API List 3 >>
Ranitidine Hydrochloride CAS number 66357-35-5
Before administering ranitidine,
* tell your doctor and pharmacist if you are allergic to ranitidine or any
* tell your doctor and pharmacist what prescription and nonprescription
medications you are taking, especially acetaminophen anticoagulants
('blood thinners') such as warfarin , propantheline, and vitamins.
* tell your doctor if you have or have ever had kidney or liver disease or
* tell your doctor if you are pregnant, plan to become pregnant, or are
breast-feeding. If you become pregnant while taking ranitidine, call your
Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia,
and vertigo. Rare cases of reversible mental confusion, agitation,
depression, and hallucinations have been reported, predominantly in severely
ill elderly patients. Rare cases of reversible blurred vision suggestive of
a change in accommodation have been reported. Rare reports of reversible
involuntary motor disturbances have been received.
Cardiovascular: As with other H2-blockers, rare reports of arrhythmias such
as tachycardia, bradycardia, atrioventricular block, and premature
Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal
discomfort/pain, and rare reports of pancreatitis.
Hepatic: There have been occasional reports of hepatocellular, cholestatic,
or mixed hepatitis, with or without jaundice. In such circumstances,
ranitidine should be immediately discontinued. These events are usually
reversible, but in rare circumstances death has occurred. Rare cases of
hepatic failure have also been reported. In normal volunteers, SGPT values
were increased to at least twice the pretreatment levels in 6 of 12 subjects
receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24
subjects receiving 50 mg intravenously 4 times daily for 5 days.
Musculoskeletal: Rare reports of arthralgias and myalgias.
Other: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever,
rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial
nephritis, and small increases in serum creatinine.Pregnancy: 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 Ranitidine HCl.
There are, however, no adequate and well-controlled studies in pregnant
Because animal reproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if clearly
needed.Pediatric Use: The safety and effectiveness of 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 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
literatureGeriatric Use: Of the total number of subjects enrolled in US and
foreign controlled clinical trials of oral formulations of 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.