Description

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.

Composition

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-inflammmatory and anti-pyretic properties. It acts by inhibiting prostaglandin synthetase, an enzyme responsible for the synthesis of prostaglandin.

Pharmacokinetics

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.

Indications

• 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.

Contraindications

• 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.

Precautions

• 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.

Warning

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.

Drug Interactions

Concurrent use with the following drugs is not recommended:

Diuretic agents, aspirin, oral anticoagulants, cimetidine and lithium carbonate.

Overdose

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.

Children (oral):

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)

Storage

Store below 25°C. Protect from light and moisture.

Presentation/Packing

Capsule 20 mg x 100's, 500's, 1000's, Blisters of 10 x 10's.