Esobest MUPS 40 - Tablet Esomeprazole Magnesium Trihydrate - 40mg 1 Tablet(s) / Tablet Sharif Pharmaceuticals Ltd. Introduction: Esobest MUPS 40 is a medicine which reduces the amount of acid produced in your stomach. It is used to treat heartburn, acid reflux and problems in your food pipe. It is also used to prevent and treat stomach ulcers. You should take Esobest MUPS 40 as your doctor advises. The dose will depend on what you are being treated for, but it should be the lowest dose for the shortest amount of time needed to treat your condition. Normally it should be swallowed whole about an hour before a meal and at the same time each day. It may... Uses of Esobest MUPS 40: Gastroesophageal reflux disease (Acid reflux)Peptic ulcer disease Side effects of Esobest MUPS 40: HeadacheDizzinessDryness in mouthNauseaAbdominal painConstipationFlatulenceDiarrhea How to use Esobest MUPS 40: 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. Esobest MUPS 40 is to be taken empty stomach. How Esobest MUPS 40 works: Esobest MUPS 40 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 Esobest MUPS 40?: If you miss a dose of Esobest MUPS 40, 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: Heartburn, Acid Related Dyspepsia, Peptic ulcer disease, Zollinger-Ellison syndrome, Gastroesophageal reflux disease (GERD), Helicobacter pylori infection, Erosive Esophagitis, Gouty arthritis, Duodenal and Gastric Ulcer. Administration: Delayed-release cap: Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals. Tab: May be taken with or without food. Adult Dose: GERD Without Erosive Esophagitis 20 mg PO qDay for 4 weeks; consider an additional 4 weeks of treatment if symptoms do not resolve completely in the first 4 weeks GERD With Erosive Esophagitis 20-40 mg PO qDay for 4-8 weeks If oral therapy inappropriate or not possible: 20-40 mg qDay IV up to 10 days; switch to PO once patient able to swallow Maintenance: 20 mg PO qDay for up to 6 months Risk Reduction of NSAID-Associated Gastric Ulcer 20-40 mg PO qDay for up to 6 months NSAID-Induced Gastric Ulcer 20 mg PO qDay for 4-8 weeks Zollinger-Ellison Syndrome... Child Dose: GERD Without Erosive Esophagitis Oral 12 years: 20-40 mg PO qDay for up to 8 weeks GERD With Erosive Esophagitis (Healing) 3.5-7.5 kg: 5 mg PO qDay for up to 6 weeks >7.5 kg: 10 mg PO qDay for up to 6 weeks 1-12 years 20 kg: 10-20 mg qDay for 8 weeks >12 years 20-40 mg PO qDay for 4-8 weeks Maintenance: 20 mg PO qDay up to 6 months Renal Dose: Renal impairment: No dosage adjustment needed. Contraindication: Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles. Mode of Action: Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole. Precaution: Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia. For patients with severe liver impairment, a dose of 20 mg should not be exceeded. Lactation Risk Summary Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Esomeprazole and any potential adverse effects on the breastfed infant from Esomeprazole... Side Effect: >10% Headache (2-11%) 1-10% Flatulence (10%),Indigestion (6%),Nausea (6%),Abdominal pain (1-6%),Diarrhea (2-4%),Xerostomia (3-4%),Dizziness (2-3%),Constipation (2-3%),Somnolence (1-2%),Pruritus (1%) <1% Blood and lymphatic system disorders: Agranulocytosis, pancytopenia Blurred vision, GI disorders: Pancreatitis, stomatitis, microscopic colitis Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice Anaphylactic reaction/shock GI candidiasis Hypomagnesemia Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture Nervous system disorders: Hepatic encephalopathy, taste disturbance Psychiatric disorders: Aggression, agitation, depression, hallucination Interstitial nephritis Gynecomastia Bronchospasm Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal fatal) Pregnancy Category Note: Pregnancy There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person) Lactation Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no... Interaction: Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts. Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.