"The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
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TRITEC (ranitidine bismuth citrate) in combination with clarithromycin is indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Most patients not eradicated of H. pylori following TRITEC (ranitidine bismuth citrate) plus clarithromycin treatment will have clarithromycin resistant H. pylori isolates. Therefore, for those patients who fail therapy, clarithromycin susceptibility testing should be done when possible. Patients with clarithromycin resistant H. pylori should not be treated with TRITEC (ranitidine bismuth citrate) plus clarithromycin or with regimens which include clarithromycin as the sole antimicrobial agent.
NOTE: TRITEC (ranitidine bismuth citrate) should not be prescribed alone for the treatment of active duodenal ulcer.
DOSAGE AND ADMINISTRATION
Eradication of H. pylori Infection in Patients With an Active Duodenal Ulcer: The recommended dosage of TRITEC (ranitidine bismuth citrate) is 400 mg b.i.d. for 4 weeks (28 days) in conjunction with clarithromycin 500 mg b.i.d. t.i.d. for the first 2 weeks (14 days). TRITEC (ranitidine bismuth citrate) and clarithromycin can be taken with or without food.
TRITEC (ranitidine bismuth citrate) 400 mg b.i.d plus clarithromycin 500 mg b.i.d.
TRITEC (ranitidine bismuth citrate) 400 mg b.i.d.
An alternative dosage regimen of TRITEC (ranitidine bismuth citrate) 400 mg b.i.d. for 4 weeks (28 days) in conjunction with clarithromycin 500 mg t.i.d. for the first 2 weeks (14 days) has been shown to be equally effective.
Dosage Adjustment in Elderly Patients: No dosage adjustment is necessary in elderly patients. (See PRECAUTIONS: Geriatric Use and clarithromycin package insert.)
Dosage Adjustment in Renally Impaired Patients: Because the principal route of excretion is renal, care should be exercised when administering this combination therapy to renally impaired patients. This combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min.
TRITEC (ranitidine bismuth citrate) Tablets 400 mg are blue, aqueous film-coated tablets in an elongated octagonal shape engraved with "TRITEC (ranitidine bismuth citrate) " on one side and a stomach-shaped logo on the other. They are available in bottles of 100 (NDC 0173-0488-01) tablets and unit dose packs of 100 tablets (NDC 0173-0488-02).
Store between 2° and 30° C (36° and 86° F) in a dry place. Protect from light. Replace cap securely after each opening.
For information on clarithromycin, refer to package insert.
CAUTION: Federal US law prohibits dispensing without prescription.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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