Classes
DEA Class; Rx, OTC
Common Brand Names; Prilosec, Prilosec OTC, OmepraCare, OmepraCare DR
- Proton Pump Inhibitors
Description
Oral proton pump inhibitor (PPI), gastric antisecretory agent.
Used for GERD, erosive esophagitis, and hypersecretory conditions; also used in antimicrobial combination regimens for H. pylori eradication.
Available OTC for heartburn.
Indications
Indicated for the short-term, self-treatment of frequent dyspepsia or pyrosis (heartburn) that occurs 2 or more times per week.
Contraindications
Hypersensitivity to omeprazole or other proton pump inhibitors (PPIs)
Adverse Effects
- 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%)
- 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)
Warnings
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 concomitantly 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
Therapy may cause severe skin reactions, including skin reddening, blisters, rash; if an allergic reaction occurs, stop use and seek medical help right away
Pregnancy and Lactation
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
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
Maximum Dosage
40 mg/day PO for most indications; however, doses up to 160 mg/day have been used off-label for H. pylori eradication; up to 360 mg/day PO for Zollinger-Ellison syndrome.
40 mg/day PO for most indications; however, doses up to 160 mg/day have been used off-label for H. pylori eradication; up to 360 mg/day PO for Zollinger-Ellison syndrome.
40 mg/day PO is FDA-approved maximum; however, doses up to 80 mg/day have been used off-label.
20 kg or more: 20 mg/day PO is FDA-approved maximum; however, doses up to 80 mg/day have been used off-label.
10 to 19 kg: 10 mg/day PO is FDA-approved maximum; however, doses up to 3.3 mg/kg/day (Max: 40 mg/day) have been used off-label.
5 to 9 kg: 5 mg/day PO is FDA-approved maximum; however, doses up to 3.3 mg/kg/day have been used off-label.
10 kg or more: 10 mg/day PO is FDA-approved maximum; however, doses up to 40 mg/day have been used off-label.
5 to 9 kg: 5 mg/day PO is FDA-approved maximum; however, doses up to 1.5 mg/kg/day have been used off-label.
3 to 4 kg: 2.5 mg/day PO is FDA-approved maximum; however, doses up to 1.5 mg/kg/day have been used off-label.
Safety and efficacy have not been established; however, 0.7 mg/kg/day PO has been used off-label for GERD. Single doses up to 1.5 mg/kg/day PO have been studied in a pharmacokinetic trial.
How supplied
Omeprazole
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
