Diclofenac Sodium, Inj/Oral/Suppositories
Anti-rheumatic, Systemic · Phenylacetic acid
Indications
CAP/TAB/SUPPOSITORIES: Muscular-skeletal disorders, rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute gout. Chronic juvenile arthritis. INJECTION: Acute back pain, post- operative pain, pain in acute trauma and fractures, renal colic.
Dosage
Adults: ORAL: 75-150 mg daily in two or three divided doses. SUPPOSITORIES: 75-150 mg rectally daily in divided doses. INJECTION: 75 mg IM once or twice daily by deep intragluteal inj for max 2 days. Continue if necessary with tab. Acute postoperative pain: By IV injection 75 mg repeated every 4-6 hr if necessary, max 150 mg in 24 hr. Prevention of postoperative pain, a loading dose of 25-50 mg should be infused after surgery over 15 min to 1 hour, followed by continuous infusion of about 5 mg per hour up to maximum 150 mg in 24 hours. Moderate to severe postoperative pain, 75 mg infused continuously over a period of 30 min to 2 hours. Children: Not recommended for children under 1 yr; suppositories not recommended for children under 6 yr except for children over 1 yr for juvenile idiopathic arthritis. Injection not recommended for children. Inflammation and mild to moderate pain: ORAL…
Administration
IV Infusion: Maximum 150 mg in 24 hours. Must not be given by IV bolus injection. By IV infusion diluted with 0.9% saline or 5% dextrose infusion solution.
Adverse Effects
Transient epigastric pain, GI disturbances, headache, oedema. Rarely blood dyshaematopoiesis, peptic ulcer, abnormalities of liver and kidney function, skin reactions, pain at injection site.
Risk Factor (Pregnancy/Lactation)
Pregnancy: No evidence of risk in humans. Lactation: Contraindicated or not recommended. Contraindications: Active peptic ulcer, aspirin/anti-inflammatory induced allergy or asthma. Proctitis. 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/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 per…
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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