|
CONTRAINDICATIONS
Omeprazole is contra-indicated in patients who are sensitive
to it.
DRUG INTERACTIONS
Concurrent use of ampicillin esters, iron salts or
ketoconazole with Omeprazole may result in a reduction in
the absorption of these drugs due to the increased
gastrointestinal pH by Omeprazole.
Omeprazole may also prevent the degradation of acid-labile
drugs.
No interaction with food or concomitantly administered
antacids has been found.
Plasma concentrations of Omeprazole and Clarithromycin
are increased during concomitant administration.
Concurrent use of digoxin with Omeprazole may result in an
increase in the plasma concentration of digoxin.
Omeprazole may cause a decrease in the hepatic
metabolism of diazepam, phenytoin and warfarin by
inhibition of the hepatic cytochrome P-450 enzyme system,
resulting in a delayed elimination and increased blood
concentrations of these medications when used
concurrently. Hence, the monitoring of blood concentrations
or prothrombin time for patients receiving warfarin or
phenytoin is recommended and a reduction of dosage may
be necessary.
Concurrent use of Omeprazole with bone marrow
depressants may increase the leukopenic and/or
thrombocytopenic effects of both these medications. If
concurrent use is required, close observation for toxic effects
should be considered.
RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND
ROUTE OF ADMINISTRATION
Benign Gastric & Duodenal Ulcer : 20 mg once daily for 4
weeks in duodenal ulceration or 8 weeks in gastric
ulceration. In severe or recurrent cases, the dose may be
increased to 40 mg once daily.
Long term therapy for patients with a history of recurrent
duodenal ulcer is recommended at a dosage of 20 mg once
daily, up to one year .
For the prevention of relapse in patients with duodenal ulcer
disease, the recommended dose is 10 mg once daily. If
needed, the dose can be increased to 20-40 mg once
daily.
Gastro-Oesophageal Reflux Disease : 20 to 40 mg once
daily for 4 to 8 weeks; thereafter maintenance therapy can
be continued with 10 mg once daily.
Zollinger-EIIison Syndrome : Initially 60 mg once daily;
usual range 20 to 120 mg daily. Doses above 80 mg should
be divided and given twice daily. The dosage should be
adjusted individually and therapy continued for as long as
clinically indicated.
Helicobacter Pylori Eradication :
Dual Therapy (2 Week Regimens)
A combination of Omeprazole 40 mg daily with Amoxycillin
750 mg twice daily or with Clarithromycin 500 mg three times
daily for 2 weeks.
Triple Therapy (1-Week Regimens)
A combination of Omeprazole 20 mg twice daily or 40 mg
once daily with Amoxycillin 500 mg 3 times daily and
Metronidazole 400 mg 3 times daily for 7 days;
A combination of Omeprazole 20 mg twice daily or 40 mg
once daily with Clarithromycin 250 mg twice daily and
Metronidazole 400 mg (or Tinidazole 500 mg) twice daily for
7 days;
A combination of Omeprazole 20 mg twice daily or 40 mg
once daily with Amoxycillin 1 g twice daily and Clarithromycin
500 mg twice daily for 7 days.
Note : Dual therapy regimens have lower eradication rates
than triple therapy regimens.
Paediatric
Dosage has not been established.
Geriatric
The daily doses usually should not exceed 20 mg.
Impaired renal function
Dose adjustment is not required in patients with impaired
renal function.
Impaired hepatic function
As bioavailability and plasma half-life of Omeprazole are
increased in patients with impaired hepatic function, a daily
dose of 10 - 20 mg may be sufficient.
Administration
Omeprazole should be taken immediately before meals,
preferably in the morning.
The capsule should be swallowed whole with liquid.
The contents of the capsule should not be chewed or
crushed.
For patients with difficulties in swallowing, the capsule might
be opened and the contents swallowed or suspended in a
slightly acidic fluid e.g. juice, yoghurt or soured milk. The
suspension should be taken within half an hour. Alternatively,
the contents can be swallowed by sucking the capsule.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND
ANTIDOTE(S)
The major clinical features are drowsiness, headache
(possibly due to a metabolite) and tachycardia.
There is no specific antidote for overdosage with
Omeprazole; the treatment should be symptomatic and
supportive.
PHARMACEUTICAL INFORMATION
Storage Conditions
Store below 25°C in a cool dry
place.
1 2 |
