S-Ome 40 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
• First single optical isomer of proton pump inhibitor
• Better acid control than racemic proton pump inhibitors
• Enteric-coated pellet formulation
• Absorption peaks at approximately 1.5 hours

Dosage

• Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks
• Maintenance of Healing of Erosive Esophagitis: 20 mg Once Daily
• Symptomatic GERD: 20 mg Once Daily for 4 Weeks
• Helicobacter Pylori eradication: Triple Therapy with Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days
• Zollinger-Ellison Syndrome: 20-80 mg once daily
• Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks
• Duodenal ulcer: 20 mg once daily for 2-4 weeks, Gastric ulcer: 20-40 mg once daily for 4-8 weeks

Administration

• Tablet or capsule: Swallowed whole, taken one hour before a meal
• Oral Suspension: Contents mixed with water, swallowed within 30 minutes
• IV Injection: Prepared using 0.9% Sodium Chloride, administered intravenously over at least 3 minutes

Interaction

• Extensively metabolized in the liver by CYP2C19 and CYP3A4
• Not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, 3A4
• Potential interference with CYP2C19
• No clinically significant interactions with specific drugs

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
• No teratogenic effects in animal studies
• Excretion in milk not studied
• Breast-feeding should be discontinued if essential

Precautions & Warnings

• Symptomatic response does not preclude the presence of gastric malignancy
• Tablets taken at least one hour before meals
• Special instruction for patients having difficulty swallowing capsules

Use in Special Populations

• Safety and effectiveness not established in pediatric patients
• No overall differences in safety and efficacy observed between elderly and younger individuals
• No dosage adjustment recommended for patients with mild to moderate hepatic insufficiency
• No alteration expected in the Pharmacokinetics in patients with renal impairment

Overdose Effects

• Acute toxicity signs in rats
• No specific antidote known
• Treatment should be symptomatic and supportive

Storage Conditions

• Temperature not exceeding 30°C
• Dry place, protect from light and moisture
• Keep out of reach of children

Chemical Structure

• Molecular Formula: C17H19N3O3S

Common Questions about S-Ome 40 mg Tablet

• Proton pump inhibitor used to treat GERD, ulcers, and conditions involving excess stomach acid
• Side effects may include headaches, diarrhea, nausea, gas, and stomach pain
• Consideration advised for pregnant or breastfeeding individuals

Related Brands

• S-Ome 20 mg (Tablet (Enteric Coated)) - somatec-pharmaceuticals-ltd