S-Ome Tablet

Esomeprazole Magnesium Trihydrate
20mg
Somatec Pharmaceuticals Ltd.
Pack size 50's pack
Unite Price 5.00 BDT

Indications

S-Ome Tablet is used for: Treatment of - Heartburn - GERD (Gastroesophageal reflux disease) - Acid Related Dyspepsia - Peptic ulcer disease - Helicobacter pylori infection - Zollinger-Ellison syndrome - Erosive Esophagitis - Gouty arthritis - Duodenal and Gastric Ulcer

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 80 mg PO divided q12hr (initial); adjust regimen to efficacy; up to 240 mg PO qDay, OR 120 mg PO q12hr administered to patients Elderly: No dosage adjustment needed. Hepatic Impairment Oral administration Mild to moderate (Child-Pugh A/B): No dosage adjustment required Severe (Child-Pugh C): Not to exceed 20 mg/day

Child Dose

GERD Without Erosive Esophagitis Oral <1 year: Safety and efficacy not established 1-12 years: 10-20 mg PO qDay for up to 8 weeks >12 years: 20-40 mg PO qDay for up to 8 weeks GERD With Erosive Esophagitis (Healing) <1 month: Safety and efficacy not established 1 month to 1 year 3.5 kg: 2.5 mg PO qDay for up to 6 weeks >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 mg PO qDay for 8 weeks >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

Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution

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.

Contra Indications

Hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation

Precautions

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 or from the underlying maternal condition.

Pregnancy-Lactation

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 clinical data on effects of esomeprazole on breastfed infant or on milk production; developmental 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 treatment or from underlying maternal condition

Interactions

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.

Side Effects

Side effects of Esomeprazole Magnesium Trihydrate : >10% Headache (2-11%) 1-10% Flatulence (10%), Nausea (6%), Indigestion (6%), Abdominal pain (1-6%), Dizziness (2-3%), Diarrhea (2-4%), Xerostomia (3-4%),Constipation (2-3%), Somnolence (1-2%), Pruritus (1%) <1% Blood and lymphatic system disorders: Agranulocytosis, pancytopenia Blurred vision, Hepatobiliary disorders: Hepatitis with or without jaundice, Hepatic failure, GI disorders: Stomatitis, Pancreatitis, microscopic colitis Hypomagnesemia GI candidiasis Anaphylactic reaction/shock 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, hyperhidrosis, erythema multiforme, Stevens-Johnson syndrome, photosensitivity, toxic epidermal necrolysis (sometimes fatal fatal)

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.

Note

S-Ome 20mg Tablet generic name is Esomeprazole Magnesium Trihydrate. S-Ome 20mg Tablet is manufactured by Somatec Pharmaceuticals Ltd.S-Ome is availble in all over Bangladesh. Mes BD drug index information on S-Ome Tablet 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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