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Tritec

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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.

Brand Name: Tritec
Generic Name: Ranitidine Bismuth Citrate

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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