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PRILOSEC(omeprazole magnesium) for delayed-release oral suspension
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PRILOSEC safely and effectively. See full prescribing information for PRILOSEC.
PRILOSEC ® (omeprazole) delayed-release capsules
PRILOSEC ® (omeprazole magnesium) for delayed-release oral suspension
Initial U.S. Approval: 1989
RECENT MAJOR CHANGES
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Indications and Usage, Treatment of Erosive Esophagitis (EE) due to Acid-Mediated GERD (1.5)
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02/2016
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Dosage and Administration, Recommended Pediatric Dosage Regimen by Indication (2.2)
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02/2016
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Contraindications (4)
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02/2016
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INDICATIONS AND USAGE
PRILOSEC is a proton pump inhibitor (PPI) indicated for the:
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Treatment of active duodenal ulcer in adults (1.1)
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Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2)
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Treatment of active benign gastric ulcer in adults (1.3)
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Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4)
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Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older (1.5)
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Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6)
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Pathologic hypersecretory conditions in adults (1.7)
DOSAGE AND ADMINISTRATION
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Indication
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Recommended Adult (2.1) and Pediatric Dosage (2.2)
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Treatment of Active Duodenal Ulcer
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20 mg once daily for 4 weeks; some patients may require an additional 4 weeks (2.1)
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H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
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Triple Therapy:
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PRILOSEC
Amoxicillin
Clarithromycin
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20 mg
1000 mg
500 mg
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Each drug twice daily for 10 days (2.1)*
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Dual Therapy:
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PRILOSEC
Clarithromycin
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40 mg once daily for 14 days**
500 mg three times daily for 14 days (2.1)
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Active Benign Gastric Ulcer
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40 mg once daily for 4 to 8 weeks (2.1)
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Symptomatic GERD
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20 mg once daily for up to 4 weeks (2.1)
See full prescribing information for weight based dosing in pediatric patients 1 year of age and older (2.2)
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EE due to Acid-Mediated GERD
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20 mg once daily for 4 to 8 weeks (2.1)***
See full prescribing information for weight based dosing in pediatric patients 1 month of age and older (2.2)
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Maintenance of Healing of EE due to Acid-Mediated GERD
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20 mg once daily (2.1)****
See full prescribing information for weight based dosing in pediatric patients 1 year of age and older (2.2)
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Pathological Hypersecretory Conditions
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Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated (2.1)
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* 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 (8.6, 8.7).
DOSAGE FORMS AND STRENGTHS
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PRILOSEC delayed-release capsules: 10 mg, 20 mg and 40 mg (3)
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PRILOSEC for delayed-release oral suspension: 2.5 mg and 10 mg unit dose packets (3)
CONTRAINDICATIONS
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Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. (4)
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Patients receiving rilpivirine-containing products. (4, 7)
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Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with PRILOSEC. (4)
WARNINGS AND PRECAUTIONS
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Gastric Malignancy: Symptomatic response does not preclude the presence of gastric malignancy. (5.1)
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Atrophic Gastritis: Noted with long-term therapy. (5.2)
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Acute Interstitial Nephritis: Observed in patients taking PPIs. (5.3)
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Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.4)
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Clostridium difficile Associated Diarrhea: PPI therapy may be associated with increased risk. (5.5)
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Interaction with Clopidogrel: Avoid concomitant use of PRILOSEC. (5.6, 7)
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Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.7)
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Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. (5.8)
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Interaction with St. John’s Wort or Rifampin: Avoid concomitant use of PRILOSEC. (5.9, 7)
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Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop PRILOSEC at least 14 days before assessing CgA levels. (5.10, 7)
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Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of PRILOSEC (5.11, 7).
ADVERSE REACTIONS
Adults: Most common adverse reactions in adults (incidence ≥2%) are
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Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence (6)
Pediatric patients (1 to 16 years of age):
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Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. (8.4)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
See full prescribing information for a list of clinically important drug interactions. (7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 2/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
PRILOSEC is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Dual Therapy
PRILOSEC in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Among patients who fail therapy, PRILOSEC with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the clarithromycin prescribing information, Microbiology section.]
1.3 Treatment of Active Benign Gastric Ulcer
PRILOSEC is indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 1 year of age and older.
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Pediatric Patients 1 Year of Age to Adults
PRILOSEC is indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 1 year of age and older.
The efficacy of PRILOSEC used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of PRILOSEC may be considered.
Pediatric Patients 1 Month to Less than 1 Year of Age
PRILOSEC is indicated for the short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD
PRILOSEC is indicated for the maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older.
Controlled studies do not extend beyond 12 months.
1.7 Pathological Hypersecretory Conditions
PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage Regimen by Indication
Table 1 shows the recommended dosage of PRILOSEC in adult patients by indication.
2.2 Recommended Pediatric Dosage Regimen by Indication
Table 2 shows the recommended dosage of PRILOSEC in pediatric patients by indication.
2.3 Administration Instructions
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Take PRILOSEC before meals.
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Antacids may be used concomitantly with PRILOSEC.
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Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
PRILOSEC Delayed-Release Capsules
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Swallow PRILOSEC delayed-release capsules whole; do not chew.
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For patients unable to swallow an intact capsule, PRILOSEC delayed-release capsules can be opened and administered as follows:
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Place one tablespoon of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
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Open the capsule.
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Carefully empty all of the pellets inside the capsule on the applesauce.
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Mix the pellets with the applesauce.
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Swallow applesauce and pellets immediately with a glass of cool water to ensure complete swallowing of the pellets. Do not chew or crush the pellets. Do not save the applesauce and pellets for future use.
PRILOSEC For Delayed-Release Oral Suspension
PRILOSEC for delayed-release oral suspension is intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube.
Oral Administration in Water
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Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
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Empty the contents of a 10 mg packet into a container containing 15 mL of water.
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Stir
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Leave 2 to 3 minutes to thicken.
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Stir and drink within 30 minutes.
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If any material remains after drinking, add more water, stir and drink immediately.
Administration with Water via a NG or Gastric Tube (Size 6 or Larger)
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Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering through a nasogastric tube or gastric tube.
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Immediately shake the syringe and leave 2 to 3 minutes to thicken.
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Shake the syringe and inject through the nasogastric or gastric tube into the stomach within 30 minutes.
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Refill the syringe with an equal amount of water.
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Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach
3 DOSAGE FORMS AND STRENGTHS
PRILOSEC Delayed-Release Capsules
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10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body.
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20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on the body.
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40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body.
PRILOSEC For Delayed-Release Oral Suspension
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2.5 mg and 10 mg unit dose packets containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules.
4 CONTRAINDICATIONS
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PRILOSEC is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [see Warnings and Precautions (5.3), Adverse Reactions (6)].
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Proton pump inhibitors (PPIs), including PRILOSEC, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].
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For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PRILOSEC, refer to the CONTRAINDICATIONS section of their package inserts.
5 WARNINGS AND PRECAUTIONS
5.1 Presence of Gastric Malignancy
Symptomatic response to therapy with PRILOSEC does not preclude the presence of gastric malignancy.
5.2 Atrophic Gastritis
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with PRILOSEC.
5.3 Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including PRILOSEC. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue PRILOSEC if acute interstitial nephritis develops [see Contraindications (4)].
5.4 Cyanocobalamin (Vitamin B-12) Deficiency
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with PRILOSEC.
5.5 Clostridium difficile Associated Diarrhea
Published observational studies suggest that PPI therapy like PRILOSEC may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with PRILOSEC, refer to Warnings and Precautions sections of the corresponding prescribing information.
5.6 Interaction with Clopidogrel
Avoid concomitant use of PRILOSEC with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using PRILOSEC, consider alternative anti-platelet therapy [see Drug Interactions (7) andClinical Pharmacology (12.3)].
5.7 Bone Fracture
Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2.1), Adverse Reactions (6.3)].
5.8 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, |
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