Thursday, April 17, 2014

. Omeprazole




.
Indication

Omeprazole Capsule and tablet is indicated for gastroesophageal reflux disease including reflux esophagitis, acid reflux disease, duodenal and benign gastric ulcers, Helicobacter pylori eradication regimens in peptic ulcer disease, prophylaxis of acid aspiration, Zollinger-Ellison Syndrome and for the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions. Omeprazole IV is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis.

Dosage & Administration

 Omeprazole Capsule and tablet:  should be taken before meal.

Disease Dosage and administration


Gastroesophageal
reflux disease
including reflux
esophagitis
The usual dosage is 20 mg  once daily. The majority of
Patients are healed after 4 weeks. For those patients not fully healed
after the initial course, healing usually occurs during a further 4-8
weeks treatment.  has also been used in a dose of 40
mg once daily in patients with reflux esophagitis refractory to other
therapy. Healing usually occurred within 8 weeks. Patients can be
continued at a dosage of 20 mg once daily.
Acid reflux disease
For long-term management  10 mg once daily is
recommended, increasing to 20 mg if symptoms return.
Duodenal and
benign gastric
ulcers
The usual dose is 20 mg  once daily. The majority of
patients with duodenal ulcer are healed after 4 weeks. The majority
of patients with benign gastric ulcer are healed after 8 weeks. In
severe or recurrent cases the dose may be increased to 40 mg
daily. Long-term therapy for patients with a history of
recurrent duodenal ulcer is recommended at a dosage of 20 mg
once daily. For prevention of relapse in patients with
duodenal ulcer the recommended dose is  10 mg once
daily, increasing to 20 mg once daily, if symptoms return.
Helicobacter pylori
eradication
regimens in peptic
ulcer disease
is recommended at a dose of 40 mg once daily or 20
mg twice daily in association with antimicrobial agents Amoxicillin
1 g and Clarithromycin 500 mg both twice a day for 7 to 14 days.
Prophylaxis of acid
aspiration
For patients considered to be at risk of aspiration of the gastric
contents during general anaesthesia, the recommended dosage
is  40 mg on the evening before surgery followed by
40 mg 2-6 hours prior to surgery.
Zollinger-Ellison
syndrome
The recommended initial dosage is 60 mg  once
daily. The dosage should be adjusted individually and treatment
continued as long as clinically indicated. More than 90% of patients
with severe disease and inadequate response to other therapies
have been effectively controlled on doses of 20-120 mg daily. With
doses above 80 mg daily, the dose should be divided and given
Twice daily.

For the treatment
of NSAIDassociated
gastric ulcers,
duodenal ulcers or
gastroduodenal
erosions
The recommended dosage of  is 20 mg once daily.
Symptom resolution is rapid and in most patients healing occurs
Within 4 weeks. For those patients who may not be fully healed
after the initial course, healing usually occurs during a further 4
Weeks treatment. For the prophylaxis of NSAID-associated gastric
ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic
symptoms in patients with a previous history of gastroduodenal
lesions who require continued NSAID treatment, the recommended
dosage of  is 20 mg once daily.

Children

GERD or other
acid-related
disorders
The recommended dose for pediatric patients 1 years of age
and older is as follows:
Age Body Weight Dose
> 1 year 10 - 20 kg 10 mg once daily, if
needed, 20 mg once daily
> 2 year > 20 kg 20 mg once daily, if
needed, 40 mg once daily

IV Injection

Duodenal ulcer,
gastric ulcer or
reflux esophagitis

In patients with duodenal ulcer, gastric ulcer or reflux
esophagitis where oral medication is inappropriate,
IV 40 mg once daily is recommended.
Zollinger-Ellison
Syndrome (ZES)
In patients with Zollinger-Ellison syndrome the
recommended initial dose of  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 and given twice daily.


Direction For Use Of IV Injection

lyophilized powder and water for injection is for intravenous administration
only and must not be given by any other route.  injection 40 mg 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 2-5 minutes at a maximum rate of 4 ml per minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction For Use Of IV Infusion

 IV infusion 40 mg 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  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.

Contraindication And Precaution

There are no known contraindications to the use of .When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with  is instituted as treatment may alleviate symptoms and delay diagnosis.

Side-Effect

Omeprazole Is well tolerated. Nausea, diarrhoea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

Use in Pregnancy & Lactation

Omeprazole Can be used during pregnancy. is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Preparation

 Omeprazole 20 mg Capsule & DR Tablet, 40 mg Capsule & 40 mg IV Injection.

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