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Ometac
DESCRIPTION
OMETAC 10: Opaque pink coloured hard gelatine capsule.
OMETAC 20: Opaque pink / reddish brown hard gelatin capsule with OMETAC 20
printed on body and cap.
COMPOSITION
OMETAC 10: Each capsule contains Omeprazole (as enteric-coated
pellets) 10 mg
OMETAC 20: Each capsule contains Omeprazole (as
enteric-coated pellets) 20 mg
ACTION & PHARMACOLOGY
Omeprazole inhibits secretion of gastric acid and is
considered to do so by irreversibly blocking the enzyme system of hydrogen /
potassium adenosine triphosphatase, the so-called proton pump of the gastric
parietal cell. It thereby inhibits the final transport of hydrogen ions (via
exchange with potassium ions) into the gastric lumen. Omeprazole inhibits
both basal and stimulated acid secretion irrespective of the stimulus.
Omeprazole also inhibits hepatic cytochrome P-450 mixed-function oxidase
system. Omeprazole is acid-labile and absorption from the gastrointestinal
tract appears to be formulation-dependent and dose dependent. Following
absorption, it is distributed in tissues, particularly gastric parietal
cells. Approximately 95% of the drug is bound to plasma proteins. Omeprazole
is almost completely metabolised in the liver and rapidly eliminated mostly
in the urine (about 80%) and faeces (about 20%). Although the elimination
half life from plasma is short (0.5 to 1.5 hour), it's duration of action
can last up to 72 hours. The inhibition of acid secretion is directly
related to the area under the plasma concentration time curve but not to the
plasma concentration at any given time.
INDICATIONS
Treatment of duodenal and benign gastric ulcers including those
complicating NSAID therapy. Treatment of reflux oesophagitis, Zollinger-Ellison
syndrome. Prophylactic treatment in patients with an increased risk of NSAID-associated
gastric ulcers, duodenal ulcers, gastroduodenal erosions or dyspeptic
symptoms.
CONTRAINDICATIONS
Contraindicated in patients sensitive to the drug.
SIDE EFFECTS
Omeprazole is generally well-tolerated and adverse reactions
are mostly mild and reversible. Adverse effects which have been reported and
which may occur rarely in isolated cases include haematological disorders (anaemia,
eosinopenia, leukocytosis, neutropenia, thrombocytopenia, haematuria),
gastrointestinal disturbances (diarrhoea, constipation, nausea, vomiting,
flatulence, abdominal pain, heartburn), endocrinological disturbances (gynaecomastia),
hepatic abnormalities (hepatitis with or without jaundice, hepatic failure,
elevated liver enzymes), dermatological disorders (skin rashes, pruritus,
photosensitivity, erythema multiforme), urinary tract infection, dizziness,
headache, muscle pain, malaise, fever.
PRECAUTIONS
When gastric ulcer is suspected, the possibility of malignancy
should be excluded before treatment with omeprazole is instituted, as
treatment may alleviate symptoms and delay diagnosis. Caution should be
exercised in patients with chronic hepatic disease or a history of liver
disease as this condition may cause the drug to accumulate in the body.
Use in pregnancy and lactation: Studies have not been done in humans.
However studies in animals have shown that omeprazole may cause harm to the
fetus. Use of the drug should be avoided in pregnancy unless there is no
safer alternative. There is no information available on the passage of
omeprazole into milk or its effects on the neonate. Breastfeeding should
therefore be discontinued if the use of omeprazole is considered essential.
Use in children: There is no previous experience of the use of omeprazole in
children.
Drug interaction: Concurrent use of omeprazole with diazepam, anticoagulants
and phenytoin may increase the blood levels of the latter drugs, thereby
increasing the propensity for side-effects.
Omeprazole may increase gastrointestinal pH, and concurrent administration
of omeprazole with ketoconazole may reduce absorption of the latter.
Concomitant administration of omeprazole with digoxin may result in
increased bioavailability of digoxin because of the increased
gastrointestinal pH.
DOSAGE & ADMINISTRATION
Ometac Capsules are
recommended to be taken in the morning and swallowed whole with liquid. For
patients with swallowing difficulties, the capsules may be opened and the
contents swallowed or suspended in a slightly acidic fluid such as 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 pellets must not be chewed
or crushed.
For duodenal benign gastric ulcers: The usual dose is 20 mg once daily.
Symptom resolution is rapid. The majority of patients with duodenal ulcer
are healed after 4 weeks, while patients with benign gastric ulcers are
healed after 8 weeks. In severe cases, the dose may be increased to 40 mg
once daily, and healing is usually achieved within 4 weeks.
Long-term therapy for patients with a history of recurrent duodenal ulcer is
recommended at a dose of 20 mg once daily, up to one year.
For prevention of relapse in patients with duodenal ulcer disease, the
recommended dose is 10 mg daily. If necessary, dosage may be increased to 20
mg - 40 mg once daily.
The effectiveness of Ometac is not affected by simultaneous NSAID treatment,
and the usual dose and duration of treatment is recommended.
For reflux oesophagitis: The recommended dosage is 20 mg once daily.
Symptoms resolve rapidly and most patients are healed within 4 weeks. For
those who are not fully healed after the initial course, healing usually
occurs during a further 4 weeks' treatment period.
In patients with severe reflux oesophagitis, 40 mg once daily is recommended
and healing is usually achieved within 8 weeks.
For long-term management of patients with healed reflux oesophagitis, the
recommended dose is 10 mg once daily. If required, dosage may be increased
to 20-40 mg once daily.
For Zollinger-Ellison syndrome: The recommended initial dosage is 60 mg once
daily. The dosage should be adjusted individually and treatment continued as
long as is clinically indicated. All patients with severe disease and
inadequate response to other therapies have been effectively controlled and
more than 90% of patients maintained on doses of 20 - 120 mg daily. With
doses above 80 mg daily, the dose should be divided and given twice daily.
For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers,
gastroduodenal erosions and dyspeptic symptoms: The recommended dosage is 20
mg once daily.
Use in children: There is no previous experience of the use of omeprazole in
children.
Use in elderly: Generally, dosage adjustment is not necessary in the
elderly.
Use in patients with impaired renal or hepatic function:
Impaired renal function: Dosage adjustment is not required in 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 daily may be sufficient.
OVERDOSAGE & TREATMENT
Symptoms include blurred vision, confusion,
diaphoresis, drowsiness, dryness of mouth, flushing, headache, nausea,
tachycardia. Since there is no specific antidote, treatment should be
symptomatic and supportive.
PRESENTATION
OMETAC 10: 28's
OMETAC 20: 14's
STORAGE:
Store in a dry place below 25°C.
Keep medicines out of reach of children. Shelf Life: Please refer outer
carton for shelf life. |
