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
Glyset Side Effects, and Drug Interactions - Miglitol
Glyset Side Effects, and Drug Interactions - Miglitol
SIDE EFFECTS
Gastrointestinal:Gastrointestinal symptoms are the most
common reactions to GLYSET Tablets. In
U.S. placebo-controlled trials, the incidences of abdominal
pain, diarrhea,
and flatulence were
11.7%, 28.7%, and 41.5% respectively in 962 patients treated with
GLYSET 25-100 mg 3 times
daily, whereas the corresponding
incidences were 4.7%, 10.0%, and 12.0% in 603 placebo-treated patients.
The incidence of diarrhea
and abdominal pain
tended to diminish considerably with continued treatment.
Dermatologic: Skin rash
was reported in 4.3% of patients treated with GLYSET compared to
2.4% of placebo-treated patients. Rashes were generally transient
and most were assessed as unrelated to GLYSET by physician-investigators.
Abnormal Laboratory Findings: Low serum
iron occurred more often
in patients treated with GLYSET (9.2%) than in placebo-treated patients
(4.2%) but did not persist in the majority of cases and was not
associated with reductions in hemoglobin
or changes in other hematologic indices.
DRUG INTERACTIONS
Several studies investigated the possible interaction between miglitol
and glyburide. In six healthy
volunteers given a single dose
of 5-mg glyburide on a background of 6 days treatment
with miglitol (50 mg 3 times
daily for 4 days followed by 100 mg
3 times daily for 2 days) or placebo,
the mean C max and AUC
values for glyburide
were 17% and 25% lower, respectively, when glyburide
was given with miglitol. In
a study in diabetic patients in which the effects of adding miglitol
100 mg 3 times daily x 7
days or placebo to a
background regimen of
3.5 mg glyburide
daily were investigated, the mean
AUC value
for glyburide was
18% lower in the group treated with miglitol, although this difference
was not statistically significant. Further information on a potential
interaction with glyburide
was obtained from one of the large U.S. clinical
trials (Study 7) in which patients were dosed with either miglitol
or placebo on a background
of glyburide 10 mg twice
daily. At the 6-month and
1-year clinic visits,
patients taking concomitant miglitol 100 mg
3 times daily exhibited mean
C max values for glyburide
that were 16% and 8% lower, respectively, compared to patients taking
glyburide alone. However,
these differences were not statistically significant. Thus, although
there was a trend toward
lower AUC and C max values for glyburide
when co-administered with GLYSET, no
definitive statement
regarding a potential
interaction can be made based on the foregoing three studies.
The effect of miglitol
(100 mg 3 times daily x 7
days) on the pharmacokinetics of a single 1000-mg dose
of metformin was investigated
in healthy volunteers.
Mean AUC and C max
values for metformin
were 12% to 13% lower when the volunteers were given miglitol as
compared with placebo,
but this difference was not statistically significant.
In a healthy volunteer
study, co-administration of either 50 mg
or 100 mg miglitol 3 times daily together with digoxin
reduced the average
plasma concentrations of digoxin
by 19% and 28%, respectively. However, in diabetic patients under
treatment with digoxin,
plasma digoxin
concentrations were not altered by co-administration of miglitol
100 mg 3 times daily x 14
days.
Other healthy volunteer
studies have demonstrated that miglitol may significantly reduce
the bioavailability
of ranitidine and propranolol by 60% and 40%, respectively. No
effect of miglitol was
observed on the pharmacokinetics or pharmacodynamics
of either warfarin or nifedipine.
Intestinal adsorbents (e.g., charcoal) and digestive
enzyme preparations containing
carbohydrate splitting
enzymes (e.g., amylase, pancreatin) may reduce the effect
of GLYSET and should not be taken concomitantly.
In 12 healthy males,
concomitantly administered antacid
did not influence the pharmacokinetics
of miglitol.
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