PIROXICAM 20mg CAPSULES
Each FELGIN-20 Capsule contains 20mg piroxicam.
A. 3. 1 Anti Rheumatics (Anti-inflammatory agents)
FELGIN has analgesic, anti-inflammatory and antipyretic properties, and is used in the treatment of rheumatoid arthritis and other rheumatic disorders. Piroxicam acts as an inhibitor of prostaglandin biosynthesis.
FELGIN is completely absorbed after oral administration: peak concentrations in plasma occur within two to four hours. Neither food nor antacids alter the rate or extent of absorption.
After absorption, piroxicam is extensively (99%) bound to plasma proteins, and has a long plasma half-life of approximately thirty-five to forty-five hours. At steady state, (e.g. after seven to ten days) concentrations of piroxicam in plasma and synovial fluid are approximately equal.
Piroxicam is metabolized in the liver by hydroxylation of the pyridyl ring of the piroxicam side chain followed by conjugation with glucuronic acid and urinary elimination. Less than 10% of the drug is excreted in the urine unchanged.
FELGIN is indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylitis, acute musculoskeletal disorders and acute gout.
FELGIN should not be used in those patients who have previously shown a hypersensitivity to the drug and patients who have hepatic dysfunction. FELGIN should be used with caution in patients with a history of gastro-intestinal haemorrhage, ulcers or aspirin sensitivity.
Use in children:
FELGIN is not recommended for children.
FELGIN should not be used in patients on coumarin-type anticoagulants.
FELGIN increases plasma lithium levels.
PREGNANCY AND LACTATION
FELGIN should not be used by patients who are pregnant.
The safety of FELGIN use during pregnancy or during lactation has not yet been established. FELGIN inhibits prostaglandin synthesis and release by an effect on prostaglandin biosynthetase. This effect has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued into late pregnancy.
Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.
DOSAGE AND DIRECTIONS FOR USE
Rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylitis:
The usual daily dose for the relief of signs and symptoms of rheumatoid arthritis or osteroarthritis is 20 mg given in single or divided doses. Since steady state concentrations in plasma are not reached for seven to ten days, maximal therapeutic responses should not be expected for two weeks. Long-term administration of doses higher than 30 mg carries an increased risk of gastrointestinal side-effects.
Acute musculoskeletal disorders:
Therapy should be initiated within 40 mg daily for the first two days, given in single or divided doses. For the remainder of the seven to fourteen day treatment period, the dose should be reduced to 20mg daily.
Therapy should be initiated by a single oral dose of 40 mg followed on the next four to six days by 40 mg given in a single or divided daily dosage. FELGIN is not indicated for the long-term, management of gout.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Gastrointestinal symptoms are the most commonly encountered side-effects. Long-term administration of doses higher than 30 mg daily carries an increased risk of gastrointestinal side-effects.
Peptic ulceration and gastrointestinal bleeding have been reported with FELGIN. Drug administration should be closely supervised in patients with a history of upper gastro-intestinal disease.
Other than the gastrointestinal symptoms, oedema, mainly ankle oedema, has been reported. Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes.
Changes in different liver function parameters have been observed. Some patients may develop increased serum transaminase levels during treatment with FELGIN.
Care should be exercised with the use of FELGIN in patients with renal dysfunction.
Blood urea nitrogen elevation has been observed in some patients. These elevations are not progressive over the course of treatment with FELGIN, a plateau being reached which returns to or towards baseline levels if treatment is stopped. The rise in blood urea nitrogen is not associated with elevations in serum creatinine. FELGIN decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind.
Dermal hypersensitivity reactions, usually in the form of skin rash, have been reported. Stevens-Johnson syndrome may develop.
Decreases in haemoglobin and haematocrit, independent of gastro-intestinal bleeding, have occurred. Thrombocytopenia and non-thrombocytopenic purpura (Henoch-Schnlein), aplastic anaemia, leucopenia and eosinophilia have been reported, and constitute indications for immediate withdrawal of FELGIN.
It should be assumed that FELGIN will precipitate bronchoconstriction in those patients who are hypersensitive to aspirin. Central nervous system effects such as dizziness, headache, somnolence and vertigo have been reported.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of overdosage with FELGIN, supportive and symptomatic therapy is indicated.
FELGIN 20 mg Capsules: Opaque maroon capsules.
FELGIN 20mg Capsules: Securitainers of 100 capsules.
Store below 25o C.
Protect from light. Keep out of reach of children.
NAFDAC REGISTRATION NUMBERS: 04-3906
YANGZHOU NO. 3 PHARMACEUTICAL LTD.
YILING, JIANGSU, JIANGSU, CHINA
JUBILEE AND ASSOCIATE INDUSTRIES LTD.
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