Felxicam 10 Capsule: Amethyst opaque/ivory
opaque capsule with "HD" printed on one end and "XCM10" printed on the other end of the capsule.
Felxicam 20 Capsule: Amethyst opaque/amethyst
opaque capsule with "HD" printed on one end and "XCM20" printed on the other end of the capsule.
Felxicam 10 capsule : Piroxicam 10 mg/capsule.
Felxicam 20 capsule : Piroxicam 20 mg/capsule.
Actions and Pharmacology
Piroxicam is a non-steroidal anti-inflammatory analgesic.
It has analgesic, anti-inflammatory and anti-pyretic properties. It acts by inhibiting
prostaglandin synthetase, an enzyme responsible for the synthesis of prostaglandin.
Piroxicam is well absorbed from the gastrointestinal tract.
It is metabolized in the liver and excreted predominantly in the urine.
It has a plasma half-life of approximately 50 hours and about 99% is bound to plasma proteins.
• For the symptomatic relief of pain
and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
• However, it should not be the first
choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions.
• Piroxicam should not be prescribed
to patients who are more likely to develop side effects, such as those with history
of gastrointestinal disorders associated with bleeding or those who have had skin reactions to other medicines.
• Should not be used in patients
sensitive to aspirin and non-steroidal anti-inflammatory drugs (NSAIDs).
• Should be avoided in patients with acute porphyria.
• Piroxicam should not be prescribed
in association with any other NSAID or an anticoagulant.
• Should be used with caution in
geriatric patients and in patients with upper gastrointestinal disease, cardiovascular disorders,
hypertension, liver cirrhosis, nephrotic syndrome and impaired renal function.
• Safety for use in pregnancy has not been established.
• Not recommended for use in nursing
mothers as clinical safety in neonates has not been established.
• Treatment should always be initiated
by a physician experienced in the treatment of rheumatic arthritis.
• Use lowest dose (no more than 20 mg per day)
and for the shortest duration possible. Treatment should be reviewed after 14 days.
• Always consider prescribing a gastroprotective agent.
RISK OF GASTROINTESTINAL ULCERATION, BLEEDING AND PERFORATION WITH NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time,
with or without warning symptoms, in patients treated with NSAIDs therapy.
Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy,
prescribers should remain alert for ulceration and bleeding in patients treated
with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients
not at risk of developing peptic ulceration and bleeding. Patients with prior history
of serious adverse events and other risk factors associated with peptic ulcer disease
(e.g. alcoholism, smoking, corticosteroid therapy) are at increased risk.
Elderly or debilitated patients seem to tolerate ulceration or bleeding less than
other individuals and account for most spontaneous reports for fatal GI events.
Main Side/Adverse Effects
• Side effects of piroxicam include gastrointestinal
disturbances and bleeding, peptic ulceration, headache, dizziness, swollen eyes, blurred vision and
eye irritations, malaise, tinnitus, skin rashes, pruritus, oedema, aplastic anaemia, paraesthesia, hair loss and severe hepatic reactions.
• Hypersensitivity reactions such as anaphylaxis, bronchospasm, urticaria/angioedema, vasculitis and serum sickness have been reported rarely.
Concurrent use with the following drugs is not recommended:
Diuretic agents, aspirin, oral anticoagulants, cimetidine and lithium carbonate.
Clinical features: Nausea, vomiting,
abdominal pain, peptic ulceration, gastrointestinal bleeding, drowsiness, hyperreflexia, coma and convulsions.
Treatment: Gastric lavage if appropriate. Symptomatic and supportive measures.
Cimetidine 200 mg IV 6 hourly and ranitidine 50 mg IV 6 hourly have been used
prophylactically to treat peptic ulceration and gastrointestinal bleeding.
Dosage and Administration
Adult (Oral): 20 mg as a single daily dose.
For juvenile chronic arthritis:
As little data are available in very young children,
it is recommended that only children aged 6 years and older are treated with piroxicam according to the following dosage schedule:
Less than 15 kg bodyweight : 5 mg daily
16 to 25 kg bodyweight : 10 mg daily
26 to 45 kg bodyweight : 15 mg daily
More than 46 kg body weight : 20 mg daily
(Dosage recommendations and indications for use
in children other than in juvenile chronic arthritis have not been established)
Store below 25°C. Protect from light and moisture.
Capsule 20 mg x 100's, 500's, 1000's, Blisters of 10 x