Alton 40

Description

Alton 40 mg IM/IV Injection

Indications
Omeprazole is indicated for the treatment ofGastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Pharmacology
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by
blocking hydrogen-potassium-adenosine triphosphatase (H /K ATPase) enzyme system in the gastric parietal cell.
After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect
occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory
activity returns gradually, over 3 to 5 days.

Dose
Oral: Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric
ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent
duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if
not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated
duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully
healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other
treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than
80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20
mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole
400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a
day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg
once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV InjectionProphylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an
intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux
oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose
of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be
adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
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Administration
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous
administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow
intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing
powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a
maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of
reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of
20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose
for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours
when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same
infusion set with any other drug.