RABIOXIN 20 MG

Therapeutic area

Gastro-Intestinal

Manufacturer

LABORATORIOS LINCOSA S.A., SPAIN; INBIOTECH LTD, BULGARI

Visa Number

840110188823

Issuing date

14/07/2023

Applicant company

Inbiotech Ltd

Active ingredient

Rabeprazole sodium

Content

20 mg

Indication

Rabioxin 20 mg are indicated for the treatment of:
• Active duodenal ulcer.
• Active benign gastric ulcer.
• Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GERD).
• Gastro-Oesophageal Reflux Disease Long-term Management.
• Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease.
• Zollinger-Ellison Syndrome and other pathological hyperacidity conditions.
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori (H. pylori) in patients with peptic ulcer disease.
Rabioxin 20 mg are indicated for the treatment of moderate to very severe gastro-oesophageal reflux disease.

Dosage

Adults /older people
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Oesophageal Reflux Disease Long-term Management: For long-term management, a maintenance dose of PARIET 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease: 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Zollinger-Ellison syndrome and other pathological hyperacidity conditions: Dosage needs to vary depending on the patient. Start with rabeprazole sodium 60 mg daily, which can then be increased to 100 mg once daily or 60 mg twice daily. Some patients require divided doses. It is necessary to continue taking the drug when clinical manifestations still indicate the need to maintain treatment. Some patients with Zollinger-Ellison symptoms have been treated with rabeprazole continuously for up to 1 year.
H. pylori eradication: Patients infected with H. pylori should receive treatment to eradicate H. pylori. Combination therapy for 7 days is recommended as follows:
Rabioxin 20 mg orally 2 times/day + Clarithromycin 500 orally 2 times/day + Amoxicillin 1 g orally 2 times/day.
Treatment regimen can be changed for each patient, based on the doctor's instructions.
For once-daily dosing indications, Rabioxin 20 mg should be taken in the morning, immediately before eating or 30 - 60 minutes before eating and although the time of day and type of food are not affected. affect the effects of rabeprazole sodium, such dosing in the morning facilitates treatment compliance.
Kidney failure and liver failure:
No dose adjustment is required for patients with renal or hepatic impairment. Refer to Warnings and Precautions when treating patients with severe hepatic impairment.
Adolescents 12 years and older:
The recommended dose for adolescents 12 years of age and older is 20 mg once daily for 8 weeks.
Children:
The safety and effectiveness of rabeprazole sodium in the treatment of GERD in children under 12 years of age have not been established. The safety and effectiveness of rabeprazole sodium for other indications have not been established in pediatric patients.
Missed dose:
Take the missed dose as soon as possible. If it is almost time for your next dose, skip the missed dose and take your medication at your regular schedule. Do not take 2 doses at the same time.