A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Feldene Side Effects, and Drug Interactions - Piroxicam
Feldene Side Effects, and Drug Interactions - Piroxicam
SIDE EFFECTS
The incidence of
adverse reactions to piroxicam is based on clinical trials involving
approximately 2300 patients, about 400 of whom were treated
for more than one year and 170 for more than two years. About 30%
of all patients receiving daily doses of 20 mg of FELDENE experienced
side effects. Gastrointestinal symptoms were the most prominent
side effects—occurring
in approximately 20% of the patients, which in most instances did
not interfere with the course of therapy. Of the patients experiencing
gastrointestinal side effects, approximately 5% discontinued therapy
with an overall incidence of peptic
ulceration of about
1%.
Other than the gastrointestinal
symptoms, edema, dizziness,
headache, changes in hematological parameters, and rash
have been reported in a small percentage of patients. Routine ophthalmoscopy
and slit-lamp examinations have revealed no
evidence of ocular
changes in 205 patients followed from 3 to 24 months while
on therapy.
Incidence Greater Than 1%
The following adverse reactions occurred more frequently than
1 in 100.
Gastrointestinal: stomatitis,
anorexia, epigastric
distress*, nausea*, constipation,
abdominal discomfort,
flatulence, diarrhea,
abdominal pain, indigestion
Hematological: decreases in hemoglobin* and hematocrit*
(see PRECAUTIONS), anemia,
leucopenia, eosinophilia
Dermatologic: pruritus,
rash
Central Nervous System: dizziness,
somnolence, vertigo
Urogenital: BUN
and creatinine elevations
(see PRECAUTIONS )
Body as a Whole: headache,
malaise
Special Senses: tinnitus
Cardiovascular/Respiratory: edema
(seePRECAUTIONS )
* Reactions occurring in 3% to 9% of patients treated with FELDENE.
Reactions occurring in 1-3% of patients are unmarked.
Incidence Less Than 1% (Causal Relationship Probable)
The following adverse reactions occurred less frequently than 1 in 100.
The probability
exists that there is a causal relationship between FELDENE and these
reactions.
Gastrointestinal: liver
function abnormalities,
jaundice, hepatitis (see PRECAUTIONS
), vomiting, hematemesis,
melena, gastrointestinal
bleeding, perforation
and ulceration (see WARNINGS
), dry mouth
Hematological: thrombocytopenia,
petechial rash,
ecchymosis, bone marrow
depression including
aplastic anemia, epistaxis
Dermatologic: sweating, erythema,
bruising, desquamation, exfoliative dermatitis,
erythema multiforme,
toxic epidermal necrolysis,
Stevens-Johnson syndrome,
vesiculo bullous reaction,
photoallergic skin reactions
Central Nervous System: depression,
insomnia, nervousness
Urogenital: hematuria,
proteinuria, interstitial
nephritis, renal failure, hyperkalemia,
glomerulitis, papillary
necrosis, nephrotic
syndrome (see PRECAUTIONS
)
Body as a Whole: pain
(colic), fever, flu-like
syndrome (see PRECAUTIONS
)
Special Senses: swollen eyes, blurred vision, eye
irritations
Cardiovascular/Respiratory: hypertension,
worsening of congestive heart
failure (see PRECAUTIONS
), exacerbation
of angina
Metabolic: hypoglycemia,
hyperglycemia,
weight increase, weight
decrease
Hypersensitivity: anaphylaxis,
bronchospasm, urticaria/angioedema,
vasculitis, "serum sickness" (see PRECAUTIONS
)
Incidence Less Than 1% (Causal Relationship Unknown)
Other adverse reactions were reported with a frequency
of less than 1 in 100, but a causal relationship between
FELDENE and the reaction
could not be determined.
Gastrointestinal: pancreatitis
Dermatologic: onycholysis, loss
of hair
Central Nervous System: akathisia,
hallucinations, mood alterations, dream
abnormalities, mental
confusion, paresthesias
Urogenital System: dysuria
Body as a Whole: weakness
Cardiovascular/Respiratory: palpitations, dyspnea
Hypersensitivity: positive
ANA
Special Senses: transient
hearing loss
Hematological: hemolytic
anemia
DRUG INTERACTIONS
FELDENE is highly protein
bound, and
therefore, might be expected to displace other protein-bound drugs.
Although this has not occurred in in vitro studies with coumarin-type
anticoagulants, interactions with coumarin-type anticoagulants have
been reported with FELDENE since marketing, therefore, physicians
should closely monitor
patients for a change in dosage requirements when administering
FELDENE to patients on coumarin-type anticoagulants and other highly
protein-bound drugs.
Plasma levels of piroxicam are depressed
to approximately 80% of their normal values when FELDENE is administered
in conjunction with aspirin (3900 mg/day), but concomitant
administration
of antacids has no effect
on piroxicam plasma levels
(see CLINICAL PHARMACOLOGY
).
Nonsteroidal anti-inflammatory
agents, including FELDENE, have been reported to increase steady
state plasma
lithium levels. It is
recommended that plasma
lithium levels be monitored
when initiating, adjusting and discontinuing FELDENE.
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