Xorel 20 is a medication containing Rabeprazole Sodium 20 mg. It is a proton pump inhibitor (PPI) and is available in both capsule and tablet forms (including MUPS tablets, Multiple Unit Pellet System). It is manufactured by The IBN SINA Pharmaceutical Industry PLC. in Bangladesh.

Indications

Xorel 20 is used to reduce the amount of acid produced in the stomach. It is indicated for the treatment of various acid-related disorders:

• Gastroesophageal Reflux Disease (GERD):
  • Healing of erosive or ulcerative GERD.
  • Maintenance of healing of erosive or ulcerative GERD.
  • Symptomatic treatment of moderate to very severe GERD (without esophagitis).
• Peptic Ulcer Disease:
  • Healing of active duodenal ulcers.
  • Healing of active benign gastric ulcers.
• Helicobacter pylori (H. pylori) Eradication: In combination with appropriate antibiotics, to eradicate H. pylorito reduce the risk of duodenal ulcer recurrence. 
• Pathological Hypersecretory Conditions:Including Zollinger-Ellison Syndrome. 
• Prevention of NSAID-associated gastric ulcers: To prevent stomach ulcers caused by long-term use of non-steroidal anti-inflammatory drugs.

Pharmacology

Rabeprazole Sodium is a specific inhibitor of the gastric enzyme H+/K+-ATPase, also known as the "proton pump," located at the secretory surface of the gastric parietal cells. By blocking this enzyme, rabeprazole effectively reduces gastric acid secretion. It also stimulates gastric mucin production, which helps protect the stomach lining. Its formulation (enteric-coated pellets in capsules or MUPS tablets) ensures stability in the stomach and provides faster action compared to some other PPIs.

Dosage and Administration

Xorel 20 tablets/capsules should be swallowed whole and not chewed or crushed. They can be taken with or without food, but for once-daily dosing, taking it in the morning before eating is often recommended to facilitate treatment compliance.

• Healing of Erosive or Ulcerative GERD:
  • Adults: 20 mg once daily for 4 to 8 weeks. An additional 8-week course may be considered if healing is not complete.
• Maintenance of Healing of Erosive or Ulcerative GERD:
  • Adults: 10 mg or 20 mg once daily, depending on patient response. Controlled studies for maintenance do not extend beyond 12 months.
• Treatment of Symptomatic GERD:
  • Adults: 10 mg or 20 mg once daily for 4 weeks. If symptoms persist, further investigation may be needed. An "on-demand" regimen of 10 mg once daily can be used for symptom control once symptoms have resolved.
• Healing of Duodenal Ulcers:
  • Adults: 20 mg once daily, usually after the morning meal, for up to 4 weeks. Most patients heal within this period, but some may require additional therapy.
• Healing of Benign Gastric Ulcers:
  • Adults: 20 mg once daily for up to 6 weeks. Some patients may require additional therapy.
• Helicobacter pylori Eradication:
  • 20 mg twice daily, in combination with Clarithromycin 500 mg twice daily and Amoxicillin 1g twice daily, for 7 days. This combination is typically taken with morning and evening meals.
• Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome):
  • Adults: Starting dose is typically 60 mg once daily. Doses can be adjusted based on individual needs, up to 120 mg/day (may require divided doses, e.g., 60 mg twice daily). Treatment continues as long as clinically indicated.
• GERD in Pediatric Patients (1 to 11 years):
  • < 15 kg body weight: 5 mg once daily for up to 12 weeks (may increase to 10 mg if inadequate response).
  • ≥ 15 kg body weight: 10 mg once daily for up to 12 weeks.

Side Effects

Xorel 20 is generally well-tolerated. Most side effects are mild, moderate, and transient.

• Common: Headache, diarrhea, nausea, abdominal pain, asthenia (weakness), flatulence, rash, dry mouth, pharyngitis.
• Less common/Rare: Vomiting, dizziness, constipation, pain.
• Long-term use: Can lead to weak bones and deficiencies in minerals like magnesium.

Contraindications

• Known hypersensitivity to Rabeprazole or any component of the formulation.
• Hypersensitivity to other proton pump inhibitors.

Precautions and Warnings

• Malignancy: Gastric malignancy should be ruled out before starting treatment, as symptom improvement with Xorel 20 might mask symptoms of a malignant condition.
• Hepatic Impairment: Caution should be exercised in patients with severe hepatic (liver) impairment, as exposure to rabeprazole may be increased and its elimination decreased.
• Long-term use: Long-term use (over a year) may be associated with an increased risk of fractures of the hip, wrist, or spine. Also, monitor for magnesium deficiency.
• Clostridium difficile-associated diarrhea: PPIs may increase the risk of Clostridium difficile infection.
• Vitamin B12 deficiency: Long-term use may lead to vitamin B12 malabsorption.
• Chromogranin A (CgA) blood test: Inform your doctor if you are due for this test, as PPIs can interfere with results.

Pregnancy and Lactation

• Pregnancy (US FDA Pregnancy Category B):There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
• Lactation: Rabeprazole is excreted in milk. Due to the potential for adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug,considering the importance of the drug to the mother. 

Drug Interactions

• pH-dependent absorption drugs: Rabeprazole significantly inhibits gastric acid secretion, which may interfere with the absorption of drugs whose bioavailability is pH-dependent (e.g., Ketoconazole, Itraconazole, Iron salts, Digoxin, Atazanavir). Avoid concurrent use with Atazanavir.
• Warfarin, Theophylline, Diazepam, Phenytoin: Rabeprazole is metabolized by the Cytochrome P450 system but generally does not show clinically significant interactions with these drugs.
• Clopidogrel: There's a potential for decreased serum concentration of clopidogrel.
• Methotrexate: Increased risk of toxicity, especially with high-dose methotrexate.

Storage Conditions

Store in a cool place (below 30°C) and dry place, protected from light. Keep out of reach of children.

Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.