Ulcerbrex Tablets
Rabeprazole
20mg
Laboratorios Cinfa S.A
| Pack size | 14's (7's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | SPAIN |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 55.00 AED |
Available as:
Indications
Ulcerbrex Tablets is used for:
Peptic ulcer disease, H. pylori infection, Gastro-oesophageal reflux disease, Paediatric GERD
Adult Dose
Oral
Gastro-oesophageal reflux disease
Adult: 20 mg daily for 4-8 wk. Maintenance: 10 or 20 mg/day. All doses to be taken once in the morning.
Zollinger-Ellison syndrome
Adult: Initially, 60 mg once in the morning, adjusted to max dose of 120 mg/day if needed. Daily doses >100 mg should be given in 2 divided doses.
Peptic ulcer
Adult: 20 mg once in the morning for 4-8 wk (duodenal ulcer) or for 6-12 wk (gastric ulcer).
H.pylori infection
Adult: 1-wk triple therapy: 20 mg bid combined w/ clarithromycin 500 mg bid and amoxicillin 1 g bid or combined w/ clarithromycin 250 mg bid and metronidazole 400 mg bid.
Erosive oesophagitis
Adult: 20 mg/day for 4-8 wk. May continue for another 8 wk if healing is incomplete. Maintenance: 10 or 20 mg/day. All doses to be taken once in the morning.
Elderly: No dosage adjustment needed.
Hepatic impairment: No dosage adjustment needed.
Child Dose
Delayed-release capsule (sprinkles)
<1 year: Safety and efficacy not established
1-11 years (<15 kg): 5 mg PO qDay 30 minutes before a meal, for up to 12 weeks; may increase to 10 mg/day if inadequate response
1-11 years (>15 kg): 10 mg PO qDay 30 minutes before a meal, for up to 12 weeks
Gastroesophageal Reflux Disease
Delayed-release tablet
<12 years: Safety and efficacy not established
>12 years: 20 mg PO qDay for up to 8 weeks
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Administer with or without meals
Contra Indications
Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, other PPIs or to any component of the formulation.
Precautions
Gastric malignancy should be ruled out. Severe hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor Mg levels prior to initiation and periodically during prolonged use.
Lactation
Risk Summary
Lactation studies have not been conducted to assess presence in human milk, effects on breastfed infant, or effects on milk production; drug is present in rat milk; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy-Lactation
Pregnancy
There are no available human data in pregnant women to inform drug associated risk; background risk of major birth defects and miscarriage for indicated populations are unknown; however, background risk in U.S. general population of major birth defects is 2-4% and of miscarriage is 15- 20% of clinically recognized pregnancies; no evidence of adverse developmental effects were seen in animal reproduction studies with rabeprazole administered during organogenesis at 13 and 8 times human area under plasma concentration-time curve (AUC) at recommended dose for GERD, in rats and rabbits, respectively; changes in bone morphology were observed in offspring of rats treated with oral doses of different PPI through most of pregnancy and lactation; when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in offspring at any age
Lactation
Lactation studies have not been conducted to assess presence in human milk, effects on breastfed infant, or effects on milk production; drug is present in rat milk; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Interactions
May decrease serum concentration of ketoconazole, itraconazole and clopidogrel. Increased risk of hypomagnesaemia w/ diuretics and digoxin. May increase prothrombin time and INR of warfarin. May increase plasma concentration of saquinavir and methotrexate. Decreased serum levels w/ sucralfate.
Potentially Fatal: May decrease plasma concentrations and pharmacological effects of rilpivirine and atazanavir.
Adverse Effects
Side effects of Rabeprazole :
1-10%
Headache (2-10%), Constipation (2%), Diarrhea (2-5%), Flatulence (3%), Pain (3%), Pharyngitis (3%), Abdominal pain (4%)
<1%
Agitation, Agranulocytosis, Alopecia, Anemia, Angioedema, Chest pain, Delirium, Erythema, Hypokalemia, Hypomagnesemia, Hyponatremia, Jaundice, Leukocytosis, Leukopenia, Migraine, Osteoporosis related fracture, Rhabdomyolysis, Stevens-Johnson syndrome, Sudden death, Toxic epidermal necrolysis, Abnormal taste
Mechanism of Action
Rabeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase at the secretory surface of the gastric parietal cell.
Note
Ulcerbrex 20mg Tablets manufactured by Laboratorios Cinfa S.A. Its generic name is Rabeprazole. Ulcerbrex is availble in United Arab Emirates.
Farmaco UAE drug index information on Ulcerbrex Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.