PRILOSEC Granule for delayed-release oral suspension (2020)

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Covis Pharma

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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 ...

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: ...

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 ...

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 ...

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 ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated ...

6.3. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of omeprazole. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Table 3 and Table 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing ...

8. Use in Specific Populations

8.7 Asian Population In studies of healthy subjects, Asians had approximately a four-fold higher exposure than Caucasians. Dosage reduction of PRILOSEC to 10 mg once daily is recommended for Asian patients ...

8.1. Pregnancy

Risk Summary There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or ...

8.2. Lactation

Risk Summary Limited data suggest omeprazole may be present in human milk. There are no clinical data on the effects of omeprazole on the breastfed infant or on milk production. The developmental and health ...

8.4. Pediatric Use

The safety and effectiveness of PRILOSEC have been established in pediatric patients 1 to 16 years for the treatment of symptomatic GERD, treatment of EE due to acid-mediated GERD, and maintenance of healing ...

8.5. 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 safety and effectiveness between the elderly and ...

8.6. Hepatic Impairment

In patients with hepatic impairment (Child-Pugh Class A, B, or C) exposure to omeprazole substantially increased compared to healthy subjects. Dosage reduction of PRILOSEC to 10 mg once daily is recommended ...

10. Overdosage

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, ...

11. Description

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]-1H-benzimidazole, magnesium ...

12.1. Mechanism of Action

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory ...

12.2. Pharmacodynamics

Antisecretory Activity After oral administration, the onset of the antisecretory effect of omeprazole occurs within one hour, with the maximum effect occurring within two hours. Inhibition of secretion ...

12.3. Pharmacokinetics

Absorption PRILOSEC for delayed-release oral suspension contains omeprazole magnesium granules and inactive granules to be administered in water. Absorption of omeprazole begins only after the gastro-resistant ...

12.4. Microbiology

Omeprazole and clarithromycin dual therapy and omeprazole, clarithromycin and amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in ...

12.5. Pharmacogenomics

CYP2C19, a polymorphic enzyme, is involved in the metabolism of omeprazole. The CYP2C19*1 allele is fully functional while the CYP2C19*2 and *3 alleles are nonfunctional. There are other alleles associated ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

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 ...

14. Clinical Studies

14.1 Active Duodenal Ulcer In a multicenter, double-blind, placebo-controlled study of 147 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per protocol) at 2 ...

15. References

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition. CLSI Document ...

16.1. How Supplied

PRILOSEC (omeprazole magnesium) for delayed-release oral suspension, 2.5 mg or 10 mg omeprazole, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole ...

16.2. Storage and Handling

Store PRILOSEC for delayed-release oral suspension at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patients healthcare ...