Voltaren/Voltaren SR

Diclofenac Na

Painful syndromes of the vertebral column (tab/SR tab/supp/inj). Inflammatory forms of rheumatism (tab/SR tab/supp/inj). Degenerative & non-articular forms of rheumatism (tab/SR tab/supp/inj). Post-traumatic (tab/SR tab/supp/inj) & post-op pain & inflammation (tab/SR tab/supp/inj). Acute gout (tab/supp/inj). Primary dysmenorrhoea or adnexitis (tab/SR tab/supp). Migraine attacks (supp/inj). Renal & biliary colic (inj). Adjuvant in severe ENT infections (tab/supp).

Tab/supp Adult 75-150 mg/day in divided doses. Dysmenorrhoea & migraine attacks Up to 200 mg/day. Adolescent & childn >1 yr 0.5-3 mg/kg/day. SR-FC tab Usual daily dose: 100 mg. In milder cases & for long-term therapy: 75 or 100 mg/day. Max daily dose: 100 mg. Inj 1 or at the most 2 amp/day IM/IV infusion as initial therapy for not more than 2 days. Post-op pain Use IV infusion.

Should be taken with food: Take immediately after meals. Swallow whole, do not chew/crush.

Known hypersensitivity to diclofenac or other NSAIDs. Active gastric &/or duodenal ulcers, GI bleeding or perforation. Hepatic failure (Child-Pugh class C) (cirrhosis of the liver & ascites). Renal failure (GFR <15 mL/min/1.73 m²). Severe cardiac failure (NYHA III-IV). 3rd trimester of pregnancy. SR-FC tab: History of bronchospasm, urticaria, acute rhinitis, nasal polyps or allergy-like symptoms. Inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis). Treatment of post-op pain after coronary bypass surgery (or use of heart-lung machine). Supp: Proctitis. Inj: Known hypersensitivity to Na metabisulfite or other excipients.

Symptoms/history of GI disorders, asthma, impaired hepatic, cardiac, or renal function. May mask infections or temporarily inhibit platelet aggregation. Porphyria. Extracellular vol depletion. Periodic monitoring of liver function & CBC are recommended during prolonged therapy. Combination w/ lithium, digoxin, methotrexate, cyclosporin, diuretics, anticoagulants, oral antidiabetic agents, quinolones. May impair the ability to drive & operate machinery. Pregnancy & lactation. Elderly & patients w/ low body wt. Tab: Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. SR-FC tab: Allergic reactions. Risk of GI ulceration, bleeding or perforation. Use w/ caution in patients w/ clinically confirmed CHD, cerebrovascular disorders, peripheral arterial occlusive disease or considerable risk factors (eg, HTN, hyperlipidaemia, DM, smoking); cardiac impairment & other conditions predisposing to fluid retention; increased risk of hypovolaemia; seasonal allergic rhinitis, swelling of nasal mucosa, COPD or chronic resp tract infections. Cutaneous reactions. Serious arterial thromboembolic events. Concomitant use w/ diuretics or ACE inhibitors; systemics NSAIDs. Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. May impair female fertility. Paed patients <18 yr. Inj: Possibility of hypersensitivity reactions to Na metabisulfite.

Common: Headache, dizziness, vertigo, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, transaminases increased, rash. Uncommon: MI, heart failure, palpitations, chest pain. Rare: Hypersensitivity, anaphylactic & anaphylactoid reactions (including hypotension & shock), somnolence, asthma (including dyspnoea), gastritis, GI haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, GI ulcer (w/ or w/o bleeding or perforation), hepatitis, jaundice, liver disorder, urticaria, oedema. SR-FC tab: Common: Decreased appetite, fluid retention, oedema, HTN. Supp: Common: Application site irritation. Inj: Common: Inj site reaction, pain, induration. Rare: Oedema, inj site necrosis.

Raise plasma conc of lithium & digoxin. Decrease antihypertensive effect of diuretics or antihypertensive agents (eg, β-blockers, ACE inhibitors). Increase the frequency of GI undesirable effects w/ other systemic NSAIDs or corticosteroids. Risk of bleeding w/ anticoagulants & anti-platelet agents. Increase the risk of GI bleeding w/ SSRIs. Hypoglycaemic or hyperglycaemic effects w/ oral antidiabetic agents. Rise of blood conc & increased toxicity of methotrexate. Increase the nephrotoxicity of ciclosporin. Risk of convulsions w/ quinolone antibacterials. Increase in peak plasma conc & exposure w/ potent CYP2C9 inhibitors (eg, sulfinpyrazone & voriconazole). Increase in exposure to phenytoin. Increased plasma K levels w/ K-sparing diuretics, ciclosporin, tacrolimus or trimethoprim. SR-FC tab: Significant decrease in plasma conc & exposure w/ CYP2C9 inducers (eg, rifampicin). Increase the nephrotoxicity of tacrolimus. Risk of metabolic acidosis w/ metformin.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

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