Diclofenac Potassium

Anti-rheumatic, Systemic · Phenylacetic acid

Indications

Short-term treatment in the following acute conditions: Painful post-traumatic inflammatory states. Post- operative inflammation and pain. Painful and/or inflammatory conditions in gynaecology. Painful syndromes of the vertebral column. Non-articular rheumatism. As adjuvant in severe painful inflammatory infections of the ear, nose and throat. (Fever alone is not an indication). Acute gout.

Dosage

Adults: Pain: 50 mg every 8 hr or 100 mg 1st dose, then 50 mg every 8 hr. Max: 150 mg/day (200 mg/day on 1st day). Osteoarthritis: 50 mg every 8 hr or every 12 hr. Max: 200 mg/day. Rheumatoid Arthritis: 50 mg every 8 hr or every 6 hr. Max: 225 mg/day. Dysmenorrhoea: 50 mg every 8 hr or 100 mg 1st dose, then 50 mg every 8 hr. Max: 150 mg/day (200 mg/day on 1st day). Migraine: 50 mg at onset, repeated after 2 hr if necessary then after 4-6 hr; max 200 mg in 24 hr. Acute gout: 75-150 mg daily in 2-3 divided doses. Children: Rheumatic disease and musculoskeletal disorders: 14-18 yr, 75-100mg daily in 2-3 divided doses. Postoperative pain: 9-14 yr and body-weight over 35 kg, up to 2 mg/kg (max 100 mg) daily in 3 divided doses; 14-18 yr, 75-100 mg daily in 2-3 divided doses. Fever in ear, nose, or throat infection: 9-18 yr and body-weight over 35 kg, up to 2 mg/kg (max 100 mg) daily in 3…

Adverse Effects

Gastro-intestinal disorders, headache, dizziness, vertigo, rash, elevation of SGOT, SGPT. Peptic ulcer, gastro-intestinal bleeding, hepatitis, hypersensitivity reactions. Disturbances of sensation, erythema multiforme, purpura, abnormalities of renal or hepatic function, blood dyscrasias, abdominal pain, anorexia, oedema, mucosal lesions or hypersensitivity (discontinue). Severe skin reactions and arterial thrombotic events.

Risk Factor (Pregnancy/Lactation)

Pregnancy: No evidence of risk in humans. Lactation: Contraindicated or not recommended. Contraindications: Active peptic ulcer. Hypersensitivity to aspirin or other prostaglandin synthesis-inhibiting drugs. Severe hepatic or renal impairment. Ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, CHF. Precautions: Monitor patients on long-term treatment. History of gastro-intestinal disease. Renal, hepatic or cardiac insufficiency and haematological abnormalities. Porphyria. Patient with extracellular volume depletion from any cause. On long term therapy monitor liver function, blood counts. Elderly. Cardiovascular disease, hypertension, cardiovascular risk factors, volume depletion. Coagulation defects. SLE and connective tissue disorders.

Interactions

Anticoagulants, antidiabetics, diuretics, methotrexate, lithium, digoxin, cyclosporin, tacrolimus, other NSAIDs, salicylates, corticosteroids, quinolones, mifepristone, antihypertensives, antiplatelets, SSRIs, phenytoin, colestipol, colestyramine, zidovudine, trimethoprim, sulfinpyrazone, voriconazole and other potent CYP2C9 inhibitors.

Advice to Patient

Take with meals to reduce GI discomfort. Do not chew, crush or dissolve tablet. Swallow whole with a full glass of water. After taking medication, do not lie down for 15-30 minutes to decrease risk of esophageal ulceration. Discontinue medication and inform prescriber if there is constant stomach pain, cramps, blood in stool. Contact prescriber if there is difficulty in breathing, blood in urine/stool/mouth/vomitus, black stool, easy bruising or bleeding, chest pain, palpitations, swelling of extremities, jaundice, unusual weight gain, unusual fatigue, nausea, diarrhoea, skin rash, skin itching, blisters, ringing in ears, changes in hearing, vision or urinary pattern, difficulty in speaking. Avoid alcohol during therapy. Do not take aspirin, aspirin-containing medications or other anti-inflammatory medications without consulting prescriber. Take sufficient amount of fluids (2-3 litres…

Pharmacokinetics

Absorption: Oral: Approx. 50% (systemically available). Metabolism: Hepatic; undergoes first-pass metabolism; forms several metabolites (1 with weak activity). Bioavailability: 55%. Half-life elimination: Oral: Approx. 2 hours; approx. 1 hour (liquid filled capsule); inj : Approx. 1.4 hours. Time to peak, serum: Note: Fasted values reported for oral products; may be delayed with food. Injection: Approx. 5 minutes. Tablet, delayed release (diclofenac sodium): 2.3 hours. Tablet, extended release (diclofenac sodium): 5.3 hours. Excretion: Urine (approx. 65%); bile (approx. 35%).

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

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