ACHEDEC
DICLOFENAC SODIUM · by DYSON R L
Composition
TAB/Cap 25 mg/50 mg/75 mg/100 mg: Diclofenacsodium 25 mg/50 mg/75 mg/ 100 mg. Inj 75 mg: Per ml: Diclofenac sodium 25 mg; 3 ml (75 mg) amp.Suppositories 12.5 mg/25 mg/50 mg/100 mg: Diclofenac
Indications & Dosage
Pain and inflammation in rheumatic disease including juvenile idiopathic arthritis: ORAL: Adult: 75-150 mg daily in 2-3 divided doses. Children 6 months-18 yrs: 1.5-2.5 mg/kg (max 75 mg) twice daily; total daily dose may alterna-tively be given in 3 divided doses. BY RECTUM: Adult: 75-150 mg Suppositories daily in divided doses; Children 6 months-18 yr: Body-weight 8-12 kg: 12.5 mg Suppositories twice daily for max 4 days; Body-weight over 12 kg: 1 mg/kg Suppositories (max 50 mg) 3 times daily for max 4 days. BY IV INF OR DEEP IM INJ: Children 2-18 yr: 0.3-1 mg/kg once or twice daily IV INF or deep IM injection into gluteal muscle, for max 2 days (max 150 mg daily). Pain and inflammation in musculoskeletal disorders, Acute gout rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute gout: ORAL: Adult: 75-150 mg daily in 2-3 divided doses. BY RECTUM: Adult: 75-150 mg suppositories daily in divided doses Children 2-18 yrs: Body-weight 8-12 kg: 12.5 mg Suppositories twice daily for max 4 days; Body-weight over 12 kg: 1 mg/kg Suppositories (max 50 mg) 3 times daily for max 4 days. BY IM INJ: Adult: 75 mg once or twice daily by deep intragluteal inj for max 2 days. Continue if necessary with tab. Acute postoperative pain, Acute back pain, pain in acute trauma and fractures, renal colic: ORAL: Adult: 75-150 mg daily in 2-3 divided doses. Children 6 months-18 yrs: 1.5-2.5 mg/kg (max 75 mg) twice daily; total daily dose may alterna-tively be given in 3 divided doses. BY RECTUM: Adult: 75-150 mg Suppositories daily in divided doses; Children 2-18 yrs: Body-weight 8-12 kg: 12.5 mg Suppositories twice daily for max 4 days; Body-weight over 12 kg: 1 mg/kg Suppositories (max 50 mg) 3 times daily for max 4 days. BY IV INJ: Adult: 75 mg repeated every 4-6 hr if necessary, max 150 mg in 24 hr. Prevention of postoperative pain: BY IV INJ: Adult: a loading dose of 25-50 mg should be infused after surgery over 15 min to 1 hour, followed by continuous INF of about 5 mg per hour up to max. 150 mg in 24 hours. Moderate to severe postoperative pain: BY IV INJ: Adult: 75 mg infused continuously over a period of 30 min to 2 hours. BY IV INF OR DEEP IM INJ: Children 2-18 yr: 0.3-1 mg/kg once or twice daily IV INF or deep IM injection into gluteal muscle, for max 2 days (max 150 mg daily). BY IM INJ: Adult: 75 mg once or twice daily by deep intragluteal inj for max 2 days. Continue if necessary with tab.
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
Contraindications
Active or recurrent GI bleeding or ulceration, cerebrovascular disease, history of GI bleeding or GI perforation related to previous NSAID therapy, history of recurrent GI haemorrhage, ischaemic heart disease, heart failure, peripheral arterial disease, moderate to severe renal impairment, aspirin/anti-inflammatory induced allergy. With intravenous use: Dehydration, history of asthma, history of confirmed or suspected cerebrovascular bleeding, history of haemorrhagic diathesis, hypovolaemia, operations with high risk of haemorrhage
Precautions
Renal, hepatic or cardiac impairment. GI disease, allergic disorders, avoid in acute porphyrias, coagulation defects, connective-tissue disorders, Crohns disease (may be exacerbated), elderly, oedema, risk factors for cardiovascular events, ulcerative colitis (may be exacerbated)
Interactions
Salicylates, methotrexate, lithium, digoxin, diu-retics, cyclosporin, anticoagulants, oral hypoglycaemics, quinolones, NSAIDs, steroids.
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated or not recommended.
Side Effects
Angioedema, blood disorders, bronchospasm, colitis, Crohns disease, depression, diarrhoea, dizziness, drowsiness, fluid retention, GI bleeding and ulceration, GI disturbances, haematuria, headache, hearing disturbances, hypersensitivity reactions, insomnia, nausea, nervousness, photosensitivity, raised blood pressure, rashes, renal failure (especially in patients with preexisting renal impairment),tinnitus, vertigo. Rare: hepatic damage, interstitial fibrosis associated with NSAIDs, Stevens-Johnson syndrome, toxic epidermal necrolysis, visual disturbances, local irritation with use of rectal suppositories