Ranitidine, 75 mg, over‐the‐counter dose: pharmacokinetic and pharmacodynamic effects in children with symptoms of gastro‐oesophageal reflux

Orenstein, Susan R.; Blumer, Jeffrey L.; Faessel, H. M.; McGuire, James A.; Fung, K.; Li, B. U. K.; Lavine, Joel E.; Grunow, John E.; Treem, William R.; Ciociola, Arthur A.

doi:10.1046/j.1365-2036.2002.01243.x

Cited by 39 publications

(31 citation statements)

References 22 publications

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“…Após a administração da droga, foi observado um aumento significativo do pH intragástrico por 5 a 6 horas, além de perfis farmacodinâmico e farmacociné-tico adequados. Assim, tal como em adultos, essa dose de ranitidina pode ser usada para controle de sintomas de queimação em crianças maiores 24 .…”

Section: A Criança Com Queimação Retroesternalunclassified

Treatment of gastroesophageal reflux disease

Guimarães¹,

Marguet²,

Camargos³

2006

J Pediatr (Rio J)

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Objective: To review the literature on the treatment of gastroesophageal reflux disease (GERD) with emphasis on pharmacological aspects. To identify particularities of pharmacological treatment of esophageal and extraesophageal manifestations of the disease.Sources: Electronic search of the PubMed/MEDLINE and Cochrane Collaboration databases. Controlled and randomized studies published since 2000 and reviews representing consensus positions and directives published within the last 10 years were identified. Summary of the findings:The drugs currently available for the treatment of GERD do not act in the primary mechanism of the disease, i.e., transitory relaxation of the lower esophageal sphincter. Pharmacological treatment of GERD with symptoms or with esophageal injury is based on the suppression of acid secretion, particularly with proton pump inhibitors. When the hyperreactivity of the lower airways coexists with esophageal GERD symptoms, suppression of acid secretions should be of benefit in managing the respiratory disease in the presence of a causal relationship; however, this is not usual. When esophageal symptoms are not present, esophageal 24-hour pH study should be carried out prior to starting pharmacological treatment for GERD. Improvement of respiratory symptoms may be delayed with relation to esophageal symptoms. It is common for GERD to recur and pharmacological treatment should be repeated or continued indefinitely, depending on clinical presentation of the disease. Conclusions:The strategies that have been proposed for the pharmacological treatment of GERD in children are primarily based on studies of case series or on studies with adults. There have been very few controlled and randomized studies in children. Undertaking a greater number of these studies might reinforce existing aspects or establish new aspects of management.J Pediatr (Rio J). 2006;82(5 Suppl):S133-45: Gastroesophageal reflux, child, drug therapy, esophagitis, respiratory tract diseases, asthma. ResumoObjetivo: Rever a literatura sobre tratamento da doença do refluxo gastroesofágico (DRGE) com ênfase nos aspectos farmacológi-cos. Identificar particularidades do tratamento farmacológico nas manifestações esofágicas e extra-esofágicas da doença.Fontes de dados: Busca eletrônica na base de dados PubMed/ MEDLINE e Cochrane Collaboration. Procurou-se identificar estudos controlados e randomizados publicados a partir de 2000, bem como revisões que representassem consensos e diretrizes publicados nos últimos 10 anos.Síntese dos dados: Nenhuma das drogas atualmente usadas no tratamento da DRGE altera comprovadamente o mecanismo principal da doença, ou seja, os relaxamentos transitórios do esfíncter esofágico inferior. O tratamento farmacológico da DRGE com sintomas ou com lesões esofágicas é baseado na inibição da secreção ácida, em particular pelos inibidores da bomba de prótons (IBP). Nas situações em que a hiper-reatividade das vias aéreas inferiores coexiste com sintomas esofágicos da DRGE, a inibição da secreção ácida deve...

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Section: A Criança Com Queimação Retroesternalunclassified

Treatment of gastroesophageal reflux disease

Guimarães¹,

Marguet²,

Camargos³

2006

J Pediatr (Rio J)

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“…This makes H 2 RAs well suited to "on-demand" use. Another plus for these drugs is that there are pediatric data supporting the use and safety of the H 2 RAs cimetidine, ranitidine, nizatidine, and famotidine in infants and children [27][28][29][30]. Cimetidine tends to be less frequently used in children, as it has more side effects than the others.…”

Section: H 2 Rasmentioning

confidence: 92%

Step-up and step-down approaches to treatment of gastroesophageal reflux disease in children

Hassall

2008

Curr Gastroenterol Rep

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The single biggest change in the approach to treating pediatric gastroesophageal reflux disease (GERD) in recent years has been the empiric use of proton pump inhibitors (PPIs) for symptoms suspected to be those of GERD. In other words, PPIs have been used increasingly as a first-line concurrent diagnostic test and treatment before any investigation. Although this approach is useful for some patients, there are a number of caveats about its application to children. In general, these caveats are related to age per se (eg, infancy) and to age-related symptoms and severity of GERD itself. The most important caveats relate to the prescription of empiric PPI therapy in infants--which generally is to be avoided--and to how PPIs are used in older children--specifically, the advisability of empiric trials being of limited duration. Even in children with proven reflux esophagitis, GERD is not chronic and relapsing in all; thus, trials of therapy withdrawal are warranted. In light of many factors, including the burgeoning literature on potential risks of infections in acid-suppressed children and adults, caution with dose and duration of acid-suppressive drugs in children is urged. The role of antireflux surgery is also mentioned.

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“…21 In the multi-center study that represented Phase 1 of the current single-center study, using a single 75 mg oral dose produced a positive correlation between ranitidine concentration and gastric pH. 9 A substantial decrease in gastric acidity lasted over 5-6 hours.…”

Section: Discussionmentioning

confidence: 99%

“…The pharmacodynamic and pharmacokinetic results of this multi-center trial (Phase 1) of fixed dose ranitidine (OTC Zantac 75) in these 19 children were reported earlier. 9 Phase 2. As an add-on to the above study, the six subjects from our center who completed Phase 1 received ranitidine 5 mg/kg orally (maximum dose 150 mg) approximately 12 hours after the dose of OTC Zantac 75 or placebo, having consumed a regular meal in the interim.…”

Section: Designmentioning

confidence: 99%

The Effects of Increasing Doses of Ranitidine on Gastric pH in Children

Khan

Shalaby

Orenstein

2004

The Journal of Pediatric Pharmacology and Therapeutics

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BACKGROUND Ranitidine is widely used for gastroesophageal reflux disease (GERD) in children, but optimal dosing is unclear. We compared effects of weight-based doses of oral ranitidine on gastric pH in children with clinical GERD. METHODS Children ages 4-11 years with clinical GERD were enrolled in a multi-center prospective randomized study comparing a fixed dose of ranitidine (Zantac 75) with placebo after an overnight fast; gastric pH was measured for 6 h after the fixed dose (Phase 1). Of the six enrollees from our center, four received active drug during Phase 1; 12 h after the fixed dose, these four children received ranitidine 5 mg/kg (maximum 150 mg) and gastric pH was measured for another 6-12 hours (Phase 2). This report details the effects of two dose ranges (Low Dose, < 3 mg/kg/dose, and High Dose, ≥ 3 mg/kg/dose) on gastric pH in children. RESULTS The four children were 6.9-11.3 years old and weighed 20.4-49.5 kg. The Low Doses were 1.5-2.7 mg/kg; the High Doses were 3-5 mg/kg. Although the mean percentage of time with gastric pH > 4 during the entire 6 hours following dosing was similar after Low and High Dose (50% vs. 57%, NS), during the last two hours of this interval the mean percentage of time with gastric pH > 4 was only 29% for Low Dose vs. 89% for High Dose (P = 0.006). Moreover, during those two hours, none of the Low Doses kept gastric pH above 4 for > 60% of the time, while all of the High Doses kept pH above 4 for > 60% of the time (P = 0.03). In three of four patients who underwent extended (9-12 h) gastric pH monitoring after High Dose ranitidine, gastric pH was above 4 for more than 40% of total time. CONCLUSIONS Doses of ranitidine ≥ 3 mg/kg/dose may be required for acid suppression lasting beyond 6 hours.

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Ranitidine, 75 mg, over‐the‐counter dose: pharmacokinetic and pharmacodynamic effects in children with symptoms of gastro‐oesophageal reflux

Cited by 39 publications

References 22 publications

Treatment of gastroesophageal reflux disease

Treatment of gastroesophageal reflux disease

Step-up and step-down approaches to treatment of gastroesophageal reflux disease in children

The Effects of Increasing Doses of Ranitidine on Gastric pH in Children

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