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Selexa-400

Selexa-400

celecoxib

Manufacturer:

Pond Chemical

Distributor:

Masa Lab
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic treatment of OA & RA. Relief of signs & symptoms of ankylosing spondylitis. Management of acute & low back pain. Primary dysmenorrhea.
Dosage/Direction for Use
OA 200 mg as single dose. May increase dose to 200 mg bid in patients w/ insufficient symptomatic relief. RA 200 mg bid. Ankylosing spondylitis 200 mg as single dose. Total daily dose: 400 mg. Acute pain & primary dysmenorrhea Initially 400 mg followed by additional 200 mg on 1st day, if needed. Subsequently 200 mg bid or 400 mg once daily as needed. Low back pain 200 mg or 400 mg daily as single 200 mg dose or as 100 or 200 mg bid. Total daily dose: 400 mg. Elderly weighing <50 kg Initiate at lowest recommended dose. Moderate hepatic impairment (Child-Pugh Class B) Initiate at ½ of recommended dose in arthritis or pain. Coadministration w/ fluconazole Initiate at ½ of recommended dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. Patients w/ asthma, urticaria, or other sensitivity reactions precipitated by aspirin or other NSAIDs. Treatment of perioperative pain in CABG surgery setting.
Special Precautions
Discontinue treatment if clinical signs & symptoms consistent w/ liver disease develop; at 1st appearance of rash or any other sign of hypersensitivity. Contraindicated in patients w/ CV or cerebrovascular diseases; MI or CHF NYHA class II-IV; history of CAD or paresis/paralysis from stroke. Anaphylactoid reactions may occur even w/o prior exposure. Serious skin reactions (eg, exfoliative dermatitis, SJS, TEN) can occur w/o warning & in patients w/o history of sulfonamide sensitivity reactions. Increased risk of serious CV thrombotic events including MI & stroke; CV events w/ duration of use or pre-existing CV risk factors or disease; GI ulceration, bleeding & perforation. New onset or exacerbation of HTN may occur; may contribute to CV event. May cause Na & fluid retention. Patients w/ risk factors for CV disease (eg, HTN, hyperlipidaemia, DM, smoking, elderly); edema, ischaemic heart disease; history of GI disease (bleeding or ulcer); asthma. Carefully evaluate individual CV risk profile prior to prescribing. Concurrent therapy w/ aspirin, anticoagulants &/or corticosteroids; other CYP2C9 inhibitors. Severe hepatic reactions including jaundice & fatal fulminant hepatitis, liver necrosis & hepatic failure. Severe hepatic (Child-Pugh Class C) & renal impairment. Not recommended during ≥30 wk gestation. Lactation. Ped patients <18 yr.
Adverse Reactions
Peripheral edema, dizziness, fever, headache, insomnia, rash, abdominal pain, diarrhea, dyspepsia, flatulence, nausea, vomiting, arthralgia, back pain, cough, nasopharyngitis, pharyngitis, rhinitis, sinusitis, URTI.
Drug Interactions
Increased plasma conc w/ fluconazole. Increased prothrombin time w/ warfarin (mainly geriatric). Decreased peak plasma conc & AUC w/ antacid containing Mg or Al. May reduce BP response to ACE inhibitors or AIIA. Decreased renal clearance of lithium. Increased incidence of GI ulceration or other complications w/ other NSAIDs.
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
Selexa-400 hard cap 400 mg
Packing/Price
1 × 10's;10 × 10's;6 × 10's
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