Generic Medicine Info
Should be taken with food. Take immediately after meals.
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-1], 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. Patient Counselling 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).
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), generalized 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, localized 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).
ROUTE(S) : Topical: B applies to 3% topical gel
ROUTE(S) : Ophth: C
ROUTE(S) : IV / PO / Parenteral / Topical: C prior to 30 weeks gestation
ROUTE(S) : IV / PO / Parenteral / Topical: D starting at 30 weeks gestation
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-sparring 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).
CIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) / Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
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.
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