Xorel 20 mg

Description

Indications Xorel is prescribed for the treatment of the following conditions:

• Active duodenal ulcer
• Active benign gastric ulcer
• Symptomatic erosive or ulcerative gastroesophageal reflux disease (GERD)
• Long-term management of GERD (GERD Maintenance)
• Symptomatic relief of moderate to severe gastroesophageal reflux disease (symptomatic GERD)
• Zollinger-Ellison Syndrome
• As part of a combination therapy for Helicobacter pylori eradication in patients with peptic ulcer disease

This medication should be used as per the guidance of a registered physician.

Pharmacology Rabeprazole, the active ingredient in Xorel, works by inhibiting the gastric H+/K+-ATPase enzyme at the secretory surface of gastric parietal cells. This enzyme functions as a proton pump, making rabeprazole a potent gastric proton-pump inhibitor that effectively reduces acid secretion.

Dosage and Administration

Active Duodenal and Benign Gastric Ulcer:

• Recommended dose: 20 mg once daily in the morning.
• Most duodenal ulcers heal within four weeks; some patients may require an additional four weeks of treatment.
• Most benign gastric ulcers heal within six weeks, though some may require up to 12 weeks.

Erosive or Ulcerative GERD:

• 20 mg once daily for 4 to 8 weeks.

GERD Maintenance Therapy:

• 10 mg or 20 mg once daily, depending on patient response.

Symptomatic GERD (Moderate to Severe):

• 10 mg once daily in patients without esophagitis.
• If symptoms persist after four weeks, further evaluation is needed.
• Once symptoms are controlled, treatment can be continued on an as-needed basis.

Pediatric GERD Treatment (Ages 1-11):

• Weight <15 kg: 5 mg once daily for 12 weeks (may be increased to 10 mg if needed).
• Weight ≥15 kg: 10 mg once daily for 12 weeks.

Zollinger-Ellison Syndrome:

• Initial dose: 60 mg once daily.
• Can be adjusted up to 120 mg/day based on individual needs.
• Single daily doses of up to 100 mg may be given; 120 mg should be divided into two doses (60 mg twice daily).
• Treatment duration is based on clinical indication.

Helicobacter Pylori Eradication:

• Combination therapy for 7 days:
  • Rabeprazole 20 mg twice daily
  • Clarithromycin 500 mg twice daily
  • Amoxicillin 1 g twice daily

Administration Instructions:

• For once-daily treatments, take the tablet in the morning before meals.
• Tablets should be swallowed whole without chewing or crushing.

Drug Interactions

• Rabeprazole significantly reduces gastric acid secretion, which may impact the absorption of medications that depend on gastric pH.
• Co-administration with ketoconazole or itraconazole may reduce their plasma levels, necessitating dose adjustments.
• No significant interaction with liquid antacids has been observed.
• Should not be used with atazanavir due to reduced drug absorption.

Contraindications

• Hypersensitivity to rabeprazole or any excipients in the formulation.
• Contraindicated in pregnancy and breastfeeding.

Side Effects Xorel is generally well tolerated. Potential side effects include:

• Common: Headache, diarrhea, abdominal pain, vomiting, constipation, dry mouth, appetite changes, muscle pain, drowsiness, dizziness.
• Serious (rare): Kidney problems, liver damage, osteoporosis with long-term use.

Pregnancy & Lactation

• Classified as a Category C drug by the FDA.
• Animal studies show no harm to the fetus, but adequate human studies are lacking.
• Likely to be excreted in breast milk; a decision should be made to discontinue the drug or nursing based on medical need.

Precautions & Warnings

• Symptom relief does not rule out the presence of gastric or esophageal malignancy; further evaluation is necessary.
• Long-term use (over a year) may increase the risk of fractures, particularly in the elderly. Adequate calcium and vitamin D intake is recommended.
• Patients with osteoporosis or fracture risk should take appropriate precautions.
• Cross-hypersensitivity with other proton pump inhibitors or benzimidazole derivatives cannot be excluded.
• Rare reports of blood disorders (thrombocytopenia, neutropenia) have been noted but usually resolve after discontinuation.
• Hepatic enzyme abnormalities have been reported but are generally reversible.
• Long-term use may increase susceptibility to gastrointestinal infections such as Salmonella, Campylobacter, and Clostridium difficile.
• Severe hypomagnesemia may occur with prolonged use (over three months), presenting as fatigue, tetany, delirium, convulsions, or arrhythmias. Magnesium levels should be monitored in long-term patients.
• Vitamin B12 absorption may be reduced with prolonged therapy, requiring monitoring in at-risk patients.
• Rare cases of subacute cutaneous lupus erythematosus (SCLE) have been reported. Discontinue use if symptoms appear.
• May interfere with neuroendocrine tumor diagnostic tests; stop use 5 days before testing.

Special Populations

• Renal and Hepatic Impairment: No dosage adjustment is needed.
• Pediatric Use: Not recommended due to insufficient safety data.

Overdose Management

• Maximum exposure reported: 60 mg twice daily or 160 mg once daily.
• Symptoms are generally mild and reversible.
• No specific antidote; treatment should be symptomatic and supportive.
• Dialysis is ineffective as rabeprazole is extensively protein-bound.

Therapeutic Class

• Proton Pump Inhibitor (PPI)

Storage Instructions

• Store below 30°C, away from light and moisture.
• Keep out of reach of children.

Common Questions What is Xorel 20 mg Tablet used for?

• It treats duodenal ulcers, gastric ulcers, GERD, Zollinger-Ellison Syndrome, and Helicobacter pylori infections.

What are the side effects of Xorel?

• Common side effects include diarrhea, constipation, nausea, headache, dizziness, and dry mouth. Rare but serious effects may include kidney or liver issues and bone fractures.

How should I take Xorel?

• Take one tablet daily with food. Follow your doctor’s prescribed dosage.

Can I take Xorel while pregnant or breastfeeding?

• It is not recommended. Consult your doctor for alternative treatments.

What should I do in case of an overdose?

• Seek immediate medical attention. Symptoms may include drowsiness, confusion, and seizures.

How long should I take Xorel?

• Treatment duration depends on the condition. GERD treatment typically lasts 4-8 weeks, but your doctor will determine the appropriate length.

Does Xorel cause bone problems?

• Long-term use may increase the risk of osteoporosis and fractures. Adequate calcium and vitamin D intake is advised.

Can I take Xorel with vitamin D?

• Yes, vitamin D supplements are recommended as long-term PPI use can reduce calcium absorption.

Quick Tips

• Well-tolerated with long-lasting relief.
• Avoid eating late at night.
• Inform your doctor if you experience persistent stomach pain or diarrhea.
• Long-term use may require monitoring of bone health and magnesium levels.
• Seek medical help if you experience swelling, rash, or reduced urination.

Always consult your doctor before starting or stopping any medication.