Piroxicam 20mg capsules
Each capsules contains 20mg piroxicam
A 3.1 Antirheumatics (Anti-inflammatory agents).
Piroxicam is a non-steroidal anti-inflammatory agent an inhibitor of prostaglandin biosynthesis, in vitro. Lt also exerts antipyretic and analgesic effects. Piroxicam is completely absorbed after oral administration; peak concentration in the plasma occurs after 2 to 4 hours. Neither food nor antacids alter the rate or extent of absorption. Mean plasma half-life is about 50 hours. After absorption, Piroxicam is axtensively (99%) bound to plasma proteins. At steady state (e.g. after 7 to 12 days), concentrations of Piroxicam in plasma and synovial fluid are approximately equal. Less than 5% of the medicine is excreted unchanged to the urine. The major metabolic transformation in man is hydroxylation in the liver of the pyridyl ring, and this inactive metabolite and its glucuronide conjugate account for about 60% of the medicine excreted in the urine and faeces.
NASACAM is indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity such as rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis, acute musculo-skeletal and acute gout.
Sensitivity to piroxicam or similar compounds.
Satety of use during pregnancy or lactation has not been established.
Not recommended for use in children.
The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory medicines. NASACAM should not be given to patients in
whom aspirin and other non-steroidal anti-inflammatory medicines induce the symptoms of asthma, rhinitis or urticaria.
Peptic ulceration or a history of gastro-intestinal bleeding.
Unsafe in patients with acute porphyria.
Care should be exercised when administering NASACAM to patients with significant impairment of renal function.
NASACAM should not be used in patients on coumarin anticoagulants.
NASACAM decreases platelet aggregation and prolongs bleeding time.
NASACAM should be used with caution in patients with cardiovascular disorders where oedema may worsen the condition.
DOSAGE AND DIRECTIONS FOR USE
NASACAM should preferably be taken after meals of with food to reduce gastro-intestinal irritation. NASACAM should be taken with a full glass (240ml) of water and the patient should remain in an upright position for up to 30 minutes after administration.
NASACAM dispersible tablets may be taken whole with fluid or dispersed in a minimum of 50 ml water and then swallowed.
Rheumatoid Arthritis, Osteo-Arthritis, Ankylosing Spondylitis
The usual dose is 30mg daily in single or divided doses with a range of 10-30mg daily.
Long term administration of doses higher than 30mg carries an increased risk of gastro-intestinal side-effects.
Acute Musculoskeletal Disorders
An initial dose of 40mg daily may be given for the first two days in a single or divided doses. For the remainder of the 7 to 14 day treatment period, the dose should be reduced to 50mg daily.
The usual dose is 40mg daily for 5-7 days.
NASACAM is not indicated for the long term management of gout.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Gastro-intestinal disturbances are the most common side-effects occurring with NASACAM. Administration of doses higher then 30mg carries an increased risk of gastro-intestinal side-effects. Diarrhoea may occur.
Peptic ulceration and gastro-intestinal bleeding have been reported as have decreased platelet aggregation and prolonged bleeding times. Oedema and changes in liver function tests have also occurred.
Some patients may develop increased serum transaminase and alkaline phosphatase levels during treatment with NASACAM. Where the abnormality continues or worsens, NASACAM must be discontinued.
Blood urea elevation has been observed. These elevations are not progressive over the course of treatment with NASACAM; a plateau being reached which returns to or towards baseline levels if treatment is stopped. The rise in blood urea is not associated with elevations in serum creatinine.
Dermal sensitivity 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 end non-thrombocytopenia purpura (Henoch-Schoniein), aplastic anaemia, leucopenia and eosinophilia have been reported, and constitute indications for immediate withdrawal of NASACAM therapy. Central nervous system effects such as dizziness, headache, somnolence, and vertigo have been reported with the use of NASCAM.
Other side-effects which have been reported include blurred vision, tinnitus and pruritis.
NASACAM should be used with caution in patients with a history of gastro-intestinal haemorrhage, ulcers or aspirin sensitivity.
NASACAM is highly protein bound and therefore, might be expected to displace other protein bound medicines.
NASACAM increases plasma lithium levels.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of overdosage, supportive and symptomatic therapy is indicated.
Store in a cool & dry place below 25oC.
Protect from light.
KEEP OUT OF REACH OF CHILDREN
20mg each capsule, 10 capsules per blister, boxes of 1 blister.
Shandong Shenglu Pharmaceutical Co., Ltd
North end of Sihe Road, Sishui County, Shandong, China.
Nasajones Industries Limited
31/32 Office Complex Middle Road by Ado Bayero Square, S/Gari,