"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
- Symptomatic response to therapy with ZANTAC (ranitidine hcl) does not preclude the presence of gastric malignancy.
- Since ZANTAC (ranitidine hcl) is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION). Caution should be observed in patients with hepatic dysfunction since ZANTAC (ranitidine hcl) is metabolized in the liver.
- Rare reports suggest that ZANTAC (ranitidine hcl) may precipitate acute porphyric attacks in patients with acute porphyria. ZANTAC (ranitidine hcl) should therefore be avoided in patients with a history of acute porphyria.
False-positive tests for urine protein with MULTISTIX® may occur during therapy with ZANTAC (ranitidine hcl) , and therefore testing with sulfosalicylic acid is recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.
Ranitidine was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays.
In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.
Teratogenic Effects - Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ZANTAC (ranitidine hcl) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Ranitidine is secreted in human milk. Caution should be exercised when ZANTAC (ranitidine hcl) is administered to a nursing mother.
The safety and effectiveness of ZANTAC (ranitidine hcl) have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of ZANTAC (ranitidine hcl) in this age-group is supported by adequate and well-controlled studies in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature (see CLINICAL PHARMACOLOGY: Pediatrics and DOSAGE AND ADMINISTRATION: Pediatric Use).
Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.
Safety and effectiveness in neonates (less than 1 month of age) have not been established (see CLINICAL PHARMACOLOGY: Pediatrics).
Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of ZANTAC (ranitidine hcl) , for which there were subgroup analyses, 4,197 were 65 and over, while 899 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function).
Last reviewed on RxList: 12/6/2010
This monograph has been modified to include the generic and brand name in many instances.
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