ranitidine (Zantac, Gastrosedol)

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Introduction

Tradename: Zantac. (ranitidine hydrochloride)

Indications

Dosage

Tabs: 150, 300 mg.

Syrup: 75 mg/5 mL.

Injection: 25 mg/mL (2 mL, 10 mL)

Dosage adjustment in renal failure

Pharmacokinetics

elimination via kidney

elimination via liver

1/2life = 0.9-2.3 hours

protein binding = 12-18 %

elimination by hemodialysis = +

Adverse effects

Drug interactions

Laboratory

Mechanism of action

Notes

  • N-nitrosodimethylamine (NDMA) found in some ranitidine products including Zantac[6]
  • levels of NDMA in ranitidine products similar to those in grilled or smoked meats[7]
  • FDA recommends removal of all ranitidine drugs from the market due to concerns that NDMA content increases over time 7 when stored above room temperature[8]
  • paper alleging that rantidine increases urinary NMMA retracted[9]
  • rantidine does not increase urinary NMMA in normal healthy adults[10]

More general terms

Component of

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
  3. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  4. Clinical Guide to Laboratory Tests, NW Tietz (ed) 3rd ed, WB Saunders, Philadelpha 1995
  5. Journal Watch 25(3):26-27, 2005 Carnahan RM, Lund BC, Perry PJ, Chrischilles EA. The concurrent use of anticholinergics and cholinesterase inhibitors: rare event or common practice? J Am Geriatr Soc. 2004 Dec;52(12):2082-7. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15571547
  6. 6.0 6.1 FDA Safety Alert. Sept 13, 2019 Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines. https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines
    FDA Safety Alert. Sept 23, 2019 Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated
  7. 7.0 7.1 Woodcock J. Director - Center for Drug Evaluation and Research FDA News Release. Nov 1, 2019 Statement on new testing results, including low levels of impurities in ranitidine drugs. https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impurities-ranitidine-drugs
  8. 8.0 8.1 FDA News Release. April 1, 2020 FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
  9. 9.0 9.1 Retraction Watch Staff Widely Covered Paper on Ranitidine-Cancer Link Retracted. Medscape 2021. June 15 https://www.medscape.com/viewarticle/953118
    Zeng T, Mitch WA Retracted: Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Carcinogenesis, Volume 37, Issue 6, June 2016, Pages 625-634 https://academic.oup.com/carcin/article/37/6/625/1744630
  10. 10.0 10.1 Florian J, Matta MK, DePalma R et al Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA). A Randomized Clinical Trial. JAMA. Published online June 28, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34180947 https://jamanetwork.com/journals/jama/fullarticle/2781670
    White CM, Hernandez AV. Ranitidine and Risk of N-Nitrosodimethylamine (NDMA) Formation. JAMA. Published online June 28, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34180953 https://jamanetwork.com/journals/jama/fullarticle/2781671

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