Ramep Tablets / Gastro-resistant

Rabeprazole
20mg
Sandoz GmbH
Pack size 14's (7's Blister x 2)
Dispensing mode POM
Source AUSTRIA
AgentALPHAMED CO. (AUH) LTD.
Retail Price 54.50 AED

Indications

Ramep Tablets / Gastro-resistant 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

Ramep 20mg Tablets / Gastro-resistant manufactured by Sandoz GmbH. Its generic name is Rabeprazole. Ramep is availble in United Arab Emirates. Farmaco UAE drug index information on Ramep Tablets / Gastro-resistant is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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