Diclofenac


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Mild to moderate acute pain As conventional tablet: 50 mg bid-tid. As conventional capsule (acid): 18-35 mg tid. As conventional capsule (K salt): 25 mg qid. As delayed-release tablet: 75-150 mg/day. Osteoarthritis; Rheumatoid arthritis; Ankylosing spondylitis; Acute musculoskeletal disorders; Pain after accidental trauma; Bursitis; Sprains; Strains; Tendinitis; Pyrophosphate arthropathy; Acute gout; Pain and inflammation associated with orthopaedic, dental and other minor surgery As conventional tablet: 50 mg bid-tid. As conventional capsule (acid): 35 mg tid. As delayed-release tablet: 75-150 mg/day in 2-3 divided doses. As extended-release tablet or capsule: 75 mg once daily - bid or 100 mg/day. Migraine As conventional tablet: 50 mg at 1st signs of attack; if needed, another 50 mg after 2 hours; if still needed, 50 mg 4-6 hourly. Max: 200 mg/day. As powder for oral solution: 50 mg in 30-60 mL water. Primary dysmenorrhoea As conventional tablet: 50 mg tid. IV Mild to moderate acute pain 37.5 mg as bolus 6 hourly. Postoperative pain Treatment: 75 mg as infusion; may repeat after 4-6 hours. Prophylaxis: After surgery, 25-50 mg as infusion; then, approx 5 mg hourly. Max: 150 mg/day. Max period: 2 days. IM Acute pain; Osteoarthritis; Rheumatoid arthritis; Acute gout; Pain after accidental trauma; Postoperative pain 75 mg/day. Renal colic 75 mg; may repeat after 30 minutes. Max: 150 mg/day. Max period: 2 days. Rectal Acute pain; Osteoarthritis; Rheumatoid arthritis; Ankylosing spondylitis; Acute musculoskeletal disorders; Pain after accidental trauma; Bursitis; Sprains; Strains; Tendinitis; Acute gout; Pain and inflammation associated with orthopaedic, dental and other minor surgery As 25, 50 or 100 mg suppository: 75-150 mg/day. Transdermal Acute pain; Pain after accidental trauma; Sprains; Strains As plaster containing 140 mg diclofenac Na: 1 plaster bid. Max period: 7 days. As patch containing 180 mg diclofenac epolamine: 1 plaster bid. Topical/Cutaneous Osteoarthritis As 1% diclofenac Na gel: Upper extremities: 2 g qid up to 8 g/joint/day. Lower extremities: 4 g qid up to 16 g/joint/day. Max: 32 g/day as body dose. As 1.5% solution: Lower extremities: 40 drops/knee qid. As 2% solution: Lower extremities: 40 mg/knee bid. Local symptomatic relief of pain and inflammation; Pain after accidental trauma; Sprains; Strains; Osteoarthritis As 1.16% diclofenac diethylammonium gel: 2-4 g tid-qid. As 2.32% diclofenac diethylammonium gel: 2-4 g bid. Max: 8 g/day. Max period: 7 days. Actinic keratoses As 3% diclofenac Na gel: Apply bid for 60-90 days. Ophthalmic Pain after accidental trauma As 0.1% solution: 1 drop qid for up to 2 days. Postoperative ocular inflammation 1 drop qid for up to 28 days. Prophylaxis of intra-operative miosis 1 drop 4 times within 2 hours before surgery. Post-photorefractive keratectomy pain Before surgery, 1 drop twice within an hour. Immediately after surgery, 1 drop twice with 5-minute interval; then, 1 drop 2-5 hourly while awake for up to 24 hours. Control of inflammation after argon laser trabeculoplasty Before procedure, 1 drop 4 times within 2 hours; afterwards, 1 drop qid for up to 7 days. Inflammation and discomfort after strabismus surgery 1 drop qid for week 1, tid for week 2, bid for week 3 and as needed for week 4. Pain and discomfort after radial keratotomy As 0.1% solution: Before surgery, 1 drop; immediately after surgery, 1 drop qid for up to 2 days. Seasonal allergic conjunctivitis 1 drop qid.
Dosage Details
Intramuscular
Renal colic
Adult: 75 mg; if needed, may repeat after 30 minutes. Max: 150 mg daily. Max period: 2 days.

Intramuscular
Acute gout, Acute pain, Osteoarthritis, Pain after accidental trauma, Postoperative pain, Rheumatoid arthritis
Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.

Intravenous
Acute pain
Adult: For mild to moderate cases: 37.5 mg as bolus inj 6 hourly as needed. Max: 150 mg daily. Max period: 2 days.

Intravenous
Postoperative pain
Adult: As treatment: 75 mg by IV infusion over 30 minutes to 2 hours or as bolus inj; if needed, may repeat after 4-6 hours. As prophylaxis: After surgery, initially, 25-50 mg by IV infusion over 15 minutes to 1 hour or as bolus inj then, a continuous infusion approx 5 mg hourly. Max: 150 mg daily. Max period: 2 days.

Ophthalmic
Pain after accidental trauma
Adult: As 0.1% solution: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily for up to 2 days.

Ophthalmic
Postoperative ocular inflammation
Adult: As 0.1% solution: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily for up to 28 days.

Ophthalmic
Post-photorefractive keratectomy pain
Adult: As 0.1% solution: Before surgery, instill 1 drop into the conjunctival sac of the affected eye(s) for 2 doses within an hour. Immediately after surgery, 1 drop for 2 doses with 5-minute interval; then, 1 drop 2-5 hourly while awake for up to 24 hours.

Ophthalmic
Prophylaxis of intra-operative miosis
Adult: As 0.1% solution: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times within 2 hours before surgery.

Ophthalmic
Inflammation and discomfort after strabismus surgery
Adult: As 0.1% solution: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily for week 1, tid for week 2, bid for week 3 and as needed for week 4.

Ophthalmic
Control of inflammation after argon laser trabeculoplasty
Adult: As 0.1% solution: Before procedure, instill 1 drop into the conjunctival sac of the affected eye(s) 4 times within 2 hours; afterwards, 1 drop 4 times daily for up to 7 days.

Ophthalmic
Seasonal allergic conjunctivitis
Adult: As 0.1% solution: Instill 1 drop into into the conjunctival sac of the affected eye(s) 4 times daily.

Ophthalmic
Pain and discomfort after radial keratotomy
Adult: As 0.1% solution: Before surgery, instill 1 drop into affected eye(s) then, immediately after surgery, 1 drop into the conjunctival sac of the affected eye(s) 4 times daily for up to 2 days.

Oral
Acute pain
Adult: For mild to moderate cases: As conventional tablet: 50 mg bid-tid. As conventional capsule in acid form: 18-35 mg tid. As conventional capsule in K salt form: 25 mg 4 times daily. As delayed-release tablet: 75-150 mg daily in 2-3 divided doses.
Child: >14 years As conventional tablet: 25 mg tid or 50 mg bid.

Oral
Primary dysmenorrhoea
Adult: As conventional tablet: 50 mg tid.

Oral
Migraine
Adult: As conventional tablet: Initially, 50 mg at the 1st signs of attack. If symptoms persist after 2 hours, may take additional dose of 50 mg. If still needed, take 50 mg 4-6 hourly. Max: 200 mg daily. As powder for oral solution: Mix 50 mg with 30-60 mL water. Drink immediately.

Oral
Juvenile chronic arthritis
Child: 1-12 years As delayed-release tablet: 1-3 mg/kg daily in divided doses.

Oral
Fever associated with ear, nose or throat (ENT) infections, Postoperative pain
Child: >9 years ≥35 kg: As delayed-release tablet: 2 mg/kg daily in 3 divided doses.

Oral
Acute gout, Acute musculoskeletal disorders, Ankylosing spondylitis, Bursitis, Osteoarthritis, Pain after accidental trauma, Pain and inflammation associated with dental surgery, Pain and inflammation associated with minor surgery, Pain and inflammation associated with orthopaedic surgery, Pyrophosphate arthropathy, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Tenosynovitis
Adult: As conventional tablet: 50 mg bid-tid. As conventional capsule in acid form: 35 mg tid. As delayed-release tablet: 75-150 mg daily in 2-3 divided doses. As extended-release tablet or capsule: 75 once daily – bid or 100 mg once daily. Max: 150 mg daily.
Child: >14 years As conventional tablet: 25 mg tid or 50 mg bid.

Rectal
Acute gout, Acute musculoskeletal disorders, Acute pain, Ankylosing spondylitis, Bursitis, Osteoarthritis, Pain after accidental trauma, Pain and inflammation associated with dental surgery, Pain and inflammation associated with minor surgery, Pain and inflammation associated with orthopaedic surgery, Rheumatoid arthritis, Sprains, Strains, Tendinitis
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.

Rectal
Postoperative pain
Child: ≥6 years As 12.5 or 25 mg supp: 1-2 mg/kg daily in divided doses. Max period: 4 days.

Rectal
Juvenile chronic arthritis
Child: 1-12 years As 12.5 or 25 mg supp: 1-3 mg/kg daily in 2-3 divided doses.

Topical/Cutaneous
Actinic keratoses
Adult: As 3% diclofenac Na gel: Apply on affected area bid for 60-90 days.

Topical/Cutaneous
Osteoarthritis
Adult: As 1% diclofenac Na gel: Upper extremities: Apply 2 g onto affected area 4 times daily. Max dose: 8 g per joint daily. Lower extremities: Apply 4 g onto affected area 4 times daily. Max dose: 16 g per joint daily. Max: 32 g daily as body dose. As 1.5% solution: Lower extremities: 40 drops per knee 4 times daily. As 2% solution: Lower extremities: 40 mg per knee bid.

Topical/Cutaneous
Local symptomatic relief of pain and inflammation, Osteoarthritis, Pain after accidental trauma, Sprains, Strains
Adult: As 1.16% diclofenac diethylammonium gel: Apply 2-4 g onto affected area 3-4 times daily. As 2.32% diclofenac diethylammonium gel: Apply 2-4 g onto affected area bid. Max: 8 g daily. Max duration of treatment: 7 days.
Child: ≥14 years Same as adult dose.

Transdermal
Acute pain, Pain after accidental trauma, Sprains, Strains
Adult: As plaster containing 140 mg diclofenac Na: 1 plaster bid. Max duration of treatment period: 7 days. As patch containing 180 mg diclofenac epolamine: 1 plaster bid.
Child: ≥16 years As plaster containing 140 mg diclofenac Na: Same as adult dose.
Renal Impairment
Oral/IV/IM/Rectal:
Severe: Contraindicated.
Hepatic Impairment
Oral/IV/IM/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. Aspirin-sensitive asthma, risk factors for volume depletion (inj). Moderate to severe heart failure, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, gastrointestinal ulceration, perforation or haemorrhage, proctitis (rectal). Treatment in the setting of CABG. Concomitant use of other NSAIDs, antiplatelets, anticoagulants. Severe hepatic or renal impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with history of gastrointestinal bleeding or peptic ulceration, coagulopathy, current or risk factors for CV disease (e.g. CHF, ischaemic heart disease, CVA, hypertension, oedema, hyperlipidaemia, diabetes mellitus), dehydration, hypovolemia, asthma, rhinitis, COPD, respiratory tract infections, SLE, mixed connective tissue disorders, porphyria, ocular disease including infections (ophthalmic). Hepatic and renal impairment. Children. Pregnancy (1st-2nd trimester) and lactation. Smokers. Avoid prolonged use for migraine (powder for oral solution).
Adverse Reactions
Significant: Na and fluid retention, oedema, HTN, liver function abnormalities (e.g. increased liver, transaminase, enzyme levels), anaemia, rare severe blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia), risk of hyperkalaemia; keratitis (ophthalmic).
Cardiac disorders: Chest pain.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Blurred vision; transient burning or stinging of the eyes, lacrimation, increased intraocular pressure (ophthalmic).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dyspepsia, flatulence, abdominal pain.
General disorders and administration site conditions: Injection site reactions (e.g. pain), application site reactions (e.g. irritation, erythema, itchiness, dryness, oedema, pyrexia.
Infections and infestations: Influenza.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia, osteoarthritis, back pain, limb pain.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Insomnia, somnolence.
Renal and urinary disorders: UTI, renal function abnormality, haematuria.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, nasopharyngitis, sinusitis, bronchitis, cough.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Vascular disorders: Hypotension.
Potentially Fatal: Anaphylaxis reaction, CV thrombotic events (e.g. MI, stroke), gastrointestinal ulceration, perforation or haemorrhage, bronchospasm; rarely, hepatotoxicity (e.g. fulminant hepatitis, hepatic necrosis or failure), Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.
Topical: C (FDA Pregnancy Category B for 3% topical gel); IV/Parenteral/PO/Rectal: C (prior to 30 weeks gestation); Ophth: C; IV/Parenteral/PO/Rectal/Topical: D (starting at 30 weeks gestation)
Patient Counseling Information
This drug may cause dizziness, drowsiness or blurred vision, if affected, do not drive or operate machinery. Avoid excessive exposure of affected area to sunlight (transdermal or topical/cutaneous). Remove contact lenses prior to administration and reinsert after 15 minutes (ophthalmic).
MonitoringParameters
Monitor CBC, blood pressure (at baseline and during therapy), K levels, LFTs (including ALT/AST levels), renal function (including urine output, BUN, serum creatinine), occult blood loss, oedema, weight gain; signs and symptoms of gastrointestinal ulceration, perforation or haemorrhage; mental confusion, disorientation, bleeding, bruising.
Overdosage
Symptoms: Lethargy, tinnitus, headache, drowsiness, nausea, vomiting, diarrhoea, dizziness, disorientation, excitation, epigastric pain, gastrointestinal bleeding, convulsions; rarely, anaphylactoid reactions, hypertension, respiratory depression, acute renal failure, coma. Management: Symptomatic and supportive treatment. Maintain a clear airway. Administration of activated charcoal within 1 hour of ingestion or perform gastric lavage. May perform osmotic cathartic within 4 hours of ingestion.
Drug Interactions
Increased risk of gastrointestinal ulceration, perforation or haemorrhage with other corticosteroids, SSRIs. Increased risk CV-related adverse reactions with cardiac glycosides. Increased risk of hyperkalaemia and renal toxicity with ACE inhibitors, diuretics, ciclosporin, tacrolimus. Increased risk of haematological toxicity with zidovudine. Increased levels and risk of toxicity with digoxin, lithium, methotrexate, pemetrexed, phenytoin. Decreased effect with colestipol, cholestyramine. Decrease effect of mifepristone. Increased peak plasma concentration with CYP2C9 inhibitors e.g. voriconazole.
Potentially Fatal: Increased risk of gastrointestinal ulceration, perforation or haemorrhage with other NSAIDs (e.g. aspirin), antiplatelets, anticoagulants (e.g. warfarin).
Food Interaction
Decreased absorption with food. Avoid alcohol.
Lab Interference
May cause false-positive aldosterone/renin ratio.
Action
Description: Diclofenac, an NSAID derived from phenylacetic acid, has analgesic, anti-inflammatory and antipyretic properties. It reversibly inhibits cyclooxygenase-1 and 2 thereby, also inhibiting prostaglandin synthesis.
Pharmacokinetics:
Absorption: 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 tablet or capsule, suppositories); 2-3 hours (delayed-release tablet); approx 4-5 hours (extended-release tablet or capsule); approx 0.25 hour (powder for oral solution); approx 5 minutes (IV); approx 20 minutes (IM); 10-20 hours (transdermal).
Distribution: Crosses the placenta and enters breastmilk. Volume of distribution: Approx 1.3-1.4 L/kg. Plasma protein binding: >99% mainly to albumin.
Metabolism: Undergoes first-pass metabolism in the liver via hydroxylation and methoxylation into metabolites including 4'-hydroxydiclofenac (major), 3'-hydroxydiclofenac, 5-hydroxydiclofenac, 4',5-dihydroxydiclofenac and 3'-hydroxy-4’-methoxydiclofenac; further metabolised via glucuronidation.
Excretion: Mainly via urine (approx 60% as metabolites including glucuronide conjugates; <1% as unchanged drug); bile (approx 35%). Terminal elimination half-life: Approx 1-2 hours (tablet, capsule, inj, suppositories); approx 12 hours (transdermal patch).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Diclofenac, CID=3033, https://pubchem.ncbi.nlm.nih.gov/compound/Diclofenac (accessed on Jan. 21, 2020)

Storage
Store between 20-25°C. Supp: Protect suppositories from heat. Gel: Protect from heat. Ophthalmic: Protect from light. IV: Protect from light and heat.
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 18/06/2018.

Anon. Diclofenac (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/06/2018.

Anon. Diclofenac (Topical). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 18/06/2018.

Anon. Diclofenac (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/06/2018.

Anon. Diclofenac. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com/. Accessed 18/06/2018.

Buckingham R (ed). Diclofenac. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/06/2018.

Cambia Diclofenac Potassium Powder, For Solution (Depomed, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

Diclofenac Potassium Tablet, Film Coated (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

Diclofenac Sodium Tablet, Delayed Release (Boehringer Ingelheim Roxane Laboratories). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

Diclofenac Sodium Tablet, Film Coated, Extended Release (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

Dyloject Injection. U.S. FDA. https://www.fda.gov/. Accessed 28/06/2018.

Flector Patch (Pfizer, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

Joint Formulary Committee. Diclofenac potassium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/06/2018.

Pennsaid Solution (Horizon Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

Pennsaid Solution (Nuvo Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

Solaraze Gel (PharmaDerm). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

Voltaren Gel (Endo Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

Voltaren Solution (Novartis Pharmaceutical Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/07/2018.

Zipsor Capsule, Liquid Filled (Depomed, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

Zorvolex Capsule (Iroko Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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