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
Tolectin Side Effects, and Drug Interactions - Tolmetin
Tolectin Side Effects, and Drug Interactions - Tolmetin
SIDE EFFECTS
The adverse reactions which have been observed in clinical trials encompass
observations in about 4370 patients treated with TOLECTIN (tolmetin sodium),
over 800 of whom have undergone at least one year of therapy. These adverse
reactions, reported below by body system, are among those typical of nonsteroidal
anti-inflammatory drugs and, as expected, gastrointestinal complaints were most
frequent. In clinical trials with TOLECTIN, about 10% of patients dropped out
because of adverse reactions, mostly gastrointestinal in nature.
Incidence Greater Than 1%
The following adverse reactions which occurred more frequently than 1 in 100
were reported in controlled clinical trials.
Gastrointestinal: Nausea (11%), dyspepsia,* gastrointestinal
distress,* abdominal pain,* diarrhea,* flatulence,* vomiting,* constipation,
gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior
history of peptic ulcer disease and/or were receiving concomitant anti-inflammatory
drugs including corticosteroids, which are known to produce peptic ulceration.
Body as a Whole: Headache,* asthenia,* chest pain
Cardiovascular: Elevated blood pressure,* edema*
Central Nervous System: Dizziness,* drowsiness, depression
Metabolic/Nutritional: Weight gain,* weight loss*
Dermatologic: Skin irritation
Special Senses: Tinnitus, visual disturbance
Hematologic: Small and transient decreases in hemoglobin
and hematocrit not associated with gastrointestinal bleeding have occurred.
These are similar to changes reported with other nonsteroidal anti-inflammatory
drugs.
Urogenital: Elevated BUN, urinary tract infection
*Reactions occurring in 3% to 9% of patients treated with TOLECTIN. Reactions
occurring in fewer than 3% of the patients are unmarked.
Incidence Less Than 1%
(Causal Relationship Probable)
The following adverse reactions were reported less frequently than 1 in 100
in controlled clinical trials or were reported since marketing. The probability
exists that there is a causal relationship between TOLECTIN and these adverse
reactions.
Gastrointestinal: Gastrointestinal bleeding with or without
evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver
function abnormalities
Body as a Whole: Anaphylactoid reactions, fever, lymphadenopathy,
serum sickness
Hematologic: Hemolytic anemia, thrombocytopenia, granulocytopenia,
agranulocytosis
Cardiovascular: Congestive heart failure in patients with
marginal cardiac function
Dermatologic: Urticaria, purpura, erythema multiforme, toxic
epidermal necrolysis
Urogenital: Hematuria, proteinuria, dysuria, renal failure
Incidence Less Than 1%
(Causal Relationship Unknown)
Other adverse reactions were reported less frequently than 1 in 100 in controlled
clinical trials or were reported since marketing, but a causal relationship
between TOLECTIN and the reaction could not be determined. These rarely reported
reactions are being listed as alerting information for the physician since the
possibility of a causal relationship cannot be excluded.
Body as Whole: Epistaxis
Special Senses: Optic neuropathy, retinal and macular changes
DRUG INTERACTIONS
The in vitro binding of warfarin to human plasma proteins is unaffected
by tolmetin, and tolmetin does not alter the prothrombin time of normal volunteers.
However, increased prothrombin time and bleeding have been reported in patients
on concomitant TOLECTIN and warfarin therapy. Therefore, caution should be exercised
when administering TOLECTIN to patients on anticoagulants.
In adult diabetic patients under treatment with either sulfonylureas or insulin
there is no change in the clinical effects of either TOLECTIN or the hypoglycemic
agents.
Caution should be used if TOLECTIN is administered concomitantly with methotrexate.
TOLECTIN and other nonsteroidal anti-inflammatory drugs have been reported to
reduce the tubular secretion of methotrexate in an animal model, possibly enhancing
the toxicity of methotrexate.
Laboratory Tests
Because serious GI tract ulceration and bleeding can occur without warning
symptoms, physicians should follow chronically treated patients for the signs
and symptoms of ulceration and bleeding and should inform them of the importance
of this follow-up (see WARNINGS Risk of GI Ulceration, Bleeding and Perforation
with NSAID Therapy ).
top
