Diclofenac


Full Prescribing Info
Dosage/Direction for Use

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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Acute gout
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Acute musculoskeletal disorders
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Ankylosing spondylitis
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Bursitis
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Osteoarthritis
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Rheumatoid arthritis
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Sprains
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Strains
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Tendinitis
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Pain after accidental trauma
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Pyrophosphate arthropathy
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Pain and inflammation associated with orthopaedic surgery
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Pain and inflammation associated with dental surgery
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Pain and inflammation associated with minor surgery
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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

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

Oral
Postoperative pain
Child: >9 years ≥35 kg: As delayed-release tablet: 2 mg/kg daily in 3 divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

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

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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Oral
Primary dysmenorrhoea
Adult: As conventional tablet: 50 mg tid.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.
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).

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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.
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).

Intramuscular
Acute gout

Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Intramuscular
Acute pain
Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Intramuscular
Osteoarthritis
Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Intramuscular
Postoperative pain
Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Intramuscular
Rheumatoid arthritis
Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Intramuscular
Pain after accidental trauma
Adult: 75 mg once daily by intragluteal inj. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Intramuscular
Renal colic
Adult: 75 mg; if needed, may repeat after 30 minutes. Max: 150 mg daily. Max period: 2 days.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Transdermal
Acute pain
Adult: As plaster containing 140 mg diclofenac Na: 1 plaster bid. Max duration of treatment: 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.

Transdermal
Sprains
Adult: As plaster containing 140 mg diclofenac Na: 1 plaster bid. Max duration of treatment: 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.

Transdermal
Strains
Adult: As plaster containing 140 mg diclofenac Na: 1 plaster bid. Max duration of treatment: 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.

Transdermal
Pain after accidental trauma
Adult: As plaster containing 140 mg diclofenac Na: 1 plaster bid. Max duration of treatment: 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.

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

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

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

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

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

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.

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.

Rectal

Acute gout
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Acute musculoskeletal disorders
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Acute pain
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Ankylosing spondylitis
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Bursitis
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Osteoarthritis
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Rheumatoid arthritis
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Sprains
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Strains
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Tendinitis
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Pain after accidental trauma
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Pain and inflammation associated with orthopaedic surgery
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Pain and inflammation associated with dental surgery
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

Rectal
Pain and inflammation associated with minor surgery
Adult: As 25, 50 or 100 mg suppository: 75-150 mg daily in divided doses.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

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.
Renal impairment: Severe: Contraindicated.
Hepatic impairment:
Severe: Contraindicated.

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

Osteoarthritis
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.

Topical/Cutaneous
Sprains
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.

Topical/Cutaneous
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.

Topical/Cutaneous
Local symptomatic relief of pain and inflammation
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.

Topical/Cutaneous
Pain after accidental trauma
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.

Topical/Cutaneous
Actinic keratoses
Adult: As 3% diclofenac Na gel: Apply on affected area bid for 60-90 days.
Administration
Should be taken with food. Take immediately after meals.
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, ulcerative colitis, Crohn's disease, 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. Elderly, children. Pregnancy (1st-2nd trimester) and lactation. Smokers. Avoid prolonged use for migraine (powder for oral solution). Patient Counselling This drug may cause dizziness, drowsiness or blurred vision, if affected, do not drive or operate machinery. Avoid use of occlusive dressing (topical). Avoid excessive exposure or affected area to sunlight (transdermal or topical/cutaneous). Remove contact lenses prior to administration and reinsert after 15 minutes (ophthalmic). Monitoring Parameters 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.
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, heartburn, constipation, dyspepsia, flatulence, abdominal pain. General disorders and administration site conditions: Injection site reactions (e.g. pain, extravasation), application site reactions (e.g. irritation, erythema, itchiness, dryness, oedema), pyrexia. Infections and infestations: Influenza. Investigations: Prolonged bleeding time. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Arthralgia, osteoarthritis, back pain, limb pain. Nervous system disorders: Headache, dizziness. Psychiatric disorder: 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, 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.
ROUTE(S) : Topical: C FDA Pregnancy Category B for 3% topical gel
ROUTE(S) : IV / Ophth / PO / Parenteral / Rectal: C prior to 30 weeks gestation
ROUTE(S) : IV / PO / Parenteral / Rectal / Topical: D starting at 30 weeks gestation
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
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.
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.
Storage
Intramuscular: Store between 20-25°C. Intravenous: Store between 20-25°C. Protect from light and heat. Ophthalmic: Store between 20-25°C. Protect from light. Oral: Store between 20-25°C. Rectal: Store between 20-25°C. Protect suppositories from heat. Topical/Cutaneous: Store between 20-25°C. Protect from heat. Transdermal: Store between 20-25°C.
ATC Classification
D11AX18 - diclofenac ; Belongs to the class of other dermatologicals.
S01BC03 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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