Rabeprazole sodium (as Rabeprazole sodium hydrate) ... 20 mg
Excipients q.s ............................................................ 1 tablet
Gastro-resistant tablet.
Box of 3 blisters x 10 tablets.
Box of 5 blisters x 10 tablets.
Raxium 20 contains the active ingredient Rabeprazole sodium which belongs to the class of antisecretory compounds, that do not exhibit anticholinergic or H2 histamine antagonist properties, but suppress gastric acid secretion by the specific inhibition of the H+/K+ - ATPase enzyme (the acid or proton pump). This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. As a weak base, rabeprazole is rapidly absorbed following all doses and is concentrated in the acid environment of the parietal cells. Rabeprazole is converted to the active sulphenamide form through protonation and it subsequently reacts with the available cysteines on the proton pump.
After oral administration of a 20 mg dose of rabeprazole sodium the onset of the anti-secretory effect occurs within one hour with the maximum effect occurring within two to four hours. Inhibition of basal and food stimulated acid secretion 23 hours after the first dose of rabeprazole sodium are 69% and 82% respectively and the duration of inhibition lasts up to 48 hours. The inhibitory effect of rabeprazole sodium on acid secretion increases slightly with repeated once-daily dosing, achieving steady state inhibition after three days. When the drug is discontinued, secretory activity normalises over 2 to 3 days.
It is unlikely that rabeprazole sodium would cause an impairment of driving performance or compromise the ability to use machinery. If however, alertness is impaired due to somnolence, it is recommended that driving and operating complex machinery be avoided.
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.
Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Patients suffered from severe hepatic disorder.
Rabeprazole is not recommended for use in children, as there is no experience of its use in this group.
Hypomagnesaemia has been reported rarely in patients treated with proton pump inhibitors (PPIs) for at least three months, and in most cases after a year of therapy. In most patients, treatment of hypomagnesaemia required magnesium replacement and discontinuation of the PPI.
Proton pump inhibitor (PPI) therapy, especially if used in high doses and over long durations (> 1 year), may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine predominantly in older people or in presence of other recognised risk factors.
Treatment with PPI, including rabeprazole sodium, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
Pregnancy: There are no adequate or well-controlled studies in pregnant women and post-marketing experience is very limited. Rabeprazole sodium should be used in pregnancy only if the potential benefit justifies the potential risk of the fetus.
Breast-feeding: It is not known whether rabeprazole sodium is excreted in human breast milk. No studies in breast-feeding women have been performed. Rabeprazole sodium is however excreted in rat mammary secretions. Therefore rabeprazole sodium should not be used during breast-feeding. If rabeprazole administration is obligatory, breast-feeding should be discontinued.
Rabeprazole produces inhibition of gastric acid secretion, so an interaction with compounds whose absorption is pH dependent may occur.
No interaction between rabeprazole with liquid antacids was observed.
Co-administration of rabeprazole with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels.
When being used in combination, rabeprazole inhibits the metabolism of cyclosporine.
Co-administration of rabeprazole and warfarin concomitantly produces an increase in INR and prothrombin time, it may lead to abnormal bleeding and even death.
Rabeprazole sodium should not be co-administered with atazanavir.
The majority of adverse events were mild or moderate in severity, and transient in nature and consistent between adults and adolescents. The following adverse events have been reported as follows:
+ Infections and infestations: Common: infection.
+ Blood disorders: Rare: neutropenia, leucopenia, thrombocytopenia, leukocytosis.
+ Immune system disorders: Rare: hypersensitivity (facial swelling, hypotension and dyspnea, erythema, bullous reactions and hypersensitivity reactions have usually resolved after discontinuation of therapy).
+ Metabolism disorders: Rare: anorexia.
+ Nervous system disorders:
· Common: insomnia, headache, dizziness.
· Uncommon: nervousness.
· Rare: depression.
+ Eye disorders: Rare: visual disturbance.
+ Respiratory disorders:
· Common: cough, pharyngitis.
· Uncommon: bronchitis, sinusitis
+ Gastrointestinal disorders:
· Common: diarrhea, abdominal pain, nausea, constipation.
· Uncommon: dyspepsia, dry mouth, eructation.
· Rare: gastritis, stomatitis, taste disturbance.
+ Musculoskeletal disorders:
· Common: non-specific pain, back pain.
· Uncommon: myalgia, leg cramps, arthralgia, fracture.
+ Renal and urinary disorders:
· Uncommon: urinary tract infection.
· Rare: interstitial nephritis.
Inform a physician about any adverse effects occur during the treatment.
The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Rabeprazole is extensively protein bound and is, therefore, not readily dialyzable. No specific antidote is known. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.
Store in dry places, not exceeding 30°C, protect from light.
Active duodenal ulcer.
Active benign gastric ulcer.
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 hypersecretory conditions.
In combination with appropriate antibacterial therapeutic regimens for eradication of Helicobacter pylori in patients with peptic ulcer disease.
Hypersensitivity to any components of the drug and substituted benzimidazole.
The tablets should not be chewed or crushed, but should be swallowed whole. The drug should be taken before breakfast or before bed time.
Adults/ older people:
- Active duodenal ulcer: The recommended oral dose should be 10 mg or 20 mg once daily for 4 to 8 weeks.
- Active benign gastric ulcer: The recommended oral dose should be 10 mg or 20 mg once daily for 6 to 12 weeks.
- Erosive or ulcerative gastro-oesophageal reflux disease (GERD): The recommended oral dose should be 10 mg or 20 mg once daily for 4 - 8 weeks.
- Gastro-oesophageal reflux disease long-term management: A maintenance dose of 10 mg or 20 mg once daily can be used.
- 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 4 weeks, the patient should be further investigated.
- Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: A starting dose of rabeprazole sodium 60 mg once daily and doses of up to 100 mg once daily, or 60 mg twice daily have been used. Some patients with Zollinger-Ellison syndrome have been treated continuously for up to one year.
- Eradication of Helicobacter pylori: The following combination given for 7 days is recommended:
Raxium 20 twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily.
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
Children:
Adolescents 12 years of age and older: Safety and effectiveness of rabeprazole for short-term (up to 8 weeks) treatment of GERD is supported.
Children younger than 12 years of age: The safety and effectiveness of rabeprazole for treatment of GERD have not been established.
Or as directed by the physician.
Keep out of reach of children.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
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