SB-Rabec - Capsule Rabeprazole - 20mg 1 Capsule(s) / Capsule Sunman-Birdem Pharma Ltd. Introduction: SB-Rabec is a medicine that reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine such as heartburn, acid reflux, peptic ulcer disease, and some other stomach conditions associated with excessive acid production. SB-Rabec is also used to prevent stomach ulcers and acidity that may be seen with the prolonged use of pain-killers. It belongs to a class of medicines known as proton pump inhibitors (PPIs). This medicine should be taken one hour before a meal, preferably in the morning. The dose will depend on your underlying condition and... Uses of SB-Rabec: Gastroesophageal reflux disease (Acid reflux)Peptic ulcer disease Side effects of SB-Rabec: DiarrheaDizzinessFlatulenceHeadacheNauseaSore throatStomach painVomiting How to use SB-Rabec: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. SB-Rabec is to be taken empty stomach. How SB-Rabec works: SB-Rabec is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid related indigestion and heartburn. What if you forget to take SB-Rabec?: If you miss a dose of SB-Rabec, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Peptic ulcer disease, H. pylori infection, Gastro-oesophageal reflux disease, Paediatric GERD Administration: Administer with or without meals 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... Child Dose: Delayed-release capsule (sprinkles) 15 kg): 10 mg PO qDay 30 minutes before a meal, for up to 12 weeks Gastroesophageal Reflux Disease Delayed-release tablet 12 years: 20 mg PO qDay for up to 8 weeks Renal Dose: Renal impairment: No dosage adjustment needed. Contraindication: Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, other PPIs or to any component of the formulation. Mode 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. Precaution: 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 Side Effect: 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 Pregnancy Category Note: Risk Summary 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... Interaction: 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.