COMPOSITION
Each
enteric coated tablet contains
Esomeprazole 20/40mg
DESCRIPTION
EMEZ contains Esomeprazole as an active ingredient. Esomeprazole is one of
the two stereo-enantiomers in omeprazole. Esomeprazole is a Proton Pump
Inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition
of H+ /K+ -ATPase in the gastric parietal cell.
PHARMACOLOGY
Pharmacodynamics
Esomeprazole
is a proton pump inhibitor that suppresses gastric acid secretion by specific
inhibition of the H+/K+-ATPase in the gastric parietal cell.
Pharmacokinetics
EMEZ is
prepared as an enteric-coated tablet so that absorption of Esomeprazole begins
only after the tablet leaves the stomach.
After
oral administration peak plasma levels (C max) occur at
approximately 1.5 hours (Tmax). The Cmax increases proportionally when the dose
is increased, and there is a three-fold increase in the area under the plasma
concentration-time curve (AUC) from 20 to 40 mg. At repeated once-daily dosing
with 40 mg, the systemic bioavailability is approximately
90% compared to 64% after a single dose of 40 mg. EMEZ should be taken at least one hour before meals.
INDICATIONS AND USAGE
·
Gastro esophageal
reflux,
·
Healing and
maintenance of healed erosive oesophagitis,
·
Eradication of
Helicobacter Pylori in combination with appropriate antibacterial regimens
·
Pathological Hypersecretory
Conditions Including Zollinger-Ellison Syndrome.
·
Risk Reduction of NSAID-Associated Gastric Ulcer
DOSAGE AND ADMINISTRATION
·
Gastroesophageal
reflux disease, healing of erosive esophagitis:
20mg or 40 mg once daily
for 4 to 8 weeks.
·
Maintenance of
Healing of Erosive Oesophagitis: 20mg
once daily.
·
Symptomatic
gastroesophageal reflux: 20mg once
daily for 4 weeks.
·
H.Pylori
eradication to reduce the risk of duodenal ulcer recurrence: Esomeprazole 40 mg daily with amoxicillin 1 g twice
daily and clarithromycin 500 mg twice daily for 10 days.
CONTRAINDICATIONS
EMEZ is contraindicated in patients with known
hypersensitivity to any component of the formulation or to substituted
benzimidazoles.
ADVERSE EFFECTS
Headache,
diarrhea, abdominal pain, nausea, flatulence, dry mouth, constipation,
increased creatinine, uric acid, increased or decreased hemoglobin, white blood
cell count, platelets, increased billirubin, alkaline phosphatase, ALT, AST,
hypokalemia, hyponatremia, altered thyroid function test.
PRECAUTIONS:
Allergic
to it; or to similar drugs (e.g., lansoprazole, omeprazole); or if you have any
other allergies.
severe
liver disease, other stomach problems (e.g., tumors).
This
medication should be used only when clearly needed during pregnancy. Discuss
the risks and benefits
Based
on information for similar drugs, this medication may pass into breast milk.
Breast-feeding while using this drug is not recommended
DRUG INTERACTION
Esomeprazole
may interfere with the absorption of drugs where gastric PH is an important
determinant of bioavailability e.g. ketoconazole, iron salts and digoxin.
