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INFOMATION:
Omeprazole (INN) /oʊˈmɛprəzoʊl/ (Prilosec and generics such as losepine) is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger–Ellison syndrome.
Medical uses
See also: Proton pump inhibitorOmeprazole can be used in the treatment of gastroesophageal reflux disease, peptic ulcers, erosive esophagitis, and Zollinger-Ellison syndrome.
Gastroesophageal reflux disease
Gastroesophageal reflux disease (GERD) is a chronic condition in which acidic stomach content leaks back into the esophagus and irritates it. It may cause heartburn, which is a painful burning feeling in the chest or throat.
Peptic ulcers
Peptic ulcers are sores that develop in the lining of either the stomach or the duodenum due to damage from stomach acid. The most common cause of a peptic ulcer is infection by Helicobacter pylori. Another major cause of a peptic ulcer is long term usage of nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or ibuprofen. Treatment of Helicobacter pylori infection can be completed by taking a triple therapy combination of omeprazole, amoxicillin, and clarithromycin for 7–14 days.
Erosive esophagitis
Erosive esophagitis is due to tissue damage to the lining of the esophagus, because of inflammation or irritation over time. It may be caused by acid reflux from GERD, infection by a virus or fungus, an autoimmune disorder, certain medications, or alcohol abuse.
Zollinger Ellison syndrome
Zollinger Ellison syndrome is a rare disorder that occurs when a tumor of the pancreas or duodenum releases a hormone that stimulates overproduction of stomach acid. This condition may form multiple peptic ulcers.
Adverse effects
The most frequent significant adverse effects occuring in at least 1% of patients include:
- Central nervous system: Headache (7%), dizziness (2%)
- Respiratory: Upper respiratory infection (2%), cough (1%)
- Gastrointestinal: Abdominal pain (5%), diarrhea (4%), nausea (4%), vomiting (3%), flatulence (3%), acid regurgitation (2%), constipation (2%)
- Neuromuscular & skeletal: Back pain (1%), weakness (1%)
- Dermatologic: Rash (2%)
There are other significant concerns related to adverse effects:
- Clostridium difficile associated diarrhea
- Increased risk of pneumonia
- Osteoporosis related fractures
- Hypomagnesemia
Concern has been expressed regarding vitamin B12 and iron malabsorption, but effects seem to be clinically insignificant, especially when supplement therapy is provided.
Since their introduction, proton pump inhibitors (especially omeprazole) have also been associated with several cases of acute interstitial nephritis, an inflammation of the kidneys that often occurs as an adverse drug reaction.
PPI use has also been associated with fundic gland polyps, whereas other authors have demonstrated a lack of association
Interactions
Omeprazole is a drug of the proton pump inhibitor (PPI) class. Although the potential for drug interactions is high, clinically important drug interactions are rare.
However, the most significant major drug interaction concern is the decreased activation of clopidogrel when taken together with omeprazole. Although still controversial, this may increase the risk of stroke or heart attack in people taking clopidogrel to prevent these events.
The mechanism that this potential interaction occurs is because omeprazole is an inhibitor of the enzymes CYP2C19 and CYP3A4. Clopidogrel is an inactive prodrug that partially depends on CYP2C19 for conversion to its active form. Inhibition of CYP2C19 may block the activation of clopidogrel, which could reduce its effects.
Almost all benzodiazepines are metabolised via the CYP3A4 and CYP2D6 pathway, and inhibition of these enzymes will result in a higher AUC (bloodlevels of the drug/compound). Other examples of drugs that are dependent on CYP3A4 for their metabolism are escitalopram, warfarin, oxycodone, tramadol, and oxymorphone. The concentrations of these drugs may increase if they are used concomitantly with omeprazole.
Omeprazole is also a competitive inhibitor of p-glycoprotein, as are other PPIs.
Drugs that depend on an acidic stomach environment (such as ketoconazole or atazanavir) may be poorly absorbed, whereas acid-labile antibiotics (such as erythromycin which is a very strong CYP3A4 inhibitor) may be absorbed to a greater extent than normal due to the more alkaline environment of the stomach.
St. John's wort, an MAO-inhibitor (Hypericum perforatum) and Gingko biloba significantly reduce plasma concentrations of omeprazole through induction of CYP3A4 and CYP2C19.
Pregnancy and breast-feeding
Epidemiological data do not show an increased risk of major birth defects after maternal use of omeprazole during pregnancy.
No clinical trials have deeply evaluated the potential consequences of the use of omeprazole in breastfeeding. However, the pharmacokietics of omeprazole molecule strongly suggest the safety of omeprazole use during breastfeeding:
- Omeprazole has a high plasma protein binding rate (95%), indicating that little amount of drug is transferred to the milk duct during breast milk formation.
- Omeprazole needs to be administrated in an enteric-coated formulation due to its rapid degradation in the acidic conditions of the stomach. This suggests that free molecules of omeprazole uptaken by the rapidly degraded in the acidic conditions of the stomach, that most of the molecules ingested by the infant are degraded before being absorbed.
The safety of omeprazole use in breastfeeding deduced from pharmacokinetic characteristics of the omeprazole molecule agree with a case report in which the presence of omeprazole in breast milk was analysed over 4 hours after omeprazole uptake. The study revealed that the peak omeprazole concentration in breast milk (that occurred 3h after omeprazole ingestion) was 7% of peak serum concentration, which corresponds to less than 1% of the usual adult dose (200 to 400 ug of omeprazole/Kg of body weight) for a 5 kg infant consuming 200 ml of breast milk per day.
Mechanism of action
Omeprazole is a selective and irreversible proton pump inhibitor. It suppresses stomach acid secretion by specific inhibition of the H +/K + ATPase system found at the secretory surface of gastric parietal cells. Because this enzyme system is regarded as the acid (proton, or H+) pump within the gastric mucosa, omeprazole will inhibit the final step of acid production.
Omeprazole will also inhibit both basal and stimulated acid secretion irrespective of the stimulus.
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