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Lexib

Lexib

celecoxib

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Acute & low back pain management. Primary dysmenorrhoea. Relief of acute & chronic pain, RA & OA inflammation; signs & symptoms of ankylosing spondylitis.
Dosage/Direction for Use
Adult Symptomatic treatment of OA 200 mg as single dose or 100 mg bd. Symptomatic treatment of RA 100 or 200 mg bd. Ankylosing spondylitis 200 mg as single dose or 100 mg bd. Total dose: 400 mg daily. Acute pain management & primary dysmenorrhea Initially 400 mg, followed by additional 200 mg if needed on 1st day. Subsequently, 200 mg bd as needed. Low back pain 100 mg bd or 200 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. Patients who have experienced asthma, urticaria or allergic-type reactions after taking ASA or other NSAIDs including other COX-2 inhibitors; established CV disease (ischaemic heart disease & stroke). Peri-op pain treatment in CABG.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Serious skin infections eg, DRESS syndrome, exfoliative dermatitis, SJS & TEN. Anaphylactoid reactions. Not a substitute for ASA in prophylaxis of CV thromboembolic disease. Increased risk of serious CV thrombotic events, MI & stroke. Risk of GI ulceration, bleeding & perforation; history of serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy. Heart disease, HTN, hyperlipidaemia, DM, peripheral arterial disease; CHF; compromised cardiac function, preexisting edema or other conditions predisposed to or worsened by fluid retention or at risk of hypovolemia. Patients who are known or suspected to be CYP2C9 poor metabolizers. Ensure adequate hydration. Avoid concomitant use w/ non-aspirin NSAIDs. Concomitant use w/ oral anticoagulants; ACE inhibitors, thiazides & loop diuretics; glucocorticoids, oral corticosteroids, antiplatelets, SSRIs; alcohol. Advanced renal disease; severe renal impairment. Not recommended in severe hepatic impairment. Moderate hepatic impairment (Child-Pugh class B). Avoid use during 2nd or 3rd trimesters of pregnancy. Lactation. Not to be used in childn. Elderly or debilitated patients.
Adverse Reactions
HTN; diarrhoea. Bronchitis, sinusitis, URTI, UTI, ear & fungal infection; insomnia; dizziness; MI, angina pectoris; cough, dyspnoea; vomiting, abdominal pain, dyspepsia, flatulence, dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum; increased hepatic enzyme; pruritus, rash; oedema, peripheral edema; muscle spasms; nephrolithiasis; vag haemorrhage, prostatitis, benign prostatic hyperplasia; increased blood creatinine, PSA & wt.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors. Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine, barbiturates. Potential in vivo interaction w/ CYP2D6-metabolized drugs. Increased lithium plasma levels. Diminished effect of anti-hypertensives eg, ACE inhibitors, ARBs, diuretics, β-blockers. Increased risk of nephrotoxicity w/ cyclosporine. Increased Cmax & AUC w/ fluconazole. Increased plasma conc of dextromethorphan, metoprolol. Reduced natriuretic effect of furosemide, thiazides.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Lexib hard cap 200 mg
Packing/Price
10 × 10's;3 × 10's
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