Download Prazole Capsule - Renata Limited

Patients weight
5 < 10kg
10 < 20kg
≥ 20kg
®
Omeprazole USP
COMPOSITION: Each capsule contains Omeprazole
(Prazole®) USP 20mg as enteric coated pellets.
PHARMACOLOGY: Omeprazole (Prazole®) belongs
to a class of antisecretory compounds, the substituted
benzimidazole, that suppress gastric acid secretion by
specific inhibition of the H+/K+ ATPase enzyme
systems at the secretory surface of the gastric parietal
cell this effect is dose related and leads to inhibition of
both basal and emulated acid secretion irrespective of
the stimulus. After oral administration, the onset of the
antisecretory effect of Omeprazole (Prazole®) occurs
within one hour, with the maximum effect occurring
within two hours. Inhibition of recreation is about 50%
of maximum at 24 hours and the duration of inhibition
lasts upto 72 hours. Omeprazole (Prazole®) is rapidly
absorbed after oral dose and absorption is not affected
by food. Following absorption Omeprazole (Prazole®)
is almost completely metabolized in the liver, primarily
by the cytochrome p450 isoenzyme CYP2C19. The
metabolites are inactive, and are excreted mostly in the
urine and to a lesser extent in bile. The elimination
half-life from plasma is about 0.5 to 3 hours.
Omeprazole (Prazole®) is about 95% bound to plasma
proteins.
INDICATIONS: Omeprazole (Prazole®) is indicated
for the treatment of gastro-oesophageal reflux disease
management of peptic ulcer disease, eradication of H.
Pylori in peptic ulceration, treatment of NSAID
associated ulceration, Zollinger-Ellison syndrome,
prophylaxis of acid aspiration, relief of acid-related
dyspepsia.
DOSAGE AND ADMINISTRATION: Omeprazole
(Prazole®) capsule should be taken about 30 minutes
before meals. Dose adjustment is not required in
elderly.
Active duodenal ulcer: Usual dose is 20mg once daily
for 4 weeks. Some patients require an additional 4
weeks of therapy.
Gastric ulcer: Usual dose is 20mg once daily for 8
weeks. In severe cases, 40mg once daily for 8 weeks.
Erosive reflux esophagitis: Usual dose is 20mg once
daily for 4 to 8 weeks.
Refractory reflux esophagitis: 40mg once daily.
Healing usually occurs within 8 weeks.
Maintenance of healing of Erosive esophagitis: The
recommended adult oral dose is 20mg daily.
Zollinger Ellison syndromes: Starting dose is 60mg
once daily and may be increased as per patients need
and should continue for as long as clinically indicated.
Dosage of 120mg thrice daily has been administered.
Daily dose of greater than 80mg should be
administered in divided dosed.
Paediatric Patients: For the treatment of GERD and
maintenance of healing of erosive esophagitis, the
recommended daily dose for paediatric patients 1 to 16
years of age is as follows:-
Omeprazole daily dose
5mg
10mg
20mg
Impaired renal or hepatic function: Dose adjustment
is not required in patients with impaired or hepatic
function. Patients with severe liver disease should not
require more than 20mg daily.
Patients with swallowing difficulties: The capsule
may be opened and the contents swallowed alone or
suspended in a small amount of fruit juice. It is
important that the contents of the capsule should not be
crushed or chewed.
CONTRAINDICATIONS: Omeprazole (Prazole®) is
contraindicated in patients with known hypersensitivity
to any component of the formulation.
PRECAUTIONS: Symptomatic response to thereby
with Omeprazole (Prazole®) does not preclude the
presence of gastric malignancy. Atrophic gastritis has
been noted occationally in gastric corpus biopsies from
patients treated long-term with Omeprazole (Prazole®).
SIDE-EFFECTS: Omeprazole (Prazole®) is generally
well tolerated. Nausea, headache, diarrhea,
constipation and flatulence have been reported but are
rare. Skin rashes have occurred in a few patients. These
events have usually been mild and transient and there
has been no consistent relationship with treatment.
DRUG INTERACTIONS: Omeprazole (Prazole®)
can delay the elimination of diazepam, phenytoin and
warfarin. Monitoring of patients, receiving warfarin or
phenytoin is recommended and reduction of warfarin
or phenytoin dose may be necessary when Omeprazole
(Prazole®) is added to treatment.
USE IN PREGNANCY AND LACTATION:
Reproductive studies in rats and rabbits with
Omeprazole (Prazole®) and multiple cohot studies in
pregnant women with Omeprazole (Prazole®) use
during the first trimester do not show an increased risk
of congenital anomalies or adverse pregnancy
outcomes. There are no adequate and well controlled
studies on the use of Omeprazole (Prazole®) in
pregnant women. Because animal reproduction studies
are not always predictive to human response, this drug
should be used during pregnancy only if clearly
needed. Because Omeprazole (Prazole®) is excreted in
human milk, a decision should be made whether to
discontinue nursing or to discontinue the drug taking
into account the importance of the mother.
STORAGE CONDITION: Store in cool, dry place &
protect from light, keep out of reach of children.
PACKAGE: Each Box containing 10 strips of 6
capsules & 5 strips of 6 capsules in Alu-Alu blister &
each capsule contains 20mg Omeprazole USP as
enteric coated pellets.
Size: 236 x 70mm
Trade Mark
®
RENATA LIMITED
Dhaka, Bangladesh
C-Code : 5001/V 01
Updated: Nov. 2013