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 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.
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
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.
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 © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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