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Feldene (Piroxicam)
description "contains piroxicam which is a member of the oxicam group of
nonsteroidal anti-inflammatory drugs (NSAIDs). Each maroon and blue capsule
contains 10 mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral
administration. The chemical name for piroxicam is
4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-
dioxide. Piroxicam occurs as a white crystalline solid, sparingly soluble in
water, dilute acid and most organic solvents. It is slightly soluble in alcohol
and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1)
and a weakly basic pyridyl nitrogen (pKa 1.8). The molecular weight of piroxicam
is 331.35. Its molecular formula is C15H13N3O4S"
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Feldene
(Piroxicam) Contraindications and precautions : University of Iowa Nursing:
"Contraindications: patients with previous hypersensitivity to Feldene,
cross-sensitivity may exist with other NSAIDS including aspirin. Do not use.
with hemophilia, gastrointestinal bleeding or ulcer disease. Safety not
established. in children, lactating or pregnant women. Monitor closely using
this medication. while on coumadin therapy. Precautions: use cautiously in
patients with bleeding, GI, or cardiac. disorders. Drug Interactions:
Anticoagulants, Heparin, thrombolytic agents- may prolong bleeding time.
Lithium- may increase lithium toxicity Alcohol- increase risk of GI bleeding
Aspirin- decreased blood level of piroxicam decreasing effectiveness."
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Clinical
Pharmacology of Feldene (Piroxicam): RxList: "In the event treatment for
overdosage is required the long plasma half-life (see CLINICAL PHARMACOLOGY), of
piroxicam should be considered. The absence of experience with acute overdosage
precludes characterization of sequelae and recommendation of specific antidotal
efficacy at this time. It is reasonable to assume, however, that the standard
measures of gastric evacuation and general supportive therapy would apply. In
addition to supportive measures, the use of activated charcoal may effectively
reduce the absorption and reabsorption of piroxicam. Experiments in dogs have
demonstrated that the use of multiple-dose treatments with activated charcoal
could reduce the half-life of piroxicam elimination from 27 hours (without
charcoal) to 11 hours and reduce the systemic bioavailability of piroxicam
by as much as 37% when activated charcoal is given as late as 6 hours after
administration of piroxicam. FELDENE should not be used in patients who have
previously exhibited hypersensitivity to it, or in individuals with the syndrome
comprised of bronchospasm, nasal polyps, and angioedema precipitated by aspirin
or other nonsteroidal anti-inflammatory drugs."
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Symptoms
of an overdose of Feldene (piroxicam): Web Med: "body as a whole
unsteadiness eyes, ears, nose, and throat, ringing in the ears, blurred,
vision,skin, rash, gastrointestinal, nausea and/or vomiting, diarrhea, stomach
pain, possible loss of blood in the stomach and intestinal areas, nervous
system, severe headache, agitation,incoherence (not understandable) confusion,
coma, drowsiness, seizures. Expectations (Prognosis)Recovery is very likely if
the acidification of the blood can be neutralized and maintained near normal
levels."
******************************************************
Pitition to
ban Piroxicam (Feldene): Citizen.org: "In spite of overwhelming evidence in
the literature and elsewhere attesting to the excess risk for piroxicam to cause
GI ulceration, bleeding and perforation, it is indeed surprising to note that
the company and the FDA continue to maintain in the 1995 Physicians' Desk
Reference that, "Studies to date are inconclusive concerning the relative risk
of various NSAIDs in causing such [gastrointestinal] reactions". The only
advantage of piroxicam which appears appealing is its once-a-day dosing.
Significantly increased toxicity, however, (a predictable concomitant of many
long-lasting drugs) is a dangerous price to pay for convenience. Piroxicam
should not be used just because of its once-a-day convenience for patients, all
of whom could use low doses of other NSAIDs or other safer alternatives to
piroxicam. In conclusion, there is a growing body of data from studies conducted
in eight different countries all of which collectively demonstrate piroxicam's
greater propensity to cause serious GI bleeding, perforation and ulceration
compared to other drugs in its class that are on the U.S. market. In addition,
we have reviewed the pharmacokinetic and dose-response (ulcer incidence) data
which explain why piroxicam is so dangerous. The evidence presented warrants a
ban on piroxicam for people of all ages. Ibuprofen or enteric-coated aspirin are
a preferable first choice for most arthritis patients because of their
relatively low incidence of serious GI toxicity. If they do not work, there are
still a variety of other drugs, safer than piroxicam, which can be tried."
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Action
and kinetics Feldene (Piroxicam): Nurses PDR: "Action/Kinetics: May inhibit
prostaglandin synthesis. Effect is comparable to that of aspirin, but with fewer
GI side effects and less tinnitus. May be used with gold, corticosteroids, and
antacids. Peak plasma levels: 1.5-2 mcg/mL after 3-5 hr (single dose).
Steady-state plasma levels (after 7-12 days): 3-8 mcg/mL. t1/2: 50 hr.
Analgesia, onset: 1 hr; duration: 2-3 days. Anti-inflammatory activity, onset:
7-12 days; duration: 2-3 weeks. Metabolites and unchanged drug excreted in urine
and feces. Uses: Acute and chronic treatment of rheumatoid arthritis and
osteoarthritis. Investigational: Juvenile rheumatoid arthritis, primary
dysmenorrhea, sunburn."
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Feldene
(Piroxicam) pharmacokinetics: Health and Age: "Absorption: FELDENE is
well absorbed following oral administration. Drug plasma concentrations are
proportional for 10 and 20 mg doses and generally peak within three to five
hours after medication. The prolonged half-life (50 hours) results in the
maintenance of relatively stable plasma concentrations throughout the day on
once daily doses and to significant accumulation upon multiple dosing. A single
20-mg dose generally produces peak piroxicam plasma levels of 1.5 to 2 mcg/mL,
while maximum drug plasma concentrations, after repeated daily ingestion of 20
mg FELDENE, usually stabilize at 3-8 mcg/mL. Most patients approximate steady
state plasma levels within 7-12 days. Higher levels, which approximate steady
state at two to three weeks, have been observed in patients in whom longer
plasma half-lives of piroxicam occurred.With food there is a slight delay in the
rate but not the extent of absorption following oral administration. The
concomitant administration of antacids (aluminum hydroxide or aluminum hydroxide
with magnesium hydroxide) have been shown to have no effect on the plasma levels
of orally administered piroxicam.Distribution: The apparent volume of
distribution of piroxicam is approximately 0.14 L/kg. Ninety-nine percent of
plasma piroxicam is bound to plasma proteins. Piroxicam is excreted into human
milk. The presence in breast milk has been determined during initial and
long-term conditions (52 days). Piroxicam appeared in breast milk at about 1% to
3% of the maternal concentration. No accumulation of piroxicam occurred in milk
relative to that in plasma during treatment. Metabolism: Metabolism of
piroxicam occurs by hydroxylation at the 5 position of the pyridyl side chain
and conjugation of this product; by cyclodehydration; and by a sequence of
reactions involving hydrolysis of the amide linkage, decarboxylation, ring
contraction and N-demethylation. The biotransformation products of piroxicam
metabolism are reported to not have any anti-inflammatory
activity.Excretion: FELDENE and its biotransformation products are excreted
in urine and feces, with about twice as much appearing in the urine as in the
feces. Approximately 5% of a FELDENE dose is excreted unchanged. The plasma
half-life (T ½) for piroxicam is approximately 50 hours."
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How
can this Feldene (Piroxicam) affect other medicines?: Net doctor: "Piroxicam
may enhance the effect of the following medicines, resulting in an increased
risk of side-effects or toxicity: cyclosporin, lithium, methotrexate, morphine,
phenytoin, quinolone antibiotics, zidovudine and blood-thinning or anti-clotting
medicines. Piroxicam can also enhance the effect of antidiabetic tablets
(belonging to the sulphonylurea group), which could lead to low blood sugar
levels. The effect of piroxicam is enhanced by the anti-viral medicine
ritonavir. The resultant increased risk of toxicity is such that the two should
not be used together. The effect of water tablets (diuretics) and blood pressure
lowering agents may be reduced by piroxicam, resulting in their being less
effective. Use of piroxicam with diuretics or ACE inhibitors may increase the
risk of kidney problems and/or an altered potassium balance as a side effect.
NSAIDS should not be used within 8-12 days of taking mifepristone. Piroxicam
should not be taken with any other NSAID."
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