Acifix ®

Rabeprazole Sodium
Tablet

Description week course may be considered. adjusted to individual patient needs and Drug Interactions
Rabeprazole Sodium (Acifix® Tablet) is Maintenance of Healing of Erosive or should continue for as long as clinically No drug interaction is reported.
an antiulcer drug in the class of proton Ulcerative Gastroesophageal Reflux indicated. Some patients may require
Pharmaceutical Precautions
pump inhibitors. Rabeprazole Sodium is Disease (GERD Maintenance): The divided doses. Doses up to 100 mg QD
Store in cool & dry place, away from
a substituted benzimidazole which recommended adult oral dose is 20 mg and 60 mg BID have been administered.
children.
suppresses gastric acid secretion by once daily. Some patients with Zollinger-Ellison
inhibiting the gastric H +/ K+-ATPase Treatment of Symptomatic syndrome have been treated Commercial Pack
engyme at the secretory surface of the Gastroesophageal Reflux Disease continuously with Rabeprazole Sodium Acifix® Tablet: Box containing 50 tablets
gastric parietal cell. It is an enteric (GERD): The recommended adult oral for up to one year. in 5 x 10’s Alu-Alu form packs. Each
coated tablet, because of its enteric dose is 20 mg once daily for 4 weeks. If enteric coated tablet contains
Contraindications
coated formulation it is highly stable in symptoms do not resolve completely Rabeprazole Sodium INN 20 mg.
Rabeprazole Sodium is contraindicated
stomach and because of higher Pka after 4 weeks, an additional course of
in patients with known hypersensitivity to
value of Rabeprazole Sodium it provides treatment may be considered.
Rabeprazole or to any component of the
faster onset of action. Healing of Duodenal Ulcers: The
formulation. Manufactured by
recommended adult oral dose is 20 mg
Indications BEXIMCO PHARMACEUTICALS LTD.
once daily after the morning meal for a Adverse Reactions
Short-term treatment in healing and
period up to four weeks. Most patients Rabeprazole Sodium may some times TONGI, BANGLADESH BL 6843 220211
symptomatic relief of duodenal ulcers
with duodenal ulcer heal within four cause headache, diarrhoea, abdominal ® Acifix is a registered trademark of Beximco Pharmaceuticals Ltd.
and erosive or ulcerative
weeks. A few patients may require pain, vomiting, constipation, dry mouth,
gastroesophageal reflux disease
additional therapy to achieve healing. increased or decreased appetite, muscle
(GERD); maintaining healing and
Helicobacter pylori Eradication to pain, drowsiness and dizziness.
reducing relapse rates of heartburn
Reduce the Risk of Duodenal Ulcer
symptoms in patients with GERD; Warning & Precautions
Recurrence:
treatment of daytime and night time Pregnant women: Rabeprazole is FDA
Rabeprazole sodium 20 mg Twice Daily for 7 Days
heartburn and other symptoms pregnancy category B. No data are
Amoxicillin 1000 mg Twice Daily for 7 Days
associated with GERD; long-term available on administration of
Clarithromycin 500 mg Twice Daily for 7 Days
treatment of pathological hypersecretory Rabeprazole to pregnant women.
All three medications should be taken
conditions, including Zollinger-Ellison However this drug should be used during
twice daily with the morning and evening
syndrome and in combination with pregnancy, only if clearly needed.
meals. It is important that patients
amoxicillin and clarithromycin to Lactating mother: There are no data on
comply with the full 7-day regimen.
eradicate Helicobacter pylori. the excretion of Rabeprazole into the
Treatment of Pathological
breast milk. A decision should be made
Dosage and Administration Hypersecretory Conditions Including
Zollinger-Ellison Syndrome: The dosage whether to discontinue nursing or to
Healing of Erosive or Ulcerative
of Rabeprazole Sodium in patients with discontinue the drug, taking into account
Gastroesophageal Reflux Disease
pathologic hypersecretory conditions the benefit of the drug to the mother.
(GERD): 20 mg to be taken once daily
varies with the individual patient. The Pediatric use: The safety and
for four to eight weeks. For those
recommended adult oral starting dose is effectiveness of Rabeprazole in pediatric
patients who have not healed after 8
60 mg once a day. Doses should be patients have not been established.
weeks of treatment, an additional 8-

105mm x 148mm FS