OMEPRAZOLE capsule, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

OMEPRAZOLE (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9)

Commercializzato da:

RxChange Co.

INN (Nome Internazionale):

OMEPRAZOLE

Composizione:

OMEPRAZOLE 20 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole delayed-release capsules, USP, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Omeprazole delayed-release capsules, USP, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)]. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared

Dettagli prodotto:

Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505- 0145-7) Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505 -0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7) Package of 12 Bottles each containing 30 Capsules (NDC 60505-3952-3) Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1) Storage Store omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
RxChange Co.
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MEDICATION GUIDE
Omeprazole Delayed-Release Capsules, USP
(oh mep’ ra zole)
Read this Medication Guide before you start taking omeprazole
delayed-release capsules and each time
you get a refill. There may be new information. This information does
not take the place of talking with
your doctor about your medical condition or your treatment.
What is the most important information I should know about omeprazole
delayed-release capsules?
Omeprazole delayed-release capsules may help your acid-related
symptoms, but you could still have
serious stomach problems. Talk with your doctor.
Omeprazole delayed-release capsules can cause serious side effects,
including:
•
Diarrhea. Omeprazole may increase your risk of getting severe
diarrhea. This diarrhea may be
caused by an infection (Clostridium difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
•
Bone fractures. People who take multiple daily doses of proton pump
inhibitor medicines for a
long period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist, or
spine. You should take omeprazole delayed-release capsules exactly as
prescribed, at the lowest
dose possible for your treatment and for the shortest time needed.
Talk to your doctor about your
risk of bone fracture if you take omeprazole delayed-release capsules.
Omeprazole can have other serious side effects. See “What are the
possible side effects of omeprazole
delayed-release capsules?”
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules is a prescription medicine called
a proton pump inhibitor (PPI).
Omeprazole delayed-release capsules reduces the amount of acid in your
stomach. Omeprazole delayed-
release capsules are used in adults:
•
for up to 8 weeks for the healing of duodenal ulcers. The duodenal
area is the area where food
passes when it leaves the stomach.
•
with certain antibiotics t

Scheda tecnica

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
RXCHANGE CO.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE DELAYED-RELEASE CAPSULES,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP.
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with Diagnostic
Investigations for Neuroendocrine Tumors (5.8) 03/2014
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for:
• Treatment in adults of duodenal ulcer (1.1) and gastric ulcer
(1.2)
• Treatment in adults and children of gastroesophageal reflux
disease (GERD) (1.3) and maintenance of healing of erosive
esophagitis (1.4)
The safety and effectiveness of omeprazole in pediatric patients <1
year of age have not been established. (8.4)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
FREQUENCY
TREATMENT OF
AC TIVE
DUODENAL ULCER
(2.1)
20 mg
Once daily
for 4 weeks.
Some
patients may
require an
additional 4
weeks
_H. PYLORI_
ERADICATION TO
REDUCE THE
RISK OF
DUODENAL ULCER
RE C URRE NC E
(2.2)
_Triple Therapy:_
Ome prazole
20 mg
Each
drug
twice
daily for
10 days
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Ome prazole
40 mg
Once
daily for
14 days
Clarithromycin
500 mg
Thre e
time s
daily for
14 days
GASTRIC ULCER
(2.3)
40 mg
Once
daily for
4 to 8
weeks
GERD (2.4)
20 mg
Once
daily for
4 to 8
4 to 8
weeks
MAINTENANCE OF
HEALING OF
ERO SIVE
ESO PHAG ITIS
(2.5)
20 mg
Once
daily
PATHO LO G IC AL
HYPE RSE C RE TO RY
CO NDITIO NS
(2.6 )
60 mg (varies with
individual patient)
Once daily
PE DIATRIC
PATIE NTS
(2 TO 16 YEARS
OF AGE) (2.7)
We ight
Dose
GERD AND
MAINTENANCE OF HEALING
OF EROSIVE ESOPHAGITIS
10 < 20 kg
10 mg
Once daily
≥ 20 kg
20 kg
DOSAGE FORMS AND STRENGTHS
Omeprazole delayed-release capsules, 10 mg, 20 mg and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or
subst