Cataflam

Diclofenac (sugar-coated tab: K, oral drops: Na)

Short-term treatment in post-traumatic & post-op pain, inflammation & swelling due to sprains, post-dental or orthopedic surgery. Adjuvant in severe painful inflammatory ENT infections. Sugar-coated tab: Painful &/or inflammatory gynaecological conditions eg, primary dysmenorrhoea or adnexitis; acute migraine attacks; painful vertebral column syndromes & non-articular rheumatism.

Sugar-coated tab Adult Initially 100-150 mg daily. Milder cases 75-100 mg daily. Primary dysmenorrhea 50-150 mg daily. Max: 200 mg daily. Migraine Initially 50 mg at 1st signs of impending attack, may take further dose of 50 mg 2 hr after 1st dose if insufficient. Further doses of 50 mg may be taken 4-6 hrly if needed. Max: 200 mg daily. Adolescent ≥14 yr 75-100 mg daily. Max: 150 mg daily. Oral drops Adolescent & childn ≥1 yr 0.5-2 mg/kg daily. Established heart disease or CV risk Doses up to ≤100 mg daily if treated >4 wk.

Sugar-coated tab: Should be taken on an empty stomach: Swallow whole w/ liqd, do not divide/chew. Oral drops: Should be taken with food: Take preferably during meals.

Hypersensitivity. Active gastric & intestinal ulcer, bleeding or perforation. Severe cardiac failure. ASA- or other NSAIDs-precipitated asthma, angioedema, urticaria or acute rhinitis in patients. Hepatic & renal failure. Last trimester of pregnancy.

Discontinue use at 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Not to be used for migraine prophylaxis. Not recommended in patients w/ established CV disease (CHF, established ischemic heart disease, peripheral arterial disease) or uncontrolled HTN; CV disease risk factors eg, HTN, hyperlipidemia, DM, smoking. Patients w/ GI disorders or history of gastric or intestinal ulceration, bleeding or perforation; ulcerative colitis or Crohn's disease; hemostasis defects; asthma, seasonal allergic rhinitis, nasal mucosal swelling, COPD or chronic resp tract infections, Quincke's edema, urticaria; hepatic porphyria. Increased risk of GI anastomotic leak. Monitor blood counts, renal & hepatic function. May mask signs & symptoms of infection. High-dose & long-term use. Avoid use w/ systemic NSAIDs including selective COX-2 inhibitors. Concomitant use w/ systemic corticosteroids, anticoagulants, antiplatelets, SSRIs. Renal & mild to moderate hepatic impairment. May impair female fertility. Not recommended in women of childbearing potential. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <14 yr. Elderly ≥65 yr, frail patients or w/ low body wt.

Headache, dizziness; vertigo; nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite; increased transaminases; rash.

Increased peak plasma conc & exposure w/ potent CYP2C9 inhibitors eg, voriconazole. Raised lithium & digoxin plasma conc. Decreased antihypertensive effect of diuretics & antihypertensive agents eg, β-blockers, ACE inhibitors. Increased ciclosporin & tacrolimus nephrotoxicity. Increased serum K levels w/ K-sparing diuretics, ciclosporin, tacrolimus or trimethoprim. Risk of convulsions w/ quinolones. Increased frequency of GI undesirable effects w/ other NSAIDs or corticosteroids. Increased risk of bleeding w/ anticoagulants & antiplatelet agents; GI bleeding w/ SSRIs. Hypo- & hyperglycemic effects w/ antidiabetics. Increased exposure to phenytoin. Increased MTX blood conc & toxicity. Decreased plasma conc & exposure w/ CYP2C9 inducers eg, rifampicin.

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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