Generic Medicine Info
Should be taken with food. Take immediately after meals.
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: 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 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.
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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