International generic name
Drug form and composition
Gelatin capsules. One gelatin capsule contains 10 mg or 20 mg of Piroxicam.
The drug is used in cases of rheumatic diseases like ankylosing spondilitis,
osteoarthritis, and rheumatoid arthritis. It is used also in the treatment of the
chronic juvenile arthritis. Piroxicam is used in acute gout attacks and in cases
Dosage and administration
In adults Piroxicam is administered orally in daily dose of 20 mg, given as a
single daily dose or divided in two doses of 10 mg each. In acute conditions, the
initial daily dose is 40 mg for the first 2 days, followed by a dose of 20 mg daily
for a period of 1 - 2 weeks. In case of acute gout attack, the commonly used dose
is 40 mg /24 hours for a period of 5 - 7 days. In dysmenorrhoea during the first
day the dose is 40 mg and after that the dose is reduced to 20 mg for the next days
up to the disappearance of the pain.
Hypersensitivity to Piroxicam or other drugs from the group of oxicams; gastrointestinal
hemorrhages or peptic ulcer; severe hepatic diseases; renal dysfunction; pregnancy
and breast feeding; children younger than 15 years.
Special warnings and precautions
Because of the risk of development of gastrointestinal ulcers, bleedings and
perforation the drug should always be taken after nutrition and with enough quantity
of liquid. The simultaneous consumption of alcohol should be avoided. The drug is
used cautiously in patients with hypersensitivity to foods and drugs. In patients
with kidney diseases, prolonged administration of this agent can lead to papillary
necrosis, and in patients with liver diseases, a change in transaminase levels is
possible. In patients suffering form hematological diseases and in people taking
anticoagulants Piroxicam is used with caution and with regular checks of the laboratory
indices. Piroxicam can reduce the concentration of the attention and suppress reactions.
Because of this the drug is used cautiously and after an assessment of the risk
in drivers and in people working with machines.
Piroxicam has a high affinity to the plasma proteins and due to this fact the
concurrent administration with coumarin anticoagulants, sulfonamides, nelidix acid,
oral antidiabetic agents, triiodothyronine, cyclophosphamide, and digoxin can lead
to an increase in their plasma levels. The concurrent administration with other
drugs of the groups of nonsteroidal anti-inflammatory agents, corticosteroids and
alcohol increases the risk of development of hypersensitivity and adverse drug reactions
by the gastrointestinal tract. Piroxicam reduces the effects of the diuretics and
hypotensive drugs and increases the activity of the lithium agents.
The most commonly observed adverse reactions associated with Piroxicam administration
are: gastrointestinal - burning sensation, nausea, vomiting, diarrhea, peptic ulcers,
and hemorrhages, which are usually dose dependent; CNS - somnolence, headache, vertigo;
hematological - granulocytopenia, anemia; hypersensitivity reactions - itching,
Piroxicam belongs to the group of nonsteroidal anti-inflammatory drugs. It exerts
strong anti-inflammatory, analgesic, and antipyretic action. The mechanism of action
is explained with the powerful and long lasting, but reversible, inhibition of the
prostaglandin synthesis. There are also other effects like the inhibition of platelet
aggregation and the influence on the white blood cells. Piroxicam accumulates selectively
in the inflamed tissues and penetrates in the synovial fluid.
20 gelatin capsules of 10 or 20 mg.