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Omeprazole Magnesium (Prilosec)

Trade Name : PRILOSEC

AstraZeneca Pharmaceuticals LP

GRANULE, DELAYED RELEASE

Strength 10 mg/1

OMEPRAZOLE MAGNESIUM Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Omeprazole Magnesium (Prilosec) which is also known as PRILOSEC and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 10 mg/1 per ml. Read more

Omeprazole Magnesium (Prilosec) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • PRILOSEC is a proton pump inhibitor (PPI) indicated for the:
  • Eradication of Helicobacter pylori
  • * if ulcer present, continue PRILOSEC 20 mg once daily for an additional 18 days.
  • ** if ulcer present, continue PRILOSEC 20 mg once daily for an additional 14 days.
  • *** an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered.
  • **** studied for 12 months. Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child-Pugh Class A, B, or C) and Asian patients , .
  • PRILOSEC Delayed-Release Capsules
  • PRILOSEC For Delayed-Release Oral Suspension
  • No data
  • (4,n- 7)
  • No data
  • Gastric Malignancy
  • Acute Interstitial Nephritis
  • Arrayn- Clostridium difficile
  • Bone Fracture
  • Cutaneous and Systemic Lupus Erythematosus
  • Interaction with Clopidogrel
  • Cyanocobalamin (Vitamin B-12) Deficiency
  • Hypomagnesemia
  • Interaction with St. Johnu2019s Wort or Rifampin:
  • Interactions with Diagnostic Investigations for Neuroendocrine Tumors:
  • Interaction with Methotrexate
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • Adults: Most common adverse reactions in adults (incidence u22652%) are
  • Pediatric patients (1 to 16 years of age):
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or .
  • Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PRILOSEC and instructions for preventing or managing them.
  • Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
  • See full prescribing information for a list of clinically important drug interactions. n
  • No data
  • Reports have been received of overdosage with omeprazole in humans. Doses ranged up 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 similar to those seen in normal clinical experience . Symptoms were transient, and no serious clinical outcome has been reported when PRILOSEC was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
  • If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
  • The active ingredient in PRILOSEC (omeprazole) delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is CHNOS, with a molecular weight of 345.42. The structural formula is:
  • Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155u00b0C. 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.
  • The active ingredient in PRILOSEC (omeprazole magnesium) for delayed-release oral suspension, is 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole, magnesium salt (2:1).
  • Omeprazole magnesium is a white to off white powder with a melting point with degradation at 200u00b0C. The salt is slightly soluble (0.25 mg/mL) in water at 25u00b0C, and it is soluble in methanol. The half-life is highly pH dependent.
  • The empirical formula for omeprazole magnesium is (CHNOS) Mg, the molecular weight is 713.12 and the structural formula is:
  • 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 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.
  • 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 xanthan 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.
  • No data
  • In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (about 0.4 to 34 times a human dose of 40 mg/day, as expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female 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 13.8 mg omeprazole/kg/day (about 3.4 times a human dose of 40 mg/day, based on body surface area) for one year, and then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of one year (94% treated vs. 10% controls). By the second year the difference between treated and control rats was much smaller (46% vs. 26%) but still 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 only one tumor is difficult to interpret. 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, 2, and 16 mg/kg/day (about 0.1 to 3.9 times the human dose of 40 mg/day, based on a body surface area basis). No astrocytomas were observed in female rats in this study. In a 2-year carcinogenicity study in Sprague-Dawley rats, no astrocytomas were found in males or females at the high dose of 140.8 mg/kg/day (about 34 times the human dose of 40 mg/day on a body surface area basis). A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53 (+/-) transgenic mouse carcinogenicity study was not positive.
  • Omeprazole was positive for clastogenic effects in an human lymphocyte chromosomal aberration assay, in one of two mouse micronucleus tests, and in an bone marrow cell chromosomal aberration assay. Omeprazole was negative in the Ames test, an mouse lymphoma cell forward mutation assay, and an rat liver DNA damage assay.
  • Omeprazole at oral doses up to 138 mg/kg/day in rats (about 34 times an oral human dose of 40 mg on a body surface area basis) was found to have no effect on fertility and reproductive performance.
  • In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals . Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H-receptor antagonists.
  • No data
  • 1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standardu2014Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.
  • 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:
  • NDC
  • 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:
  • NDC
  • NDC
  • 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:
  • NDC
  • NDC
  • 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 unit dose packets are supplied as follows:
  • NDC 0186-0625u201301 unit dose packages of 30: 2.5 mg packets
  • NDC 0186-0610u201301 unit dose packages of 30: 10 mg packets
  • Storage
  • Store PRILOSEC delayed-release capsules in a tight container protected from light and moisture. Store between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F).
  • Store PRILOSEC for delayed-release oral suspension at 25u00b0C (77u00b0F); excursions permitted to 15 u2013 30u00b0C (59 u2013 86u00b0F). [See USP Controlled Room Temperature.]
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • Adverse Reactions
  • Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
  • Drug Interactions
  • Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. Johnu2019s Wort or rifampin; or, if they take high-dose methotrexate n n .
  • Administration
  • PRILOSEC Delayed-Release Capsules
  • PRILOSEC For Delayed-Release Oral Suspension
  • PRILOSEC is a trademark of the AstraZeneca group of companies.
  • Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
  • u00a9AstraZeneca 2016
  • PRILOSEC (pry-lo-sec)
  • (omeprazole)
  • delayed-release capsules
  • PRILOSEC (pry-lo-sec)
  • (omeprazole magnesium)
  • for delayed-release oral suspension
  • Read this Medication Guide before you start taking PRILOSEC 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 PRILOSEC?
  • PRILOSEC may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
  • PRILOSEC can cause serious side effects, including:
  • PRILOSEC can have other serious side effects. Seen
  • What is PRILOSEC?
  • PRILOSEC is a prescription medicine called a proton pump inhibitor (PPI). PRILOSEC reduces the amount of acid in your stomach.
  • PRILOSEC is used in adults:
  • For children 1 to 16 years of age, PRILOSEC is used:
  • For children 1 month to less than 12 months (1 year) of age, PRILOSEC is used:
  • Who should not take PRILOSEC?
  • Do not take PRILOSEC if you:
  • What should I tell my doctor before taking PRILOSEC?
  • Before taking PRILOSEC, tell your doctor about all of your medical conditions, including if you:
  • Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take PRILOSEC?
  • PRILOSEC Delayed-Release Capsules
  • PRILOSEC For Delayed-Release Oral Suspension
  • If you miss a dose of PRILOSEC, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.
  • If you take too much PRILOSEC, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.
  • Array
  • What are the possible side effects of PRILOSEC?
  • PRILOSEC can cause serious side effects, including:
  • You may or may not have symptoms of low magnesium. n
  • Your doctor may check the level of magnesium in your body before you start taking PRILOSEC or during treatment if you will be taking PRILOSEC for a long period of time.
  • The most common side effects with PRILOSEC in adults and children include:
  • In addition to the side effects listed above, the most common side effects in children 1 to 16 years of age include:
  • Other side effects:
  • Serious allergic reactions.
  • Your doctor may stop PRILOSEC if these symptoms happen. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects with PRILOSEC. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088n
  • How should I store PRILOSEC?
  • Keep PRILOSEC and all medicines out of the reach of children.
  • General information about the safe and effective use of PRILOSEC.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PRILOSEC for a condition for which it was not prescribed. Do not give PRILOSEC to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about PRILOSEC. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.
  • What are the ingredients in PRILOSEC?
  • Active ingredient in PRILOSEC Delayed-Release Capsules:
  • Inactive ingredients in PRILOSEC Delayed-Release Capsules:
  • Active ingredient in PRILOSEC For Delayed-Release Oral Suspension:
  • Inactive ingredients in PRILOSEC For Delayed-Release Oral Suspension:
  • Inactive granules in PRILOSEC For Delayed-Release Oral Suspension:
  • Manufactured by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
  • PRILOSEC is a trademark of the AstraZeneca group of companies. u00a92016 AstraZeneca Pharmaceuticals LP. All rights reserved.
  • For more information, go to www.astrazeneca-us.com or call 1-800-236-9933n
  • INSTRUCTIONS FOR USE
  • PRILOSECn- (pry-lo-sec)
  • (omeprazole)
  • delayed-release capsules
  • PRILOSECn- (pry-lo-sec)
  • (omeprazole magnesium)
  • for delayed-release oral suspension
  • PRILOSEC delayed-release capsules (PRILOSEC Capsules)
  • Taking PRILOSEC Capsules with applesauce:
  • PRILOSEC for delayed-release suspension (PRILOSEC Suspension)
  • Taking PRILOSEC Suspension:
  • Giving PRILOSEC Suspension with water through a nasogastric tube (NG tube) or gastric tube:
  • For people who have an NG tube or gastric tube that is , PRILOSEC may be given as follows:
  • NDC 0186-0606-31
  • PRILOSECn
  • (omeprazole)
  • 30 Delayed-Release Capsules
  • 10 mg
  • Dispense the accompanying Medication Guide to each patient.
  • Rx only
  • AstraZeneca
  • NDC 0186-0742-31
  • PRILOSECn
  • (omeprazole)
  • 30 Delayed-Release Capsules
  • 20 mg
  • Dispense the accompanying Medication Guide to each patient.
  • Rx only
  • AstraZeneca
  • NDC 0186-0743-31
  • PRILOSECn
  • (omeprazole)
  • 30 Delayed-Release Capsules
  • 40 mg
  • Dispense the accompanying Medication Guide to each patient.
  • Rx only
  • AstraZeneca
  • NDC 0186-0625-01
  • PRILOSECn
  • (omeprazole magnesium)
  • For Delayed-Release Oral Suspension
  • 2.5 mg
  • This packet contains 2.8 mg of omeprazole magnesium which is equivalent
  • to 2.5 mg of omeprazole as delayed-release granules.
  • Dispense the enclosed Medication Guide to each patient.
  • Rx only
  • Mfd for: AstraZeneca LP, Wilmington, DE 19850
  • By: AstraZeneca AB, Sodertalje, Sweden
  • Product of Sweden
  • AstraZeneca
  • NDC 0186-0610-01
  • PRILOSECn
  • (omeprazole magnesium)
  • For Delayed-Release Oral Suspension
  • 10 mg
  • This packet contains 11.2 mg of omeprazole magnesium which is equivalent
  • to 10 mg of omeprazole as delayed-release granules.
  • Dispense the enclosed Medication Guide to each patient.
  • Rx only
  • Mfd for: AstraZeneca LP, Wilmington, DE 19850
  • By: AstraZeneca AB, Sodertalje, Sweden
  • Product of Sweden
  • AstraZeneca

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