OMEPRAZOLE capsule, delayed release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

REMEDYREPACK INC.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Omeprazole Delayed-Release Capsules is 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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole Delayed-Release Capsules in combination with clarithromycin and amoxicillin, is 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. Dual Therapy Omeprazole Delayed-Release Capsules in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H . pylori in adults. Among patients who fail therapy, Omeprazole Delayed-Release Capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. 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 Clinical Pharmacology ( 12.4)  and the clarithromycin prescribing information, Microbiology section ] . Omeprazole Delayed-Release Capsules is indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. Omeprazole Delayed-Release Capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 1 year of age and older. Pediatric Patients 1 Year of Age to Adults Omeprazole Delayed-Release Capsules is indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 1 year of age and older. The efficacy of Omeprazole Delayed-Release Capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of Omeprazole Delayed-Release Capsules may be considered. Omeprazole Delayed-Release Capsules is indicated for the maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older. Controlled studies do not extend beyond 12 months. Omeprazole Delayed-Release Capsules is indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults. - Omeprazole Delayed-Release Capsules is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions ( 5.2)] or any substituted benzimidazole.Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2), Adverse Reactions ( 6)] . Omeprazole Delayed-Release Capsules is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions ( 5.2)] or any substituted benzimidazole.Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2), Adverse Reactions ( 6)] . - Proton pump inhibitors (PPIs), including Omeprazole Delayed-Release Capsules, are contraindicated in patients receiving rilpivirine-containing products [see D rug Interactions ( 7)]. Proton pump inhibitors (PPIs), including Omeprazole Delayed-Release Capsules, are contraindicated in patients receiving rilpivirine-containing products [see D rug Interactions ( 7)]. - For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Omeprazole Delayed-Release Capsules, refer to the CONTRAINDICATIONS section of their package inserts. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Omeprazole Delayed-Release Capsules, refer to the CONTRAINDICATIONS section of their package inserts. Risk Summary There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsules in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person).  Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. When maternal administration was confined to gestation only, there were no effects on the bone physeal morphology in the offspring at any age [see Data] . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H 2 -receptor antagonists or other controls. A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995 to 99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837, 317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester. A retrospective cohort study reported on 689 pregnant women exposed to either H 2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an H 2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures). The reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. Animal Data Omeprazole Reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 3.4 to 34 times an oral human doses of 40 mg on a body surface area basis), administered prior to mating through the lactation period. Esomeprazole The data described below was generated from studies using esomeprazole, an enantiomer of omeprazole. The animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. No effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) or in rabbits at oral doses up to 86 mg/kg/day (about 42 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis) administered during organogenesis.  A pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with esomeprazole magnesium at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). Neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). Body weight and body weight gain were reduced and neurobehavioral or general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/day (about 17 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). In addition, decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate and minimal to mild bone marrow hypocellularity were noted at doses equal to or greater than 14 mg/kg/day (about 3.4 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). Physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). Effects on maternal bone were observed in pregnant and lactating rats in the pre- and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). When rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). A pre- and postnatal development study in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium study) produced similar results in dams and pups as described above. A follow up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age. Risk Summary Limited data suggest omeprazole may be present in human milk.  There are no clinical data on the effects of omeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Omeprazole Delayed-Release Capsules and any potential adverse effects on the breastfed infant from Omeprazole Delayed-Release Capsules or from the underlying maternal condition.  The safety and effectiveness of Omeprazole Delayed-Release Capsules have been established in pediatric patients 1 to 16 years for the treatment of symptomatic GERD, treatment of EE due to acid-mediated GERD, and maintenance of healing of EE due to acid-mediated GERD. Use of Omeprazole Delayed-Release Capsules in this age group is supported by adequate and well-controlled studies in adults and uncontrolled safety, efficacy and pharmacokinetic studies performed in pediatric and adolescent patients [see C li n i cal  P harmacology ( 12.3), C l i n i cal Studies ( 14.8)] . In the pediatric population, adverse reactions of the respiratory system were frequently reported in the entire (1 year to 16 year) age group. Fever was frequently reported in the 1 to <2 year age group, and accidental injuries were frequently reported in the 2 to 16 year age group [see A dverse Reactions ( 6.1)] . The safety and effectiveness of Omeprazole Delayed-Release Capsules have not been established in: - patients less than 1 year of age for any indication. - pediatric patients for: Treatment of active duodenal ulcer H. pylori eradication to reduce the risk of duodenal ulcer recurrence Treatment of active benign gastric ulcer Pathological hypersecretory conditions - Treatment of active duodenal ulcer - H. pylori eradication to reduce the risk of duodenal ulcer recurrence - Treatment of active benign gastric ulcer - Pathological hypersecretory conditions - patients less than 1 month of age for any indication. Juvenile Animal Data Esomeprazole, an enantiomer of omeprazole, was shown to decrease body weight, body weight gain, femur weight, femur length, and overall growth at oral doses about 34 to 68 times a daily human dose of 40 mg esomeprazole or 40 mg omeprazole based on body surface area in a juvenile rat toxicity study.  The animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. A 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with esomeprazole magnesium at doses of 70 to 280 mg/kg/day (about 17 to 68 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). An increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35.  In addition, doses equal to or greater than 140 mg/kg/day (about 34 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis), produced treatment-related decreases in body weight (approximately 14%) and body weight gain, decreases in femur weight and femur length, and affected overall growth. Comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole. Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. However, no dosage adjustment is necessary in the elderly [see Clinical Pharmacology ( 12.3)] . In patients with hepatic impairment (Child-Pugh Class A, B, or C) exposure to omeprazole substantially increased compared to healthy subjects. Dosage reduction of Omeprazole Delayed-Release Capsules to 10 mg once daily is recommended for patients with hepatic impairment for maintenance of healing of EE [see D osage and Administration ( 2.1), C l i n i cal Pharmacology  ( 12.3 )] . In studies of healthy subjects, Asians had approximately a four-fold higher exposure than Caucasians. Dosage reduction of Omeprazole Delayed-Release Capsules to 10 mg once daily is recommended for Asian patients for maintenance of healing of EE [see D osage and  A dministration ( 2.1 ) , C l i nical Pharmacology ( 12.5 )] .

製品概要:

Omeprazole Delayed-Release Capsules, 40 mg, are opaque gold cap and opaque gold body capsules imprinted with "KU" and "136" in black ink. They are supplied as follows: NDC: 70518-2235-00 NDC: 70518-2235-01 NDC: 70518-2235-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC Storage Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store at 20° - 25°C (68° - 77°F) (See USP Controlled Room Temperature). Dispense in a tight and light-resistant container, as described in USP. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

REMEDYREPACK INC.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/omeprazole
Omeprazole ( oh mep’ ra zole) Delayed-Release Capsules, USP
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?
You should take Omeprazole Delayed-Release Capsules exactly as
prescribed, at the lowest dose possible
and for the shortest time needed.
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:
A type of kidney problem (acute tubulointerstitial nephritis).Some
people who take proton pump inhibitor
(PPI) medicines, including Omeprazole Delayed-Release Capsules, may
develop a kidney problem called
acute tubulointerstitial nephritis that can happen at any time during
treatment with Omeprazole Delayed-
Release Capsules. Call your doctor right away if you have a decrease
in the amount that you urinate or if
you have blood in your urine.
Diarrhea.Omeprazole Delayed-Release Capsules 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 PPI 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 ta

製品の特徴

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE DELAYED-
RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OMEPRAZOLE
DELAYED-RELEASE CAPSULES.
OMEPRAZOLE DELAYED-RELEASE CAPSULES USP
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Tubulointerstitial Nephritis ( 5.2)
11/2020
INDICATIONS AND USAGE
Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI)
indicated for the:
Treatment of active duodenal ulcer in adults (1.1)
Eradication of _Helicobacter pylori_to reduce the risk of duodenal
ulcer recurrence in adults (1.2)
Treatment of active benign gastric ulcer in adults (1.3)
Treatment of symptomatic gastroesophageal reflux disease (GERD) in
patients 1 year of age and older
(1.4)
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 1 year of age and older
(1.5)
Maintenance of healing of EE due to acid-mediated GERD in patients 1
year of age and older (1.6)
Pathologic hypersecretory conditions in adults (1.7)
DOSAGE AND ADMINISTRATION
INDICATION
RECOMMENDED ADULT ( 2.1) AND PEDIATRIC DOSAGE ( 2.2)
Treatment of Active Duodenal
Ulcer
20 mg once daily for 4 weeks; some patients may require an additional
4
weeks ( 2.1)
_H. pylori_Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
_Triple Therapy:_
Omeprazole Delayed-Release
Capsules
20 mg
Each drug twice daily for 10 days ( 2.1)*
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Omeprazole Delayed-Release
Capsules
40 mg once daily for 14 days**
Clarithromycin
500 mg three times daily for 14 days ( 2.1)
Active Benign Gastric Ulcer
40 mg once daily for 4 to 8 weeks ( 2.1)
Symptomatic GERD
20 mg once daily for up to 4 weeks ( 2.1)
See full prescribing information for weight based dosing in pediatric
patients 1 year of age and older ( 2.2)
EE due to Acid-Mediated GERD
20 mg once daily for 4 to 8 weeks ( 2.1)***
See full