Products Details
Indication:
Esomeprazole is indicated for the relief of heartburn and
other symptoms associated with gastroesophageal reflux
disease (GERD) and for the healing of erosive
esophagitis, a potentially serious condition association
with GERD. The FDA approved Esomeprazole for
maintenance of healing of erosive esophagitis and in
combination with Amoxicillin and Clarithromycin, for the
eradication of Helicobacter Pylori infection in patients with
duodenal ulcer disease.
Dosage & Administration:
*The majority of patients are healed within 4 to 8 weeks.
For patients who do no heal after 4 to 8 weeks, an
additional 4 to 8 weeks treatment may be considered.
**Controlled studies did not extend beyond 6 months.
***If symptoms do not resolve completely after 4 weeks,
an additional 4 weeks of treatment may be considerered.
CONTRAINDICATIONS:
Patients with known hypersensitivity to any component of
the formulation.
ADVERSE REACTIONS:
Esomeprazole is well tolerated in both short and long-
term use. Common adverse events are headache and
diarrhoea. Other side effects include nauses, flatulence,
abdominal pain, constipation and dry mouth.
SPECIAL PRECAUTION:
Geriatric: No dosage adjustment is necessary.
Paediatric: Safety and effectiveness in paediatric patients
have not been established.
Renal insufficiency: No dosage adjustment is necessary
in patients with mild to moderate liver impairment. For
patients with severe liver impairment, a dosage of 20 mg
of Esmotac should not be exceeded.
Gender: No dosage adjustment is necessry.
DRUG INTERACTIONS:
Esomeprazole inhibits gastric acid secretion, Therefore,
Esomeprazole may interfare with the absorption of drugs
where gastric pH is an important determinant of
bioavilability (e.g. Ketoconazole, Iron salts and Digoxin).
Renal insufficiency: No dosage adjustment is necessary
in patients with mild to moderate liver impairment. For
patients with severe liver impairment, a dosage of 20 mg
of Esmotac should not be exceeded.
Gender: No dosage adjustment is necessry.
DRUG INTERACTIONS:
Esomeprazole inhibits gastric acid secretion, Therefore,
Esomeprazole may interfare with the absorption of drugs
where gastric pH is an important determinant of
bioavilability (e.g. Ketoconazole, Iron salts and Digoxin).
OVER DOSE:
There is no experience to data with deliberate over dose.
Data are limited but single dose of 80 mg Esomeprazole
were uneventful. Esomeprazole is extensively plasma
protein bound and is therefore not readily dialyzable. As in
any case of over dose, treatment should be symptomatic
and general supportive measures should be utilized.
USE IN PREGNANCY AND LACTATION:
Pregnancy:
FDA approved pregnancy category B.
Esomeprazole should be used during pragnancy only if
the potential benifit justifies the potential risk to the fetus.
Nursing mothers:
There is no data on the excretion of Esomeprazole into
human milk