What Is Omeprazole Dr Used For

INDICATIONS & USAGE

1.1 Duodenal Ulcer (adults)

Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Nigh patients heal inside iv 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 handling of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-twelvemonth 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 [seeClinical Studies (14.1) and Dosage and Assistants (2)].

Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more than likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should exist done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.)

1.2 Gastric Ulcer (adults)

Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to eight weeks) of active beneficial gastric ulcer in adults [meet Clinical Studies (fourteen.two)].

1.3 Treatment of Gastroesophageal Reflux Affliction (GERD) (adults and pediatric patients)

Symptomatic GERD
Omeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.

Erosive Esophagitis
Omeprazole delayed-release capsules, USP are indicated for the short-term treatment (iv to 8 weeks) of erosive esophagitis that has been diagnosed past endoscopy in pediatric patients and adults [see Clinical Studies (xiv.iv)].

The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients has not been established. If a patient does not reply to 8 weeks of treatment, an boosted 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional four to eight week courses of omeprazole may be considered.

1.iv Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)

Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.

Controlled studies do non extend across 12 months [see Clinical Studies (fourteen.iv)].

ane.v Pathological Hypersecretory Conditions (adults)

Omeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory atmospheric condition (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

DOSAGE & Assistants

Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.

Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.

For patients unable to swallow an intact sheathing, alternative administration options are available [see Dosage and Administration (2.eight)].

2.1 Short-Term Treatment of Active Duodenal Ulcer

The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal inside four weeks. Some patients may crave an additional iv weeks of therapy.

two.2 H. pylori Eradication for the Reduction of the Gamble of Duodenal Ulcer Recurrence

Triple Therapy (omeprazole/clarithromycin/amoxicillin)
The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional xviii days of omeprazole delayed-release capsules 20 mg one time daily is recommended for ulcer healing and symptom relief.

Dual Therapy (omeprazole/clarithromycin)
The recommended developed oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an boosted 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.

2.3 Gastric Ulcer

The recommended adult oral dose is 40 mg once daily for four to 8 weeks.

ii.4 Gastroesophageal Reflux Illness (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for upwardly 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 eight weeks.

2.v Maintenance of Healing of Erosive Esophagitis

The recommended adult oral dose is 20 mg daily [see Clinical Studies (14.iv)].

ii.6 Pathological Hypersecretory Conditions

The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily 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 delayed-release capsules for more than five years.

2.seven Pediatric Patients

For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients ii to 16 years of historic period is as follows:

Patient Weight Omeprazole Daily Dose

ten < 20 kg 10 mg

≥ 20 kg xx mg

On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.

Culling administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].

two.8 Alternative Administration Options

Omeprazole is available as a delayed-release sheathing.

For patients who take difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule tin be added to applesauce.

Ane tablespoon of applesauce should be added to an empty bowl and the capsule should exist opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should exist mixed with the applesauce and so swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft plenty to exist swallowed without chewing. The pellets should not be chewed or crushed. The pellets/absurdity mixture should not be stored for hereafter utilise.

DOSAGE FORMS & STRENGTHS

Omeprazole delayed-release capsules, USP 10 mg are hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. "APO 010" is imprinted on each capsule in black ink.

Omeprazole delayed-release capsules, USP 20 mg are hard gelatin capsules with a pinkish opaque body and a reddish brownish opaque cap. "APO 020" is imprinted on each sheathing in black ink.

Omeprazole delayed-release capsules, USP forty mg are hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. "APO 040" is imprinted on each sheathing in black ink.

CONTRAINDICATIONS

Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to whatsoever component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [see Adverse Reactions (6)].

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS department of their parcel inserts.

WARNINGS AND PRECAUTIONS

five.1 Concomitant Gastric Malignancy

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

v.2 Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

5.3 Clostridium difficile associated diarrhea

Published observational studies suggest that PPI therapy like omeprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should exist considered for diarrhea that does not improve [see Adverse Reactions (6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy advisable to the condition being treated.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more than information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for employ in combination with omeprazole, refer to WARNINGS and PRECAUTIONS sections of those package inserts.

5.four Interaction with Clopidogrel

Avoid concomitant utilise of omeprazole with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet assemblage past clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its agile metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity. Concomitant employ of clopidogrel with eighty mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours autonomously. When using omeprazole, consider culling anti-platelet therapy [meet Drug Interactions (7.3) and Pharmacokinetics (12.three)].

5.v Bone Fracture

Several published observational studies propose that proton pump inhibitor (PPI) therapy may be associated with an increased take a chance for osteoporosis-related fractures of the hip, wrist, or spine. The chance of fracture was increased in patients who received high-dose, divers as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should employ the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at run a risk for osteoporosis-related fractures should be managed co-ordinate to established treatment guidelines [see Dosage and Administration (two) and Adverse Reactions (half dozen.iii)].

5.6 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such every bit digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.3)].

5.7 Concomitant Use of Omeprazole with St. John's Wort or Rifampin

Drugs which induce CYP2C19 or CYP3A4 (such equally St. John's Wort or rifampin) can substantially decrease omeprazole concentrations [see Drug Interactions (vii.iii)]. Avoid concomitant utilize of omeprazole with St. John'south Wort or rifampin.

5.viii Interactions with Diagnostic Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may crusade simulated positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily terminate omeprazole treatment at least fourteen days earlier assessing CgA levels and consider repeating the test if initial CgA levels are loftier. If serial tests are performed (e.yard. for monitoring), the same commercial laboratory should be used for testing, equally reference ranges betwixt tests may vary.

5.9 Concomitant utilise of Omeprazole with Methotrexate

Literature suggests that concomitant utilize of PPIs with methotrexate (primarily at high dose; meet methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, perchance leading to methotrexate toxicities. In high-dose methotrexate assistants a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (seven.7)].

ADVERSE REACTIONS

six.1 Clinical Trials Experience with Omeprazole Monotherapy

Considering clinical trials are conducted under widely varying atmospheric condition, agin reaction rates observed in the clinical trials of a drug cannot be direct compared to rates in the clinical trials of another drug and may not reflect the rates observed in do.

The safety data described beneath reflects exposure to omeprazole delayed-release capsules in 3096 patients from worldwide clinical trials (465 patients from United states of america studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The nearly common agin reactions reported (i.east., with an incidence rate ≥ 2%) from omeprazole-treated patients enrolled in these studies included headache (6.ix%), abdominal pain (five.2%), nausea (4.0%), diarrhea (iii.seven%), airsickness (3.2%), and flatulence (two.vii%).

Boosted adverse reactions that were reported with an incidence ≥ane% included acrid regurgitation (1.ix%), upper respiratory infection (ane.9%), constipation (1.5%), dizziness (1.5%), rash (ane.5%), asthenia (one.three%), dorsum pain (ane.ane%), and cough (1.1%).

The clinical trial condom profile in patients greater than 65 years of age was like to that in patients 65 years of age or less. The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients. Unique to the pediatric population, all the same, adverse reactions of the respiratory system were almost ofttimes reported in the 2 to 16 year age group (18.five%). Similarly, accidental injuries were reported frequently in the two to 16 yr age group (three.8%) [see Use in Specific Populations (8.4)].

half dozen.ii Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication

In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin lonely.

Dual Therapy (omeprazole/clarithromycin)
Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (north = 346) that differed from those previously described for omeprazole alone were sense of taste perversion (fifteen%), natural language discoloration (two%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (i%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).

Triple Therapy (omeprazole/clarithromycin/amoxicillin)
The most frequent agin reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (due north = 274) were diarrhea (fourteen%), taste perversion (10%), and headache (vii%). None of these occurred at a college frequency than that reported by patients taking antimicrobial agents solitary. (For more data on clarithromycin or amoxicillin, refer to the respective prescribing information, Agin Reactions sections).

6.3 Post-marketing Experience

The following agin reactions take been identified during post-blessing employ of omeprazole delayed-release capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or constitute a causal relationship to drug exposure.

Body As a Whole

Hypersensitivity reactions including anaphylaxis, anaphylactic daze, angioedema, bronchospasm, interstitial nephritis, urticaria, (see as well Skin below); fever; pain; fatigue; angst;

Cardiovascular

Breast pain or angina, tachycardia, bradycardia, palpitations, elevated blood force per unit area, peripheral edema

Endocrine

Gynecomastia

Gastrointestinal

Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, intestinal swelling, dry oral fissure, microscopic colitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when handling is discontinued. Gastroduodenal carcinoids accept been reported in patients with ZE syndrome on long-term treatment with omeprazole. This finding is believed to exist a manifestation of the underlying status, which is known to be associated with such tumors.

Hepatic

Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]

Infections and Infestations

Clostridium difficile associated diarrhea

Metabolism and Nutritional disorders

Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain

Musculoskeletal

Muscle weakness, myalgia, muscle cramps, articulation pain, leg pain, bone fracture

Nervous System/Psychiatric

Psychiatric and sleep disturbances including low, agitation, aggression, hallucinations, defoliation, insomnia, nervousness, aloofness, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo

Respiratory

Epistaxis, pharyngeal hurting

Skin

Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry out peel; hyperhidrosis

Special Senses

Tinnitus, taste perversion

Ocular

Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital

Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic

Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis

DRUG INTERACTIONS

seven.i Interference with Antiretroviral Therapy

Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may consequence in a loss of therapeutic result and the development of drug resistance. Co-assistants of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and crave dose reduction.

Omeprazole has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms backside these interactions are not always known. Increased gastric pH during omeprazole handling may modify the assimilation of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19.

Reduced concentrations of atazanavir and nelfinavir

For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily), AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin past 39% and 75% respectively for nelfinavir and M8. Following multiple doses of atazanavir (400 mg, daily) and omeprazole (twoscore mg, daily, two hr before atazanavir), AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore non recommended.

Increased concentrations of saquinavir

For other antiretroviral drugs, such every bit saquinavir, elevated serum levels accept been reported, with an increment in AUC by 82%, in Cmax past 75%, and in Cmin by 106%, post-obit multiple dosing of saquinavir/ritonavir (grand/100 mg) twice daily for 15 days with omeprazole 40 mg daily co-administered days xi to 15. Therefore, clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with omeprazole. Dose reduction of saquinavir should be considered from the safe perspective for individual patients.

There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with omeprazole.

seven.ii Drugs for Which Gastric pH Tin Affect Bioavailability

Considering of its profound and long lasting inhibition of gastric acid secretion, it is theoretically possible that omeprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that subtract the intragastric acidity, the absorption of drugs such as ketoconazole, ampicillin esters, iron salts and erlotinib can subtract, while the assimilation of drugs such as digoxin tin increase during treatment with omeprazole. Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in 2 subjects). Therefore, patients may need to be monitored when digoxin is taken concomitantly with omeprazole. In the clinical trials, antacids were used concomitantly with the assistants of omeprazole.

7.3 Furnishings on Hepatic Metabolism/Cytochrome P-450 Pathways

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. At that place have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin fourth dimension may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin may need to be monitored for increases in INR and prothrombin time.

Although in normal subjects no interaction with theophylline or propranolol was constitute, there have been clinical reports of interaction with other drugs metabolized via the cytochrome P450 organization (due east.one thousand., cyclosporine, disulfiram, benzodiazepines). Patients should be monitored to make up one's mind if information technology is necessary to adjust the dosage of these drugs when taken concomitantly with omeprazole.

Concomitant administration of omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure. Dose aligning of omeprazole is non normally required. However, in patients with Zollinger-Ellison syndrome, who may require college doses up to 240 mg/solar day, dose adjustment may be considered. When voriconazole (400 mg Q12h x 1 24-hour interval, and so 200 mg x 6 days) was given with omeprazole (40 mg in one case daily 10 7 days) to healthy subjects, it significantly increased the steady-country Cmax and AUC0-24 of omeprazole, an boilerplate of 2 times (90% CI: 1.8, ii.6) and 4 times (90% CI: 3.3, iv.4) respectively as compared to when omeprazole was given without voriconazole.

Omeprazole acts as an inhibitor of CYP2C19. Omeprazole, given in doses of 40 mg daily for one week to 20 salubrious subjects in cantankerous-over study, increased Cmax and AUC of cilostazol by eighteen% and 26% respectively. Cmax and AUC of one of its agile metabolites, 3,four-dihydro-cilostazol, which has 4 to 7 times the activity of cilostazol, were increased by 29% and 69% respectively. Co-administration of cilostazol with omeprazole is expected to increase concentrations of cilostazol and its higher up mentioned active metabolite. Therefore a dose reduction of cilostazol from 100 mg twice daily to fifty mg twice daily should exist considered.

Drugs known to induce CYP2C19 or CYP3A4 (such as rifampin) may lead to decreased omeprazole serum levels. In a cross-over study in 12 healthy male subjects, St. John'southward Wort (300 mg iii times daily for 14 days), an inducer of CYP3A4, decreased the systemic exposure of omeprazole in CYP2C19 poor metabolisers (Cmax and AUC decreased past 37.5% and 37.nine%, respectively) and extensive metabolisers (Cmax and AUC decreased by 49.6% and 43.9%, respectively). Avert concomitant employ of St. John'due south Wort or rifampin with omeprazole.

Clopidogrel
Omeprazole is an inhibitor of CYP2C19 enzyme. Clopidogrel is metabolized to its active metabolite in role by CYP2C19. Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avert concomitant assistants of omeprazole with clopidogrel. When using omeprazole, consider use of alternative anti-platelet therapy [run into Pharmacokinetics (12.3)].

There are no adequate combination studies of a lower dose of omeprazole or a college dose of clopidogrel in comparison with the approved dose of clopidogrel.

7.4 Tacrolimus

Concomitant assistants of omeprazole and tacrolimus may increase the serum levels of tacrolimus.

7.v Interactions with Investigations of Neuroendocrine Tumors

Drug-induced decrease in gastric acidity results in enterochromaffin-like prison cell hyperplasia and increased Chromogranin A levels which may interfere with investigations for neuroendocrine tumors [meet Warnings and Precautions (five.viii) and Clinical Pharmacology (12)].

vii.6 Combination Therapy with Clarithromycin

Concomitant administration of clarithromycin with other drugs can pb to serious agin reactions due to drug interactions [run into Warnings and Precautions in prescribing information for clarithromycin]. Considering of these drug interactions, clarithromycin is contraindicated for co-assistants with sure drugs [see Contraindications in prescribing information for clarithromycin].

seven.7 Methotrexate

Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing data) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs accept been conducted [come across Warnings and Precautions (five.nine)].

Employ IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Risk Summary

There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data neglect to demonstrate an increased risk of major built malformations or other adverse pregnancy outcomes with first trimester omeprazole utilise.

Animal reproduction studies with omeprazole in rats and rabbits resulted in dose-dependent embryolethality at doses that were approximately 2.eight to 28 times the daily human dose of 40 mg.

Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 57 times and 35 times, respectively, an oral human dose of 40 mg. Still, changes in os morphology were observed in offspring of rats dosed through near of pregnancy and lactation at doses equal to or greater than approximately 33.6 times an oral human dose of 40 mg (encounter Creature Data). Because of the observed effect at loftier doses of esomeprazole magnesium on developing bone in rat studies, omeprazole should exist used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Man Data

Four published epidemiological studies compared the frequency of congenital abnormalities among infants built-in to women who used omeprazole during pregnancy with the frequency of abnormalities amid infants of women exposed to H2-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 kickoff trimester with 39 of these exposed beyond starting time trimester, and 131 exposed subsequently the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had whatsoever 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 written report roofing all live births in Denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the showtime 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 get-go trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to whatever proton pump inhibitor during the first trimester.

A retrospective accomplice report reported on 689 pregnant women exposed to either H2-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 H2-blocker, or were unexposed was 3.6%, v.v%, and four.ane% respectively.

A small prospective observational accomplice study followed 113 women exposed to omeprazole during pregnancy (89% get-go trimester exposures). The reported charge per unit of major built malformations was 4% in the omeprazole group, two% in controls exposed to non-teratogens, and two.eight% in illness-paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational historic period at delivery, and mean nativity weight were similar among the groups.

Several studies take reported no apparent adverse brusk-term furnishings on the infant when unmarried dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.

Creature Data

Reproductive studies conducted with omeprazole in rats at oral doses upwardly to 138 mg/kg/day (about 28 times an oral human dose of twoscore mg on a torso surface area basis) and in rabbits at doses up to 69 mg/kg/mean solar day (most 28 times an oral human dose of 40 mg on a body surface area ground) did not disclose any testify for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.one mg/kg/twenty-four hours (about 2.8 to 28 times an oral human dose of 40 mg on a trunk surface surface area basis) 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 xiii.8 to 138.0 mg/kg/mean solar day (about 2.viii to 28 times an oral homo doses of twoscore mg on a trunk surface area basis).

Reproduction studies take been performed with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 57 times an oral human dose of 40 mg on a body surface expanse basis) and in rabbits at oral doses up to 86 mg/kg/day (about 35 times an oral human dose of twoscore mg on a body surface surface area ground) and have revealed no evidence of dumb fertility or harm to the fetus due to esomeprazole magnesium.

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 (nearly three.4 to 57 times an oral human being dose of twoscore mg on a trunk surface area ground). Neonatal/early postnatal (nativity to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (most 33 times an oral human dose of 40 mg on a body surface area ground). Trunk weight and body weight gain were reduced and neurobehavioral or full general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/twenty-four hours (about 16.8 times an oral human dose of 40 mg on a body surface surface area ground). 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 being dose of 40 mg on a body surface area footing). 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/twenty-four hour period (about 33.6 times an oral human dose of twoscore mg on a body surface area ground).

Furnishings 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/twenty-four hours (about 3.4 to 57 times an oral human dose of 40 mg on a body surface area basis). When rats were dosed from gestational day 7 through weaning on postnatal 24-hour interval 21, a statistically significant decrease in maternal femur weight of upwardly to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 138 mg/kg/day (most 33.6 times an oral human being dose of 40 mg on a body surface expanse basis).

A pre- and postnatal development report in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium written report) produced similar results in dams and pups as described to a higher place.

viii.3 Nursing Mothers

Omeprazole is present in human milk. Omeprazole concentrations were measured in chest milk of a woman following oral administration of 20 mg. The peak concentration of omeprazole in breast milk was less than 7% of the peak serum concentration. This concentration would correspond to 0.004 mg of omeprazole in 200 mL of milk. Caution should exist exercised when omeprazole is administered to a nursing woman.

8.4 Pediatric Use

Use of omeprazole in pediatric and boyish patients 2 to 16 years of age for the handling of GERD and maintenance of healing of erosive esophagitis is supported by a) extrapolation of results from acceptable and well-controlled studies that supported the approval of omeprazole for adults, and b) safety and pharmacokinetic studies performed in pediatric and boyish patients [encounter Clinical Pharmacology, Pharmacokinetics, Pediatric for pharmacokinetic information (12.3) and Dosage and Administration (2), Agin Reactions (6.1) and Clinical Studies, (14.vi)]. The safety and effectiveness of omeprazole for the treatment of GERD in patients <1 year of historic period accept not been established. The safety and effectiveness of omeprazole for other pediatric uses accept non been established.

Juvenile Animal Data

In a juvenile rat toxicity written report, esomeprazole was administered with both magnesium and strontium salts at oral doses about 34 to 57 times a daily human dose of 40 mg based on torso expanse. Increases in death were seen at the high dose, and at all doses of esomeprazole, in that location were decreases in body weight, body weight gain, femur weight and femur length, and decreases in overall growth [run across Nonclinical Toxicology (thirteen.2)].

eight.5 Geriatric Use

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 condom and effectiveness between the elderly and younger subjects. Other reported clinical feel 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 take shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (nearly half that of young volunteers) and its plasma half-life averaged i hour, about twice that of immature good for you volunteers. However, no dosage aligning is necessary in the elderly [see Clinical Pharmacology (12.3)].

viii.6 Hepatic Damage

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis [see Clinical Pharmacology (12.iii)].

viii.7 Renal Harm

No dosage reduction is necessary [see Clinical Pharmacology (12.3)].

8.viii Asian Population

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis [encounter Clinical Pharmacology (12.3)].

OVERDOSAGE

Reports have been received of overdosage with omeprazole in humans. Doses ranged upward to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions like to those seen in normal clinical experience [see Adverse Reactions (six)]. Symptoms were transient, and no serious clinical result has been reported when omeprazole was taken lone. No specific antitoxin for omeprazole overdosage is known. Omeprazole is extensively poly peptide bound and is, therefore, non readily dialyzable. In the issue of overdosage, treatment should be symptomatic and supportive.

As with the management of any overdose, the possibility of multiple drug ingestion should exist considered. For current information on treatment of any drug overdose, contact a Poison Command Middle at one-800-222-1222.

Unmarried oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activeness, trunk temperature, and respiratory charge per unit and increased depth of respiration.

DESCRIPTION

The agile ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, v-methoxy-2-[[(4-methoxy-iii, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acrid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42.

Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is speedily degraded in acid media, simply has adequate stability under alkaline metal conditions.

Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2.

Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either x mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the post-obit inactive ingredients: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The sheathing shells have the following inactive ingredients: gelatin, cerise iron oxide and titanium dioxide. The sheathing imprinting ink contains ammonium hydroxide, black fe oxide, ethyl booze, isopropyl alcohol, northward-butyl alcohol, potassium hydroxide, propylene glycol and shellac.

NONCLINICAL TOXICOLOGY

13.i Carcinogenesis, Mutagenesis, Impairment of Fertility

In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, xiii.viii, 44.0 and 140.8 mg/kg/twenty-four hours (well-nigh 0.35 to 28 times a human dose of forty mg/day, as expressed on a torso surface area ground) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this issue was markedly higher in female person rats, which had higher blood levels of omeprazole. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.viii mg omeprazole/kg/day (about two.viii times a human dose of forty mg/twenty-four hour period, based on body area) for ane yr, then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL prison cell hyperplasia was observed at the stop of one twelvemonth (94% treated vs ten% controls). By the second year the deviation between treated and control rats was much smaller (46% vs 26%) but even so showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male or female rats treated for two years. For this strain of rat no similar tumor has been noted historically, but a finding involving merely one tumor is hard to translate. In a 52-week toxicity study in Sprague-Dawley rats, brain astrocytomas were found in a small number of males that received omeprazole at dose levels of 0.4, two, and 16 mg/kg/day (about 0.1 to iii.2 times the human dose of 40 mg/twenty-four hour period, based on a body surface surface area basis). No astrocytomas were observed in female person rats in this study. In a 2-year carcinogenicity report in Sprague-Dawley rats, no astrocytomas were found in males or females at the high dose of 140.8 mg/kg/mean solar day (almost 28 times the man dose of 40 mg/day on a body surface surface area ground). A 78-week mouse carcinogenicity report of omeprazole did non show increased tumor occurrence, simply the study was not conclusive. A 26-week p53 (+/-) transgenic mouse carcinogenicity study was non positive.

Omeprazole was positive for clastogenic effects in an in vitro human lymphocyte chromosomal abnormality assay, in one of two in vivo mouse micronucleus tests, and in an in vivo os marrow cell chromosomal aberration assay. Omeprazole was negative in the in vitro Ames test, an in vitro mouse lymphoma jail cell forward mutation assay, and an in vivo rat liver DNA damage assay.

Omeprazole at oral doses upwardly to 138 mg/kg/day in rats (about 28 times an oral human dose of 40 mg on a body expanse basis) was found to accept no consequence on fertility and reproductive performance.

In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric carcinoid tumors and ECL jail cell hyperplasia was observed in both male person and female animals [see Warnings and Precautions (5)]. Carcinoid tumors have likewise been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H2-receptor antagonists.

thirteen.2 Fauna Toxicology and/or Pharmacology

Reproduction Studies

Reproductive Toxicology Studies

Reproductive studies conducted with omeprazole in rats at oral doses upwardly to 138 mg/kg/24-hour interval (about 28 times the human being dose of 40 mg/24-hour interval on a body area basis) and in rabbits at doses up to 69 mg/kg/day (almost 28 times the human dose on a body surface area basis) did non disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.ix to 69.i mg/kg/day (near 2.8 to 28 times the homo dose of 40 mg/day on a torso surface area basis) 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.viii to 138.0 mg/kg/day (virtually ii.viii to 28 times the human being dose of 40 mg/day on a body surface expanse ground) [run across Pregnancy, Brute Data (8.1)].

Juvenile Animal Study

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/solar day (about 17 to 57 times a daily oral homo dose of xl mg on a body surface area basis). An increment in the number of deaths at the high dose of 280 mg/kg/solar day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35. In add-on, doses equal to or greater than 140 mg/kg/day (nigh 34 times a daily oral human dose of 40 mg on a body surface expanse basis), produced treatment-related decreases in body weight (approximately xiv%) and trunk weight proceeds, decreases in femur weight and femur length, and affected overall growth. Comparable findings described above accept likewise been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole.

INFORMATION FOR PATIENTS

"See FDA-Canonical Medication Guide"

Omeprazole delayed-release sheathing should be taken before eating. Patients should be informed that the omeprazole delayed-release sheathing should be swallowed whole.

For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. I tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the sheathing should exist carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to exist swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not exist stored for future use.

Propose patients to immediately written report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea [see Warnings and Precautions (5.3)].

Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (v.6)].

MEDICATION GUIDE

Omeprazole Delayed-Release Capsules, USP

(oh mep' ra zole)

Read this Medication Guide before yous start taking omeprazole delayed-release capsules and each time y'all get a refill. There may be new information. This information does non have the place of talking with your dr. about your medical status or your handling.

What is the near important information I should know about omeprazole delayed-release capsules?

Omeprazole delayed-release capsules may assist your acid-related symptoms, but you could withal have serious stomach problems. Talk with your doctor.

Omeprazole delayed-release capsules tin can cause serious side effects, including:

Diarrhea. Omeprazole may increase your risk of getting severe diarrhea. This diarrhea may exist caused by an infection (Clostridium difficile) in your intestines.

Call your doctor right away if you take watery stool, tum pain, and fever that does not go abroad.

Bone fractures. People who accept multiple daily doses of proton pump inhibitor medicines for a long flow of time (a twelvemonth or longer) may have an increased hazard of fractures of the hip, wrist, or spine. Y'all 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 doc about your risk of bone fracture if yous take omeprazole delayed-release capsules.

Omeprazole tin have other serious side effects. Run into "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 corporeality of acid in your breadbasket. Omeprazole delayed-release capsules are used in adults:

for upwardly to 8 weeks for the healing of duodenal ulcers. The duodenal area is the area where food passes when it leaves the tummy.
with sure antibiotics to care for an infection caused past leaner called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to exist treated to preclude the ulcers from coming back.
for up to 8 weeks for healing stomach ulcers.
for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux illness (GERD).

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour gustatory modality, or burping.

for upward to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) . If needed, your doctor may decide to prescribe another 4 weeks of omeprazole delayed-release capsules.
to maintain healing of the esophagus. Information technology is not known if omeprazole delayed-release capsules is safe and constructive when used for longer than 12 months (i year) for this purpose.
for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.

For children and adolescents two to 17 years of age, omeprazole delayed-release capsules are used:

for upward to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
for up to viii weeks to heal acrid-related damage to the lining of the esophagus (called erosive esophagitis or EE)
to maintain healing of the esophagus. Information technology is not known if omeprazole delayed-release capsules are safe and effective when used longer than 12 months (1 year) for this purpose.

It is not known if omeprazole delayed-release capsules are safety and constructive for the treatment of gastroesophageal reflux illness (GERD) in children nether 1 twelvemonth of historic period.

Who should not take omeprazole delayed-release capsules?

Do non take omeprazole delayed-release capsules if y'all:

are allergic to omeprazole delayed-release capsules or whatever of the ingredients in omeprazole delayed-release capsules. See the cease of this Medication Guide for a consummate listing of ingredients in omeprazole delayed-release capsules.
are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What should I tell my dr. before taking omeprazole delayed-release capsules?

Before yous accept omeprazole delayed-release capsules, tell your dr. if you:

have been told that you have depression magnesium levels in your blood
have liver bug
have whatever other medical conditions
are pregnant or plan to get pregnant. It is not known if omeprazole will harm your unborn baby.
are breastfeeding or plan to breastfeed. Omeprazole passes into your chest milk. Talk to your doctor about the all-time way to feed your baby if you take omeprazole delayed-release capsules.

Tell your doc nigh all of the medicines you lot take including prescription and non-prescription drugs, anti-cancer drugs, vitamins and herbal supplements. Omeprazole delayed-release capsules may bear upon how other medicines work, and other medicines may affect how omeprazole delayed-release capsules works.

Especially tell your doctor if yous take:

atazanavir (Reyataz)
nelfinavir (Viracept)
saquinavir (Fortovase)
cilostazol (Pletal)
ketoconazole (Nizoral)
voriconazole (Vfend)
an antibiotic that contains ampicillin, amoxicillin or clarithromycin
products that contain iron
warfarin (Coumadin, Jantoven)
digoxin (Lanoxin)
tacrolimus (Prograf)
diazepam (Valium)
phenytoin (Dilantin)
disulfiram (Antabuse)
clopidogrel (Plavix)
St. John's Wort (Hypericum perforatum)
rifampin (Rimactane, Rifater, Rifamate),
erlotinib (Tarceva)
methotrexate

Ask your physician or pharmacist for a listing of these medicines if you are not sure.

Know the medicines that you take. Proceed a list of them to testify your doctor and chemist when y'all get a new medicine.

How should I take omeprazole delayed-release capsules?

Take omeprazole delayed-release capsules exactly equally prescribed by your md.
Practise not change your dose or terminate omeprazole delayed-release capsules without talking to your doctor.
Take omeprazole delayed-release capsules at least 1 hour earlier a repast.
Consume omeprazole delayed-release capsules whole. Exercise not chew or beat out omeprazole delayed-release capsules.
If you take problem swallowing omeprazole delayed-release capsules, you may accept as follows:
Place 1 tablespoon of absurdity into a make clean bowl.
Advisedly open up the sheathing and empty the contents (pellets) onto the applesauce. Mix the pellets with the applesauce.
Eat the applesauce and pellet mixture correct away with a glass of cool water. Do not chew or shell the pellets. Do not store the applesauce and pellet mixture for later apply.
If yous forget to take a dose of omeprazole delayed-release capsules, have it as soon as y'all remember. If information technology is virtually fourth dimension for your next dose, do not have the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
If y'all take too much omeprazole delayed release capsules, tell your doc right away.

What are the possible side effects of omeprazole delayed-release capsules?

Omeprazole tin can cause serious side furnishings, including:

Run into "What is the almost important information I should know near omeprazole?"
Chronic (lasting a long fourth dimension) inflammation of the breadbasket lining (Atrophic Gastritis). Using omeprazole delayed-release capsules for a long period of time may increase the risk of inflammation to your breadbasket lining. You may or may non have symptoms. Tell your doctor if you have stomach hurting, nausea, vomiting, or weight loss.
Low magnesium levels in your body. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a twelvemonth of treatment. You may or may not have symptoms of depression magnesium.

Tell your doctor right away if you develop any of these symptoms:

seizures
dizziness
abnormal or fast eye beat
jitteriness
jerking movements or shaking (tremors)
musculus weakness
spasms of the easily and feet
cramps or muscle aches
spasm of the voice box

Your medico may cheque the level of magnesium in your body before y'all kickoff taking omeprazole delayed-release capsules or during treatment if you volition exist taking omeprazole delayed-release capsules for a long period of time.

The almost mutual side furnishings with omeprazole delayed-release capsules in adults and children include:

headache
tum pain
nausea
diarrhea
vomiting
gas

In addition to the side furnishings listed above, the most common side effects in children 2 to 16 years of age include:
respiratory arrangement events
fever

Other side effects:

Serious allergic reactions. Tell your dr. if you become any of the following symptoms with omeprazole:
rash
face swelling
throat tightness
difficulty breathing

Your doc may end omeprazole if these symptoms happen.

Tell your md if yous have whatsoever side outcome that bothers you or that practice not go abroad. These are not all the possible side effects with omeprazole delayed-release capsules.

Call your medico for medical advice about side furnishings. You may report side effects to FDA at 1-800-FDA-1088.

How should I shop omeprazole delayed-release capsules?

Store omeprazole delayed-release capsules at room temperature betwixt 68°F to 77°F (20°C to 25°C).
Go along the container of omeprazole delayed-release capsules closed tightly.

Go on omeprazole delayed-release capsules and all medicines out of the reach of children.

General information near omeprazole delayed-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole delayed-release capsules for a condition for which it was non prescribed. Practice not give omeprazole delayed-release capsules to other people, fifty-fifty if they have the aforementioned symptoms you take. It may harm them.

This Medication Guide summarizes the most important data about omeprazole delayed-release capsules.

For more information, ask your dr.. You can enquire your physician or pharmacist for data that is written for healthcare professionals.

For more information contact Apotex Corp., Drug Safety at ane-800-706-5575.

Instructions for Use

For instructions on taking omeprazole delayed-release capsules, delight run into "How should I take omeprazole delayed-release capsules?"

What are the ingredients in omeprazole delayed-release capsules?

Agile ingredient in omeprazole delayed-release capsules: omeprazole

Inactive ingredients in omeprazole delayed-release capsules: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the post-obit inactive ingredients: gelatin, red iron oxide and titanium dioxide. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl booze, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac.

This Medication Guide and Instructions for Employ has been approved by the U.S. Nutrient and Drug Administration.

Packet LABEL.PRINCIPAL Brandish Panel

NDC: 51655-022-26

MFG: 60505-0065-one

OMEPRAZOLE DR 20 MG

90 Capsules

Rx Merely

Lot#

Exp. Date:

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dosage: Encounter prescriber'due south instructions

Each capsule contains 20 mg omeprazole

Store at 68 to 77 degrees F.

Protect from light and moisture

Keep out of the reach of children.

Mfg. by Apotex Inc. Ontarion Canada M9L 1T9

Mfg for Apotex Corp. Weston, FL 33326 Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-022-26

Package Label.Principal Display Section

NDC: 51655-022-25

MFG: 60505-0065-one

Omeprazole DR 20MG

60 Capsules

Rx Only

Lot #:

Exp Date:

Each capsule contains 20mg omeprazole.

Dosage: See prescriber'due south instructions.

Shop at 68 to 77 degrees F; excursions permitted to 59 to 86 F.

Manipulate in this tight, light-resistant container.

Protect from calorie-free & moisture.

Proceed out of the reach of children. Medication guide is institute at www.fda.gov/drugs/drugsafety/ucm085729

Mfg. by: Apotex Inc. Ontario Canada M9L 1T9

Mfg. for: Apotex Corp. Weston, FL 33326

Lot# ME7878

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-022-25