Light caramel opaque and flesh opaque capsule with OMEZOLE 20" printed on
one end and "hovid" printed on the other end of
Each capsule contains: Omeprazole 20 mg.
Actions and Pharmacology
Omeprazole is activated at an acidic pH to a sulphenamide derivative that
binds irreversibly to H+/K+ ATPase, an enzyme system
found at the secretary surface of parietal cells. It thereby inhibits the
final transport of hydrogen ions (via exchange with potassium
ions) into the gastric lumen. Since the H+/K+ ATPase enzyme system is
regarded as the acid (proton) pump of the gastric mucosa,
omeprazole is known as a gastric acid pump inhibitor. Omeprazole inhibits
both basal and stimulated acid secretion irrespective of
Omeprazole is rapidly absorbed, but net to a variable extent, following oral
administration. Absorption of omeprazole is not affected
by food. The absorption of omeprazole, as well as being
formulation-dependent, also appears to be dose-dependent, as increasing
dosage above 40 mg has been reported to increase the plasma concentrations
in a non-linear fashion. Following absorption,
meprazole is almost completely metabolised in the liver, primarily by
cytochrome P450 isoform CVP2C19. It is eliminated 72 to
80% through renal and 18 to 23% through fecal. In dialysis, it is not
readily dialyzable because of extensive protein binding.
Omeprazole is indicated for:
• treatment of reflux oesophagitis.
• duodenal ulcer; benign gastric ulcer.
• long term treatment of pathologic gastric hyperscretion associated with
Side Effects/Adverse Reactions
• Cases of haematologic abnormalities, specifically a a (unusual tiredness o
weakness), eosinopenia, leukocylosis (so
throat and fever), neutropenia (continuing ulcers or sore in mouth,
pancylopenia or thrombocylopenia (unusual bleeding or
bruising), haematuria (bloody urine), proteinuria (cloudy urine), urinary
tract infection (difficult, burning, or painful urination
frequent urge to urinate or bloody or cloudy urine).
• Abdominal pain and colic.
• Asthenia (unusual tiredness, muscle pain): central nervous system (CNS)
disturbances, specifically dizziness, headache,
somnolence (unusual drowsiness), or unusual tiredness, chest pain;
gastrointestinal disturbances, specifically acid regurgitation
heartburn), constipation, diarrhoea or loose stools, flatulence (gas), or
nausea and vomiting: skin rash or itching.
• Before giving omeprazole to patients with gastric ulcers the possibility
of malignancy should be considered since omeprazole
may mask symptoms and delay diagnosis.
• Omeprazole is extensively metabolised in the liver and some sources
recommended that dosage should be reduced in hepatic
• Risk-benefit should be considered when the following medical problems
exist: chronic, current or history of hepatic disease
where dosage reduction may be required due to increased half-life.
Use in pregnancy and lactation
Adequate and well-controlled studies in humans have not been done. There is
no evidence on the safety of omeprazole in
human pregnancy. Animal studies have revealed no teratogenic effect, but
reproduction studies have revealed reduced litter
weights. Avoid in pregnancy unless There is no safer alternative.
It is not known whether omeprazole is excreted in human milk. However,
because omeprazole has been shown to cause
tumorigenic and carcinogenic effects in animals, a decision should be made
on whether nursing should be discontinued or the
medication withdrawn, taking into account the importance of the omeprazole
to the mother.
• Contraindicated in patients known to be hypersensitive to omeprazole.
• Since omeprazole may increase gastrointestinal pH, concurrent use with
ampicillin esters, iron salts or ketoconazole may result in a reduction in
absorption of these medications.
• Inhibition of the cylochrome P-450 enzyme system by omeprazole, especially
in high doses, may cause a decrease in the
hepatic metabolism of anticoagulants (coumarin or indandione-derivative) or
diazepam or phenyloin, which may result in
delayed elimination and increased blood concentrations, when these
medications are used concurrently with omeprazole.
• Concurrent use of omeprazole with bone marrow depressants may increase the
leukopenic and/or thrombocylopenic effects of
both these medications: if concurrent use is required, close observation for
toxic effects should be considered.
Symptoms and treatment for Overdosage
No information available on the effects of overdosage in man.
Treatment for overdosage
Since there is no specific antidote, treatment should be symptomatic and
Dosage and Administration
Omezole capsules are recommended to be taken immediately before meals,
preferably in the morning and swallowed whole with liquid. For patients with swallowing difficulties the capsule might be
opened and the contents swallowed or suspended in a slightly
acidic fluid e.g juice, soured milk, or non-carbonated water. The dispersion
should be taken immediately or within 30 minutes.
Alternatively patients can suck the capsule and swallow the pellets with
liquid. The point, must not be chewed or crushed.
Usual adult and adolescent dose:
• Reflux Oesophagitis: The recommended dosage is Omezole 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 period. In patients with severe
reflux oesophagitis, Omezole 40 mg once daily is
recommended and healing is usually achieved within 8 weeks.
• Duodenal Ulcer/ Benign Gastric Ulcer: Oral, 20 mg once a day. The
dosage can be increased to 40 mg once a day for
duodenal/gastric ulcer refractory to other treatment regimens. If healing of
gastric ulcer has not occurred within 4 weeks, an
additional 4 weeks of treatment is recommended. Long term therapy for
patients with history of recurrent duodenal ulcer is recommended at a dosage
of 20 mg Omezole once daily, up to one year.
• Gastric hypersecretory (e.g., Zollinger-Ellison): Oral, 60 mg once
a day, the dosage being adjusted as needed, and therapy
continued for as long as clinically indicated.
• Dose adjustment is not required in the elderly.
• 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 20 mg may be sufficient.
Store below 25°C. Protect from
Capsule 20 mg x Blisters of 4 x