Zobrex

Zobrex

celecoxib

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Full Prescribing Info
Contents
Celecoxib.
Description
Each capsule contains Celecoxib 200 mg.
Indications/Uses
Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA).
Relief of signs and symptoms of ankylosing spondylitis (AS).
Management of acute pain.
Treatment of primary dysmenorrhea.
Management of low back pain.
Dosage/Direction for Use
Celecoxib capsules, at dose up to 200 mg twice per day can be taken with or without food. As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Symptomatic Treatment of Osteoarthritis (OA): The usual recommended dose of celecoxib is 200 mg administered as a single dose. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after 2 weeks, other therapeutic options should be considered.
Symptomatic Treatment of Rheumatoid Arthritis (RA): The recommended dose of celecoxib is 200 mg twice per day.
Ankylosing Spondylitis (AS): The recommended dose of celecoxib is 200 mg administered as a single dose. If no response is observed after 6 weeks, the dosage may be increased to 400 mg daily.
Management of Acute Pain: The recommended dose of celecoxib is 400 mg initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily or 400 mg once daily as needed.
Treatment of Primary Dysmenorrhea: The recommended dose of celecoxib is 400 mg initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily or 400 mg once daily as needed.
Low Back Pain (LBP): The recommended dose of celecoxib is 200 mg or 400 mg daily, administered as a 200 mg single dose, or as 100 or 200 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.
CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose.
Co-administration with Fluconazole: Celecoxib should be introduced at half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution is advised when co-administering celecoxib with other CYP2C9 inhibitors.
Elderly: Dose adjustment in the elderly is not generally necessary. However, for patients less than 50 kg in body weight, initiate therapy at the lowest recommended dose or as directed by the physicians.
Hepatic Impairment: Dose adjustment in the patients with mild hepatic impairment is not generally necessary. Treatment should be initiated at half of the recommended dose in patients with established moderate liver impairment with serum albumin of 25-35 g/l. There is no clinical experience in patients with severe hepatic impairment.
Renal Impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore, such patients should be treated with caution. There is no clinical experience in patients with severe renal impairment.
Children: There are no adequate data from the use of celecoxib in children under 18 years. Celecoxib should not be used in children.
Overdosage
There is no clinical experience of overdose. Single doses up to 1200 mg or 600 mg twice daily have been administered to healthy subjects without clinically significant adverse effects. In the event of suspected overdose, appropriate supportive medical care should be provided. Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Contraindications
Hypersensitivity to celecoxib or other ingredients of Zobrex.
Hypersensitivity to sulfonamide.
Patients who have experienced asthma, urticaria, rhinitis, nasal polyps, angioneurotic edema or allergic-type reactions after taking aspirin or other NSAIDs and COX-2 inhibitors.
Children under 18 years, pregnancy especially in the 3rd trimester and lactation.
GI ulceration and bleeding.
Severe hepatic impairment (serum albumin < 25 g/l) or child-pugh score ≥ 10.
Renal impairment with creatinine clearance < 30 ml/min.
Gastroenteritis.
Severe heart failure (NYHA III-IV).
Warnings
Must not be used in cases of persons allergic to this drug as well as in pregnant and breastfeeding women.
Must not be used in cases of persons who have recently undergone coronary artery surgery in the immediate post-operative period.
Must not be used in patients in case of persons with cardiovascular or cerebrovascular diseases.
If after using this drug, symptoms of erythema multiforme or flu-like symptoms occur, stop using this drug and consult a physician immediately.
Must not be used in cases of persons who have had allergic reactions to this drug and patients with a history of sulfonamide hypersensitivity.
If the following symptoms occur while using this drug e.g., fever, erythema multiforme, vesicle, skin lesions and other lesions appear in the mucous membranes (such as in the mouth cavity, throat, nasal cavity, sexual organs) and conjunctivitis, stop using this drug and consult a physician immediately as this may be signs of Stevens-Johnson Syndrome.
Must not be used in patients who have had myocardial infarction or congestive heart failure (NHYA II-IV).
Must not be used in patients who have had coronary heart disease (stenosed or occluded) or paresis, paralysis due to cerebrovascular incidents.
Use with caution in patients with risk factors for developing coronary heart disease, i.e., hypertension, hyperlipidemia, diabetes, smoking, elderly, etc.
Use with caution in patients with hepatic and renal impairment.
Special Precautions
May induce GI ulceration in patient with history of GI disease especially patient who take celecoxib with aspirin.
Complication may occur with GI tract e.g. bleeding, perforation; may be fatal, in rare cases.
Celecoxib is not a substitute for aspirin for cardiovascular prophylaxis.
Increase of severe adverse reaction of celecoxib in cardiovascular especially myocardial infarction has been reported in long term study in treatment of sporadic adenomatous polyps compare between celecoxib 200 mg two times daily and placebo, celecoxib 400 mg two times daily and placebo.
The risk of cardiovascular adverse effect tends to be higher depending on the dose and treatment time, therefore celecoxib should be use of minimum dose and short term treatment.
Use with caution in patients with hepatic impairment, cardiac disease, hypertension because fluid retention may occur.
Erythema multiforme, exfoliative dermatitis and Steven-Johnson Syndrome can occur in some patients.
Use In Pregnancy & Lactation
Pregnancy: No studies have been conducted to evaluate the effect of celecoxib on the closure of the ductus arteriosus in humans. Therefore, should be avoided during the 3rd trimester of pregnancy.
Lactation: Since no studies have been conducted in humans, celecoxib should not be used during breastfeeding.
Adverse Reactions
GI tract: abdominal pain, diarrhea, dyspepsia, flatulence, nausea, constipation, gastroenteritis, vomiting, intestinal ulceration, intestinal perforation, esophagitis, gastric bleeding, pancreatitis, aggravated intestinal perforation symptom.
Nervous system: headache, vertigo.
Psychiatric: insomnia, somnolence, confusion, anxiety.
Respiratory system: bronchitis, rhinitis, sinusitis, upper respiratory tract infection.
Skin: rash, urticaria, photosensitivity reaction, dermatitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson Syndrome.
Vascular system: hypertension, aggravated hypertension, cerebral stroke, vasculitis.
Heart: myocardial infarction, heart failure, palpitation.
Hemic and lymphatic: ecchymosis, epistaxis, thrombocytopenia, anemia.
Other: edema, hypertension, blurred vision, acute renal failure, flushing.
Drug Interactions
General: Celecoxib metabolism is predominantly mediated via CYP2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 should be done with caution. In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are CYP2D6.
ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking celecoxib concomitantly with ACE inhibitors.
Furosemide: Clinical studies have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.
Aspirin: Concomitant administration of aspirin with celecoxib may result in an increased rate of GI ulceration or other complications, compared to use celecoxib alone.
Fluconazole: Concomitant administration of fluconazole at 200 mg four times daily resulted in a 2-fold increase in celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving fluconazole.
Lithium: In a study conducted in healthy subject, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg twice a day with celecoxib 200 mg twice a day as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Warfarin: Celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. However, caution should be used when administering celecoxib with warfarin since these patients are at increased risk of bleeding complications.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Cap 200 mg x 10 x 10's, 12 x 10's.
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