Formulary
Diclofenac sodium: Indications, Dosing, Side Effects and Interactions
Diclofenac sodium clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 9 min read
Diclofenac sodium: Indications, Dosing, Side Effects and Interactions
Diclofenac sodium clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Inhibition of intra-operative miosis during cataract surgery (but does not possess intrinsic mydriatic properties),Postoperative inflammation in cataract surgery, strabismus surgery or argon laser trabeculoplasty,Pain in corneal epithelial defects after photorefractive keratectomy, radial keratotomy or accidental trauma,Seasonal allergic conjunctivitis**
- **Adult** (To The Eye): (consult product literature).
**Pain and inflammation in rheumatic disease and other musculoskeletal disorders,Acute gout,Postoperative pain**
- **Adult** (By Mouth Using Immediate-Release Medicines): 75-150 mg daily in 2-3 divided doses.
- **Adult** (By Mouth Using Modified-Release Medicines): 75 mg 1-2 times a day, alternatively 100 mg once daily.
- **Adult** (By Rectum): 75-150 mg daily in 2-3 divided doses, alternatively 100 mg once daily.
**Actinic keratosis [using gel containing diclofenac sodium 3%]**
- **Adult** (To The Skin): Apply twice daily usually for 60-90 days, maximum 8 g per day.
**Pain and inflammation in rheumatic disease and other musculoskeletal disorders [using gel containing diclofenac sodium 1%]**
- **Adult** (To The Skin): Apply 3-4 times a day review after 14 days.
**Osteoarthritis of the knee or hand [using gel containing diclofenac sodium 1%]**
- **Adult** (To The Skin): Apply 3-4 times a day review after 28 days.
**Postoperative pain**
- **Adult** (By Deep Intramuscular Injection): 75 mg once daily for maximum 2 days, alternatively 75 mg twice daily for maximum 2 days, twice-daily administration to be used in severe cases.
**Acute exacerbations of pain**
- **Adult** (By Deep Intramuscular Injection): 75 mg once daily for maximum 2 days, alternatively 75 mg twice daily for maximum 2 days, twice-daily administration to be used in severe cases.
**Ureteric colic**
- **Adult** (By Deep Intramuscular Injection): 75 mg for 1 dose, dose can be repeated after 30 minutes if required; maximum 150 mg per day for maximum 2 days.
**Acute postoperative pain (in hospital setting)**
- **Adult** (By Intravenous Infusion): 75 mg for 1 dose, dose can be repeated after 4-6 hours if required; maximum 150 mg per day for maximum 2 days.
**Prevention of postoperative pain (in hospital setting)**
- **Adult** (By Intravenous Infusion): 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.
**Inhibition of intra-operative miosis during cataract surgery (but does not possess intrinsic mydriatic properties), Postoperative inflammation in cataract surgery, strabismus surgery, argon laser trabeculoplasty for diclofenac sodium**
- **Child** (To the eye): (consult product literature).
**Pain and inflammation in rheumatic disease including juvenile idiopathic arthritis for diclofenac sodium**
- **Child 6 months-17 years** (By mouth using immediate-release medicines): 1.5-2.5 mg/kg twice daily (max. per dose 75 mg), total daily dose may alternatively be given in 3 divided doses; maximum 150 mg per day.
**Postoperative pain for diclofenac sodium**
- **Child 6 months-17 years (body-weight 8-11 kg)** (By rectum): 12.5 mg twice daily for maximum 4 days.
- **Child 6 months-17 years (body-weight 12 kg and above)** (By rectum): 1 mg/kg 3 times a day (max. per dose 50 mg) for maximum 4 days.
**Inflammation, Mild to moderate pain for diclofenac sodium**
- **Child 6 months-17 years** (By mouth using immediate-release medicines, or by rectum): 0.3-1 mg/kg 3 times a day (max. per dose 50 mg).
- **Child 12-17 years** (By mouth using modified-release capsules): 75 mg 1-2 times a day, alternatively 100 mg once daily.
**Pain and inflammation in rheumatic disease and other musculoskeletal disorders [using gel containing diclofenac sodium 1%] , Osteoarthritis of the knee or hand [using gel containing diclofenac sodium 1%] for diclofenac sodium**
- **Child 14-17 years** (To the skin): Apply 3-4 times a day review after 7 days.
**Postoperative pain for Voltarol solution for injection**
- **Child 2-17 years** (By intravenous infusion, or by deep intramuscular injection): 0.3-1 mg/kg 1-2 times a day for maximum 2 days, for intramuscular injection, to be injected into the gluteal muscle; maximum 150 mg per day.
Cautions
When used by eye Bleeding tendency (increased risk of ocular tissue bleeding, including hyphaema); concomitant use of ocular corticosteroids; corneal epithelial breakdown (if evidence of, then discontinue immediately); may mask symptoms of infection; may slow or delay wound healing; patients at increased risk of corneal side-effects 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; may mask symptoms of infection; 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) Cautions, further information Concomitant use of ocular corticosteroids When used by eye: Concomitant use of ocular formulations containing NSAIDs with ocular formulations containing corticosteroids may increase the risk of corneal healing problems, leading to corneal melt or scarring and loss of vision. M Patients at increased risk of corneal side-effects When used by eye: Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases, rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk of corneal side-effects which may become sight threatening. M
Contraindications
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
Side effects
General side-effects: Common or very common Oedema; skin reactions Rare or very rare Hypersensitivity Specific side-effects: Common or very common With oral use Appetite decreased; diarrhoea; dizziness; gastrointestinal discomfort; gastrointestinal disorders; headache; nausea; rash (discontinue); vertigo; vomiting With parenteral use Appetite decreased; diarrhoea; dizziness; gastrointestinal discomfort; gastrointestinal disorders; headache; nausea; rash (discontinue); vertigo; vomiting With rectal use Appetite decreased; diarrhoea; dizziness; gastrointestinal discomfort; gastrointestinal disorders; headache; nausea; rash (discontinue); vertigo; vomiting With topical use Conjunctivitis; muscle tone increased; rash (discontinue); sensation abnormal; skin ulcer Uncommon With parenteral use Chest pain; heart failure; myocardial infarction; palpitations With rectal 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 When used by eye (topical) Asthma exacerbated With oral use Acute kidney injury; agranulocytosis; alopecia; anaemia; angioedema; anxiety; aplastic anaemia; asthma; chest pain; confusion; constipation; depression; drowsiness; dyspnoea; haemolytic anaemia; haemorrhage; hearing impairment; heart failure; hepatic disorders; hypertension; hypotension; irritability; leucopenia; memory loss; meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible); myocardial infarction; nephritis tubulointerstitial; nephrotic syndrome; oesophageal disorder; oral disorders; palpitations; 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 parenteral use Acute kidney injury; agranulocytosis; alopecia; anaemia; angioedema; anxiety; asthma; confusion; constipation; depression; drowsiness; dyspnoea; erectile dysfunction; fatigue; haemolytic anaemia; haemorrhage; hearing impairment; hepatic disorders; 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); sleep disorders; stroke; taste altered; thrombocytopenia; tinnitus; tremor; vasculitis; vision disorders With rectal 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; 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; ulcerative colitis aggravated; vasculitis; vision disorders With topical use Acute kidney injury; angioedema; asthma; photosensitivity reaction; rash pustular Frequency not known When used by eye (topical) Dyspnoea; eye discomfort; eye disorders; eye inflammation; rhinitis; vision blurred With oral use Erectile dysfunction; fertility decreased female; fluid retention; hallucination; malaise; optic neuritis; platelet aggregation inhibition With parenteral use Aplastic anaemia; fertility decreased female; fluid retention; hallucination; injection site necrosis; malaise; optic neuritis; platelet aggregation inhibition; shock With rectal use Fertility decreased female; 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 When used by eye (topical) Prolonged use can cause epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration and corneal perforation which might be sight-threatening. Discontinue if corneal epithelial breakdown occurs and monitor closely.
Interactions
**Other interactions (1):**
- Diuretics, Angiotensin Converting Enzyme Inhibitors (ACE inhibitors) and Angiotensin II Antagonists (AAII): NSAIDs may decrease the effectiveness of diuretics and other antihypertensive medicinal...
Pregnancy
Important safety information For diclofenac sodium MHRA/CHM advice: NSAIDs: potential risks following prolonged use after 20 weeks of pregnancy (June 2023) With systemic use: See Non-steroidal anti-inflammatory drugs .
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.
Hepatic impairment
With systemic use: Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment.
Renal impairment
With systemic use: In general, for NSAIDs the MHRA advises to avoid where possible; if necessary, use with caution (risk of fluid retention and further renal impairment, including renal failure). For diclofenac sodium , manufacturers advise avoid in severe impairment. With intravenous use: Manufacturers advise avoid in moderate to severe impairment. With topical use: In general, manufacturers advise caution (deterioration in renal function has also been reported after topical use).
Medicinal forms
Tablet,Tablet,Tablet,Tablet,Capsule,Solution,Drops,Suppository,Gel
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
Inside MedNext for this topic
- 411 MedNext-authored chapters
- 80,000+ MCQ bank
- 15 study modes
- Growing visual cheat sheets
Study modes
- Notes
- MCQ
- Audio
- Video
- Visual
- 3D Anatomy
- Trace
- Flashcards
- Mnemonics
- Image Bank
- Clinical
- Microscopy
- Audio QBank
- Cadaver
- Book Match
Continue reading
Subject HubPharmacology Hub
All pharmacology resources in one place.
Drug SchedulesIndian Drug Schedules
Schedule H, H1, X and G classifications.
FormularyBrowse all drugs
Search 1,850+ drug profiles.
Study Diclofenac sodium in the MedNext app
Challenge yourself with targeted pharmacology MCQs on this drug class. Every explanation links back to the chapter that teaches the concept.
Start drug challengeExplore the full formulary