Rabestad 20

Rx

Indications

• Active duodenal ulcer.
• Active benign gastric ulcer.
• Gastro-oesophageal reflux disease (GORD).
• Zollinger-Ellison syndrome.
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori (H. pylori) in patients with peptic ulcer disease.
• Gastro-oesophageal reflux disease long-term management (GORD maintenance).

Dosage

• Erosive or ulcerative gastro-oesophageal reflux disease (GORD)
  The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
  For long-term management, a maintenance dose of 20 mg or 10 mg once daily can be used depending upon patient response.
• Active duodenal ulcer and active benign gastric ulcer
  20 mg to be taken once daily in the morning for patients with active duodenal ulcer heal within 4 – 8 weeks.
  Most patients with active benign gastric ulcer heal within 6 – 12 weeks.
• Zollinger-Ellison syndrome
  The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
• Eradication of H. pylori
  Combination given for 7 days is recommended: Rabeprazole sodium 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily.
  For indications requiring once daily treatment rabeprazole sodium should be taken in the morning, before eating.
• Renal and hepatic impairment|
  No dosage adjustment is necessary.
• Rabeprazole sodium is not recommended for use in children.

Usage

• Administered orally. Patients should be cautioned that the Rabestad 20 should not be chewed or crushed, but should be swallowed whole.

• Hypersensitivity to any of the ingredients.
• Pregnancy and during breast feeding.

The majority of adverse events experienced were mild or moderate in severity, and transient in nature.

Most common

• Headache,
• Diarrhoea, abdominal pain,
• Asthenia,
• Rash and dry mouth.

Common

• Infection;
• Insomnia;
• Headache, dizziness;
• Cough, pharyngitis, rhinitis;
• Diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence, fundic gland polyps (benign);
• Non-specific pain, back pain;
• Asthenia, influenza like illness.

• Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with rabeprazole sodium.
• Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
• A risk of cross-hypersensitivity reactions with other proton pump inhibitor (PPI) or substituted benzimidazoles cannot be excluded.
• In case of blood dyscrasias, discontinuation of rabeprazole sodium should be done.
• In the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with rabeprazole sodium.
• Treatment with PPIs, including rabeprazole sodium, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
• PPIs, especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in presence of other recognised risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
• Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole sodium for at least three months, and in most cases for a year. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
• Co-administration of atazanavir with rabeprazole sodium is not recommended.
• Concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
• Rabeprazole sodium may reduce the absorption of vitamin B12 (cyanocobalamin).
• PPIs are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping rabeprazole sodium. SCLE after previous treatment with a PPI may increase the risk of SCLE with other PPIs.
• Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, rabeprazole sodium treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment.
• Rabestad 20 contains tartrazine lake, which may cause allergic reactions.
• Rabeprazole should not be used during pregnancy and breast feeding.
• Alertness is impaired due to somnolence, it is recommended that driving and operating complex machinery be avoided.