Description and Composition of Protege
Table of Contents
Protege is a painkiller that contains Piroxicam as its active pharmaceutical ingredient. In addition, it contains other inactive ingredients called excipients in sufficient quantities. It is a non-steroidal anti-inflammatory analgesic. It therefore has analgesic, anti-inflammatory and antipyretic properties. Piroxicam acts by inhibiting prostaglandin synthetase, an enzyme responsible for the synthesis of prostaglandin. It come in 10 and 20 mg capsules. In some countries, Piroxicam injections are available.
Pharmacokinetics of Protege
Protege 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 and Uses of Protege
What is Protege used for ?
For the symptomatic relief of pain and inflammation in patients with osteoarthritis, rhuematoid arthritis and ankylosing spondylitis
However, it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions
Contraindications of Protege
When should Protege not be used?
- Protege 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,
- It should not be used in patients sensitive to aspirin and non-steroidal anti-inflammatory drugs (NSAIDs).
- It should be avoided in patients with acute porphyria
- Piroxicam should not be proscribed in association with any other NSAID or an anticoagulant
What are precautions to take while using Protege?
- Protege 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
- It not recommended for use in nursing mothers as clinical safely 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 gastro-protective agent alongside Piroxicam
- Risk of gastrointestinal ulceration and bleeding
- 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 (eg, 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 Gl tract symptoms
Side Effects of Protege
What are the side effects of Protege?
- Side effects of Protege include gastrointestinal disturbances and bleeding peptic ulceration, headache dizziness, swollen eyes blurred vision and eye irritations malaise, tinnitus skin rashes. pruritus, oedema, aplastic anemia, paraesthesia hair joss and severe hepatic reactions
- Hypersensitivity reactions such anaphylaxis, bronchospasm, urticaria /angioedema vasculitis and serum sickness have been reported
Drug Interactions of Protege
What drugs do Protege interact with Piroxicam?
Concurrent use with the following drugs is not recommended:
- Diuretic agents
- Oral anticoagulants
- Cimetidine and
- Lithium carbonate
Overdose of Protege
Nausea, vomiting, abdominal pain, peptic ulceration, gastrointestinal bleeding. drowsiness, hyperreflexia con and convulsions
Treatment of Protege Overdose
- 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 of Protege
How should Protege be taken
Take Protege with food.
Adult (Oral )
20 mg as a single daily dose or 10 mg 12 hourly.
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:
16 to 25 kg bodyweight:
10 mg daily
26 to 45 kg bodyweight:
15 mg daily
More than 48 kg body weight :
20 mg daly
(Dosage recommendations and indications for use in children other than in juvenile chronic arthritis have not been established)
Note: The information given here is limited For further information, consult your doctor or pharmacist.