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Zantac
Clinical Pharmacology
Zantac
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. |
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Generic Name: Ranitidine Hcl
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