Esozol 40 mg (Capsule (Enteric Coated))

Indications

• Relief from chronic heartburn symptoms and other symptoms associated with GERD
• Healing of erosive esophagitis
• Maintenance of healing of erosive esophagitis
• Eradication of Helicobacter pylori infection in patients with duodenal ulcer disease
• Zollinger-Ellison Syndrome
• Acid related Dyspepsia
• Duodenal & Gastric ulcer

Pharmacology

• Proton pump inhibitor
• Specific inhibition of the H+/K+-ATPase in the gastric parietal cell
• Better acid control than racemic proton pump inhibitors
• Enteric-coated pellet formulation of esomeprazole magnesium
• Peak plasma levels occur at approximately 1.5 hours
• Three-fold increase in the area under the plasma concentration-time curve from 20 to 40 mg
• Metabolized in the liver by the cytochrome P450 (CYP) enzyme system
• Extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system
• Excreted as inactive metabolites in the urine and faeces

Dosage

• 20 mg or 40 mg Once Daily for 4-8 Weeks for Healing of Erosive Esophagitis
• 20 mg Once Daily for Maintenance of Healing of Erosive Esophagitis
• 20 mg Once Daily for Symptomatic GERD
• 40 mg Once Daily for Helicobacter Pylori eradication
• 20-80 mg once daily for Zollinger-Ellison Syndrome
• 20-40 mg once daily for Acid-related Dyspepsia

Administration

• Tablet or capsule should be swallowed whole and taken one hour before a meal
• Oral Suspension should be taken with water
• IV Injection: solution for injection prepared by adding 0.9% Sodium Chloride for intravenous injection into the vial containing the dry powder

Interaction

• Metabolized in the liver by CYP2C19 and CYP3A4
• Not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4
• No clinically relevant interactions with drugs metabolized by these CYP enzymes
• May interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability

Contraindications

• Known hypersensitivity to any of the formulation

Side Effects

• Headache
• Diarrhoea
• Nausea
• Flatulence
• Abdominal pain
• Constipation
• Dry mouth

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Excretion in milk not studied
• Breast-feeding should be discontinued if use is considered essential

Precautions & Warnings

• Symptomatic response to therapy does not preclude the presence of gastric malignancy
• Capsules should be taken at least one hour before meals
• Antacids may be used while taking the medication

Use in Special Populations

• No established safety and effectiveness in paediatric patients
• No overall differences in safety and efficacy observed between the elderly and younger individuals
• No dosage adjustment recommended for patients with mild to moderate hepatic insufficiency

Overdose Effects

• Major signs of acute toxicity include reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions
• No specific antidote known
• Treatment should be symptomatic and supportive

Storage Conditions

• Store at a temperature not exceeding 30°C in a dry place
• Protect from light and moisture
• Keep out of reach of children

Chemical Structure

• Molecular Formula: C17H19N3O3S
• Chemical Structure Image: (Link to chemical structure image)

Common Questions about Esozol 40 mg Capsule

• PPI used to treat GERD, ulcers, and conditions involving excess stomach acid
• Side effects include headaches, diarrhea, nausea, and stomach pain
• Use and safety during pregnancy and breastfeeding should be discussed with a doctor
• Typically starts working within a few hours of taking it

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