Esoget DRT

Esoget DRT

esomeprazole

Manufacturer:

Alvita Pharma

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
Esomeprazole Mg
Indications/Uses
Short-term treatment (4-8 wk) in the healing & symptomatic resolution of diagnostically confirmed erosive esophagitis; maintenance of symptom resolution & healing of erosive esophagitis; short-term treatment (4-8 wk) of heartburn & other symptoms associated w/ GERD in adults & childn ≥1 yr; risk reduction of NSAID-associated gastric ulcer; long-term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. Short-term treatment (up to 6 wk) of erosive esophagitis due to acid-mediated GERD in infants 1 mth to <1 yr. H. pylori infection & duodenal ulcer disease (active or history of w/in the past 5 yr) to eradicate H. pylori in combination w/ amoxicillin & clarithromycin (triple therapy).
Dosage/Direction for Use
GERD, healing of erosive esophagitis 20 or 40 mg once daily for 4-8 wk. Maintenance of healing of erosive esophagitis 20 mg once daily. Symptomatic GERD 20 mg once daily for 4 wk. Ped patient 12-17 yr Healing of erosive esophagitis 20 or 40 mg once daily for 4-8 wk. Symptomatic GERD 20 mg once daily for 4 wk. Patient 1-11 yr Short-term treatment of symptomatic GERD 10 mg once daily for up to 8 wk. Healing of erosive esophagitis Patient ≥20 kg 10 or 20 mg once daily for 8 wk, <20 kg 10 mg once daily for 8 wk. Ped patient 1 mth to <1 yr Erosive esophagitis due to acid mediated GERD Patient >7.5-12 kg 10 mg once daily for up to 6 wk, >5-7.5 kg 5 mg once daily for up to 6 wk, 3-5 kg 2.5 mg once daily for up to 6 wk. Risk reduction of NSAID-associated gastric ulcer 20 or 40 mg once daily for up to 6 wk. H. pylori eradication to reduce the risk of duodenal ulcer recurrence Triple therapy: Esomeprazole 40 mg once daily + amoxicillin 1,000 mg bid + clarithromycin 500 mg bid for 10 days. Pathological hypersecretory conditions including Zollinger-Ellison syndrome 40 mg bid.
Administration
Should be taken on an empty stomach: Take at least 1 hr before meals. Swallow whole. For patients w/ swallowing difficulties, open tab & empty granules in 1 tbsp applesauce. Swallow mixt immediately, do not chew/crush granules. For patients w/ nasogastric tube, open tab & empty granules in 60 mL catheter tipped syringe & mix w/ 50 mL of water.
Special Precautions
Atrophic gastritis; C. difficile-associated diarrhea; increased risk of fracture in patients who received high-dose; patients at risk for osteoporosis-related fractures; patients on prolonged treatment or taking PPIs w/ medications eg, digoxin or drugs that may cause hypomagnesaemia (eg, diuretics). Monitor Mg levels prior to initiation of PPI treatment & periodically. Avoid concomitant use w/ clopidogrel, St. John's wort or rifampin. False +ve results in diagnostic investigations. Pregnancy & lactation. Neonates 0-1 mth. Elderly.
Adverse Reactions
Agranulocytosis, pancytopenia; blurred vision; pancreatitis, stomatitis; microscopic colitis; hepatic failure, hepatitis w/ or w/o jaundice; anaphylactic reaction/shock; GI candidiasis, C. difficile-associated diarrhea; hypomagnesemia; muscular weakness, myalgia, bone fracture; hepatic encephalopathy, taste disturbance; aggression, agitation, depression, hallucination; interstitial nephritis; gynecomastia; bronchospasm; alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal).
Drug Interactions
Loss of therapeutic effect & development of drug resistance of atazanavir. Increased conc & toxicity of saquinavir. Change of absorption of retroviral drug. Reduced conc of atazanavir & nelfinavir. Decreased absorption of drugs eg, ketoconazole, atazanavir, Fe salt & erlotinib. Increased absorption of digoxin. Increased INR & prothrombin time w/ warfarin. Decreased clearance of diazepam. Reduced plasma conc of the active metabolite & reduction in platelet inhibition of clopidogrel. Increased conc of cilostazol. Increased chromogranin A levels which may interfere w/ investigations for neuroendocrine tumors. Increased serum levels of tacrolimus. Increased plasma levels w/ clarithromycin. May elevate & prolong serum levels of methotrexate &/or its metabolite hydroxymethotrexate (high dose).
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Esoget DRT delayed release tab 40 mg
Packing/Price
30 × 10's (P1,515/box)
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