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Composition :
Omeprazole -10 Capsules
Each capsule contains Omeprazole 10 mg (enteric coated granules)
Omeprazole -20 Capsules
Each capsule contains Omeprazole 20 mg (enteric coated granules)
Description :
Omeprazole is a substituted benzimidazole that suppresses gastric
acid secretion by specific inhibition of the H + /K + -ATPase
enzyme system (proton pump) at the secretory surface of the
gastric parietal cell thus blocking the final step of acid
production.
Indications :
Omeprazole is indicated for short-term treatment of active
duodenal ulcer, short-term treatment (4-8 weeks) of active benign
gastric ulcer, treatment of heartburn and other symptoms
associated with GERD, short-term treatment (4-8 weeks) of erosive
esophagitis, Maintenance of Healing of Erosive Esophagitis and for
the long-term treatment of pathological hypersecretory conditions
(eg, Zollinger-Ellison syndrome).
Dosage and Administration :
Omeprazole capsules should not be opened, chewed or crushed
and should be swallowed whole. The capsule should be taken before
meals.
Duodenal ulcers
20 mg once daily for four weeks.
Gastric ulcers
20 mg once daily for eight weeks. In severe cases it can be
increased to 40 mg once daily.
Gastroesophageal reflux disease
20 mg-40 mg daily for 4-8 weeks.
GERD, long-term management
10 mg once daily,dose maybe increased to 20 mg once daily if
symptoms return.
Zollinger Ellison syndrome
Initial dose is 60 mg daily. It is to be adjusted as per the
individual requirement and continued till clinically indicated.
The patients are usually effectively controlled on doses of 20
mg–120 mg daily. With doses above 80 mg the dose should be divided
and given twice daily.
Contraindications :
Hypersensitivity to the components of the formulation.
Warnings and Precautions :
Drug Interactions
Drugs metabolised in the liver
:
Omeprazole can prolong the elimination of diazepam, warfarin and
phenytoin which are metabolised by oxidation in the liver. Hence,
at the time of concomitant administration, dosage adjustment
should be done after careful monitoring of the patient.
Ketoconazole, ampicillin esters and iron salts: Because of its
profound and long lasting inhibition of gastric acid secretion,
omeprazole may interfere with the absorption of these drugs as
gastric pH is an important determinant of their bioavailability.
Pregnancy :
There are no adequate or well-controlled studies of omeprazole in
pregnancy. Omeprazole should be used during pregnancy only
if potential benefits outweigh potential risks.
Lactation :
It is not known whether omeprazole is secreted in breast milk.
But, because of the potential for adverse effects, a decision
should be made whether to discontinue nursing or to discontinue
the drug.
Paediatric Use :
Safety and effectiveness of omeprazole in children has not been
established.
Side Effects :
Nausea, headache, diarrhoea, constipation and flatulence are
reported rarely with adminstration of omeprazole. These events are
mild and transient and there has been no consistent relationship
with the treatment.
Overdosage :
Reports have been received of overdosage with omeprazole in
humans. Doses ranged up to 2400 mg (120 times the usual
recommended clinical dose). Manifestations were variable, but
included confusion, drowsiness, blurred vision, tachycardia,
nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and
other adverse reactions similar to those seen in normal clinical
experience.Symptoms were transient, and no serious clinical
outcome has been reported when omeprazole was taken alone. No
specific antidote for omeprazole overdosage is known. Omeprazole
is extensively protein bound and is, therefore, not readily
dialyzable. In the event of overdosage, treatment should be
symptomatic and supportive.
Presentation :
Omeprazole - 10 Blister pack of 10 capsules
Omeprazole - 20 Blister pack of 10 capsules
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Quality
