Proton Pump Inhibitor
Short-term (4-8 weeks) treatment of severe erosive esophagitis (grade 2 or
above), diagnosed by endoscopy and short-term treatment of symptomatic
gastroesophageal reflux disease (GERD) poorly responsive to customary medical
treatment; treatment of heartburn and other symptoms associated with GERD;
pathological hypersecretory conditions; peptic ulcer disease; gastric ulcer
therapy; maintenance of healing of erosive esophagitis; approved for combination
use in the eradication of H. pylori in patients with active duodenal
Clinical effects on the fetus: Crosses the placenta
Breast-feeding/lactation: No data available. American Academy of Pediatrics
makes NO RECOMMENDATION.
Known hypersensitivity to omeprazole
In long-term (2-year) studies in rats, omeprazole produced a dose-related
increase in gastric carcinoid tumors. While available endoscopic evaluations and
histologic examinations of biopsy specimens from human stomachs have not
detected a risk from short-term exposure to omeprazole, further human data on
the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule
out the possibility of an increased risk for the development of tumors in humans
receiving long-term therapy. Bioavailability may be increased in the
1% to 10%:
Central nervous system: Headache (6.9%), dizziness (1.5%)
Dermatologic: Rash (1.5%)
Gastrointestinal: Diarrhea (3%), abdominal pain (2.4%), nausea (2.2%),
vomiting (1.5%), constipation (1.1%), taste perversion (<1% to 15%)
Neuromuscular & skeletal: Weakness (1.1%), back pain (1.1%)
Respiratory: Upper respiratory infection (1.9%), cough (1.1%)
<1%: Fever, pain, fatigue, malaise, abdominal swelling, angina,
tachycardia, bradycardia, palpitation, hypertension, peripheral edema,
pancreatitis, anorexia, irritable colon, flatulence, fecal discoloration,
esophageal candidiasis, mucosal atrophy (tongue), dry mouth, benign gastric
polyps, gastroduodenal carcinoids, elevated serum transaminases, jaundice,
increased serum alkaline phosphatase, liver disease (hepatocellular,
cholestatic, mixed), hepatic necrosis, hepatic failure, hepatic encephalopathy,
hyponatremia, hypoglycemia, weight gain, muscle cramps, myalgia, muscle
weakness, joint pain, leg pain, psychic disturbance, depression, aggression,
hallucinations, confusion, insomnia, nervousness, tremor, apathy, somnolence,
anxiety, abnormal dreams, vertigo, paresthesia, hemifacial dysesthesia,
epistaxis, pharyngeal pain, toxic epidermal necrolysis, Stevens-Johnson
syndrome, erythema multiforme, skin inflammation, urticaria, angioedema,
pruritus, alopecia, dry skin, increased sweating, tinnitus, interstitial
nephritis, urinary tract infection, microscopic pyuria, urinary frequency,
elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain,
gynecomastia, pancytopenia, agranulocytosis, thrombocytopenia, neutropenia,
anemia, leukocytosis, hemolytic anemia
Symptoms of overdose include hypothermia, sedation, convulsions, decreased
respiratory rate demonstrated in animals only
Treatment is supportive; not dialyzable
CYP2C8, 2C9, 2C18, 2C19, and 3A3/4 enzyme substrate; CYP1A2 enzyme inducer;
CYP2C19, 2C8, 2C9, and 2C19 enzyme inhibitor, CYP3A3/4 enzyme inhibitor (weak)
Increased toxicity: Diazepam may increase half-life; increased digoxin,
increased phenytoin, increased warfarin
Omeprazole stability is a function of pH; it is rapidly degraded in acidic
media, but has acceptable stability under alkaline conditions.
Prilosec™ is supplied as capsules for oral
administration; each capsule contains omeprazole in the form of enteric coated
granules to inhibit omeprazole degradation by gastric
Suppresses gastric acid secretion by inhibiting the parietal cell H+/K+ ATP
Onset of antisecretory action: Oral: Within 1 hour
Peak effect: 2 hours
Duration: 72 hours
Protein binding: 95%
Metabolism: Extensive in the liver
Half-life: 0.5-1 hour
GERD or erosive esophagitis: 20 mg/day for 4-8 weeks
Pathological hypersecretory conditions: 60 mg once daily to start; doses up
to 120 mg 3 times/day have been administered; administer daily doses >80 mg
in divided doses
Helicobacter pylori: Combination therapy with bismuth subsalicylate,
tetracycline, and clarithromycin; or with clarithromycin alone. Adult dose:
Oral: 20 mg twice daily
Gastric ulcers: 40 mg/day for 4-8 weeks
Food delays absorption, administer on an empty stomach
Omeprazole has been administered via a nasogastric (NG) tube for the
prevention of stress-related mucosal damage in ventilated, critically ill
patients. The contents of one or two 20 mg omeprazole capsules were poured into
a syringe; 10-20 mL of an 8.4% sodium bicarbonate solution was withdrawn in the
syringe; 30 minutes were allowed for the enteric-coated omeprazole granules to
break down. The resulting milky substance was shaken prior to administration.
The NG tube was then flushed with 5-10 mL of water then clamped for at least 1
hour. Patients received omeprazole 40 mg once, then 40 mg 6-8 hours later, then
20 mg once daily using this technique.
The manufacturer makes no judgment regarding the safety or efficacy of these
|Mental Health: Effects
on Mental Status|
May cause dizziness; may rarely cause sedation
Effects on Psychiatric
May inhibit the metabolism of diazepam; monitor for increased
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
No effects or complications reported
Take as directed, before eating. Do not crush or chew capsules. You may
experience anorexia; small frequent meals may help to maintain adequate
nutrition. Report changes in urination or pain on urination, unresolved severe
diarrhea, testicular pain, or changes in respiratory status.
Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend
to be pregnant. Discontinue breast-feeding prior to starting this
Capsule should be swallowed whole; not chewed, crushed, or
Capsule, delayed release: 10 mg, 20 mg, 40 mg
Andersson T, "Omeprazole Drug Interaction Studies," Clin
Pharmacokinet, 1991, 21(3):195-212.
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"Efficacy and Safety of Omeprazole for Severe Gastroesophageal Reflux in Children,"
J Pediatr, 1993, 123(1):148-54.
Kane DL, "Administration of Omeprazole (Prilosec®) in
the Atypical Patient," Int J Pharm Compounding, 1997, 1(1):13.
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