Dear colleagues, in line with requests from pediatricians regarding magistral compounding practices, I plan to also include pediatric formulations in my articles. Starting this week, I will occasionally share preparations used in children with you.
This week, we will examine a formulation included in the Pharmaceutical Society of Australia that is particularly preferred in pediatrics for the treatment of reflux esophagitis.
Before moving on to the formulation, let us recall some general information regarding reflux esophagitis;
In the preschool / play age period, which we refer to as early childhood, children frequently experience abdominal pain, nausea, heartburn, and pain in the chest, precordial area, or sternal region. However, without any of these complaints occurring, it may also present as chronic hoarseness, cough, or sinusitis. It may even present with a clinical picture resembling recurrent bronchitis and asthma. Patients may have received treatment for years under a diagnosis of asthma. Gastric contents that reach the pharynx can remain on the teeth and cause cavities. Therefore, dental caries during this period may sometimes be a finding of reflux.
In infants, reflux disease frequently presents with vomiting, irritability, and weight loss. This is because the passage of gastric contents into the esophagus occurs especially in the supine position, and the child signals the irritation it causes there by crying. Sometimes children wake up crying at night. Sometimes this reflux reaches the pharynx, affecting the Eustachian tube, and can also present with recurrent otitis media. In other cases, chronic hoarseness, cough, and wheezing may be the only findings.
In older children, abdominal pain, heartburn, and regurgitation of bitter fluid can be clearly described. However, unfortunately, these children often receive treatment and follow-up with diagnoses of gastritis and ulcers. Temporary improvements occur, but it constantly recurs. In addition to these gastrointestinal findings, complaints of hoarseness are very common. In fact, upon examining their larynx, the damage caused by reflux is clearly visible. For this reason, reflux disease should be considered in all cases of laryngitis, otitis, and asthma, especially in patients without allergies, or those that are treatment-resistant or constantly recurring. They may wake up at night with heartburn, acid indigestion, and chest pain.
Pediatric use of Omeprazole
In an uncontrolled study conducted in children (1–16 years old) with severe reflux esophagitis, omeprazole at doses between 0.7 and 1.4 mg/kg improved the degree of esophagitis in 90% of cases and significantly reduced reflux symptoms. In a single-blind study, clinically diagnosed GERD patients between 0–24 months of age were treated with 0.5 mg, 1.0 mg, and 1.5 mg omeprazole/kg. The frequency of vomiting/regurgitation episodes decreased by 50% after 8 weeks of treatment, independent of the dose.
In the eradication of H. pylori in children:
A randomized, double-blind clinical trial (the Héliot study) concluded that the combination of omeprazole with two antibiotics (amoxicillin and clarithromycin) is safe and effective in the treatment of H. pylori infection in children aged 4 years and older with gastritis: The eradication rate of H. pylori was 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin, and 9.4% (3/32 patients) with amoxicillin + clarithromycin. However, there is no evidence of any clinical benefit based on dyspeptic symptoms. This study does not support any information for children under 4 years of age.
Returning to our formulation;
Omeprazole dispersion CF-2 mg/ml
Rp
Omeprazole ……………………… 200 mg
Sodium bicarbonate ……………………8 g
Compound hydroxybenzoate solution ..1 ml
Purified water …………………………to 100 ml
Substances included in the formula:
Omeprazole – omeprazolum: Omeprazole is a member of a new pharmacological group of drugs that reduce gastric acid secretion. The reason omeprazole is characterized as a gastric acid pump inhibitor is that it blocks gastric acid production at the final stage. Unlike other antiulcer drugs, omeprazole does not antagonize histamine H2 receptors or cholinergic receptors. Omeprazole inhibits both basal and stimulated acid secretion. It is a very potent drug. The intragastric pH of patients taking omeprazole is usually higher, and its effect is seen to last longer when compared to maintained treatment with H2 receptor antagonists. Omeprazole is more effective than H2 receptor antagonists or sucralfate in the treatment of gastroesophageal reflux. Omeprazole is administered orally. It is recommended to be taken in the morning and before meals.
Sodium bicarbonate – Bicarbonate de sodium – sal de Vichy – sodium hydrogen carbonate: Sodium bicarbonate is a systemically acting alkalinizing drug. Although sodium bicarbonate is a potent antacid, because it is absorbed and affects the body’s systemic acid-base balance, it is rarely used in the long-term treatment of peptic ulcer disease. Due to the rapid onset of its antacid effect, it is generally used in combination with other antacids. When administered orally, sodium bicarbonate neutralizes hydrochloric acid in the stomach by forming sodium chloride, carbon dioxide, and water. When administered orally, sodium bicarbonate is rapidly absorbed and passes into the blood as bicarbonate and sodium ions. It is not metabolized in the body, and bicarbonate ions are reabsorbed after filtration in the kidneys.
Compound hydroxybenzoate solution; Compound hydroxybenzoate solution
It has a preservative effect in high concentrations in syrup, glycerol, and ethanol.
Methyl hydroxybenzoate ………… 8 g
Propyl hydroxybenzoate …………2 g
Propylene glycol ………………to 100 ml
1 ml per 100 ml of oral liquid provides 0.1% parabens.
Methyl hydroxybenzoate is also known as methyl parahydroxybenzoate or Methylparaben.
Propyl Hydroxybenzoate is also known as Propyl Parahydroxybenzoate or Propylparaben.
Purified water – Distilled water
Preparation of the formula
Sodium bicarbonate is dissolved in distilled water. The amount of Omeprazole capsules calculated in the formula (10 capsules) is emptied into the sodium bicarbonate solution. The hydroxybenzoate solution included in the formula is added for preservative purposes, and the mixture is shaken for approximately 10 minutes to obtain a homogeneous preparation.
The formula is stored at 2–8°C. It must be protected from light. Shake well before use. It can be administered in fruit juice.
It should be used with caution in children with renal failure and in infants under 6 months of age, as it may disrupt the acid-base balance.
Wishing you a good week…
Exp. Pharm. Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/
