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Zantac

Clinical Pharmacology
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Clinical Pharmacology

Pediatrics: Oral doses of 6 to 10 mg/kg per day in 2 or 3 divided doses maintain gastric pH>4 throughout most of the dosing interval.

Clinical Trials: Active Duodenal Ulcer: In a multicenter, double-blind, controlled, US study of endoscopically diagnosed duodenal ulcers, earlier healing was seen in the patients treated with ZANTAC as shown in Table 3.

Table 3. Duodenal Ulcer Patient Healing Rates


  ZANTAC* Placebo*
Number Entered Healed/ Evaluable Number Entered Healed/ Evaluable
Outpatients 195   188  
Week 2 69/182
(38%)†
31/164
(19%)
Week 4 137/187
(73%)†
76/168
(45%)
*All patients were permitted p.r.n. antacids for relief of pain. †P<0.0001.

In these studies, patients treated with ZANTAC reported a reduction in both daytime and nocturnal pain, and they also consumed less antacid than the placebo-treated patients.

Table 4. Mean Daily Doses of Antacid


  Ulcer Healed Ulcer Not Healed
ZANTAC 0.06 0.71
Placebo 0.71 1.43

Foreign studies have shown that patients heal equally well with 150 mg b.i.d. and 300 mg h.s. (85% versus 84%, respectively) during a usual 4-week course of therapy. If patients require extended therapy of 8 weeks, the healing rate may be higher for 150 mg b.i.d. as compared to 300 mg h.s. (92% versus 87%, respectively).

Studies have been limited to short-term treatment of acute duodenal ulcer. Patients whose ulcers healed during therapy had recurrences of ulcers at the usual rates.

Maintenance Therapy in Duodenal Ulcer: Ranitidine has been found to be effective as maintenance therapy for patients following healing of acute duodenal ulcers. In 2 independent, double-blind, multicenter, controlled trials, the number of duodenal ulcers observed was significantly less in patients treated with ZANTAC (150 mg h.s.) than in patients treated with placebo over a 12-month period.

Table 5. Duodenal Ulcer Prevalence


Double-Blind, Multicenter, Placebo-Controlled Trials
Multicenter Trial Drug Duodenal Ulcer Prevalence No. of Patients
  0-4 Months 0-8 Months 0-12 Months  
USA RAN 20%* 24%* 35%* 138
PLC 44% 54% 59% 139
Foreign RAN 12%* 21%* 28%* 174
PLC 56% 64% 68% 165
% = Life table estimate.
* = P<0.05 (ZANTAC versus comparator).
RAN = ranitidine (ZANTAC).
PLC = placebo.
Brand Name: Zantac
Generic Name: Ranitidine Hcl

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