Actrel

Actrel

celecoxib

Manufacturer:

Pharos
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Relief of signs & symptoms of OA, RA in adults, ankylosing spondylitis.
Dosage/Direction for Use
100-200 mg twice daily. Ankylosing spondylitis 200 mg once daily or 100 mg twice daily. Max total daily dose: 400 mg. Moderate hepatic impairment Reduce daily dose by 50%.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.
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 specific inhibitors. Treatment of peri-op pain in the setting of CABG surgery.
Special Precautions
Increased risk of serious CV thrombotic events, MI & stroke; serious GI adverse events eg, bleeding, ulceration & perforation of the stomach or intestines. Patients w/ fluid retention or heart failure. Concurrent use w/ ASA, non-aspirin NSAID, diuretics, ACE inhibitors. New onset of HTN or worsening of preexisting HTN. Closely monitor BP during initiation & throughout course of therapy. Fluid retention or heart failure; compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia. Prior history of PUD &/or GI bleeding & those who use NSAIDs. Dehydrated patients; rehydrate patients prior to start therapy. Not to be given in patients w/ ASA triad. Serious skin reactions eg, exfoliative dermatitis, SJS & TEN. Discontinue at 1st appearance of skin rash or any other sign of hypersensitivity. Long-term administration of NSAIDs. Periodically check CBC & chemistry profile. Not a substitute for corticosteroids or to treat corticosteroid insufficiency. Check Hb or hematocrit if patient exhibit any signs or symptoms of anemia or blood loss. Pre-existing asthma. Unexplained wt gain or edema. Advanced renal disease. Evaluate patients w/ signs &/or symptoms suggesting liver dysfunction or in whom abnormal liver test occurred. Consider w/drawal of treatment in women who have difficulties conceiving or who are undergoing investigation of infertility. Avoid use in pregnancy, particularly in early gestation. Lactation. Ped patient <18 yr. Elderly or debilitated patient.
Adverse Reactions
Increased allergies, allergic reactions, asthenia, chest pain, cyst NOS, generalized edema, facial edema, fatigue, fever, hot flushes, flu-like symptoms, pain, peripheral pain; constipation, diverticulitis, gastroenteritis, GERD; aggravated HT, angina pectoris, palpitation, tachycardia; herpes simplex, herpes zoster, bacterial & fungal infection; leg cramps, migraine, vertigo, earache, tinnitus; breast pain, dysmenorrhea; abnormal hepatic function, increased BUN & CPK; arthralgia; ecchymosis, thrombocythemia; anorexia, anxiety; anemia; bronchitis, laryngitis, pneumonia; alopecia, dermatitis, cellulitis; blurred vision, conjunctivitis; albuminuria, cystitis, dysuria.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors & fluconazole. Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine & barbiturates. May diminish effect of antihypertensives including ACE inhibitors. Reduced natriuretic effect of furosemide & thiazides. Increased rate of GI ulceration or other complications w/ ASA. Not a substitute for ASA for CV prophylaxis. Increased risk of bleeding w/ oral anticoagulants.
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
Actrel cap 100 mg
Packing/Price
3 × 10's
Form
Actrel cap 200 mg
Packing/Price
3 × 10's
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