Description

Othera contains Esomeprazole Magnesium Trihydrate USP as enteric-coated micro-pellets, available in 20 mg and 40 mg strengths. The Multiple-Unit Pellet System (MUPS) combines pellets into a tablet form, ensuring higher bioavailability, rapid dissolution, consistent drug release, and lower risk of gastric irritation.

Indications

Adult Indications: Treatment and maintenance of gastroesophageal reflux disease (GERD), non-erosive reflux disease (NERD), erosive esophagitis, NSAID-associated gastric ulcers, Zollinger-Ellison Syndrome, and H. pylori eradication. Pediatric Indications (12 to 17 years): Management of GERD, NERD, and erosive esophagitis.

Dosage and Administration

Adult GERD and NERD: 20 mg once daily. Reflux Esophagitis: 20 mg or 40 mg once daily for 4 to 8 weeks. Zollinger-Ellison Syndrome: 40 mg twice daily. H. pylori Eradication: 20 mg twice daily or 40 mg once daily combined with amoxicillin and clarithromycin. Pediatric Dosage: 20 mg once daily for NERD, or 20 mg to 40 mg once daily for erosive esophagitis. Administration: Swallow whole with liquid. Alternatively, disperse in non-carbonated water, stir, and drink within 30 minutes. Do not crush or chew the pellets.

Interactions and Side Effects

Interactions: May reduce diazepam clearance and alter the absorption of pH-dependent drugs such as digoxin, iron salts, and ketoconazole. Side Effects: Common reactions include headache, diarrhea, abdominal pain, nausea, vomiting, flatulence, and constipation.

Precautions and Overdose

Precautions: Use with caution in patients with severe liver or renal impairment. Long-term use may slightly increase the risk of bone fractures. Use during pregnancy only if essential, and avoid during breastfeeding. Overdose: Symptoms include weakness and gastrointestinal distress. Provide symptomatic treatment, as the drug is not easily dialyzable.