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DISPERCAM
is a nonsteroidal compound
with marked antiinflammatory,
antirheumatic, analgesic and
antipyretic properties. Its
active substance, piroxicam,
strongly inhibits prostaglandin
synthetase and also has an
inhibitory effect on platelet
aggregation. DISPERCAM is
suitable for the treatment
of inflammatory and degenerative
rheumatic diseases, as well
as for use in painful conditions
due to inflammation of non-rheumatic
origin, and in post-operative
pain. It is structurally unrelated
to other NSAIDs currently
available. DISPERCAM has a
long half-life and may be
administered as a single daily
dose. The antiinflammatory
potential of DISPERCAM has
been equated with that of
indomethacin, and its analgesic
activity has been shown to
be greater than that of aspirin.
The dispersible tablets have
short disintegration times
and are easily and quickly
absorbed so that they give
peak plasma levels in relatively
shorter times than the conventional
oral dosage forms.
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| INDICATIONS: |
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Inflammatory
and degenerative forms of rheumatism
(such as rheumatoid arthritis,
ankylosing spondylitis, osteoarthrosis
and spondylarthritis), non-articular
rheumatism, acute attacks of
gout, painful post-operative
and post-traumatic inflammation
and swelling, painful inflammatory
conditions in gynecology, headache
and toothache especially prior
to dental operations or workout
to provide sustained analgesic
effect after dental work owing
to long duration of action.  |
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| DOSAGE
AND ADMINISRATION: |
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Dispercam
dispersible tablet is dropped
in a quarter of a glass of water,
wait for nearly 30 seconds,
till complete dispersion, then
stir and take orally. Dispercam
ampoules are only given through
deep intramuscular injection,
preferably into the upper external
quadrant of the gluteal muscle.
Dispercam suppositories are
inserted deeply in the rectum.
The following dosages may be
recommended:
Rheumatoid Arthritis, Osteoarthritis,
Ankylosing Spondylitis: Initial
treatment: One DISPERCAM 20-mg
dispersible tablet, orally;
or one DISPERCAM ampoule by
intramuscular injection, or
one DISPERCAM suppository rectally.
Maintenance treatment: One DISPERCAM
10mg or 20mg-tablet, or one
DISPERCAM ampoule by intramuscular
injection, or one DISPERCAM
suppository rectally once daily.
Acute
Gout: Therapy could be initiated
with 30 up to 40 mg daily in
single or divided doses for
4 to 6 days. DISPERCAM is not
suitable for long term management
of chronic gout.
Acute
Musculoskeletal Disorders: Therapy
may be initiated with 30 up
to 40 mg daily in single or
divided doses for the first
2 days, then maintained by 20
mg daily for 7 - 14 days. Long
term administration of doses
higher than 20mg is not recommended.
Postoperative
and Post-traumatic Pain, or
Dentistry: The recommended starting
dose is a single 20 mg daily.
In cases where a more rapid
onset of action is desired,
therapy could be initiated with
40 mg daily for the first 2
days given as a single or divided
doses. For the remainder of
the treatment period the dose
should not exceed 20 mg daily.
Dysmenorrhea:
Treatment should be initiated
at the earliest onset of symptoms
with a starting dose of 40 mg
for 2 days and continuation
with 20 mg dose.
Upper
Respiratory Tract Inflammation,
or Headache: Adult dose of 10mg
up to 20mg daily orally.
Juvenile
Rheumatoid Arthritis: Dose for
children is based on the body
weight as follows:
- 15-30 kg body weight: 5 mg.
- 31-45 kg body weight: 10 mg.
- 46-55 kg body weight: 15 mg.
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| PHARMACOKINETICS: |
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Absorption:
After I.M., rectal or oral administration,
Dispercam is rapidly and almost
completely absorbed, with peak
plasma concentrations occurring
in 1-2 hours. The rate of absorption,
but not the extent, is delayed
by food, so that its bioavailability
is unchanged.
Distribution:
Piroxicam is highly (about 99%)
plasma protein-bound. Its concentrations
in synovial fluid are roughly
40% of plasma concentrations.
Concentrations in breast milk
are 1% of maternal plasma concentrations.
It is unknown whether Piroxicam
crosses the placenta.
Metabolism:
About 50% of the drug is metabolized
in the liver via hydroxylation
and glucuronide conjugation
to a hydroxy metabolite. The
mean half-life is approximately
45 hours.
Excretion:
Piroxicam undergoes enterohepatic
circulation. Urinary excretion
of piroxicam and its metabolites
is twice that of fecal excretion.  |
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| CONTRAINDICATIONS: |
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Active
or recurrent peptic ulcer.
Hypersensitivity
to the active ingredient.
Patients
in whom aspirin or other nonsteroidal
antiinflammatory drugs induce
the symptoms of asthma, rhinitis
or urticaria.
The
suppositories are contraindicated
in patients with inflammatory
lesions of rectum or anus.
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| PRECAUTIONS: |
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Monitor for
GI ulceration or bleeding
in patients who receive prolonged
treatment, with special caution
in tobacco smoking patients.
Periodically monitor liver-function
tests, especially serum transaminase
levels. The drug should be
discontinued if elevated liver-function
tests persist or worsen, or
if signs and symptoms of hepatic
disease develop. Observe caution
with patients with preexisting
coagulopathy or hemophilia
due to the effect of the drug
on platelet function. Maintain
therapy with the lowest effective
dose.  |
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| INTERACTIONS: |
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Concomitant
administration of Piroxicam
and Aspirin lowers plasma
levels of Piroxicam and is
not recommended.
Concomitant use of Piroxicam
with Warfarin requires close
monitoring of anticoagulant
dosage as Piroxicam, like
other NSAIDs, affects platelet
function.
Concurrent use of Piroxicam
with Digoxin, Methotrexate,
or Cyclosporine may increase
the toxicity of these drugs.
Concurrent use of Piroxicam
with Lithium decreases the
renal clearance of Lithium
and therefore increases its
plasma levels and may lead
to lithium toxicity.
Concurrent use of Piroxicam
with diuretics may inhibit
the action of diuretics; use
with potassium-sparing diuretics
may increase serum potassium
levels.  |
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| EFFECTS
ON DIAGNOSTIC TESTS: |
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Piroxicam increases
platelet aggregation time
but does not affect bleeding
time, plasma thrombin clotting
time, plasma fibrinogen, or
factors V and VII to XII.  |
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| OVERDOSE
AND TREATMENT: |
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There is no
special antidote. Supportive
and symptomatic treatment
may include induction of vomiting
or gastric lavage. Treatment
with activated charcoal may
also be appropriate.  |
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| GERIATRIC
USE: |
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Use
with caution in elderly patients,
as they may be more susceptible
to adverse reactions. Reduce
dosage to lowest level that
controls symptoms.  |
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| BREAST
- FEEDING: |
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Low
levels of Piroxicam have been
measured in human breast milk.
Risk-to-benefit ratio must be
considered.  |
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| PATIENT
INFORMATION: |
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Avoid
Aspirin and alcoholic beverages
while taking medication.
If
gastrointestinal upset occurs,
take with food, milk or antacids.
If GI symptoms persist, notify
physician.
Piroxicam
may cause drowsiness, dizziness
or blurred vision. Observe
caution while driving or performing
tasks requiring alertness.
If
you miss a dose, take it as
soon as you can. If it is
almost time for your next
dose, take only that dose.
Do not take double or extra
doses.
Tell
your doctor or pharmacist
about all other medicines
you are taking, caffeine or
alcohol you are drinking regularly,
or if you smoke.
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| HOW
SUPPLIED: |
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DISPERCAM 10:
Box of 20 Dispersible Tablets.
DISPERCAM 20: Box of 10 Dispersible
Tablets.
DISPERCAM Ampoules: Box of
Three 1-ml ampoules (20 mg
per ml).
DISPERCAM Suppositories: Box
of 5 suppositories.
DISPERCAM Topical Gel: Collapsible
aluminium tubes, each contains
15 grams of 0.5% Piroxicam
gel with a penetration enhancer.  |
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