omeprazole (Rx, OTC)

Brand and Other Names:Prilosec, Prilosec OTC, more...OmepraCare, OmepraCare DR
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

packet

  • 2.5mg
  • 10mg

suspension

  • 2mg/mL

tablet, delayed release

  • 20mg (Prilosec OTC, OmepraCare)

capsule, delayed release

  • 10mg (generic)
  • 20mg (OmepraCare DR, generic)
  • 40mg (generic)

oral disintegrating tablets

  • 20mg

Duodenal Ulcer

20 mg PO qDay for 4-8 weeks

Safety and efficacy of omeprazole for maintenance treatment past 1 year not established

Helicobacter Pylori Infection

Various regimens exist of PPIs combined with antibiotics, an example is listed below

20 mg PO q12hr for 10 days, WITH

Amoxicillin 1000 mg PO q12hr, AND

Clarithromycin 500 mg PO q12hr for 10-14 days

Dosing considerations

  • This regimen is available as a prepackaged 10-day supply of omeprazole, amoxicillin, and clarithromycin from Dava Pharms Inc, for eradication of H pylori

Gastric Ulcer

40 mg PO qDay for 4-8 weeks

GERD

20 mg PO qDay for 4 weeks

Erosive Esophagitis

20 mg PO qDay for 4-8 weeks

Maintenance: 20 mg PO qDay for up to 1 year

Hypersecretory Conditions (eg, Zollinger-Ellison Syndrome)

60 mg PO qDay (initial) up to 360 mg/day divided q8hr PO

If dose >80 mg, divide it

Dosage Modifications

Hepatic impairment: Not studied; expert analysis recommends a reduction in dose, especially for maintenance of healing of erosive esophagitis

Renal impairment: Dose adjustments not necessary

Dosage Forms & Strengths

packet

  • 2.5mg
  • 10mg

suspension

  • 2 mg/mL

tablet/capsule

  • 10mg (generic)
  • 20mg (OmepraCare DR, generic)
  • 40mg (generic)

oral disintegrating tablets

  • 20mg

GERD

Indicated for treatment of GERD

<1 year: Safety and efficacy not established

5-10 kg: 5 mg PO qDay

10-20 kg: 10 mg PO qDay

>20 kg: 20 mg PO qDay

Erosive Esophagitis

Indicated for treatment and to maintain healing of erosive esophagitis caused by acid-mediated GERD

Treatment

  • <1 month: Safety and efficacy not established
  • Aged 1 month to <1 year
    • 3 to <5 kg: 2.5 mg qDay
    • 5 to <10 kg: 5 mg qDay
    • ≥10 kg: 10 mg qDay
    • May treat for up to 6 weeks
  • Aged 1-16 years
    • 5 to <10 kg: 5 mg PO qDay
    • 10 to <20 kg: 10 mg PO qDay
    • ≥20 kg: 20 mg PO qDay
    • May treat for 4-8 weeks

Maintenance of healing

  • <1 year: Safety and efficacy not established
  • ≥1 year: Controlled trials for maintenance do not extend beyond 12 months

Neonates (Off-label)

Refractory duodenal ulcer or reflux esophagitis: 0.5-1.5 mg/kg PO qDay for up to 8 weeks  

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Interactions

Interaction Checker

and omeprazole

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Headache (7%)

            Abdominal pain (5%)

            Diarrhea (4%)

            Nausea (4%)

            Vomiting (3%)

            Flatulence (3%)

            Dizziness (2%)

            Upper respiratory infection (2%)

            Acid regurgitation (2%)

            Constipation (2%)

            Rash (2%)

            Cough (1%)

            Frequency Not Defined

            Fracture of bone, osteoporosis-related

            Hepatotoxicity (rare)

            Agranulocytosis

            Anorexia

            Gastric polyps

            Hip fracture

            Alopecia

            Atrophic gastritis

            Interstitial nephritis (rare)

            Pancreatitis (rare)

            Rhabdomyolysis

            Taste perversion

            Abnormal dreams

            Toxic epidermal necrolysis (rare)

            Postmarketing Reports

            Bone fracture

            Fundic gland polyps

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            Warnings

            Contraindications

            Hypersensitivity to omeprazole or other proton pump inhibitors (PPIs)

            Cautions

            PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

            May require dosage reduction with liver disease

            Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist

            Shown to cause gastric carcinoid tumors in rats with increased doses, but risk in humans unconfirmed

            Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 yr), high-dose therapy

            Hypomagnesemia may occur with prolonged use (>1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued

            Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

            Inhibits hepatic isoenzyme CYP2C19 and may alter metabolism of drugs that are CYP2C19 substrates

            PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

            Stop use and inform a healthcare professional if rash or joint pain develops

            Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin

            Acute interstitial nephritis has been observed in patients taking PPIs

            Relief of symptoms does not eliminate the possibility of a gastric malignancy

            Therapy increases risk of Salmonella, Campylobacter, and other infections

            May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered oncomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy therapy with high dose methotrexate administration

            PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated

            If patient taking a prescription drug, the patient should ask a doctor or a pharmacist whether acid reducers can be taken concomitantly with it

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)

            Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person); changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole; when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in offspring at any age

            Lactation

            Limited data suggest omeprazole may be present in human milk; there are no clinical data on effects of omeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in suppression of basal and stimulated acid secretion

            Absorption

            Bioavailability: 30-40%

            Onset of action: 1 hr (antisecretory effect)

            Duration: 73 hr

            Peak plasma time: 0.5-3.5 hr

            Peak response (PUD): 2 hr (initial); 5 days (peak)

            Distribution

            Protein bound: 95-96%

            Vd: 0.39 L/kg

            Metabolism

            Metabolized extensively by hepatic CYP2C19; slow metabolizers are deficient in CYP2C19 enzyme system; plasma concentration can increase by 5-fold or higher in comparison with that found in persons with the enzyme

            Metabolites: Hydroxyomeprazole, omeprazole sulfone, omeprazole sulfide (inactive)

            Enzymes inhibited: CYP2C19

            Elimination

            Half-life: 0.5-1 hr; increases to 3 hr with hepatic impairment

            Dialyzable: No

            Total body clearance: 500-600 mL/min

            Excretion: Urine (77%); feces (16-19%; mainly in bile)

            Pharmacogenomics

            CYP2C19 poor metabolizers

            • Asians have ~4-fold higher exposure to omeprazole than whites
            • CYP2C19, a polymorphic enzyme, is involved in the metabolism of omeprazole
            • ~15-20% of Asians are CYP2C19 poor metabolizers
            • Tests are available to identify a patient’s CYP2C19 genotype
            • Avoid use in Asian patients with unknown CYP2C19 genotype or those who are known to be poor metabolizers
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.