Prilosec: Package Insert and Label Information

PRILOSEC- omeprazole magnesium granule, delayed release
Covis Pharma

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.

Table 1: Recommended Dosage Regimen of PRILOSEC in Adults by Indication
Indication Dosage of PRILOSEC Treatment Duration
*
Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing
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.
Dosage reduction to 10 mg once daily is recommended for patients with hepatic impairment (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of healing of EE [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3, 12.5)].

Treatment of Active Duodenal Ulcer

20 mg once daily

4 weeks *

Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy

PRILOSEC 20 mg

Amoxicillin 1000 mg

Clarithromycin 500 mg

Take all three drugs twice daily

10 days

In patients with an ulcer present at the time of initiation of therapy, continue PRILOSEC 20 mg once daily for an additional 18 days for ulcer healing and symptom relief.

Dual Therapy

PRILOSEC 40 mg once daily

Clarithromycin 500 mg three times daily

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.

Active Benign Gastric Ulcer

40 mg once daily

4 to 8 weeks

Treatment of Symptomatic GERD

20 mg once daily

Up to 4 weeks

Treatment of EE due to Acid-Mediated GERD

20 mg once daily

4 to 8 weeks

Maintenance of Healing of EE due to Acid-Mediated GERD

20 mg once daily

Controlled studies do not extend beyond 12 months.

Pathological Hypersecretory Conditions

Starting dose is 60 mg once daily; adjust to patient needs

Daily dosages of greater than 80 mg should be administered in divided doses.

Dosages up to 120 mg three times daily have been administered.

As long as clinically indicated.

Some patients with Zollinger-Ellison syndrome have been treated continuously for more than 5 years.

2.2 Recommended Pediatric Dosage Regimen by Indication

Table 2 shows the recommended dosage of PRILOSEC in pediatric patients by indication.

Table 2: Recommended Dosage Regimen of PRILOSEC in Pediatric Patients by Indication
*
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.

Indication

PRILOSEC Dosage Regimen and Duration

Patient Age

Weight-Based Dose (mg)

Regimen and Duration

Treatment of Symptomatic GERD

1 to 16 years

5 to less than 10 kg: 5 mg

Once daily for up to 4 weeks

10 to less than 20 kg: 10 mg

20 kg and greater: 20 mg

Treatment of EE due to Acid-Mediated GERD

1 to 16 years

5 to less than 10 kg: 5 mg

Once daily for 4 to 8 weeks *

10 to less than 20 kg: 10 mg

20 kg and greater: 20 mg

1 month to less than 1 year

3 to less than 5 kg: 2.5 mg

Once daily up to 6 weeks

5 to less than 10 kg: 5 mg

10 kg and greater: 10 mg

Maintenance of Healing of EE due to Acid-Mediated GERD

1 to 16 years

5 to less than 10 kg: 5 mg

Once daily. Controlled studies do not extend beyond 12 months

10 to less than 20 kg: 10 mg

20 kg and greater: 20 mg

2.3 Administration Instructions

PRILOSEC is intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube.
Take PRILOSEC before meals.
Antacids may be used concomitantly with PRILOSEC.
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.

Oral Administration in Water

1.
Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
2.
Empty the contents of a 10 mg packet into a container containing 15 mL of water.
3.
Stir.
4.
Leave 2 to 3 minutes to thicken.
5.
Stir and drink within 30 minutes.
6.
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)

1.
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.
2.
Immediately shake the syringe and leave 2 to 3 minutes to thicken.
3.
Shake the syringe and inject through the nasogastric or gastric tube into the stomach within 30 minutes.
4.
Refill the syringe with an equal amount of water.
5.
Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

3 DOSAGE FORMS AND STRENGTHS

PRILOSEC For Delayed-Release Oral Suspension: 2.5 mg and 10 mg omeprazole in unit dose packets containing a fine yellow powder, consisting of white to brownish omeprazole magnesium granules and pale yellow inactive granules.

4 CONTRAINDICATIONS

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 (5.2), Adverse Reactions (6)].
Proton pump inhibitors (PPIs), including PRILOSEC, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].
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

In adults, symptomatic response to therapy with PRILOSEC does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2 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)].

5.3 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.

5.4 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)].

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