Zollinger-Ellison syndrome
† non-FDA-approved indication
Ranitidine (Zantac) Indications and Dosage
For the treatment of peptic ulcer disease (duodenal ulcer or gastric ulcer) or gastritis † :
NOTE: If gastritis or ulceration is due to NSAID therapy, every effort should be made to discontinue the NSAID.
- for the short-term treatment of active benign gastric ulcer, active duodenal ulcer or gastritis † :
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO twice daily or 300 mg PO once daily at bedtime. Most duodenal ulcers
heal within 4 weeks, most gastric ulcers heal within 6 weeks. The manufacturer states that many foreign trials have shown that
100 mg PO twice daily has been as effective as 150 mg PO twice daily for duodenal ulcer. The safety of ranitidine therapy
beyond 8 weeks in the treatment of uncomplicated duodenal ulcer or beyond 6 weeks in the treatment of benign gastric ulcer has
not been assessed. If follow-up maintenance therapy is indicated, see dosage below.
Children and infants >= 1 month: 2 - 4 mg/kg/day PO, administered in 2 divided doses. Maximum dosage for active treatment 300
mg/day PO.
Intermittent intravenous or intramuscular dosage:
Adults including the elderly, and adolescents: 50 mg IV (intermittent infusion) or IM every 6 - 8 hours.
Continuous intravenous infusion dosage:
Adults including the elderly, and adolescents: 6.25 mg/hour via continuous IV infusion (i.e., total daily dosage will equal 150
mg/24 hours).
- for maintenance therapy of gastric or duodenal ulcer or gastritis † after treatment phase is complete:
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO once daily at bedtime. No placebo-controlled studies have lasted for
periods of longer than 1 year.
Children and infants >= 1 month: 2 - 4 mg/kg/day PO, administered once daily at bedtime. Maximum maintenance dosage 150 mg/day
PO.
- for the treatment of Helicobacter pylori-associated active duodenal ulcer or gastric ulcer in combination with bismuth
subsalicylate, metronidazole, and tetracycline (e.g., Helidac® or equivalent dosage of these individual drugs in combination):
NOTE: Ranitidine is not effective as a single agent for the eradication of H. pylori. However, 4-drug regimens which include a
H2-blocker as an anti-secretory agent are approved regimens, but are associated with lower compliance and efficacy rates than
other recommended regimens. It is not acceptable to substitute an H2-blocker for a PPI in any current 2- or 3-drug H.
pylori treatment regimen.
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO twice daily or 300 mg PO once daily at bedtime with these drugs at the
currently recommended dosages for 14 days. Subsequently, ranitidine should be continued at this dosage for an additional 2 - 4
weeks after the discontinuation of the antibiotic therapy to ensure appropriate healing of the active ulcer. This drug
combination is expected to result in eradication of H. pylori in 80 - 90% of patients.
- for the treatment of Helicobacter pylori-associated active duodenal ulcer or gastric ulcer in combination with bismuth
subsalicylate, metronidazole, and amoxicillin † :
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO twice daily or 300 mg PO once daily at bedtime with these drugs at the currently recommended dosages for 14 days. Subsequently, ranitidine should be continued at this dosage for an additional 2 - 4
weeks after the discontinuation of the antibiotic therapy to ensure appropriate healing of the active ulcer. This drug
combination is expected to result in eradication of H. pylori in 70 - 80% of patients.
For the treatment of gastroesophageal reflux disease (GERD):
- for the short-term treatment (acute healing phase) of GERD:
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO twice daily. However, many experts recommend dosages of 300 mg PO
twice daily for 4 - 8 weeks. Symptomatic relief usually occurs within 1 - 2 weeks after starting therapy.
Children and infants >= 1 month: 5 - 10 mg/kg/day PO, administered in 2 or 3 divided doses. Continue therapy for 6 - 8 weeks if
improvement in symptoms is noted.
- for the maintenance treatment † (relapse prevention) of GERD:
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO twice daily for up to 12 months. No placebo-controlled studies have
lasted for periods of longer than 1 year.
Children and infants >= 1 month: Specific guidelines for dosage for maintenance treatment of GERD have not been established.
For the treatment of erosive esophagitis:
- for the treatment of endoscopically diagnosed erosive esophagitis:
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO four times per day for up to 12 weeks. Symptomatic relief may begin
within 24 hours of initiation of treatment.
Children and infants >= 1 month: 5 - 10 mg/kg/day PO, administered in 2 or 3 divided doses.
- to maintain healing in erosive esophagitis after the initial treatment phase is complete:
Oral dosage:
Adults including the elderly, and adolescents: 150 mg PO twice daily. NOTE: Single doses administered prior to bedtime (i.e., 300 mg PO qhs) have been less effective than 150 mg PO twice daily. Placebo-controlled studies have been carried out for
48 weeks.
Children and infants >= 1 month: Specific guidelines have not been established for maintenance of erosive esophagitis.
For the treatment of pathologic GI hypersecretory conditions such as Zollinger-Ellison syndrome, systemic mastocytosis, or
multiple endocrine adenoma syndrome:
Oral dosage:
Adults including the elderly, and adolescents: Initially, 150 mg PO twice daily; however, larger doses are usually necessary.
Maximum dose for this condition is 6 g/day PO, administered in divided doses. Continue as long as clinically indicated.
Children † and infants † >= 1 month: 5 - 10 mg/kg/day PO, administered in 2 or 3 divided doses. Exact dosages for hypersecretory
conditions have not been established.
Intravenous or intramuscular dosage:
Adults including the elderly, and adolescents: 50 mg IV (intermittent infusion) or IM every 6 - 8 hours; however, larger doses
may be necessary. In general, do not exceed 400 mg/day IV, administered in divided doses.
Continuous intravenous infusion dosage:
Adults including the elderly, and adolescents: For patients with Zollinger-Ellison syndrome, infusion rate should commence at 1
mg/kg/hour. If after 4 hours, the measured gastric acid output is > 10 mEq/hr or the patient is symptomatic, the dose should be
adjusted upward in 0.5 mg/kg/hr increments, and the acid output should be remeasured. Dosages up to 2.5 mg/kg/hr or infusion
rates up to 220 mg/hr have been used.
For acid aspiration prophylaxis † prior to anesthesia:
NOTE: Routine use of H2-blockers prior to surgery to decrease the risks of pulmonary aspiration in patients who have no
apparent increased risk for pulmonary aspiration is not recommended. Consult current practice guidelines.
IV or IM dosage:
Adults including the elderly, and adolescents: 50 mg IV or IM 45 - 60 minutes prior to induction of anesthesia.
Children: 1 mg/kg IV or IM 45 - 60 minutes prior to induction of anesthesia.
For NSAID-induced ulcer prophylaxis † :
Oral dosage:
Adults: A study of 263 patients with either rheumatoid arthritis or osteoarthritis revealed that ranitidine 150 mg PO twice
daily reduced the incidence of duodenal ulceration but not gastric ulceration. Efficacy was determined by endoscopy in this
placebo-controlled, double-blind study.
For stress gastritis prophylaxis † in critically-ill patients:
Intermittent intravenous dosage:
Adults including the elderly, and adolescents: 50 mg IV (via intermittent infusion) or IM every 6 - 8 hours.
Children and infants >= 1 month: 2 - 4 mg/kg/day IV in divided doses every 6 - 8 hours. In a prospective study of 45 critically ill
patients (median age: 3 years; range: 2 weeks - 22 years), a dosage of at least 3 mg/kg/day IV given in divided doses was
required in most children to maintain gastric pH >= 4. Dosages of up to 1.5 mg/kg IV every 6 hours have been used.
Premature and term neonates: Initially, 1.5 mg/kg IV as a bolus dose; then start maintenance dose of 1.5 mg/kg/day IV in
divided doses every 8 - 12 hours. Dosages as low as 1 mg/kg/day IV, administered in divided doses every 12 hours, have been
adequate for some premature neonates. Alternatively, dosages of up to 5 mg/kg/day IV, administered in divided doses every 8
hours, have been used.
Continuous intravenous infusion dosage:
Adults including the elderly, and adolescents: 6.25 mg/hour via continuous IV infusion (i.e., total daily dosage will equal 150
mg/24 hours).
Children and infants >= 1 month: 1 mg/kg IV as a loading dose, followed by an infusion of 0.1 - 0.125 mg/kg/hr (i.e, total daily
dosage will be 2.4 - 3 mg/kg/day given over 24 hours).
Premature and term neonates † : 1.5 mg/kg IV as a loading dose, followed by a 0.04 mg/kg/hour IV infusion (i.e., total daily
dosage will be 1 mg/kg/day given over 24 hours).
For the self-medication of non-ulcer dyspepsia (acid indigestion), pyrosis (heartburn), and sour stomach:
Oral dosage - OTC product:
Adults including the elderly, and adolescents: 75 - 150 mg PO immediately before eating or up to 60 minutes before consuming food
and beverages that may cause heartburn. Maximum daily dosage is 150 mg/day. Do not take the maximum dose for more than 2 weeks
without consulting physician.
Children < 12 years of age: Do not self-medicate. Use only if advised by qualified health care prescriber.
Oral dosage - OTC product:
Adults including the elderly, and adolescents: 75 - 150 mg PO once or twice daily. Maximum daily dosage is 150 mg/day. Do not
take the maximum dose for more than 2 weeks without consulting physician.
Children < 12 years of age: Do not self-medicate. Use only if advised by qualified health care prescriber.
Maximum Dosage Limits:
- Adults: 300 mg/day PO for most indications; 600 mg/day PO for GERD. Up to 6 grams/day PO for pathologic hypersecretory
conditions.
- Elderly: 300 mg/day PO for most indications; 600 mg/day PO for GERD. Up to 6 grams/day PO for pathologic hypersecretory
conditions.
- Adolescents: 300 mg/day PO for most indications; 600 mg/day PO for GERD. Up to 6 grams/day PO for pathologic hypersecretory
conditions.
- Children: 4 mg/kg/day PO for most indications, not to exceed 300 mg/day for active treatment or 150 mg/day PO for maintenance treatment of peptic ulcer disease. Doses of 5 - 10 mg/kg/day PO have been used for treatment of GERD/erosive esophagitis, and
pathologic hypersecretory conditions.
- Infants >= 1 month: 4 mg/kg/day PO for most indications. Doses of 5 - 10 mg/kg/day PO have been used for treatment of
GERD/erosive esophagitis, and pathologic hypersecretory conditions.
Patients with hepatic impairment:
In patients with compensated cirrhosis, there are minor but clinically insignificant alterations in ranitidine half-life and
clearance. It appears that no dosage adjustment is needed in patients with hepatic impairment.
Patients with renal impairment:
CrCl >= 50 ml/min: No dosage adjustment needed.
CrCl < 50 ml/min: Reduce recommended dose by 50% (or extend dosing interval). For example, the manufacturer recommends a dosage
of 150 mg PO every 24 hours or 50 mg IV every 18 - 24 hours for adults. Depending upon the patient’s condition, the PO or IV
dosage may be cautiously increased to every 12 hours if required.
Intermittent Hemodialysis:
Ranitidine is removed to some degree by hemodialysis. The patient’s normal dosage schedule based on CrCl should be adjusted,
when possible, so that the timing of a regularly scheduled dose coincides with the end of a hemodialysis session.
† non-FDA-approved indication
[ Last revised: 12/16/2004 1:54:00 PM ]
References
. Koelz HR, Birchler R, Bretholz A et al. Healing and relapse of reflux esophagitis during treatment with ranitidine.
Gastroenterology 1986;91:1198 - 1205.
. Ehsanullah RSB, Page MC, Tildesley G et al. Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of ranitidine. Br Med J 1988;297:1017 - 21.
. Harrison AM, Lugo RA, Vernon DD. Gastric pH control in critically ill children receiving intravenous ranitidine. Crit
Care Med 1998;26:1433 - 6.
. Lopez-Herce Cid J, Albajara Velasco L, Codoceo R, et al. Ranitidine prophylaxis in acute gastric mucosal damage in
critically ill pediatric patients. Crit Care Med 1988;16:591 - 3.
. Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Am J Gastroenterol 1998;93:2330 - 8.
. Faubion WA and Zein NN. Gastroesophageal reflux in infants and children. Mayo Clin Proc 1998;73:166 - 73.
. Kuusela AL, Ruuska T, Karikoski R, et al. A randomized, controlled study of prophylactic ranitidine in preventing stress
-induced mucosal lesions in neonatal intensive care unit patients. Crit Care Med 1997;25:346 - 51.
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