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
Tritec Side Effects, and Drug Interactions - Ranitidine Bismuth Citrate
Tritec Side Effects, and Drug Interactions - Ranitidine Bismuth Citrate
SIDE EFFECTS
Placebo-controlled trials in patients with active duodenal
ulcer in the United States
included 1,428 patients given TRITEC alone or in combination with
clarithromycin, 120 patients given clarithromycin alone, and 469
patients given placebo.
Incidence of Drug-Related Adverse Reactions in Placebo-Controlled
Clinical Trials: The following table
lists drug- related adverse reactions that occurred at a frequency
of ³1% among patients treated with
TRITEC who participated in US placebo-controlled trials.
Table 3: Drug- Related Adverse Reactions During Treatment*
|
Adverse Reaction
|
Placebo
(n=469)
|
TRITEC Tablets 800 mg
(n=903)
|
Clarithromycin 1500 mg
(n=120)
|
TRITEC Tablets 800 mg
+
Clarithromycin 1,000 mg
(n=196)
|
TRITEC Tablets 800 mg
+
.Clarithromycin 1,500 mg
(n=329)
|
| Gastrointestinal |
|
|
|
|
|
| Diarrhea |
1%
|
2%
|
5%
|
4%
|
58%
|
| Nausea & Vomiting |
1%
|
<1%
|
2%
|
5%
|
3%
|
| Constipation |
<1%
|
1%
|
0%
|
2%
|
2%
|
| Gas |
<1%
|
<1%
|
2%
|
1%
|
<1%
|
| Neurological |
|
|
|
|
|
| Headache |
<1%
|
1%
|
<1%
|
2%
|
3%
|
| Dizziness |
<1%
|
<1%
|
2%
|
0%
|
<1%
|
| Miscellaneous |
|
|
|
|
|
| Disturbance of taste |
<1%
|
<1%
|
11%
|
8%
|
11%
|
| Sleep disorder |
<1%
|
<1%
|
<1%
|
<1%
|
2%
|
| Skin |
|
|
|
|
|
| Pruritus |
0%
|
<1%
|
0%
|
<1%
|
1%
|
| Rashes |
<1%
|
<1%
|
0%
|
2%
|
<1%
|
| Urogenital |
|
|
|
|
|
| Gynecological problems† |
0%
(n=159)
|
<1%
(n=267)
|
6%
(n=32)
|
1%
(n=69)
|
2%
(n=125)
|
*Total daily doses.
† n= number of females
Although seen in US clinical
trials at a frequency
of <1%, the following events may be associated with the use of
TRITEC:
Gastrointestinal: Abdominal discomfort, gastric
pain.
Hepatic: Transient changes in the liver
enzymes SGPT (ALT) and
SGOT (AST).
Hypersensitivity: There have been rare reports of
hypersensitivity reactions, including skin
rash and anaphylaxis.
Central Nervous System: Tremors have been reported
rarely in patients receiving TRITEC. The relationship to TRITEC
has been unclear.
For information on adverse reactions associated with ranitidine,
refer to the ZANTAC ® package insert. For information on adverse
reactions associated with clarithromycin, refer to the clarithromycin
package insert.
DRUG INTERACTIONS
Coadministration of TRITEC with clarithromycin resulted in increased
plasma ranitidine concentrations (57%), increased plasma
bismuth trough concentrations
(48%), and increased 14- hydroxy- clarithromycin plasma concentrations
(31%). Coadministration with aspirin
results in a slight decrease in the rate
of salicylate absorption
that is clinically unimportant. Coadministration with a high dose
of antacid (170 mEq)
results in a 28% decrease in plasma
concentrations of ranitidine and may decrease plasma concentrations
of bismuth from TRITEC.
These effects are clinically insignificant.
For information on drug
interactions associated with ranitidine, refer to the ZANTAC ®
package insert.
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