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Omeprazole DR

Class
Acid suppression agents
Subclass
Proton pump inhibitors
Generic name
Omeprazole magnesium DR
Brand names
Prilosec®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment
Duodenal ulcer • Active
•
20 mg PO daily for 4-8 weeks
Erosive esophagitis
•
20 mg PO daily for 4 to 8 weeks
Given before meals. Consider increasing the duration of treatment for additional 4 weeks if the patients do not respond to 8 weeks of treatment.
Erosive esophagitis • Maintenance therapy
•
20 mg PO daily
Given before meals.
Gastric ulcer • Active, benign
•
40 mg PO daily for 4-8 weeks
Given before meals.
H. pylori infection
•
20 mg PO BID for 10 days
Consider giving an additional 18 days of omeprazole delayed-release capsules 20 mg daily in patients with ulcer present at initiation of therapy.
Alternative
•
40 mg PO daily for 14 days
Consider giving an additional 14 days of omeprazole delayed-release capsules 20 mg daily in patients with ulcer present at initiation of therapy.
Pathological hypersecretory gastrointestinal conditions
•
60 mg PO daily
Prevention
Prevention of NSAID-induced peptic ulcer • Off-label
•
20-40 mg PO daily
Symptomatic relief
GERD
•
20 mg PO daily for 4 weeks
Heartburn • Off-label
•
20 mg PO daily for 14 days
Repeat 14-day treatment every 4 months.
Other off-label uses
•
Treatment of Barrett's esophagus
Indications for use
Labeled indications
Adults
•
Treatment of H. pylori infection
•
Treatment of duodenal ulcer (active)
•
Treatment of erosive esophagitis
•
Treatment of erosive esophagitis (maintenance therapy)
•
Treatment of gastric ulcer (active, benign)
•
Treatment of pathological hypersecretory gastrointestinal conditions
•
Symptomatic relief of GERD
Off-label indications
Adults
•
Treatment of Barrett's esophagus
•
Prevention of NSAID-induced peptic ulcer
•
Symptomatic relief of heartburn
Safety risks
Contraindications
Hypersensitivity to omeprazole or its components or other substituted benzimidazoles
In patients using rilpivirine-containing products.
Warnings and precautions
Bone fracture
•
Use caution in patients with risk factors for osteoporosis or osteopenia, or receiving high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
Gastric cancer, atrophic gastritis
•
Use caution in patients with long term PPI use.
Gastric polyps
•
Use caution in patients with prolonged use of PPI.
Hypomagnesemia
•
Use caution in patients with prolonged use of omeprazole.
Methotrexate toxicity
•
Use caution in patients with concomitant use of high dose PPIs with methotrexate.
Pseudomembranous colitis
•
Maintain a high level of suspicion especially amongst hospitalized patients.
Reactivation of SLE
•
Use caution in patients with a history of SLE.
Vitamin B12 deficiency
•
Use caution in patients with daily treatment with gastric acid-suppressing medication such as omeprazole over a long period of time (e.g., generally ≥ 2-3 years).
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Use with caution. Reduce dose. Consider dose reduction, particularly for maintenance of healing of erosive esophagitis to 10 mg daily, and 20 mg daily maximum for other indications.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Self-medication with omeprazole (OTC formulations) during pregnancy is not recommended.
•
Pregnant patients should see their health care professional for a proper diagnosis and for treatment recommendations.
Breastfeeding
Unlikely to have adverse effects in breastfed infants.
•
Acceptable for use during breastfeeding.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Common 1-10%
•
Gastroesophageal reflux disease, abdominal pain, asthenia, back pain, constipation, cough, diarrhea, dizziness, flatulence, headache, nausea, skin rash, vomiting, upper respiratory tract infections
Unknown frequency
•
Acute liver failure, abdominal swelling, acute pancreatitis, agitation, agranulocytosis, angioedema, anterior ischemic optic neuropathy, bone fracture, bradycardia, bronchospasm, Clostridioides difficile infection, cholestatic liver disease, ↓ WBC count, ↓ blood glucose, ↓ platelet count, ↓ serum magnesium, ↓ serum sodium, dry eye disease, erythema multiforme, esophageal candidiasis, gynecomastia, hemolytic anemia, hepatic encephalopathy, hyperhidrosis, irritable bowel syndrome, ↑ BP, ↑ WBC count, ↑ liver enzymes, ↑ serum CK, ↑ urine glucose, interstitial nephritis, interstitial nephritis, jaundice, microscopic colitis, optic atrophy, optic neuritis, peripheral edema, petechiae, photosensitivity of skin, purpura, rectal mucosal atrophy, aggressive behavior, anorexia, anxiety, apathy, blurred vision, change in taste, chest pain, confusion, depression, diplopia, dry mouth, fatigue, fever, hair loss, hallucination, hematuria, insomnia, itching, joint pain, leg pain, malaise, melena, muscle cramps, muscle weakness, myalgia, nervousness, nosebleed, paresthesia, somnolence, testicular pain, tinnitus, urinary frequency, vertigo, weight gain, skin dryness, Stevens-Johnson syndrome, stomatitis, tachycardia, toxic epidermal necrolysis, tremor, urinary tract infections, urticaria
Interactions
Drug(s)
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