Othera 40

Indications for Othera MUPS Tablet

Othera MUPS tablet is used for the following conditions:

• Gastro-esophageal Reflux Disease (GERD)
• Prevention of NSAID-associated Gastric Ulcers
• H. pylori Eradication (Triple Therapy)
• Zollinger-Ellison Syndrome and Idiopathic Hypersecretion

Note: Always consult with a registered healthcare professional before using this medication.

Composition

• Othera Esomeprazole MUPS 20 mg Tablet: Each tablet contains 133.33 mg (15% w/w) of Esomeprazole enteric-coated pellets, equivalent to 20 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP).
• Othera Esomeprazole MUPS 40 mg Tablet: Each tablet contains 266.67 mg (15% w/w) of Esomeprazole enteric-coated pellets, equivalent to 40 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP).

Product Description

MUPS stands for Multiple-Unit Pellet System. In simple terms, MUPS refers to tablets made from compacted modified-release pellets, combining the advantages of both tablets and pellet-filled capsules. This technology offers several benefits:

• Higher bioavailability and uniform drug release.
• Facilitates rapid dissolution and drug absorption, resulting in early Tmax and Cmax.
• Reduces the risk of dose dumping.
• Once-daily dosing ensures patient convenience.
• Minimizes the chance of localized irritation.
• Better drug absorption and more uniform plasma concentration.

Pharmacology

Esomeprazole, a proton pump inhibitor, works by inhibiting the hydrogen-potassium adenosine triphosphatase enzyme system (proton pump) in the gastric parietal cells, reducing stomach acid production. It is highly effective in the short-term treatment of gastric and duodenal ulcers and helps prevent NSAID-induced gastric ulcers.

Dosage Recommendations

• Erosive Esophagitis:
  • Adults (≥18 years): 40 mg once daily for 4 weeks.
  • Children & Adolescents (12-18 years): 40 mg once daily for 4 weeks.
• Maintenance of Healing:
  • Adults (≥18 years): 20 mg once daily.
  • Children & Adolescents (12-18 years): 20 mg once daily.
• NSAID-associated Gastric Ulcer Prevention:
  • Adults (≥18 years): 20 mg once daily for 4-8 weeks.
• H. pylori Eradication (with Amoxicillin & Clarithromycin):
  • Adults (≥18 years): 20 mg twice daily for 7 days.
  • Children & Adolescents (12-18 years): 20 mg twice daily for 7 days.
• Zollinger-Ellison Syndrome & Idiopathic Hypersecretion:
  • Adults (≥18 years): 40-80 mg twice daily.

For Children (1-11 years):

• Erosive Esophagitis:
  • Weight <20 kg: 10 mg once daily for 8 weeks.
  • Weight ≥20 kg: 10-20 mg once daily for 8 weeks.
• Maintenance of Healing: 10 mg once daily.

Note: Not approved for use in children under 1 year. Always follow a healthcare provider’s advice.

Administration Instructions

Esomeprazole MUPS tablets should be swallowed whole with water. Do not chew or crush the tablets. If necessary, dissolve the tablet in half a glass of non-carbonated water (not mineral water). Stir until the tablet disintegrates, then drink immediately or within 30 minutes. Rinse the glass with water and drink the remaining liquid.

Drug Interactions

• CYP2C19 & CYP3A4 Metabolism: Esomeprazole is metabolized in the liver by these enzymes. It does not significantly interact with drugs metabolized by CYP1A2, 2A6, 2C9, 2D6, 2E1, or 3A4.
• Diazepam: Co-administration with Othera reduces the clearance of diazepam by 45%.
• Acidic Drug Absorption: Esomeprazole may affect the absorption of drugs dependent on gastric pH (e.g., ketoconazole, iron salts, digoxin).
• Combination with Clarithromycin: Increases plasma levels of Othera and 14-hydroxyclarithromycin.

Contraindications

Esomeprazole should not be used by individuals with known hypersensitivity to any component of the formulation.

Side Effects

Common side effects include:

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

No significant differences in side effects were noted between short-term and long-term use (up to 12 months).

Pregnancy & Lactation

Esomeprazole should be used with caution during pregnancy. It is not known whether Esomeprazole is excreted in breast milk, so consult a healthcare provider before use during breastfeeding.

Precautions & Warnings

• Use carefully in patients with severe liver dysfunction or renal impairment.
• Long-term use may slightly increase the risk of fractures, especially in the hip, wrist, and spine.

Storage Instructions

Store Othera in a cool, dry place below 25°C, away from light. Keep out of reach of children.