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
Meclofenamate Side Effects, and Drug Interactions - Meclofenamate
Meclofenamate Side Effects, and Drug Interactions - Meclofenamate
SIDE EFFECTS
Incidence Greater Than 1%
The following adverse reactions were observed in clinical
trials and included observations from more than 2,700 patients,
594 of whom were treated for one year and 248 for at least two years.
Gastrointestinal: The most frequently reported adverse
reactions associated with meclofenamate sodium
involve the gastrointestinal system. In
controlled studies of up to six months duration, these disturbances
occurred in the following decreasing order
of frequency with
the approximate incidences in parentheses: diarrhea
(10% to 33%), nausea
with or without vomiting (11%), other gastrointestinal
disorders (10%), and abdominal
pain.* In long-term uncontrolled studies of up to four years duration,
one third of the patients had at least one episode
of diarrhea some time
during meclofenamate sodium therapy. In
approximately 4% of the patients in controlled studies, diarrhea
was severe enough to require discontinuation of meclofenamate sodium.
The occurrence of diarrhea
is dose related, generally
subsides with dose reduction,
and clears with termination
of therapy. The incidence of diarrhea
in patients with osteoarthritis
is generally lower than that reported in patients with rheumatoid
arthritis.
Other reactions less frequently reported were pyrosis, flatulence,*
anorexia, constipation,
stomatitis, and peptic
ulcer. The majority of the patients with peptic
ulcer had either a history
of ulcer disease
or were receiving concomitant
anti-inflammatory
drugs, including corticosteroids which are known to produce peptic
ulceration.
Cardiovascular: edema
Dermatologic: rash,* urticaria,
pruritus
Central Nervous System: headache,
dizziness*
Special Senses: tinnitus
*Incidence between 3% and 9%.
Those reactions occurring in 1% to 3% of patients
are not marked with an asterisk.
Incidence Less Than 1% - Probably Causally Related
The following adverse reactions were reported less frequently than
1% during controlled clinical
trials and through voluntary
reports since marketing. The probability
of a causal relationship exists between the drug
and these adverse reactions.
Gastrointestinal: bleeding
and/or perforation
with or without obvious ulcer
formation, colitis,
cholestatic jaundice
Renal: renal
failure
Hematologic: neutropenia,
thrombocytopenic purpura,
leukopenia, agranulocytosis, hemolytic
anemia, eosinophilia,
decrease in hemoglobin and/or hematocrit
Dermatologic: erythema
multiforme, Stevens-Johnson syndrome, exfoliative dermatitis
Hepatic: alteration of liver
function tests
Allergic: lupus
and serum sickness-like
symptoms
Incidence Less Than 1% - Causal Relationship Unknown
Other reactions have been reported but under conditions where a
causal relationship could not be established. However, in these
rarely reported events, that possibility cannot be excluded. Therefore,
these observations are listed to alert physicians.
Cardiovascular: palpitations
Central Nervous System: malaise,
fatigue, paresthesia,
insomnia, depression
Special Senses: blurred vision, taste
disturbances, decreased visual acuity,
temporary loss of vision,
reversible loss
of color vision, retinal
changes including macular fibrosis,
macular and perimacular edema, conjunctivitis, iritis
Renal: nocturia
Gastrointestinal: paralytic
ileus
Dermatologic: erythema
nodosum, hair loss
DRUG INTERACTIONS
Warfarin
Meclofenamate sodium
enhances the effect of
warfarin. Therefore, when meclofenamate sodium
is given to a patient
receiving warfarin, the dosage of warfarin should be reduced to
prevent excessive prolongation of the prothrombin time.
Aspirin
Concurrent administration
of aspirin may lower
meclofenamate sodium plasma levels, possibly by competing for protein-binding
sites. The urinary excretion of meclofenamate sodium
is unaffected by aspirin, indicating no change in meclofenamate
sodium absorption. Meclofenamate
sodium does not affect
serum salicylate
levels. Greater fecal blood
loss results from concomitant
administration
of both drugs than from either drug
alone.
Propoxyphene
The concurrent administration
of propoxyphene hydrochloride
does not affect the bioavailability
of meclofenamate sodium.
Antacids
Concomitant administration
of aluminum and magnesium
hydroxides does not interfere with absorption
of meclofenamate sodium.
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