| OMEP
Omeprazole
Description:
Omeprazole is a
specific inhibitor of the gastric proton pump (H+/K+
-ATPase) in the parietal cell. There it produces dose dependent
inhibition of acid secretion by binding to the enzyme and effectively
reduces gastric acid secretion. After oral administration the
onset of the antisecretory effect of Omeprazole 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 2
to 5 days.
Composition:
Omep-20 Capsule:
Each capsule contains Omeprazole BP 20 mg as enteric-coated
pellets.
Omep-40 Capsule:
Each capsule contains Omeprazole BP 40 mg as enteric-coated
pellets.
Indications:
Omep is
indicated where suppression of acid secretion is of therapeutic
benefit. It may be used for short and long term therapy in the
treatment of duodenal ulcer, gastric ulcer, resistant ulcer,
NSAIDs-induced peptic ulcer and gastroduodenal erosions, erosive
reflux esophagitis, refractory reflux esophagitis, acid reflux
disease, acid related dyspepsia, gastric acid reduction during
general anesthesia, Zollinger-Ellison syndrome.
Dosage &
administration:
Omep capsule
should be taken before meal.
Duodenal ulcer:
20 mg once daily for 4 weeks. In severe cases 40 mg once daily
for 4 weeks.
Gastric ulcer
: 20 mg once daily for 8 weeks in severe case, 40 mg once
daily for 8 weeks. Long term use is not recommended.
Resistant ulcer:
40 mg daily for 4 weeks. For long term therapy the maintenance
dose is 40 mg daily.
NSAIDs induced
peptic ulcer and gastroduodenal erosions: 20 mg once daily
for 4 weeks, followed by a further 4 weeks if not fully healed.
Prophylaxis in patients with a history of NSAIDs associated
gastroduodenal lesions that require continued NSAIDs treatment,
20 mg once daily.
Erosive reflux
esophagitis: 20 mg once daily for 4 weeks for those not
fully healed, to be continued for more 4 weeks.
Refractory reflux
esophagitis: 40 mg once daily for 8 weeks, may be continued
at 20 mg once daily.
Acid reflux
disease: for long term management, 10 mg daily, increasing
to 20 mg once daily if symptoms return.
Acid related
dyspepsia: 10-20 mg once daily for 2-4 weeks according to
response.
Gastric acid
reduction during general anesthesia: In the prophylaxis
of acid aspiration, 40 mg on the preceding evening then 40 mg
2-6 hours before surgery.
Zollinger-Ellision
Syndrome: 60 mg once daily adjusted individually and continued
as long as necessary. Most patients will be effectively controlled
with 20-120 mg daily. Dosage above 80 mg should be divided and
given twice daily. Long term treatment with Omep is not
recommended.
Impaired renal
function: in such cases, dosage adjustment is not required.
Impaired hepatic
function: As bioavailability and half-life can be increased
in patient with impaired hepatic function. The dose requires
adjustment with a maximum daily dose of 20 mg.
The Elderly:
Dosage adjustment is not required in the elderly.
Paediatric use:
Safety and effectiveness in children have not been established.
Contraindications
& warnings:
There is no known
contraindication to the use of Omep. When gastric
ulcer is suspected, the possibility of malignancy should be
excluded before treatment with Omep is instituted as
treatment may alleviate symptoms and delay diagnosis.
Side-effects:
Omep is
generally well tolerated. Nausea, diarrhoea, flatulence, abdominal
pain, constipation, dizziness and headache have been stated
to be generally mild and transient and not requiring a reduction
in dosage. Skin rash, urticaria and pruritus have been reported,
usually resolved after discontinuation of the treatment.
Use in Pregnancy
and lactation:
There is no evidence
on the safety of Omep in human pregnancy. Avoid in pregnancy
unless there is no safer alternative. There is no information
available on the passage of Omep into milk or its effects
on the neonate. Breast-feeding should therefore be discontinued
if the use of Omep is considered essential.
Drug Interaction:
Omep can
delay the elimination of diazepam, phenytoin and warfarin. There
is no evidence of an interaction with theophylline, propranolol
or antacids.
Storage:
Store in a cool
and dry place, away from light. Keep put of the reach of children.
Packing:
Omep-20 Capsule:
Box containing 6X10's capsules in Alu-Alu pack.
Omep-40 Capsule:
Box containing 3x10's capsules in blister pack. |
