Flamic/Flamic Gel

Flamic Anti-inflammatory & analgesic in symptomatic treatment of RA including juvenile RA, OA, ankylosing spondylitis, acute musculoskeletal disorders & gout, pain after operative intervention & pain following acute trauma, primary dysmenorrhea in patients ≥12 yr & relief of fever & pain associated w/ acute upper resp tract inflammation. Flamic Gel OA, post-traumatic or acute musculoskeletal disorders including tendinitis, tenosynovitis, periarthritis, sprains.

Flamic cap Adult RA, OA, ankylosing spondylitis Initially 20 mg as single daily dose. Maintenance dose: 10-20 mg daily. Acute gout Initially 40 mg as single dose, followed by 40 mg daily as single or divided doses on the next 4-6 days. Acute musculoskeletal disorders Initially 40 mg daily for the 1st 2 days as single or divided doses. Maintenance dose: Reduce to 20 mg daily for 7-14 days. Post-op & traumatic pain 20 mg as single daily dose. Dysmenorrhea Initially 40 mg as single daily dose for 1st 2 days. May be continued w/ 20 mg as single daily dose for the next 1-3 days as necessary. Upper resp tract inflammation 10 or 20 mg once daily for 5-7 days. Juvenile idiopathic arthritis Childn ≥6 yr weighing >45 kg 20 mg once daily, >25-45 kg 15 mg once daily, 15-25 kg 10 mg once daily, <15 kg 5 mg once daily. Flamic Gel Depending on the surface area involved, apply 1.5-4.5 cm bid to qid.

Should be taken with food: Flamic: Take immediately after meals.

Hypersensitivity. Patients w/ aspirin or other NSAIDs-induced hypersensitivity symptoms of asthma, rhinitis, urticarial, nasal polyps, angioedema, bronchospasm & other symptoms of allergic or anaphylactoid reactions. Flamic Perioperative pain in CABG surgery setting, GI ulceration, bleeding or perforation, active peptic ulcer, severe heart failure. Severe renal or hepatic failure.

Flamic Discontinue treatment if erythema multiforme or flu-like symptom; SJS including fever, vesicle, skin & other lesions appear in mucous membranes (eg, in the mouth & nasal cavity, throat, sexual organs) & conjunctivitis; TEN; if abnormal tests persist or worsen, clinical signs & symptoms consistent w/ liver disease develop or systemic manifestations occur. Not to be used in patients w/ hypersensitivity, asthma, urticarial & acute sinusitis from aspirin or NSAID hypersensitivity. Not to be used in 1st-line treatment for dysmenorrhea, acute gout & musculoskeletal disorders when NSAIDs is indicated & in patients most at risk of developing serious GI adverse events; in patients suspected w/ dengue fever or platelet disorder from other causes. Not indicated for long-term management of gout. Reduce dose in patients' w/ liver dysfunction. Monitor patients w/ CHF, liver cirrhosis, nephrotic syndrome & overt renal disease or impaired renal function. May increase risk of bleeding or ulcer in stomach & intestine; MI; stroke & CAD especially when using prolonged high dose. Onset of new or worsening pre-existing HTN. Acute renal insufficiency, interstitial nephritis w/ hematuria, nephrotic syndrome, proteinuria, hyperkalemia, renal papillary necrosis & other renal medullary changes. History of PUD &/or GI bleeding. Patients w/ heart disease; on long-term diuretic therapy or conditions predisposing to fluid retention; severe dehydration; in whom renal prostaglandins have compensatory role in maintenance of renal perfusion. Known or suspected to be poor CYP2C9 metabolizers based on previous history/experience w/ other CYP2C9 substrate. Smoking, alcoholism & poor general health status. Closely monitor BP during initiation of treatment & throughout course of therapy. Perform ophth exam if visual disturbance occurs. Avoid concomitant use w/ systemic non-aspirin NSAIDs including COX-2 inhibitors. May increase frequency of GI ulcers & bleeding w/ concomitant use of another NSAIDs. Concomitant use w/ oral corticosteroids, anticoagulants & longer duration of NSAIDs therapy. Not recommended in patients w/ severe hepatic & renal disease. Avoid use during last trimester of pregnancy. Not recommended to use during breast feeding. Elderly or debilitated patients. Flamic Gel Do not apply to eyes, mucosa, open skin lesions.

Pruritus, rash. Flamic CHF, MI, palpitations, vasculitis, HTN, edema, fluid retention, arrhythmia, hypotension, syncope, tachycardia, exacerbation of angina; alopecia, angioedema, severe cutaneous adverse reaction (eg, exfoliative dermatitis, erythema multiforme, SJS, TEN (Lyell's disease), non-thrombocytopenic purpura (Henoch-Schoenlein), onycholysis, photoallergic reactions, pruritus, urticaria, vesiculobullous reactions, increased sweating, bruising, petechial rash; anorexia, hyper- & hypoglycemia, hyperkalemia, hyponatremia, wt change; abdominal pain, constipation, diarrhea, esophagitis, flatulence, gastritis, GI bleeding (including hematemesis & melena), indigestion, nausea, pancreatitis, perforation, stomatitis, ulceration, vomiting, appetite change, dry mouth, glossitis; anemia, aplastic & hemolytic anemia, eosinophilia, leukopenia, thrombocytopenia; fatal hepatitis, jaundice, liver failure; anaphylaxis, serum sickness; depression, dream abnormalities, hallucinations, insomnia, mental confusion, mood alterations, nervousness, aseptic meningitis, dizziness, headache, paresthesia, somnolence, vertigo, convulsion, drowsiness, tremor, malaise; blurred vision, swollen eyes, hearing impairment, tinnitus, conjunctivitis; nephrotic syndrome, glomerulonephritis, interstitial nephritis, renal failure, cystitis, dysuria, hematuria, oliguria, proteinuria, renal function impairment, polyuria, acute nephrotoxicity; asthma, pneumonia, dyspnea, epistaxis, bronchospasm; fever, infection, flu-like disease, sepsis, decreased fertility; +ve ANA test, increased bleeding time & serum transaminase levels, liver test abnormalities, reversible elevations of BUN & creatinine, decreased Hb & hematocrit unassociated w/ obvious GI bleeding, increased serum transaminase levels, increased & decreased wt.

Flamic Increased risk of serious GI events w/ aspirin & NSAIDs. Decreased plasma conc w/ aspirin. Synergistic GI bleeding effects w/ warfarin. Reduced BP response of ACE inhibitors or AIIA. Reduced efficacy of diuretic, ACE inhibitors, AIIA & β-blockers. Increased deterioration of renal function & possibility of acute renal failure w/ ACE inhibitors, AIIA &/or diuretics. Decreased effects w/ cholestyramine. Enhanced plasma clearance & GI absorption of cholestyramine. Increased GI ulcer or bleeding w/ corticosteroids. Enhanced nephrotoxic effect of cyclosporine. Nephrotoxicity w tacrolimus. Increased plasma conc of digoxin; serum conc of lithium. Decreased renal clearance leading to increased serum conc & potential toxicity of MTX. Increased conc & toxicity w/ ritonavir. Increased bleeding risk w/ TCAs, SNRIs or SSRIs.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA07 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AC01 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.

Flamic: D; Flamic Gel: E