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Placebo-controlled trials in patients with active duodenal ulcer in the United States included 1,428 patients given TRITEC (ranitidine bismuth citrate) 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 (ranitidine bismuth citrate) who participated in US placebo-controlled trials.

Table 3: Drug- Related Adverse Reactions During Treatment*

Adverse Reaction

Placebo

(n=469)

TRITEC (ranitidine bismuth citrate) Tablets 800 mg

(n=903)

Clarithromycin 1500 mg

(n=120)

TRITEC (ranitidine bismuth citrate) Tablets 800 mg +

Clarithromycin 1,000 mg

(n=196)

TRITEC (ranitidine bismuth citrate) 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 (ranitidine bismuth citrate) :

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 (ranitidine bismuth citrate) . The relationship to TRITEC (ranitidine bismuth citrate) 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.