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Ranitidine

Classification: A

Drug products: Artonil®, Inside, Inside Brus, Ranilin, Rani-Q, Ranitidin Actavis, Ranitidin Apofri, Ranitidin Mylan, Ranitidin Sandoz, Ranitidine, Ranitidine Alliance, Ranitidin-ratiopharm, Stomacid, Zantac, Zantac Brus, Zantac®, Zantac® Brus

ATC code: A02BA02

Substances: ranitidine, ranitidine bismuth citrate, ranitidine hydrochloride

Summary

Most studies have shown that ranitidin heals gastric ulcers equally well in men and women. However, one study found women to have a lower recurrence rate after long term treatment than men.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

One study has investigated if pharmacokinetic parameters of a single dose oral ranitidine differ in men and women in different phases of the menstrual cycle. Healthy volunteers (10 men, 10 women) received a single dose of 300 mg ranitidine. Differences were seen in women at different stages of the menstrual cycle. In the follicular phase distribution volume and total clearance was lower while AUC and maximum concentration was higher than in the luteal phase. Men had 56% higher AUC and 9% lower clearance than women in their follicular phase [1]. Another study, without considering the phase of the menstrual cycle, found no sex differences in ranitidine pharmacokinetics in patients (8 men, 8 women) receiving 300 mg ranitidine [2]. Despite the pharmacokinetic differences of ranitidine, the clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested [3].

Effects

A randomized, double-blind, placebo-controlled trial (99 men, 127 women) showed that 150 mg ranitidine for 48 weeks was more effective in maintaining healed gastric ulcers compared with placebo, in both men and women [4]. A case-controlled clinical trial in patients (63 men, 17 women) with giant gastric ulcer receiving ranitidine 300 mg daily for 8 weeks showed that healing rates were not related to sex [5].Recurrence of duodenal ulcer after withdrawal of long-term treatment with ranitidine has been analyzed in several studies. A single-blind study found that women had lower relapse rates than men at 12 months (80% vs. 92%) [6] while other, randomized, placebo-controlled studies have not found sex to be a risk factor for recurrence [7, 8].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of ranitidine have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2015-03-25

References

  1. Flores Pérez J, Juárez Olguín H, Flores Pérez C, Pérez Guillé G, Guillé Pérez A, Camacho Vieyra A et al. Effects of gender and phase of the menstrual cycle on the kinetics of ranitidine in healthy volunteers. Chronobiol Int. 2003;20:485-94. PubMed
  2. Abad-Santos F, Carcas AJ, Guerra P, Govantes C, Montuenga C, Gómez E et al. Evaluation of sex differences in the pharmacokinetics of ranitidine in humans. J Clin Pharmacol. 1996;36:748-51. PubMed
  3. Zantac (ranitidin). Summary of Product Characteristics. Medical Products Ageny - Sweden; 2015.
  4. Sue SO, Dawson DM, Brown JA, Wood DR, Kleoudis CS. Effectiveness of ranitidine 150 mg at bedtime as maintenance therapy for healed gastric ulcers. Clin Ther. 1996;18:1175-83. PubMed
  5. Takemoto T, Sakaki N, Tsuneoka K, Namiki M, Ishikawa M, Oshiba S. Clinical usefulness of ranitidine in giant gastric ulcer. J Clin Gastroenterol. 1984;6:413-7. PubMed
  6. Lee FI, Samloff IM, Hardman M. Comparison of tri-potassium di-citrato bismuthate tablets with ranitidine in healing and relapse of duodenal ulcers. Lancet. 1985;1:1299-302. PubMed
  7. Koelz HR, Birchler R, Bretholz A, Bron B, Capitaine Y, Delmore G et al. Healing and relapse of reflux esophagitis during treatment with ranitidine. Gastroenterology. 1986;91:1198-205. PubMed
  8. Penston JG, Dixon JS, Boyd EJ, Wormsley KG. A placebo-controlled investigation of duodenal ulcer recurrence after withdrawal of long-term treatment with ranitidine. Aliment Pharmacol Ther. 1993;7:259-65. PubMed
  9. Conicse. Stockholm: eHälsomyndigheten. 2015 [cited 2016-03-23.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson