Simprazol

Simprazol

esomeprazole

Manufacturer:

Simex
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
GERD in patients w/ esophagitis &/or severe reflux symptoms; healing of gastric ulcers associated w/ NSAIDs. Short-term maintenance of haemostasis & prevention of rebleeding in patients following endoscopy for acute gastric bleeding or duodenal ulcer.
Dosage/Direction for Use
20-40 mg once daily. Reflux esophagitis 40 mg once daily. Reflux symptoms 20 mg once daily. Healing of NSAID-associated gastric ulcers 20 mg once daily. Maintenance of haemostasis & prevention of rebleeding of gastric & duodenal ulcers 80 mg as bolus infusion over 30 min followed by continuous IV infusion of 8 mg/hr for 3 days or 72 hr. Period of parenteral treatment should be followed by gastric acid suppression therapy by 40 mg orally once daily for 4 wk.
Administration
Should be taken on an empty stomach: Take at least 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to esomeprazole or benzimidazole. Concomitant use w/ atazanavir & nelfinavir.
Special Precautions
Exclude gastric malignancy before treatment. Pregnancy & lactation.
Adverse Reactions
Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypersensitivity reactions (eg, fever, angioedema, anaphylaxis reactions or shock), peripheral edema, hyponatremia, hypomagnesemia, insomnia, agitation, mental confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, taste disturbances, blurred vision, vertigo, bronchospasm, abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting, constipation, dry mouth, increased liver enzyme, hepatitis, liver failure, hepatic encephalopathy, reactions at inj site, dermatitis, pruritus, rash, urticaria, alopecia, photosensitivity, erythema multiforme, SJS, TEN, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, fatigue, hyperhidrosis.
Drug Interactions
Concomitant use w/ ketoconazole, itraconazole, erlotinib, digoxin, diazepam, phenytoin, warfarin, cisapride, tacrolimus, MTX, antiretroviral (atazanavir, nelvinavir), clarithromycin, voriconazole, rifampicin, St. John's wort.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
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
Simprazol EC tab 20 mg
Packing/Price
2 × 10's
Form
Simprazol EC tab 40 mg
Packing/Price
2 × 10's
Form
Simprazol powd for inj 40 mg
Packing/Price
1's (Rp165,000/boks)
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