Diclofenac sodium oral modified release
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Modified release formulations of diclofenac sodium.
Gout - acute
Pain - mild to moderate
Treatment of post-operative pain
75mg once or twice a day, or 100mg once a day.
Maximum dose: 150mg a day.
Pain and inflammation (unlicensed)
Children aged 12 to 18 years
75mg administered once or twice daily, or 100mg administered once daily.
Where the symptoms are most pronounced during the night or in the morning, the dose should preferably be taken in the evening.
Children under 12 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
Children aged 12 to 18 years
Females attempting to conceive
Risk factors for cardiovascular disorder
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of major gastrointestinal surgery
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 ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Some formulations contain lactose
Some formulations contain sucrose
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
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
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Elderly patients and patients of low body weight are more susceptible to the adverse reactions of NSAIDs, including gastrointestinal bleeding and perforation. As such, they should be started on and maintained on the lowest possible dose and monitored for gastrointestinal bleeding for 4 weeks after initiation of NSAID therapy. Concomitant gastro-protection (e.g. proton pump inhibitors) should be considered in these patients and those on other drugs, which increase gastrointestinal risk.
Patients with mixed connective tissue disorders such as systemic lupus erythematosus may be especially susceptible to aseptic meningitis.
Pregnancy and Lactation
Diclofenac sodium is contraindicated in the third trimester of pregnancy.
Use diclofenac sodium with caution in the first trimester and second trimesters of pregnancy
The manufacturer does not recommend this product in pregnancy.
Studies suggest increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
Diclofenac should not be given in the first and second trimester unless necessary and the dose should be kept as low and duration of treatment as short as possible.
Diclofenac 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.
Use of any NSAID is considered contraindicated during the third trimester of pregnancy.
Use diclofenac sodium with caution in breastfeeding.
The manufacturer recommends avoiding the use of diclofenac when breastfeeding.In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations.
Advise patients that they should report any unusual abdominal symptoms (especially gastrointestinal bleeding).
Advise patients that the ability to drive or operate machinery may be affected by side effects such as dizziness, vertigo, somnolence, central nervous system disturbances, drowsiness and fatigue.
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: December 2020
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. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Diclomax Retard. Galen Ltd. Revised June 2020.
Summary of Product Characteristics: Diclomax SR. Galen Ltd. Revised October 2020.
Summary of Product Characteristics: Diclo-SR. Strides Pharma UK Ltd. Revised November 2020.
Summary of Product Characteristics: Enstar XL 100mg tablets. Ennogen Pharma Ltd. Revised October 2019.
Summary of Product Characteristics: Motifene 75mg. Daiichi-Sankyo UK Ltd. Revised September 2020.
The Renal Drug Handbook. 5th edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed : 15 December 2020
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