Diclofenac Sodium and Misoprostol

Anti-rheumatic, Systemic · Phenylacetic acid/Prostaglandin

Indications

Prophylaxis against NSAIDs induced gastric ulceration in patients requiring diclofenac sodium for rheumatoid arthritis, osteoarthrosis.

Dosage

Adults: 1 tab of 50 mg two-three times daily or 1 tab of 75 mg two times daily. Children: Not recommended.

Adverse Effects

GI upset, menorrhagia, intermenstrual bleeding, skin reactions, headache, dizziness, oedema, rash, pruritus, foetal malformation, raised LFTs.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Active peptic ulcer, aspirin/anti-inflammatory induced allergy or asthma. Women planning pregnancy. Severe hepatic or renal failure. Ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, CHF. Treatment of pain before CABG surgery. Precautions: Monitor patients on long-term treatment. History of gastro-intestinal lesions. Renal, hepatic or cardiac impairment. Cerebrovascular coronary or peripheral disease. Pre-menopausal women should use effective contraception. Haematopoietic disorders, defective coagulation or history of cerebrovascular bleeding. Severe dehydration. Hypertension; monitor BP during and throughout therapy. Monitor liver function periodically. Monitor blood counts and renal function during long term treatment. Use lowest effective dose for…

Interactions

Salicylates, methotrexate, lithium, digoxin, diuretics, cyclosporin, anticoagulants, oral hypoglycaemics, quinolones, NSAIDs, corticosteroids, methotrexate, tacrolimus, azole antifungals, antiplatelets, SSRIs, antihypertensives, mifepristone, antacids, CYP2C9 inhibitors.

Pharmacokinetics

DICLOFENAC SODIUM: 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%). MISOPROSTOL: Onset of action: 30 min. Duration of action: 3 hrs. Absorption: Rapid and extensive. Metabolism: Hepatic. Half-life elimination: 20-40 min. Time to peak, serum: Fasting: 12 ± 3 min. Excretion: Urine.

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

Always consult a pharmacist or doctor.