Cataflam/Cataflam Fast

Cataflam/Cataflam Fast

diclofenac

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Diclofenac K
Indications/Uses
Acute & chronic treatment of signs & symptoms of RA, OA & ankylosing spondylitis. Management of pain & primary dysmenorrhoea, when prompt pain relief is desired. Short-term treatment in acute migraine attacks & post-op pain & inflammation following dental & orthopaedic surgery.
Dosage/Direction for Use
Adult Initially 150 mg max dose on day 1, then 100 mg max daily dose in 2-3 divided doses. Migraine Initially 50 mg, further 50 mg may be taken if insufficient relief w/in 2 hr. If needed, further 50 mg may be taken at 4-6 hr intervals. Max: 100 mg daily. Adolescent ≥14 yr 50-100 mg daily in 1-2 divided doses. Max: 100 mg daily in divided doses (Cataflam Fast).
Administration
May be taken with or without food: Take preferably before meals.
Contraindications
Hypersensitivity to diclofenac, ASA or other NSAIDs. Active GI ulceration, bleeding or perforation. Patients who have experienced asthma, urticaria or allergic reactions after aspirin or NSAID therapy. Peri-op pain in CABG surgery. CHF [New York Heart Association (NYHA) class II-IV]. Ischemic heart disease. Peripheral arterial &/or cerebrovascular disease. Renal (GFR <15 mL/min/1.73 m2) & hepatic failure. Pregnancy (last trimester) & lactation.
Special Precautions
Discontinue treatment if GI bleeding or perforation, serious allergic reactions occur. Patient requiring low dose ASA. Concomitant use w/ corticosteroids, anticoagulants, anti-platelet agents or SSRIs. Patients w/ symptoms or history of GI disease, ulcerative colitis or Crohn's disease, asthma, seasonal allergic rhinitis or chronic pulmonary disease. Post GI surgery. Periodic re-evaluation & dose adjustment in patients w/ established heart disease (NYHA I), HTN, or significant CV risk factors. Monitor BP during initiation & through out the treatment course. Monitor blood counts, liver function during prolonged treatment. Avoid use w/ other systemic NSAIDs including COX-2 inhibitors. May mask signs & symptoms of infection. Monitor patients w/ haemostasis defects. Severe fluid retention & edema. Monitor renal function in patients w/ history of HTN, impaired cardiac or renal function, extracellular vol depletion, elderly, receiving diuretics or other drugs that impact renal function. Patients w/ hepatic porphyria. Cataflam Fast Not recommended in childn & adolescent <14 yr.
Adverse Reactions
Headache, dizziness, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, epigastric pain; increased transaminases; rash.
Drug Interactions
Lithium, digoxin, diuretics & other antihypertensives, methotrexate, other NSAIDs, corticosteroids, SSRIs, cyclosporin, tacrolimus, quinolone antibacterials, CYP2C9 inhibitors & inducers, anticoagulants, antiplatelets, phenytoin. Concomitant use w/ K-sparing drugs may increase serum K levels. Co-administration w/ metformin may cause metabolic acidosis. Synergistic side effects w/ warfarin on GI bleeding.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Cataflam Fast powd for oral soln 50 mg/dose
Packing/Price
(900-mg net wt) 3 × 3 × 1's (Rp71,743/boks)
Form
Cataflam sugar-coated tab 25 mg
Packing/Price
5 × 10's (Rp148,688/boks)
Form
Cataflam sugar-coated tab 50 mg
Packing/Price
5 × 10's (Rp276,641/boks)
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