Drug reference

Diclofenac sodium

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1220, 1221, 1222

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Pain and inflammation in musculoskeletal disorders | Acute gout ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: 75–150 mg daily in 2–3 divided doses ▶BY RECTUM ▶Adult: 75–150 mg daily in divided doses Pain and inflammation in rheumatic disease including juvenile idiopathic arthritis ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: 75–150 mg daily in 2–3 divided doses ▶BY RECTUM ▶Adult: 75–150 mg daily in divided doses Postoperative pain ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: 75–150 mg daily in 2–3 divided doses ▶BY RECTUM ▶Adult: 75–150 mg daily in divided doses DICLOMAX RETARD ® Pain and inflammation in rheumatic disease (including juvenile idiopathic arthritis) and other musculoskeletal disorders | Acute gout | Postoperative pain ▶BY MOUTH ▶Adult: 1 capsule once daily DICLOMAX SR ® Pain and inflammation in rheumatic disease (including juvenile idiopathic arthritis) and other musculoskeletal disorders | Acute gout | Postoperative pain ▶BY MOUTH ▶Adult: 1 capsule 1–2 times a day, alternatively 2 capsules once daily MOTIFENE ® Pain and inflammation in rheumatic disease (including juvenile idiopathic arthritis) and other musculoskeletal disorders | Acute gout | Postoperative pain ▶BY MOUTH ▶Adult: 1 capsule 1–2 times a day VOLTAROL ® 75MG SR TABLETS Pain and inflammation in rheumatic disease (including juvenile idiopathic arthritis) and other musculoskeletal disorders | Acute gout | Postoperative pain ▶BY MOUTH ▶Adult: 1 tablet 1–2 times a day VOLTAROL ® EMULGEL Relief of pain in musculoskeletal conditions | Adjunctive treatment in knee or hand osteoarthritis ▶TO THE SKIN ▶Adult: Apply 3–4 times a day, therapy should be reviewed after 14 days (or after 28 days for osteoarthritis) VOLTAROL ® RETARD Pain and inflammation in rheumatic disease (including juvenile idiopathic arthritis) and other musculoskeletal disorders | Acute gout | Postoperative pain ▶BY MOUTH ▶Adult: 1 tablet once daily VOLTAROL ® SOLUTION FOR INJECTION Postoperative pain ▶BY DEEP INTRAMUSCULAR INJECTION ▶Adult: 75 mg 1–2 times a day for maximum 2 days, twice daily administration in severe cases, to be injected into the gluteal muscle Acute exacerbations of pain ▶BY DEEP INTRAMUSCULAR INJECTION ▶Adult: 75 mg 1–2 times a day for maximum 2 days, twice daily administration in severe cases, to be injected into the gluteal muscle Ureteric colic ▶BY DEEP INTRAMUSCULAR INJECTION ▶Adult: 75 mg, then 75 mg after 30 minutes if required Acute postoperative pain (in hospital setting) ▶BY INTRAVENOUS INFUSION ▶Adult: 75 mg, then 75 mg after 4–6 hours if required for maximum 2 days; maximum 150 mg per day Prevention of postoperative pain (in hospital setting) ▶BY INTRAVENOUS INFUSION ▶Adult: Initially 25–50 mg, to be given after surgery over 15–60 minutes, then 5 mg/hour for maximum 2 days; maximum 150 mg per day

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Contra Indications

▶With intravenous use Dehydration. history of asthma. history of conﬁrmed or suspected cerebrovascular bleeding . history of haemorrhagic diathesis. hypovolaemia. operations with high risk of haemorrhage ▶With systemic use Active gastro-intestinal bleeding. active gastro-intestinal ulceration. avoid suppositories in proctitis. cerebrovascular disease. history of gastro- intestinal bleeding related to previous NSAID therapy. history of gastro-intestinal perforation related to previous NSAID therapy. history of recurrent gastro-intestinal haemorrhage (two or more distinct episodes). history of recurrent gastro-intestinal ulceration (two or more distinct episodes). ischaemic heart disease. mild to severe heart failure. peripheral arterial disease

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Cautions

▶With systemic use Allergic disorders. cardiac impairment (NSAIDs may impair renal function). coagulation defects. connective-tissue disorders. dehydration (risk of renal impairment). elderly (risk of serious side-effects and fatalities). history of cardiac failure. history of gastro- intestinal disorders (e.g. ulcerative colitis, Crohn’s disease) . hypertension. oedema. risk factors for cardiovascular events ▶With topical use Avoid contact with eyes. avoid contact with inﬂamed or broken skin. avoid contact with mucous membranes. not for use with occlusive dressings. topical application of large amounts can result in systemic effects, including hypersensitivity and asthma (renal disease has also been reported)

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Allergy And Cross Sensitivity

Contra-indicated in patients with a history of hypersensitivity to aspirin or any other NSAID—which includes those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAID.

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Prescribing And Dispensing Information

Voltarol ® dispersible tablets are more suitable for short-term use in acute conditions for which treatment required for no more than 3 months (no information on use beyond 3 months).

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Exceptions To Legal Category

▶With topical use for relief of pain in musculoskeletal conditions and adjunctive treatment in knee or hand osteoarthritis Various pack sizes of gel preparations may be available on sale to the public.

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Safety

Interactions

→Appendix 1: NSAIDs

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Side Effects

▶Common or very common ▶With systemic use Appetite decreased. diarrhoea. dizziness . gastrointestinal discomfort. gastrointestinal disorders. Musculoskeletal system headache. nausea. oedema. rash (discontinue). skin reactions. vertigo. vomiting ▶With topical use Conjunctivitis. muscle tone increased. rash (discontinue). sensation abnormal. skin ulcer ▶Uncommon ▶With systemic use Chest pain. heart failure. myocardial infarction. palpitations ▶With topical use Abdominal pain. alopecia. diarrhoea. eye pain. haemorrhage. lacrimation disorder. nausea. seborrhoea ▶Rare or very rare ▶With rectal use Ulcerative colitis aggravated ▶With systemic use Acute kidney injury. agranulocytosis. alopecia. anaemia. angioedema. anxiety. aplastic anaemia. asthma. confusion. constipation. depression. drowsiness. dyspnoea. erectile dysfunction. fatigue. haemolytic anaemia. haemorrhage. hearing impairment. hepatic disorders. hypersensitivity. hypertension. hypotension. irritability. leucopenia. memory loss. meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible). nephritis tubulointerstitial. nephrotic syndrome. oesophageal disorder. oral disorders . pancreatitis. photosensitivity reaction. pneumonitis. proteinuria. psychotic disorder. renal papillary necrosis. seizure. sensation abnormal. severe cutaneous adverse reactions (SCARs). shock. sleep disorders. stroke. taste altered. thrombocytopenia. tinnitus. tremor. vasculitis. vision disorders ▶With topical use Acute kidney injury. angioedema. asthma. photosensitivity reaction. rash pustular ▶Frequency not known ▶With parenteral use Injection site necrosis ▶With systemic use Fertility decreased female. ﬂuid retention . hallucination. malaise. optic neuritis. platelet aggregation inhibition ▶With topical use Hair colour changes SIDE-EFFECTS, FURTHER INFORMATION Topical application of large amounts of diclofenac can result in systemic effects. For information about cardiovascular and gastrointestinal side-effects, and a possible exacerbation of symptoms in asthma, see Non-steroidal anti- inﬂammatory drugs p. 1193

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Conception And Contraception

▶With systemic use Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment.

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Pregnancy

▶With systemic use Avoid unless the potential beneﬁt outweighs the risk. Avoid during the third trimester (risk of closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the newborn); onset of labour may be delayed and duration may be increased. ▶With topical use Patient packs for topical preparations carry a warning to avoid during pregnancy.

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Breast Feeding

▶With systemic use Use with caution during breast-feeding. Amount in milk too small to be harmful. ▶With topical use Patient packs for topical preparations carry a warning to avoid during breast-feeding.

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Hepatic Impairment

▶With systemic use Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment.

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Renal Impairment

▶With systemic use Avoid if possible or use with caution. Musculoskeletal system Avoid in severe impairment. ▶With intravenous use Avoid intravenous use if serum creatinine greater than 160 micromol/litre. Contra- indicated in moderate or severe renal impairment. Dose adjustments ▶With systemic use The lowest effective dose should be used for the shortest possible duration. Monitoring ▶With systemic use In renal impairment monitor renal function; sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure.

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Dose and formulations

Directions For Administration

▶With intravenous use For intravenous infusion (Voltarol ®), give continuously or intermittently in Glucose 5% or Sodium chloride 0.9%. Dilute 75 mg with 100–500 mL infusion ﬂuid (previously buffered with 0.5 mL sodium bicarbonate 8.4% solution or with 1 mL sodium bicarbonate 4.2% solution). For intermittent infusion give 25–50 mg over 15–60 minutes or 75 mg over 30–120 minutes. For continuous infusion give at a rate of 5 mg/hour. ▶With topical use For topical preparations, apply with gentle massage only.

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: dispersible tablet, oral suspension, oral solution Gastro-resistant tablet CAUTIONARY AND ADVISORY LABELS 5, 25 ▶Diclofenac sodium (Non-proprietary) Diclofenac sodium 25 mg Diclofenac sodium 25mg gastro-resistant tablets | 28 tablet P £8.99 DT = £1.69 | 84 tablet P £1.50– £26.97 Diclofenac sodium 50 mg Diclofenac sodium 50mg gastro-resistant tablets | 28 tablet P £4.97 DT = £1.63 | 84 tablet P £2.48– £15.00 ▶Fenactol (Dexcel-Pharma Ltd) Diclofenac sodium 50 mg Fenactol 50mg gastro-resistant tablets | 100 tablet P £3.70 Suppository ▶Econac (Advanz Pharma) Diclofenac sodium 100 mg Econac 100mg suppositories | 10 suppository P £3.04 DT = £3.64 ▶Voltarol (Novartis Pharmaceuticals UK Ltd) Diclofenac sodium 12.5 mg Voltarol 12.5mg suppositories | 10 suppository P £0.70 DT = £0.70 Diclofenac sodium 25 mg Voltarol 25mg suppositories | 10 suppository P £1.24 DT = £1.24 Diclofenac sodium 50 mg Voltarol 50mg suppositories | 10 suppository P £2.04 DT = £2.04 Diclofenac sodium 100 mg Voltarol 100mg suppositories | 10 suppository P £3.64 DT = £3.64 Solution for injection EXCIPIENTS: May contain Benzyl alcohol, propylene glycol ▶Voltarol (Novartis Pharmaceuticals UK Ltd) Diclofenac sodium 25 mg per 1 ml Voltarol 75mg/3ml solution for injection ampoules | 10 ampoule P £9.91 DT = £9.91 Modified-release capsule CAUTIONARY AND ADVISORY LABELS 21(does not apply to Motifene ® 75 mg), 25 EXCIPIENTS: May contain Propylene glycol ▶Diclomax Retard (Galen Ltd) Diclofenac sodium 100 mg Diclomax Retard 100mg capsules | 28 capsule P £8.20 DT = £8.20 ▶Diclomax SR (Galen Ltd) Diclofenac sodium 75 mg Diclomax SR 75mg capsules | 56 capsule P £11.40 DT = £11.40 ▶Motifene (Daiichi Sankyo UK Ltd) Diclofenac sodium 75 mg Motifene 75mg modified-release capsules | 56 capsule P £8.00 DT = £8.00 Gel ▶Voltarol Emulgel (GlaxoSmithKline Consumer Healthcare) Diclofenac diethylammonium 11.6 mg per 1 gram Voltarol 1.16% Emulgel | 100 gram p £4.63 DT = £4.63

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Clinical care

Patient And Carer Advice

For topical preparations, patients and their carers should be advised to wash hands immediately after use. Photosensitivity Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity. l PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Diclofenac Sodium Tablets may be prescribed.

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Dose text by age group

Adult

75–150 mg daily in 2–3 divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in 2–3 divided doses

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75–150 mg daily in divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in 2–3 divided doses

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75–150 mg daily in divided doses

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 capsule once daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 capsule 1–2 times a day, alternatively

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 capsule 1–2 times a day

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 tablet 1–2 times a day

First-line fragment. Read the complete Indications and Dose section above.

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Adult

Apply 3–4 times a day, therapy should be

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 tablet once daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75 mg 1–2 times a day for maximum 2 days,

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75 mg 1–2 times a day for maximum 2 days,

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75 mg, then 75 mg after 30 minutes if required

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75 mg, then 75 mg after 4–6 hours if required for

First-line fragment. Read the complete Indications and Dose section above.

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Adult

Initially 25–50 mg, to be given after surgery over

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1221

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Diclofenac sodium

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1220, 1221, 1222

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF pages 1220, 1221

Contra Indications

PDF page 1221

Cautions

PDF page 1221

Allergy And Cross Sensitivity

PDF page 1221

Prescribing And Dispensing Information

Voltarol ® dispersible tablets are more suitable for short-term use in acute conditions for which treatment required for no more than 3 months (no information on use beyond 3 months).

PDF page 1222

Exceptions To Legal Category

PDF page 1222

Safety

Interactions

→Appendix 1: NSAIDs

PDF page 1221

Side Effects

PDF page 1221

Conception And Contraception

▶With systemic use Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment.

PDF page 1221

Pregnancy

PDF pages 1221, 1222

Breast Feeding

PDF page 1222

Hepatic Impairment

▶With systemic use Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment.

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Renal Impairment

PDF page 1222

Dose and formulations

Directions For Administration

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Medicinal Forms

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Clinical care

Patient And Carer Advice

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Dose text by age group

Adult

75–150 mg daily in 2–3 divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in 2–3 divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in 2–3 divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

75–150 mg daily in divided doses

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

1 capsule once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1220

Adult

1 capsule 1–2 times a day, alternatively

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 capsule 1–2 times a day

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 tablet 1–2 times a day

First-line fragment. Read the complete Indications and Dose section above.

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Adult

Apply 3–4 times a day, therapy should be

First-line fragment. Read the complete Indications and Dose section above.

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Adult

1 tablet once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1221

Adult

75 mg 1–2 times a day for maximum 2 days,

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75 mg 1–2 times a day for maximum 2 days,

First-line fragment. Read the complete Indications and Dose section above.

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Adult

75 mg, then 75 mg after 30 minutes if required

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1221

Adult

75 mg, then 75 mg after 4–6 hours if required for

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1221

Adult

Initially 25–50 mg, to be given after surgery over

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1221

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.