Heartburn during Pregnancy
Tony Hollingworth in Differential Diagnosis in Obstetrics and Gynaecology: An A-Z, 2015
Antacids and sucralfate (an aluminium-containing compound) are considered the first-line drug therapy. They have little systemic absorption, and therefore do not pose much risk to the fetus. Over-the-counter remedies for neutralising stomach acid can be helpful. However, using them too often and for too long can cause constipation (if they contain aluminium) or diarrhoea (if they contain magnesium). Antacids that contain sodium bicarbonate should be avoided as they can cause maternal alkalosis and fluid overload. Women should be advised to take antacids at a different time from when they take oral iron supplements, as hydrochloric acid is required for iron absorption. Sucralfate is also poorly absorbed, inhibits pepsin and locally protects against ulcers. Alginates are used for the symptomatic treatment of heartburn and oesophagitis, and appear to act by a unique mechanism, which differs from traditional antacids. Gaviscon is an alginate, which in the presence of gastric acid precipitates to form a gel. Both in vitro and in vivo studies have demonstrated that alginate-based rafts can entrap carbon dioxide, thus providing a relatively pH-neutral barrier. Several studies have demonstrated that the alginate raft can preferentially move into the oesophagus in place, or ahead, of acidic gastric contents during episodes of gastro-oesophageal reflux; furthermore they can act as a physical barrier to reduce reflux episodes.2
Information on level of drugs into breastmilk
Wendy Jones in Breastfeeding and Medication, 2013
Alginate of choice for mother during breastfeeding based on evidence of benefit and safety for the baby: All alginates are safe during breastfeeding Choose according to personal preference and cost Alginates form a pH neutral raft on top of the food contents of the stomach in order to prevent regurgitation and heartburn resulting from irritation of the oesophagus. They are poorly absorbed from the GI tract (15 to 30%) and can be taken during lactation without risk to the baby. Compatible with use during breastfeeding – Infant Gaviscon is also given directly to infants to relieve symptoms of reflux. Anti-spasmodics Anti-spasmodic of choice for mother during breastfeeding based on evidence of benefit and safety for the baby: Mebeverine or peppermint oil – or if these are ineffective, hyoscine hydrombromide Anti-spasmodics are used to relieve the spasmodic pain of irritable bowel syndrome (IBS). IBS can present as abdominal pain with constipation or diarrhoea. Taking antimuscarinic drugs e.g. dicloverine before food as required may relieve abdominal pain in IBS by reducing intestinal mobility. Smooth muscle relaxants e.g. alverine directly relax intestinal smooth muscle. This drug group may also be useful in relieving symptoms of diverticular disease. Alverine Brand name: Relaxyl, Spasmonal US brand: Australian brand: Alvercol 110
Extra-oesophageal reflux
Declan Costello, Guri Sandhu in Practical Laryngology, 2015
Alginates are seaweed compounds that form a raft on gastric contents. A buoyant CO2 retaining gel contacts the gastric contents preventing reflux. In-vitro experiments have shown removal of pepsin and bile salts from the refluxate.38 There is a single randomised, open, parallel study of Gaviscon Advance (GA), which contains sodium alginate and potassium bicarbonate, 10 ml four times daily versus ‘no treatment’ (n = 49).39 Although no placebo medication could be identified as appropriate and the ‘no treatment’ group received high-quality speech therapy input, the methodology is sound. Both groups showed an improvement in RSI and RFS at 2 months, with a significant additional benefit noted in the GA group. The benefit in RSI persisted until 6 months, again to a greater extent with GA, whereas RFS remained improved at 6 months in the GA group alone. The RSI improved from 23.9 in the GA group and 24.6 in the no-treatment group to 11.2 and 16.8 at 2 months, with scores of 11.2 and 18.3 at 6 months.
Development and characterization of novel ambroxol sustained-release oral suspensions based on drug-polymeric complexation and polymeric raft formation
Published in Pharmaceutical Development and Technology, 2020
Ahmad Bani-Jaber, Samaa Abdullah
Gaviscon liquid had higher raft volume and weight than F3 and F6 suspension of nearly two folds (Table 4). This reflected the higher solid content of Gaviscon liquid label claimed to contain 250 mg NA, 133.5 mg sodium bicarbonate, and 80 mg CC per 5 ml i.e. total solid per 5 ml 463.5 mg. According to Table 1, the corresponding solid content of F3 and F6 suspensions are 185 and 152.5 mg per 5 ml, respectively. In addition, NA grade used in this study was high MWt, whereas the grade that is used to prepare NA-antacid raft forming formulation, such as Gaviscon, is low MWt, which allows for the incorporation of NA at higher concentration (Hampson et al. 2005). The three products exhibited similar raft strengths (Table 4) indicative of similar degree of NA-crosslinking by calcium for Gaviscon and F3 suspension and the high efficacy of excess CRG in F6 suspension without CC in maintaining raft strength. However, rafts of F3 suspension and F6 suspension were more durable than that of Gaviscon liquid under agitation that simulate stomach movement as the median resilience time of their rafts was almost four folds longer than that of Gaviscon (Table 4). The use of high MWt NA in the suspensions would suppress agitation driven raft erosion and polymer dissolution.
Safety considerations when managing gastro-esophageal reflux disease in infants
Published in Expert Opinion on Drug Safety, 2021
Melina Simon, Elvira Ingrid Levy, Yvan Vandenplas
Literature does not report severe adverse events [103–107]. Some alginates are for more than 20 years aluminum-free. A randomized parallel-group trial in term neonates and infants (n = 90) mentioned adverse events such as teething syndrome, nausea and vomiting, diarrhea as well as constipation, colic, fever, and acute nasopharyngitis [104]. Although, the events reported were not significantly more frequent in the treatment than in the placebo group (p > 0.1) [104]. However, Gaviscon Infant® in combination with Anti-Regurgitation formula was reported to be possibly associated with intestinal obstruction due to the risk of agglutinated intragastric materials being formed [108,109]. Sodium alginates were associated with bezoar formation in at least four infants [110]. Sodium alginates should be given with caution in infants i) which are born preterm, ii) suffering renal impairment, iii) with congestive cardiac failure, iv) with diarrhea and vomiting with risk of dehydration [107,108]. No study evaluated long-term consequences.
Two placebo-controlled crossover studies in healthy subjects to evaluate gastric acid neutralization by an alginate–antacid formulation (Gaviscon Double Action)
Published in Drug Development and Industrial Pharmacy, 2019
Joanne Wilkinson, Khalid Abd-Elaziz, Izaak den Daas, Johan Wemer, Michiel van Haastert, Victoria Hodgkinson, Michelle Foster, Cathal Coyle
Alginate-containing treatments have been used for the symptomatic treatment of heartburn and indigestion for over 40 years. Alginates are natural polysaccharides, derived from seaweed, that form a viscous “raft” on exposure to acid and act to impede or replace the reflux of gastric material [14,15]. Gaviscon Double Action (Gaviscon DA; RB, Slough, UK) is an alginate formulation that was developed to deliver the dual action of reflux suppression and acid neutralization, with the addition of two antacids, calcium carbonate and sodium bicarbonate [16]. Clinical studies demonstrate that Gaviscon DA is effective for the relief of reflux and dyspeptic symptoms [17,18], likely owing to both the alginate raft and antacid components of the formulation. The mode of action of the alginate raft of Gaviscon DA has been well-characterized both in vitro and in vivo [16,19,20]. It rapidly localizes on top of the acid pocket, a major source of postprandial reflux, physically replacing it and shifting the pH transition point away from the esophago-gastric junction [19,20]. Furthermore, compared to non raft-forming antacids alone, Gaviscon DA shows significant superiority in decreasing postprandial acid reflux and esophageal acid exposure [19,21]. The antacid action of Gaviscon DA is less well characterized. While the acid neutralization capacity has been assessed in vitro [22], confirmation of intragastric acid neutralization activity in vivo is lacking. Owing to regional variations in gastric acid content, determination of intragastric pH over time requires a net measurement of acidity throughout the stomach [23]. Here, we present the findings from studies evaluating the intragastric acid neutralization activity of Gaviscon DA versus placebo in healthy subjects using a multielectrode catheter.
Related Knowledge Centers
- Calcium
- Constipation
- Gastric Acid
- Heartburn
- Indigestion
- Magnesium
- Diarrhea
- Neutralization
- Salt
- Aluminium