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
Dipentum Side Effects, and Drug Interactions - Olsalazine
Dipentum Side Effects, and Drug Interactions - Olsalazine
SIDE EFFECTS
Olsalazine has been evaluated in ulcerative
colitis patients in
remission as well as those with acute
disease. Both sulfasalazine-tolerant and intolerant patients have
been studied in controlled clinical
trials. Overall, 10.4% of patients discontinued olsalazine
because of an adverse experience
compared with 6.7% of placebo
patients. The most commonly reported adverse reactions leading to
treatment withdrawal
were diarrhea or loose
stools (olsalazine 5.9%; placebo
4.8%), abdominal pain
and rash or itching (slightly
more than 1% of patients receiving olsalazine). Other adverse reactions
to olsalazine leading to withdrawal
occurred in fewer than 1% of patients (TABLE 1).
TABLE 1
Adverse Reactions Resulting in Withdrawal From Controlled
Studies
|
Adverse Reactions Resulting in Withdrawal
From Controlled Studies
|
|
|
Total
|
|
|
|
Olsalazine
|
Placebo
|
|
|
(N = 441)
|
(N = 208)
|
|
Diarrhea/ Loose Stools
|
26( 5.9%)
|
10( 4.8%)
|
|
Nausea
|
3
|
2
|
|
Abdominal Pain
|
5( 1.1% )
|
0
|
|
Rash/ Itching
|
5( 1. 1% )
|
0
|
|
Headache
|
3
|
0
|
|
Heartburn
|
2
|
0
|
|
Rectal Bleeding
|
1
|
0
|
|
Insomnia
|
1
|
0
|
|
Dizziness
|
1
|
0
|
|
Anorexia
|
1
|
0
|
|
Light Headedness
|
1
|
0
|
|
Depression
|
1
|
0
|
|
Miscellaneous
|
4 (0.9%)
|
3 (1.4%)
|
|
Total Number of Patients Withdrawn
|
46 (10.4%)
|
14(6.7%)
|
For those controlled studies, the comparative incidences of adverse
reactions reported in 1% or more patients treated with olsalazine
or placebo are provided in TABLE 2.
TABLE 2
COMPARATIVE INCIDENCE (%) OF ADVERSE EFFECTS REPORTED BY
ONE PERCENT OR MORE OF
ULCERATIVE COLITIS PATIENTS TREATED WITH OLSALAZINE OR PLACEBO
IN DOUBLE BLIND CONTROLLED STUDIES
|
ADVERSE EVENT
|
Olsalazine
(N = 441)
%
|
Placebo
(N = 208)
%
|
|
Digestive System
|
|
Diarrhea
|
11. 1
|
6.7
|
|
Abdominal Pain/ Cramps
|
10.1
|
7.2
|
|
Nausea
|
5.0
|
3.9
|
|
Dyspepsia
|
4.0
|
4.3
|
|
Bloating
|
1.5
|
1.4
|
|
Anorexia
|
1.3
|
1.9
|
|
Vomiting
|
1.0
|
-
|
|
Stomatitis
|
1.0
|
-
|
|
Increased Blood in Stool
|
-
|
3.4
|
|
CNS/ Psychiatric
|
|
Headache
|
5.0
|
4.8
|
|
Fatique/ Drowsiness/ Lethargy
|
1.8
|
2.9
|
|
Depression
|
1.5
|
|
|
Vertigo/ Dizziness
|
1.0
|
|
|
insomnia
|
-
|
2.4
|
|
Skin
|
|
Rash
|
2.3
|
1.4
|
|
Itching
|
1.3
|
-
|
|
Musculoskeletal
|
|
Arthralgia/ Joint Pain
|
4.0
|
2.9
|
|
Miscellaneous
|
|
Upper Respiratory Infection
|
1.5
|
-
|
Over 2,500 patients have been treated with olsalazine
in various controlled and uncontrolled clinical
studies. In these as well
as in the post-marketing experience, olsalazine
was administered mainly to patients intolerant to sulfasalazine.
There have been rare reports of the following adverse effects in
patients receiving olsalazine. These were often difficult to distinguish
from possible symptoms of the underlying disease
or from the effects of prior and/or concomitant
therapy. A causal relationship to the drug
has not been demonstrated for some of these reactions.
Digestive: Pancreatitis, diarrhea
with dehydration,
increased blood in stool,
rectal bleeding,
flare in symptoms, rectal
discomfort, epigastric, discomfort, flatulence.
Rare cases of granulomatous
hepatitis and nonspecific,
reactive hepatitis have been reported in patients receiving olsalazine.
Additionally; a patient developed mild cholestatic, hepatitis
during treatment with
sulfasalazine and experienced the same symptoms two weeks later
after the treatment
was changed to olsalazine. Withdrawal of olsalazine
led to complete recovery in these cases.
Neurologic: Paresthesia, tremors, insomnia,
mood swings, irritability,
fever chills, rigors.
Dermatologic: Erythema nodosum, photosensitivity,
erythema, hot flashes, alopecia.
Musculoskeletal: Muscle cramps.
Cardiovascular/Pulmonary: Pericarditis, second degree
heart block, interstitial
pulmonary disease
hypertension, orthostatic
hypotension, peripheral edema,
chest pains, tachycardia,
palpitations, bronchospasm, shortness of breath.
A patient who developed
thyroid disease
9 days after starting DIPENTUM Capsules was given propranolol and
radioactive iodine
and subsequently developed shortness of breath
and nausea. The patient
died 5 days later with signs and symptoms of acute
diffuse myocarditis.
Genitourinary: Frequency, dysuria,
hematuria, proteinuria,
nephrotic syndrome,
interstitial nephritis,
impotence, menorrhagia.
Hematologic: Leucopenia, neutropenia,
lymphopenia, eosinophilia, thrombocytopenia, anemia,
hemolytic anemia,
reticulocytosis.
Laboratory: ALT (SGPT) or AST
(SGOT) elevated beyond the normal range.
Special Senses: Tinnitus, dry mouth,
dry eyes, watery eyes, blurred vision.
DRUG ABUSE AND DEPENDENCE
Abuse: None reported.
Dependence: Drug dependence
has not been reported with chronic administration
of olsalazine.
DRUG INTERACTIONS
Increased prothrombin
time in patients taking
concomitant warfarin
has been reported.
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