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CELCOX 100, 200 CAPSULES

Prescribing Information

COMPOSITION:
Active ingredients:
Each white capsule of CELCOX 100mg contains Celecoxib 100mg
Each white/orange capsule of CELCOX 200mg contains Celecoxib 200mg

INDICATIONS
Symptomatic treatment of inflammation and pain in osteoarthritis and rheumatoid arthritis.

DOSAGE AND ADMINISTRATION
For osteoarthritis and rheumatoid arthritis, the lowest dose of CELCOX should be sought for each patient. These doses can be given without regard to timing of meals.
Osteoarthritis: For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice a day.
Rheumatoid arthritis: For relief of the signs and symptoms of rheumatoid arthritis the recommended oral dose is 100 to 200 mg twice a day.
Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on CELCOX. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2 x 200 mg capsules) twice per day to be taken with food.
Hepatic insufficiency: The daily recommended dose of CELCOX capsules in patients with moderate hepatic impairment (Child-Pugh Class II) should be reduced by approximately 50%.

CAUTIONS
Contraindications
• Hypersensitivity to celecoxib
• Avoid in late pregnancy due to possible premature closure of ductus arteriosus
• Patients with documented allergic-type reaction to sulfonamides
• Urticaria, asthma, or allergic reactions to aspirin or other nonsteroidal anti-inflammatory agents
• Avoid while breastfeeding

Special warnings and special precautions for use
Upper gastrointestinal perforations, ulcers or bleeds (PUBs) have occurred in patients treated with celecoxib. Therefore, caution should be taken in patients with a history of gastrointestinal disease, such as ulceration and inflammatory conditions or in patients at special risk.
As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking celecoxib. Therefore, celecoxib should be used with caution in patients with an history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention. Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly in whom the lowest effective dose should be used and therefore medically appropriate supervision should be maintained. Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
In patients on concurrent therapy with warfarin, serious bleeding events have occurred. Caution should be exercised when combining celecoxib with warfarin.
There are no data on the possible interaction between celecoxib and the oral contraceptive pill. Until data from formal interaction studies are available an interaction cannot be excluded and women should be advised to use alternative methods of contraception.
Celecoxib inhibits CYP2D6. Although it is not a strong inhibitor of this enzyme, a dose reduction may be necessary for individually dose-titrated drugs that are metabolised by CYP2D6.
Celecoxib may mask fever.
The amount of lactose in each capsule (40mg in the 100mg capsule; 80mg in the 200mg capsule) is probably not sufficient to cause specific symptoms of lactose intolerance.

Pregnancy and lactation
No clinical data on exposed pregnancies are available for celecoxib. Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations. The potential for human risk in pregnancy is unknown, but cannot be excluded. Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Celecoxib is contraindicated in pregnancy and in women who can become pregnant. If a woman becomes pregnant during treatment, celecoxib should be discontinued.
There are no studies on the excretion of celecoxib in human milk. Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma. Women who take celecoxib should not breastfeed.

Undesirable effects
Approximately 7400 patients were treated with celecoxib in controlled trials and of those approximately 2300 have received it for 1 year or longer. The following reactions have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials. Side-effects listed have a rate equal or greater than placebo, and the discontinuation rate due to side effects was 7.1% in patients receiving celecoxib and 6.1% in patients receiving placebo.
Additional events including very rare and isolated reports, irrespective of causality, from post-marketing experience in >5.3 million treated patients are included.