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Tritec

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Tritec

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Tritec Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tritec (ranitidine, bismuth, citrate) is a combination of a histamine receptor antagonist, and antibiotic, and a form of salt used to decrease the amount of acid in the stomach and to treat Helicobacter pylori, a bacterial infection involved in causing stomach ulcers. It is most commonly used with clarithromycin (Biaxin), an antibiotic, to treat this infection. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include changes in taste, headache, dizziness, diarrhea, nausea, constipation, or tremor (shaking).

The recommended dosage of Tritec is 400 mg twice daily for 4 weeks (28 days) in conjunction with clarithromycin 500 mg two or three times daily for the first 2 weeks (14 days). Tritec may interact with sedatives, sleeping pills, tranquilizers, anticoagulants, seizure medications, medications for heart disorders, oral diabetes drugs, cisapride, or antifungal drugs. Tell your doctor all medications and supplements you use. It is unknown if Tritec will harm a fetus. Tell your doctor if you are pregnant before taking this medication. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Tritec (ranitidine bismuth citrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tritec FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS


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.

Read the entire FDA prescribing information for Tritec (Ranitidine Bismuth Citrate) »

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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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