Diclofenac


Generic Medicine Info
Indications and Dosage
Intramuscular
Acute pain, Pain and inflammation associated with musculoskeletal and joint disorders, Postoperative pain
Adult: 75 mg once daily via deep intragluteal inj. If necessary, may give another 75 mg at alternate site. Max: 150 mg daily. Max duration: 2 days. Dosing recommendations and administration may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Use lowest effective dose and shortest treatment duration possible.

Intravenous
Postoperative pain
Adult: 75 mg via infusion over 30 minutes to 2 hours, may repeat after 4-6 hours if necessary. Max: 150 mg daily. As prophylaxis: Loading dose: 25-50 mg given after surgery via infusion over 15 minutes to 1 hour, followed by a continuous infusion of 5 mg/hour. Max: 150 mg daily. Dosing recommendations and administration may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Use lowest effective dose and shortest treatment duration possible.

Ophthalmic
Prophylaxis of intra-operative miosis
Adult: In patients undergoing cataract surgery: As 0.1% solution: Instil 1 drop into the affected eye(s) 4 times during 2 hours before surgery. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Ophthalmic
Ocular pain
Adult: After accidental trauma: As 0.1% solution: Instil 1 drop into the affected eye(s) 4 times daily for up to 2 days. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Ophthalmic
Postoperative ocular pain
Adult: As 0.1% solution: Radial keratotomy: Instil 1 drop into the affected eye(s) before surgery, followed by 1 drop immediately after surgery, then 1 drop 4 times daily for up to 2 days. Corneal refractive surgery: Instil 1-2 drops into the affected eye(s) within the hour before surgery, then 1-2 drops within 15 minutes after surgery, continue for 4 times daily for up to 3 days. Photorefractive keratectomy: Instil 1 drop into the affected eye(s) for 2 doses within an hour before surgery, then 1 drop for 2 doses at 5-minute interval immediately after surgery, then 1 drop every 2-5 hourly while awake for up to 24 hours. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Ophthalmic
Postoperative ocular inflammation
Adult: As 0.1% solution: Strabismus surgery: Instil 1 drop into the affected eye(s) 4 times daily for Week 1, then tid for Week 2, then bid for Week 3, then as needed for Week 4. Cataract surgery: Instil 1 drop into the affected eye(s) 4 times daily beginning 24 hours after surgery, continue up to 2 weeks post-surgery. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Ophthalmic
Control of inflammation after argon laser trabeculoplasty
Adult: As 0.1% solution: Instil 1 drop into the affected eye(s) 4 times during 2 hours before the procedure, then 1 drop 4 times daily for up to 7 days. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Ophthalmic
Seasonal allergic conjunctivitis
Adult: For relief of signs and symptoms: As 0.1% solution: Instil 1 drop into the affected eye(s) 4 times daily as needed. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Acute pain, Pain and inflammation associated with musculoskeletal and joint disorders, Pain and inflammation associated with periarticular disorders, Pain and inflammation associated with soft tissue disorders, Postoperative inflammation, Postoperative pain
Adult: 75-150 mg daily in divided doses. Max: 150 mg daily. Use the lowest effective dose for the shortest duration needed to achieve response. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Use lowest effective dose and shortest treatment duration possible.
Child: ≥14 years As diclofenac K conventional tab: 75-100 mg daily in 2-3 divided doses. Use the lowest effective dose for the shortest duration needed to achieve desired response.

Oral
Primary dysmenorrhoea
Adult: Initially, 50-100 mg given at the 1st sign of symptoms. Maintenance: Up to Max 150 mg daily in divided doses. Usual duration: 1-5 days. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Acute migraine attacks
Adult: Use the lowest effective dose for the shortest duration needed to achieve response. As diclofenac K conventional tab or cap: Initially, 50 mg at the 1st signs of attack. If symptoms persist after 2 hours, may give additional dose of 50 mg. If still needed, give 50 mg 4-6 hourly. Max: 200 mg daily. As diclofenac K powder for oral solution: 50 mg as a single dose; dissolve the contents in 30-60 mL of water. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Use lowest effective dose and shortest treatment duration possible.

Rectal
Acute pain, Pain and inflammation associated with musculoskeletal and joint disorders, Postoperative inflammation, Postoperative pain
Adult: 75-150 mg daily in divided doses. Max: 150 mg daily.
Elderly: Use lowest effective dose and shortest treatment duration possible.
Child: 1-12 years As 12.5 or 25 mg supp: 0.5-2 mg/kg daily in divided doses, depending on the severity of condition. Max: 150 mg daily.

Rectal
Juvenile rheumatoid arthritis
Child: 1-12 years As 12.5 or 25 mg supp: 0.5-2 mg/kg daily in divided doses, depending on the severity of condition. Max: 3 mg/kg daily in divided doses.

Rectal
Postoperative pain
Child: As monotherapy or as adjunct to opiate therapy: 6-12 years As 12.5 or 25 mg supp: 1-2 mg/kg daily in divided doses. Max: 4 days. 

Rectal
Primary dysmenorrhoea
Adult: 50-150 mg daily in divided doses. Max: 200 mg daily. 

Topical/Cutaneous
Pain and inflammation associated with musculoskeletal and joint disorders, Pain and inflammation associated with periarticular disorders, Pain and inflammation associated with soft tissue disorders, Sprains
Adult: As 1%, 1.16%, 2.32% diclofenac gel: Apply 2-4 g onto the affected area 2-4 times daily as necessary. As 4% diclofenac Na topical spray: Apply 4-5 sprays tid; Max: 15 sprays daily. Re-evaluate symptomatic relief after 7 days. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Initiate at the lower end of the dosing range.

Topical/Cutaneous
Actinic keratoses
Adult: As 3% diclofenac Na gel: Apply onto the affected area(s) bid. Usual treatment duration: 60-90 days. 
Elderly: Use lowest effective dose and shortest treatment duration possible.

Transdermal
Pain and inflammation associated with soft tissue disorders
Adult: As 1.3% diclofenac epolamine patch: Apply 1 patch to the most painful area once daily or bid. Use the lowest effective dose for the shortest duration needed to achieve desired response. Max treatment duration: 14 days (epicondylitis); 3 days (ankle sprain). Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Initiate at the lower end of the dosing range.
Child: ≥6 years Apply 1 patch bid to the most painful area up to 14 days.
Renal Impairment
Oral, Intravenous, Intramuscular, Rectal:
Severe: Contraindicated.
Hepatic Impairment
Oral, Intravenous, Intramuscular, Rectal:
Severe: Contraindicated.
Administration
Should be taken with food. Take immediately after meals.
Reconstitution
IV infusion: Dilute with 100-500 mL of NaCl 0.9% or glucose 5% solution (buffered with 0.5 mL of 8.4% or 1 mL of 4.2% of Na bicarbonate solution).
Contraindications
Hypersensitivity to diclofenac or other NSAIDs; history of asthma attacks, angioedema, urticaria or acute rhinitis precipitated by ibuprofen, aspirin or other NSAIDs. History or active gastrointestinal ulcers, bleeding or perforation (≥2 distinct episodes of proven ulceration or bleeding); history of gastrointestinal bleeding or perforation associated with previous NSAID treatment; established CHF (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, previous MI (within the last 6-12 months); when for IV use: patient with history of haemorrhagic diathesis, history of confirmed or suspected cerebrovascular bleeding, history of asthma, risk factors for volume depletion. Hypovolaemic or dehydrated patients (IV); proctitis (rectal). Treatment in the setting of CABG. Patient undergoing operations associated with high risk of haemorrhage (IV). Moderate to severe renal impairment in perioperative period for those at risk for volume depletion (inj). Severe renal and hepatic impairment. Pregnancy (3rd trimester). Concomitant use with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors; anticoagulant including heparin (IV).
Special Precautions
Patient with current or risk factors for CV disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, oedema, heart failure [NYHA-I], smoking); ulcerative colitis, Crohn’s disease; coagulopathy, coagulation disorders, haematological abnormalities, hypovolaemia, SLE, mixed connective tissue disorders, porphyria, asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps), COPD, chronic infection of the respiratory tract, coronavirus disease 2019 (COVID-2019); complicated ocular surgeries, repeat ocular surgeries (within short timeframe), corneal denervation, corneal epithelial defects or ocular surface disease (ophthalmic). Debilitated, dehydrated patients. Not indicated for migraine prophylaxis (oral). Different diclofenac oral formulations are not bioequivalent or interchangeable. Mild to moderate renal and hepatic impairment. Children and elderly. Pregnancy (1st-2nd trimester) and lactation.
Adverse Reactions
Significant: Kounis syndrome; Na and fluid retention, new-onset or exacerbation of hypertension, decreased platelet adhesion and aggregation, prolonged bleeding time; rarely, severe blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia); increased transaminase, increased risk of hyperkalaemia, renal papillary necrosis and other renal injury (systemic long-term use); increased risk of gastrointestinal anastomotic leak; Quincke’s oedema or urticaria; masks signs and symptoms of infection; rarely, increased risk of aseptic meningitis; keratitis, sight-threatening complication (e.g. corneal perforation) (ophthalmic).
Cardiac disorders: Chest pain.
Ear and labyrinth disorders: Tinnitus, vertigo (oral, inj).
Eye disorders: Visual impairment, blurred vision, diplopia; eye pain, irritation or pruritus, ocular hyperaemia, conjunctival hyperaemia (ophthalmic).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, flatulence, abdominal pain.
General disorders and administration site conditions: Injection site reactions (e.g. pain, induration), generalised oedema (inj); application site reactions (e.g. irritation, erythema, itchiness, dryness, oedema, blisters), pyrexia.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Limb discomfort (inj).
Nervous system disorders: Headache, dizziness, somnolence, tiredness; hypertonia, hyperaesthesia, localised paraesthesia (topical/cutaneous).
Psychiatric disorders: Insomnia, disorientation, depression, nightmare, irritability, psychotic disorder.
Skin and subcutaneous tissue disorders: Rash, skin eruptions; dermatitis (e.g. contact dermatitis), dry skin, eczema, erythema, pruritus, skin hypertrophy or ulcer, vesiculobullous or scaly rash (topical/cutaneous).
Potentially Fatal: Anaphylaxis, CV thrombotic events (e.g. MI, stroke), serious gastrointestinal inflammation, ulceration, perforation, or bleeding (e.g. haematemesis, melaena), bronchospasm; rarely, hepatotoxicity (e.g. fulminant hepatitis, hepatic necrosis or failure); serious skin reactions (e.g. drug reaction with eosinophilia and systemic symptoms, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
IV/Parenteral/PO/Topical: C (prior to 30 weeks gestation), D (starting at 30 weeks gestation); Ophth: C; Topical: B (applies to 3% topical gel); IM/IV/Parenteral/PO/Topical: Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
Patient Counseling Information
This drug may cause dizziness, drowsiness, or blurred vision, if affected, do not drive or operate machinery. Remove contact lenses prior to administration and reinsert after 15 minutes (ophthalmic). Do not apply on nonintact or damaged skin (e.g. eczema, exudating dermatitis, infected lesions, burns, wounds), eyes or mucosa. Avoid use of occlusive dressing (topical). Avoid exposure of affected area to direct sunlight or solarium UV light (transdermal or topical).
Monitoring Parameters
Assess cardiac risk and potential for gastrointestinal bleeding before initiation of therapy. Monitor CBC, blood pressure (at baseline and during therapy), K levels, LFTs (at baseline and during chronic therapy), renal function (e.g. urine output, serum creatinine and BUN), occult blood loss, signs of oedema, weight gain; signs and symptoms of gastrointestinal ulceration, perforation, or haemorrhage; mental confusion or disorientation, bleeding, bruising; serious arteriothrombotic events. Re-evaluate need for symptomatic relief and response to therapy periodically. Perform ophthalmic evaluations in patients who develop eye complaints (on long-term therapy).
Overdosage
Symptoms: Tinnitus, headache, dizziness, drowsiness, nausea, vomiting, diarrhoea, disorientation, excitation, coma, epigastric pain, gastrointestinal bleeding, fainting or convulsions. Rarely, acute renal failure, liver damage. Management: Symptomatic and supportive treatment. Administer activated charcoal post-ingestion of a potentially toxic overdose and perform gastric decontamination (e.g. vomiting, gastric lavage) post-ingestion of a potentially life-threatening overdose.
Drug Interactions
Increased risk of ulceration or bleeding with antiplatelet (e.g. aspirin), anticoagulants (e.g. warfarin), systemic corticosteroids, SSRIs. May decrease the antihypertensive effect and increase the risk of nephrotoxicity of antihypertensive drugs (e.g. β-blockers, ACE inhibitors). May increase serum K levels with K-sparing diuretics, drospirenone, ciclosporin, tacrolimus, trimethoprim. May increase serum concentration of lithium, digoxin, methotrexate, phenytoin. Increased risk of nephrotoxicity with ciclosporin, tacrolimus. Possible occurrence of convulsions with quinolones. May have decreased absorption with colestipol and cholestyramine. May exacerbate cardiac failure, decrease GFR and increase serum glycoside levels with cardiac glycosides. May decrease the effect of mifepristone. Significantly increased peak plasma concentration and exposure with potent CYP2C9 inhibitors (e.g. sulfinpyrazone, voriconazole). May increase toxicity of baclofen, pemetrexed. Increased risk of haematological toxicity with zidovudine. Decreases serum concentration with CYP2C9 inducers (e.g. rifampicin). May aggravate gastrointestinal side effects with glucocorticoids. Increased risk of developing corneal complication and delayed or impaired healing with topical steroids (topical). Increased risk of adverse effect with oral NSAIDs (topical/cutaneous).
Potentially Fatal: Increased risk of gastrointestinal bleeding or ulceration with other systemic NSAIDs.
Food Interaction
Increased risk of gastrointestinal bleeding with alcohol.
Action
Description:
Mechanism of Action: Diclofenac, an NSAID derived from phenylacetic acid, has analgesic, anti-inflammatory and antipyretic properties. It reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, resulting in the suppression of prostaglandin synthesis.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract, skin. Decreased absorption rate with food. Bioavailability: 55%. Time to peak plasma concentration (under fasted conditions): Approx 1 hour (conventional tab or cap, supp); approx 4-5 hours (extended-release tab or cap); approx 0.25 hour (powder for oral solution); approx 20 minutes (IM); 10-20 hours (transdermal).
Distribution: Penetrates the synovial fluid. Crosses the placenta, enters breast milk. Volume of distribution: Approx 1.3-1.4 L/kg (oral). Plasma protein binding: >99%, mainly to albumin.
Metabolism: Undergoes first-pass metabolism in the liver and metabolised via hydroxylation and methoxylation into 4'-hydroxydiclofenac, 3'-hydroxydiclofenac, 5-hydroxydiclofenac, 4',5-dihydroxydiclofenac and 3'-hydroxy-4'-methoxydiclofenac; further metabolised via glucuronidation or sulfation.
Excretion: Mainly via urine (approx 60% as glucuronide and sulfate conjugates); bile (approx 35%). Terminal elimination half-life: Approx 1-2 hours; approx 12 hours (transdermal).
Chemical Structure

Chemical Structure Image
Diclofenac

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3033, Diclofenac. https://pubchem.ncbi.nlm.nih.gov/compound/Diclofenac. Accessed Apr. 27, 2023.

Storage
Tab/Cap/Powder for oral solution: Store between 20-25°C. Protect from light and moisture. Solution for inj/Eye drop solution: Store between 20-25°C. Protect from light. Supp: Store below 25°C. Protect from heat. Topical gel: Store below 30°C. Protect from heat. Topical solution/Patch: Store between 20-25°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) / Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
S01BC03 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
D11AX18 - diclofenac ; Belongs to the class of other dermatologicals.
References
Anon. Diclofenac (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 17/03/2023.

Anon. Diclofenac (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 17/03/2023.

Anon. Diclofenac (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 17/03/2023.

Buckingham R (ed). Diclofenac. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/03/2021.

Cambia Powder for Solution (Assertio Therapeutics, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/03/2021.

Cataflam Sugar-coated Tablets (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/03/2023.

Cataflam Tablet (Blucrest Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/03/2023.

Diclofenac Epolamine System (Teva Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/03/2023.

Diclofenac Sodium Solution/Drops (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/03/2023.

Dicloflex Retard 100 mg (Dexcel-Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 23/03/2023.

Econac 75 mg/3 mL Solution for Injection (Mercury Pharma Group Ltd). MHRA. https://products.mhra.gov.uk. Accessed 03/03/2021.

Flector Tissuegel 140 mg Medicated Plaster (IBSA Farmaceutici Italia S.r.l.). MHRA. https://products.mhra.gov.uk. Accessed 23/03/2023.

Joint Formulary Committee. Diclofenac Potassium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/03/2023.

Joint Formulary Committee. Diclofenac Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/03/2021.

Novartis New Zealand Limited. Voltaren 12.5 mg, 25 mg, 50 mg, 100 mg Suppositories data sheet 04 November 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 23/03/2023.

Novartis New Zealand Limited. Voltaren 75 mg/3 mL Solution for Injection data sheet 03 November 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 23/03/2023.

Novartis New Zealand Limited. Voltaren D 50 mg Dispersible Tablet data sheet 03 November 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 03/03/2021.

Novartis New Zealand Limited. Voltaren Ophtha Eye Drops 0.1% data sheet 02 November 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 23/03/2023.

Pennsaid Solution (Horizon Therapeutics USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/06/2021.

Voltaren Emulgel 1% (GlaxoSmithKline Consumer Healthcare Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/03/2023.

Voltaren Film-coated Tablets (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/03/2023.

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Voltarol 12 Hour Emulgel P 2.32% Gel, Voltarol Max Strength Pain Relief 2.32% Gel, Voltarol 12 Hour Joint Pain Relief 2.32% Gel (GlaxoSmithKline Consumer Healthcare [UK] Trading Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/03/2021.

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Disclaimer: This information is independently developed by MIMS based on Diclofenac from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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