Esprazo 20 mg (Tablet (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
• Suppresses gastric acid secretion
• Enteric-coated pellet formulation of esomeprazole magnesium
• Plasma protein binding is constant over the concentration range
• Metabolized in the liver
• Plasma elimination half-life of esomeprazole is approximately 1–1.5 hours

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 in combination therapy
• 20-80 mg once daily for Zollinger-Ellison Syndrome
• 20-40 mg once daily for Acid-related Dyspepsia
• 20 mg once daily for 2-4 weeks for Duodenal ulcer
• 20-40 mg once daily for 4-8 weeks for Gastric ulcer
• Dosage form also includes IV Injection or IV infusion for different conditions and patient categories

Administration

• Tablet or capsule should be swallowed whole and taken one hour before a meal
• Oral Suspension should be taken with water and administered carefully through nasogastric or gastric tube
• IV Injection must be administered intravenously over a period of at least 3 minutes

Interaction

• Metabolized in the liver by CYP2C19 and CYP3A4
• Not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4
• Potential interference with CYP2C19, diazepam, and drugs requiring particular gastric pH for bioavailability
• No clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin

Contraindications

• Known hypersensitivity to the formulation

Side Effects

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

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• No teratogenic effects in animal studies
• Breastfeeding should be discontinued if the use of esomeprazole is considered essential

Precautions & Warnings

• Symptomatic response to therapy with Esprazo does not preclude the presence of gastric malignancy
• Special instructions for patients who have difficulty swallowing capsules
• Use of antacids may be allowed while taking Esprazo

Use in Special Populations

• Safety and effectiveness in paediatric patients have not been established
• 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
• Pharmacokinetics not expected to be altered in patients with renal impairment

Overdose Effects

• Lethal to rats at high doses
• Major signs of acute toxicity include reduced motor activity, respiratory changes, tremor, and 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 provided in image form

Common Questions about Esprazo 20 mg Tablet

• Proton pump inhibitor used to treat various conditions related to stomach acid
• Multiple uses including relief from heartburn, healing erosive esophagitis, and preventing its recurrence
• Common side effects and precautions
• Usage during pregnancy or breastfeeding
• Time it takes to start working

Mode of Action

• Suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell
• First single optical isomer of proton pump inhibitor providing better acid control than racemic proton pump inhibitors
• Peak plasma levels occur at approximately 1.5 hours after oral administration
• Plasma protein binding is constant over the concentration range of 2 20 mmol/L

Distribution

• Esomeprazole is 97% bound to plasma proteins
• Apparent volume of distribution at steady state in healthy volunteers is approximately 16 L

Metabolism

• Extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system
• The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme

Excretion

• Plasma elimination half-life of esomeprazole is approximately 1–1.5 hours
• Less than 1% of parent drug is excreted in the urine

Combination Therapy with Antimicrobials

• Esomeprazole magnesium 40 mg once daily given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days

Cautions

• Immediate medical attention advised for specific symptoms
• Long-term use may cause weak bones and mineral deficiencies
• Special use instructions for patients with swallowing difficulties

Chemical Formula

• C17H19N3O3S

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