A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Prilosec Indications, Dosage, Storage, Stability - Omeprazole
Prilosec Indications, Dosage, Storage, Stability - Omeprazole
INDICATIONS
Duodenal Ulcer
Omeprazole delayed-release capsules are indicated for short-term
treatment of active duodenal
ulcer. Most patients heal
within four weeks. Some patients may require an additional four
weeks of therapy.
Omeprazole delayed-release capsules, in combination with clarithromycin,
are also indicated for the treatment
of patients with H. pylori infection and active duodenal
ulcer to eradicated H.
pylori. Eradication of H. pylori has been shown to reduce
the risk of duodenal
ulcer recurrence
(see CLINICAL STUDIES and
DOSAGE AND ADMINISTRATION
).
In patients who fail therapy, susceptibility testing should be
done. If resistance
to clarithromycin is demonstrated or susceptibility testing is not
possible, alternative antimicrobial
therapy should be instituted. (See Clarithromycin, CLINICAL
PHARMACOLOGY: Microbiology.)
Gastric Ulcer
Omeprazole delayed-release capsules are indicated for the short-term
treatment (4-8 weeks) of active benign
gastric ulcer. (See CLINICAL STUDIES.)
Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD: Omeprazole delayed-release capsules
are indicated for the treatment
of heartburn and other
symptoms associated with GERD.
Erosive Esophagitis: Omeprazole delayed-release capsules
are indicated for the short-term treatment
(4-8 weeks) of erosive
esophagitis which has been diagnosed by endoscopy (see CLINICAL
STUDIES).
The efficacy of omeprazole
used for longer than 8 weeks in these patients has not been established.
In the rare instance of a
patient not responding
to 8 weeks of treatment, it may be helpful to give up to an additional
4 weeks of treatment. If there is recurrence
of erosive esophagitis
or GERD symptoms (e.g., heartburn), additional 4-8 week courses
of omeprazole may be considered.
Maintenance of Healing of Erosive Esophagitis
Omeprazole delayed-release capsules are indicated to maintain healing
of erosive esophagitis.
Controlled studies do not extend
beyond 12 months.
Pathological Hypersecretory Conditions
Omeprazole delayed-release capsules are indicated for the long-term
treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison syndrome, multiple
endocrine adenomas
and systemic mastocytosis).
DOSAGE AND ADMINISTRATION
Duodenal Ulcer
Short-Term Treatment of Active Duodenal Ulcer: The
recommended adult oral
dose of omeprazole
is 20 mg once daily. Most
patients heal within four
weeks. Some patients may require an additional four weeks of therapy.
(See INDICATIONS
AND USAGE.)
Reduction of the Risk of Duodenal Ulcer Recurrence:
Combination therapy with clarithromycin. Days 1-14: omeprazole
40 mg q.d. (in the morning)
plus clarithromycin 500 mg
t.i.d. Days 15-28: omeprazole
20 mg q.d.
Please refer to clarithromycin, CONTRAINDICATIONS
and WARNINGS, and for information
regarding dosing in elderly and renally impaired patients (clarithromycin,
PRECAUTIONS, General;
clarithromycin, PRECAUTIONS,
Geriatric Use and clarithromycin, DRUG
INTERACTIONS.)
Gastric Ulcer
The recommended adult
oral dose
is 40 mg once a day for 4-8
weeks. (See CLINICAL STUDIES,
Gastric Ulcer and INDICATIONS
AND USAGE,
Gastric Ulcer).
Gastroesophageal Reflux Disease (GERD)
The recommended adult
oral dose
for the treatment
of patients with symptomatic GERD and no esophageal
lesions is 20 mg daily for
up to 4 weeks. The recommended adult oral
dose for the treatment
of patients with erosive
esophagitis and accompanying symptoms due to GERD
is 20 mg daily for 4 to 8
weeks (see INDICATIONS
AND USAGE.)
Maintenance of Healing of Erosive Esophagitis
The recommended adult
oral dose
is 20 mg daily. (See CLINICAL
STUDIES.)
Pathological Hypersecretory Conditions
The dosage of omeprazole
in patients with pathological hypersecretory conditions varies with
the individual patient. The recommended adult
oral starting dose is 60
mg once a day. Doses should
be adjusted to individual patient needs and should continue for
as long as clinically indicated. Doses up to 120 mg
t.i.d. have been administered. Daily dosages of greater than 80
mg should be administered
in divided doses. Some patients with Zollinger-Ellison syndrome
have been treated continuously with omeprazole for more than 5 years.
No dosage adjustment
is necessary for patients with renal
impairment, hepatic dysfunction
or for the elderly.
Omeprazole delayed-release capsules should be taken before eating.
In the clinical trials,
antacids were used concomitantly with omeprazole.
Patients should be cautioned that the omeprazole
delayed-release capsule should not be opened, chewed or crushed,
and should be swallowed whole.
HOW SUPPLIED
No. 3426: Prilosec Delayed-Release Capsules, 10
mg: are opaque, hard gelatin, apricot and amethyst colored capsules,
coded 606 on cap and Prilosec
10 on the body.
No. 3440: Prilosec Delayed-Release Capsules, 20
mg: are opaque, hard gelatin, amethyst colored capsules, coded
742 on cap and Prilosec
20 on body.
Storage: Store Prilosec Delayed-Release Capsules in a tight
container protected from
light and moisture. Store between
15°C and 30°C (59°F and 86°F).
top
