Paricel (Rabeprazole Sodium): A Proton Pump Inhibitor (PPI)

Paricel contains Rabeprazole Sodium, an antisecretory compound that effectively suppresses gastric acid secretion. It is used to treat various acid-related conditions of the stomach and intestine, including peptic ulcers, reflux disease, and as part of H. pylori eradication therapy. It belongs to the therapeutic class of Proton Pump Inhibitor.

How Paricel Works (Pharmacology)

Rabeprazole Sodium is a proton pump inhibitor (PPI). It works by:

• Inhibiting Gastric H+, K+-ATPase: Rabeprazole suppresses gastric acid secretion by inhibiting the H+, K+-ATPase enzyme system (also known as the gastric proton pump) at the secretory surface of the gastric parietal cells. This enzyme is responsible for pumping acid into the stomach.
• Reducing Acid Production: By inhibiting this pump, Rabeprazole effectively reduces the amount of acid produced in the stomach.

Key Indications & Benefits

Paricel is indicated for conditions where suppression of acid secretion provides therapeutic benefit:

• Active duodenal ulcer
• Active benign gastric ulcer
• Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD)
• Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
• Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
• Zollinger-Ellison Syndrome
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Dosage & Administration

For indications requiring once-daily treatment, Rabeprazole tablets should be taken in the morning, before eating. Tablets should not be chewed or crushed but should be swallowed whole. Always consult a registered physician for medication use.

• Active Duodenal Ulcer and Active Benign Gastric Ulcer:
  • Recommended oral dose: 20 mg once daily in the morning.
  • Duodenal ulcer: Most heal within 4 weeks; some may need an additional 4 weeks.
  • Benign gastric ulcer: Most heal within 6 weeks; some may need an additional 6 weeks.
• Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD):
  • Recommended oral dose: 20 mg once daily for 4 to 8 weeks.
• Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance):
  • Maintenance dose: 20 mg or 10 mg once daily, depending on patient response.
• Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD):
  • 10 mg once daily in patients without oesophagitis.
  • If symptom control is not achieved in 4 weeks, further investigation is needed.
  • Once symptoms resolve, subsequent control can be achieved with an on-demand regimen of 10 mg once daily when needed.
• Treatment of GERD in pediatric patients 1 to 11 years of age:
  • Less than 15 kg: 5 mg once daily for 12 weeks, with option to increase to 10 mg if inadequate response.
  • 15 kg or more: 10 mg once daily for 12 weeks.
• Zollinger-Ellison Syndrome:
  • Recommended adult starting dose: 60 mg once daily.
  • Dose may be titrated upwards to 120 mg/day based on individual needs.
  • Single daily doses up to 100 mg/day are possible. 120 mg dose may require divided doses (60 mg twice daily).
  • Treatment should continue as long as clinically indicated.
• Eradication of H. pylori (7-day triple drug regimen):
  • Rabeprazole sodium 20 mg twice daily
  • Clarithromycin 500 mg twice daily
  • Amoxicillin 1g twice daily
  • All three medications should be taken twice daily with the morning and evening meals.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking Paricel.

Contraindications:

• Hypersensitivity to the active substance, any excipients, or other proton pump inhibitors.
• Pregnancy and during breastfeeding.

Side Effects:

• Generally well-tolerated in both short-term and long-term studies.
• Common: Headache, diarrhea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.
• Post-marketing reports (rare): Blood dyscrasias (thrombocytopenia, neutropenia), hepatic enzyme abnormalities (usually resolve on discontinuation).
• Serious (with long-term PPI use):
  • Increased risk of hip, wrist, and spine fracture, predominantly in the elderly or with other risk factors.
  • Severe hypomagnesaemia (low magnesium levels) reported in patients treated for at least three months, often a year. Symptoms can include fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia. Magnesium levels should be monitored before and periodically during prolonged PPI treatment.
  • May possibly increase the risk of gastrointestinal infections (e.g., Salmonella, Campylobacter, and Clostridium difficile).
  • May reduce absorption of vitamin B12 (cyanocobalamin) due to reduced stomach acid.
  • Subacute cutaneous lupus erythematosus (SCLE) has been reported in very infrequent cases.

Pregnancy & Lactation:

• US FDA pregnancy category 'C'.
• Animal studies show no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy is contraindicated.
• Rabeprazole is likely to be excreted in human milk. Use during breastfeeding is contraindicated; a decision should be made whether to discontinue nursing or the drug.

Precautions & Warnings:

• Gastric/Esophageal Malignancy: Symptomatic response to Paricel does not rule out malignancy. Exclude malignancy before starting treatment.
• Long-term Treatment: Patients on long-term treatment (especially >1 year) should be kept under regular surveillance.
• Osteoporosis Risk: PPIs, especially at high doses and long durations (>1 year), may modestly increase fracture risk. Patients at risk should receive adequate vitamin D and calcium intake.
• Cross-hypersensitivity: A risk of cross-hypersensitivity reactions with other PPIs or substituted benzimidazoles cannot be excluded.
• Tablet Administration: Do not chew or crush tablets; swallow whole.
• Hepatic Impairment: Exercise caution when initiating treatment in patients with severe hepatic dysfunction due to lack of clinical data. No dose adjustment is necessary for patients with renal or hepatic impairment (based on a separate section, though caution is advised for severe hepatic impairment).
• Co-administration with Atazanavir:Not recommended.
• Laboratory Tests: Increased Chromogranin A (CgA) levels may interfere with investigations for neuroendocrine tumors. Stop Paricel at least 5 days before CgA measurements. Repeat measurements 14 days after cessation if levels have not returned to reference range.

Use in Special Populations:

• Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment (contradicts previous warning for severe hepatic impairment slightly, suggesting careful consideration is key).
• Pediatric populations:Not recommended for use in children due to lack of safety and efficacy data, except for specific GERD indications in children 1-11 years.

Overdose Effects

• There is no experience with large overdoses of Rabeprazole.
• Effects are generally minimal, representative of known adverse event profile, and reversible without further medical intervention.
• No specific antidote is known.
• Rabeprazole is extensively protein bound and is not dialyzable.
• Treatment should be symptomatic and general supportive measures should be utilized.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.