Ranitidine
Generic: RANITIDINE
Basic Information
Manufacturer
Pharmaceutical Associates, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
d0da9dd6-c691-4614-99c7-531b0bf34837
Indications & Usage
INDICATIONS AND USAGE Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: Short-term treatment of active duodenal ulcer.
Most patients heal within 4 weeks.
Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer.
Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.
Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers.
Placebo-controlled studies have been carried out for 1 year.
Treatment of GERD.
Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
Treatment of endoscopically diagnosed erosive esophagitis.
Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis.
Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
Most patients heal within 4 weeks.
Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer.
Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.
Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers.
Placebo-controlled studies have been carried out for 1 year.
Treatment of GERD.
Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
Treatment of endoscopically diagnosed erosive esophagitis.
Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis.
Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
Adverse Reactions
ADVERSE REACTIONS The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine.
The relationship to therapy with ranitidine has been unclear in many cases.
Headache, sometimes severe, seems to be related to administration of ranitidine.
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 H 2 -blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.
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.
Hematologic Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients.
These were usually reversible.
Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted.
However, occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population.
Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.
Integumentary Rash, including rare cases of erythema multiforme.
Rare cases of alopecia and vasculitis.
Respiratory A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H 2 RAs) compared to patients who had stopped H 2 RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).
However, a causal relationship between use of H 2 RAs and pneumonia has not been established.
Other Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.
The relationship to therapy with ranitidine has been unclear in many cases.
Headache, sometimes severe, seems to be related to administration of ranitidine.
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 H 2 -blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.
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.
Hematologic Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients.
These were usually reversible.
Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted.
However, occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population.
Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.
Integumentary Rash, including rare cases of erythema multiforme.
Rare cases of alopecia and vasculitis.
Respiratory A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H 2 RAs) compared to patients who had stopped H 2 RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).
However, a causal relationship between use of H 2 RAs and pneumonia has not been established.
Other Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.