Children under 9 years
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
Females attempting to conceive
Risk factors for cardiovascular disorder
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
New York Heart Association class I failure
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 brands are licensed for all age groups
Not all available brands are licensed for all indications
Some formulations contain sucrose
Some products may contain soya or soya derivative
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 hepatic impairment
Monitor renal function on long term therapy
Perform blood counts on prolonged use of this treatment
Advise patient to inform their physician if dyspnoea/chest pain occur
Advise patient to report gastrointestinal signs or symptoms
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
Dose varies with brand
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 potassium may reversibly inhibit platelet aggregation. Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.
Pregnancy and Lactation
Diclofenac potassium is contraindicated during the third trimester of pregnancy but may be used with caution during the first and second trimester.
The manufacturer does not recommend this product during 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 diclofenac potassium with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking diclofenac potassium.
In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations.
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.
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: November 2019
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.
Summary of Product Characteristics: Diclofenac potassium 25 mg tablets. Accord UK ltd. Revised July 2018.
Summary of Product Characteristics: Diclofenac potassium 50 mg tablets. Accord UK ltd. Revised July 2018.
Summary of Product Characteristics: Voltarol Rapid tablets 50mg. Novartis Pharmaceuticals UK Ltd. Revised September 2019.
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: 06 November 2019.
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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