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Sylecox 200mg Capsule
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Celecoxib is a selective COX-2 Inhibitor for Osteoarthritis and acute pain
Each Capsule contains:
Celecoxib ……………………………………………………………..……….200 mg
Celecoxib (Sylecox) 200 mg Capsule: Each hard gelatin capsule with pink cap and light-gray body contains 200 mg of
Celecoxib is an NSAID reported to be a selective inhibitor of cyclooxygenase-2 (COX-2). It is used in the treatment of
rheumatoid arthritis including juvenile idiopathic arthritis, osteoarthritis, and ankylosing spondylitis, and in the adjunctive
treatment of adenomatous colorectal polyps. Celecoxib is also used in the management of acute pain and dysmenorrhea.
DOSAGE AND ADMINISTRATION
For osteoarthritis – Adult: 200 mg daily given as a single dose or in 2 divided doses. If necessary, a dose of 200 mg twice
daily may be used.
For rheumatoid arthritis – Adult: 100 to 200 mg given twice daily.
For ankylosing spondylitis – Adult: an initial dose of 200 mg daily, as a single dose or in 2 divided doses.
In the treatment of pain and dysmenorrhea – Adult: an initial dose of 400 mg followed by an additional dose of 200 mg, if
necessary, is recommended on the first day; thereafter the dose is 200 mg twice daily.
As an adjunctive treatment of adenomatous colorectal polyps – Adult: may be given in doses of 400 mg twice daily with food.
Reduced doses are recommended in patients with hepatic impairments.
Or as prescribed by a physician.
Therapy is contraindicated in patients with moderate to severe heart failure (NYHA class II to IV), inflammatory bowel
disease, and renal impairment associated with a creatinine clearance of less than 30 mL/minute. Celecoxib should also
not be used in patients with severe hepatic impairment (Child-Pugh category C). Caution is recommended when using
celecoxib in dehydrated patients; rehydration may be advisable before giving celecoxib. Celecoxib treatment may need to
be stopped if signs or symptoms of organ toxicity develop.
Celecoxib should not be used after coronary artery bypass surgery as there may be an increased risk of adverse effects
such as myocardial infarction and stroke. It should be used with caution, if at all, in patients with a history of ischemic heart
disease, peripheral arterial disease, or cerebrovascular disease; it should also be used with caution in patients with
significant risk factors for cardiovascular disease such as hypertension, hyperlipidemia, and diabetes mellitus. Celecoxib is
not given to patients with allergy to NSAIDs and those with asthma. Use the lowest effective dose for the shortest duration
of treatment. Intake of celecoxib should be stopped with appearance of skin rash and signs of hypersensitivity.
PREGNANCY AND LACTATION
There are no studies in pregnant women. Studies in animals have shown reproductive toxicity. The relevance of these
data for humans is unknown. Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia
and premature closure of the ductus arteriosus and should be avoided during the third trimester of pregnancy. Celecoxib
should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Studies in rats show that celecoxib is excreted in milk at concentrations similar to those in plasma. Administration of
celecoxib to lactating women has shown very low transfer of celecoxib into breast milk. Because of the potential for
adverse reactions in nursing infants from celecoxib, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the expected benefit of the drug to the mother.
The metabolism of celecoxib is mediated mainly by the cytochrome P450 isoenzyme CYP2C9. Use with other drugs that
inhibit or induce or are metabolized by this isoenzyme may result in changes in plasma concentration of celecoxib;
fluconazole has increased plasma concentrations of celecoxib and it is recommended that the dose of celecoxib should be
halved when given with fluconazole. Celecoxib is an inhibitor of the isoenzyme CYP2D6 and the potential therefore exists
for an effect on drugs metabolized by this enzyme.
Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have
been reported with celecoxib. Other hypersensitivity reactions, including anaphylaxis and angioedema, have also
occurred. Celecoxib should be stopped at the first signs of hypersensitivity. Some of these reactions have been seen in
patients with a history of allergic reactions to sulfonamides and the use of celecoxib is contraindicated in such patients