Finix 10 mg (Sprinkle Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Rabeprazole sodium |
| Company | Opsonin pharma ltd |
| Also available as |
Indications
- Treatment of active duodenal ulcer
- Treatment of active benign gastric ulcer
- Treatment of symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD)
- Long-term management of gastro-esophageal reflux disease (GERD Maintenance)
- Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease
- Treatment of Zollinger-Ellison syndrome
- Eradication of Helicobacter pylori in patients with peptic ulcer disease
Pharmacology
Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+ / K+-ATPase at the secretory surface of the gastric parietal cell. This enzyme is regarded as the acid (proton) pump within the parietal cell, and rabeprazole has been characterized as a gastric proton-pump inhibitor.
Dosage
- Recommended oral dose for active duodenal ulcer and active benign gastric ulcer is 20 mg once daily in the morning
- Recommended oral dose for erosive or ulcerative gastro-esophageal reflux disease (GERD) is 20 mg once daily for 4 to 8 weeks
- For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response
- Treatment for pediatric patients 1 to 11 years of age is based on weight and may vary from 5 mg to 10 mg once daily
- For Zollinger-Ellison syndrome, the recommended adult starting dose is 60 mg once a day, which may be titrated upwards based on individual patient needs
- For eradication of H. pylori, recommended regimen includes rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1g twice daily for 7 days
Administration
Rabeprazole tablets should be taken in the morning, before eating, and should not be chewed or crushed, but swallowed whole.
Interaction
Respite produces a profound and long-lasting inhibition of gastric acid secretion, and may interact with compounds whose absorption is pH dependent. Co-administration with ketoconazole, itraconazole, or atazanavir may necessitate monitoring and possible dosage adjustment.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients
- Rabeprazole is contra-indicated in pregnancy and during breastfeeding
Side Effects
- Headache
- Diarrhoea
- Abdominal pain
- Vomiting
- Constipation
- Dry mouth
- Increased or decreased appetite
- Muscle pain
- Drowsiness
- Dizziness
Pregnancy & Lactation
US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. No adequate and well-controlled studies in pregnant women are available.
Precautions & Warnings
- Symptomatic response to therapy does not preclude the presence of gastric or esophageal malignancy
- Long-term treatment should be under regular surveillance
- Proton pump inhibitors may modestly increase the risk of hip, wrist, and spine fracture, especially in the elderly or in presence of other risk factors
- A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles
- Hepatic enzyme abnormalities and blood dyscrasias have been reported
- Caution advised for patients with severe hepatic dysfunction during treatment initiation
- Co-administration with atazanavir is not recommended
- May possibly increase the risk of gastrointestinal infections
- Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole and may require magnesium replacement
- May reduce the absorption of vitamin B12
- Associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE)
- May interfere with investigations for neuroendocrine tumours
Use in Special Populations
- No dosage adjustment is necessary for patients with renal or hepatic impairment
- Not recommended for use in children due to a lack of safety and efficacy data
Overdose Effects
Effects are generally minimal, reversible without further medical intervention, and may require only symptomatic and general supportive measures.
Therapeutic Class
Proton Pump Inhibitor
Storage Conditions
Keep below 30°C temperature, away from light & moisture, and out of the reach of children.