For patients unable to swallow an intact capsule, alternative administration options are available.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Respiratory: Epistaxis, pharyngeal pain.
NDC unit dose packages of 30: 2.5 mg packets NDC unit dose packages of 30: 10 mg packets.
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:
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]
The clinical trial safety profile in pediatric patients who received PRILOSEC Delayed-Release Capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to < 2 and 2 to 16 year age groups (75.0% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33.0%), and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%).
NDC unit of use bottles of 30.
Store PRILOSEC For Delayed-Release Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F).
Due to its effects on gastric acid secretion, omeprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with omeprazole.
NDC unit of use bottles of 30 NDC bottles of 1000.
PRILOSEC is indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
The most frequent adverse reactions observed in clinical trials using combination therapy with PRILOSEC, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections.).
Each packet of PRILOSEC For Delayed-Release Oral Suspension contains either 2.8 mg or 11.2 mg of omeprazole magnesium (equivalent to 2.5 mg or 10 mg of omeprazole), in the form of enteric -coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer C, polysorbate, sugar spheres, talc, and triethyl citrate, and also inactive granules. The inactive granules are composed of the following ingredients: citric acid, crospovidone, dextrose, hydroxypropyl cellulose, iron oxide and xantham gum. The omeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric or direct gastric administration.
Additional adverse reactions that were reported with an incidence ≥ 1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).
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PRILOSEC is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults.
Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia ; vertigo.
Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision.
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).
PRILOSEC is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults.
The salt is slightly soluble (0.25 mg/mL) in water at 25°C, and it is soluble in methanol. Omeprazole magnesium is a white to off white powder with a melting point with degradation at 200°C. The half-life is highly pH dependent.
Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis.
PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults for up to 4 weeks.
The recommended adult oral dose is 40 mg once daily for 4-8 weeks.
PRILOSEC Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with PRILOSEC.
For patients who have difficulty swallowing capsules, the contents of a PRILOSEC Delayed-Release Capsule can be added to applesauce.
Co-administration of digoxin with PRILOSEC is expected to increase the systemic exposure of digoxin. Therefore, patients may need to be monitored when digoxin is taken concomitantly with PRILOSEC. Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in two subjects).
Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of PRILOSEC Delayed-Release Capsules.
If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered. The efficacy of PRILOSEC used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given.
In patients who fail therapy, susceptibility testing should be done. Among patients who fail therapy, PRILOSEC with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted, and the clarithromycin package insert, Microbiology section.
PRILOSEC is available as a delayed-release capsule or as a delayed-release oral suspension.
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.
PRILOSEC (omeprazole) Delayed-Release Capsules.
There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with omeprazole.
In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief. The recommended adult oral regimen is PRILOSEC 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days.
Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema Endocrine: Gynecomastia.
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 by 39% and 75% respectively for nelfinavir and M8. For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended. Following multiple doses of atazanavir (400 mg, daily) and omeprazole (40 mg, daily, 2 hr before atazanavir), AUC was decreased by 94%, C max by 96%, and Cmin by 95%.
Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with PRILOSEC. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
Controlled studies do not extend beyond 12 months.
For patients with a nasogastric or gastric tube in place:
Common side effects may include:
pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies and DOSAGE AND ADMINISTRATION ]. Eradication of H.
PRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:.
Call your doctor at once if you have:
Special Senses: Tinnitus, taste perversion.
The recommended adult oral starting dose is 60 mg once daily. The dosage of PRILOSEC in patients with pathological hypersecretory conditions varies with the individual patient. Some patients with Zollinger-Ellison syndrome have been treated continuously with PRILOSEC for more than 5 years. Daily dosages of greater than 80 mg should be administered in divided doses. Doses up to 120 mg three times daily have been administered. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.
The capsule shells have the following inactive ingredients: gelatin-NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD&C Blue #2, D&C Red #7 Calcium Lake, and, in addition, the 10 mg and 40 mg capsule shells also contain D&C Yellow #10. PRILOSEC is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate and other ingredients.
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. 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 clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.
Revised December 2014. AstraZeneca Pharmaceuticals LP Wilmington, DE 19850.
Metabolism and Nutritional disorders: Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain.
NDC unit of use bottles of 30 NDC bottles of 100.
PRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules.
PRILOSEC For Delayed-Release Oral Suspension should be administered as follows:
Controlled studies do not extend beyond 12 months. The recommended adult oral dose is 20 mg daily.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. Omeprazole has been reported to interact with some antiretroviral drugs. Other possible interaction mechanisms are via CYP2C19. The clinical importance and the mechanisms behind these interactions are not always known.
pylori in adults. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H.
Infections and Infestations: Clostridium difficile associated diarrhea.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule.
PRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on the body.
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. They are supplied as follows:.
The structural formula is:. Its empirical formula is C 17 H 19 N 3 O 3 S, with a molecular weight of 345.42. The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[ sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion.
pylori infection and duodenal ulcer disease to eradicate H. PRILOSEC in combination with clarithromycin is indicated for treatment of patients with H. pylori in adults.
Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Co-administration of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance.
(For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section.). Adverse reactions observed in controlled clinical trials using combination therapy with PRILOSEC and clarithromycin (n = 346) that differed from those previously described for PRILOSEC alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%).
The active ingredient in PRILOSEC (omeprazole magnesium) for Delayed-Release Oral Suspension, is 5-Methoxy-2-[sulfinyl]-1H-benzimidazole, magnesium salt (2:1).
Some patients may require an additional four weeks of therapy. The recommended adult oral dose of PRILOSEC is 20 mg once daily. Most patients heal within four weeks.
All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should be mixed with the applesauce and then swallowed immediay with a glass of cool water to ensure complete swallowing of the pellets. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened.
These polyps are benign and appear to be reversible when treatment is discontinued. Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely.
The safety data described below reflects exposure to PRILOSEC Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US 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 most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from PRILOSEC-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).
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 rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C.
The recommended adult oral regimen is PRILOSEC 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 additional 14 days of PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief.
Therefore, clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with PRILOSEC. Dose reduction of saquinavir should be considered from the safety perspective for individual patients. For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported, with an increase in AUC by 82%, in Cmax by 75%, and in Cmin by 106%, following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily co-administered days 11 to 15.
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 skin; hyperhidrosis.
PRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body.
PRILOSEC unit dose packets are supplied as follows:. PRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules.
PRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows:.
Some patients may require an additional four weeks of therapy. Most patients heal within four weeks. PRILOSEC is indicated for short-term treatment of active duodenal ulcer in adults.
Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture.
Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain.
The empirical formula for omeprazole magnesium is (C 17 H 18 N 3 O 3 S) 2 Mg, the molecular weight is 713.12 and the structural formula is:
Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below ); fever; pain; fatigue; malaise ;
Patient Weight Omeprazole Daily Dose 5 < 10 kg 5 mg 10 < 20 kg 10 mg ≥ 20 kg 20 mg.
PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis ) in adults.
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Patients should be informed that the PRILOSEC Delayed-Release Capsule should be swallowed whole.Prilosec