The information provided below corresponds to the official product information from Patient Information Leaflet provided by the manufacturer.
The text does not contain any of medical advices, mode of administration and prescription plans.
Before beginning any treatment, we kindly advise you to consult your healthcare provider.
Active ingredient: Omeprazole
Omeprazole is a prescription medication that belongs to a group of "stomach" medications called proton pump inhibitors; it is a potent antisecretory and antiulcer remedy. Omeprazole comes in the form of capsules 20mg and 10mg and it is used to treat gastric and duodenal ulcers, reflux esophagitis, NSAID - gasrtoenteropathy, conditions associated by hypesecretion of stomach acid. Omeprazole 20mg is used in combination with antibiotics (amoxicillin, clarithromycin) to treat Helicobacter pylori infections. It is made by many pharmaceutical companies like GSK, Cipla, Ranbaxy and other. It is available as brand (Prilosec) and generic medication.
Omeprazole is an antiulcer agent, inhibitor of proton pump inhibitor - the enzyme called - H +-K +-ATPase. Antisecretory action mechanism of omeprazole is associated with inhibition of H +-K +-ATPase in gastric parietal cells. This results in blockage of the final stage of hydrochloric acid formation. Omeprazole is converted into an active form in the intracellular tubules of parietal cells, where it inhibits H +-K +-ATPase, located in the apical membrane of secretory cells. Omeprazole 20mg reduces basal and stimulated secretion of hydrochloric acid regardless of the nature of the stimuli.
Omeprazole possesses high lipophilicity, easily penetrates the parietal cells. Therapeutic effect of omeprazole occurs quickly and is dose-dependent. Antisecretory effect after oral administration of 20mg omeprazole occurs within the first hour, maximum in 2 hours. In high level of PH in the stomach, the neutralization of ammonium (produced by Helicobacter Pylori) is not possible. As a result accumulation of ammonium becomes toxic for the microorganism.
Omeprazole is rapidly absorbed from the gastrointestinal tract. Maximum concentration is achieved after 0.5-1 hour. Bioavailability is 30-40%. Plasma protein binding is 90-95%. Omeprazole 20mg is almost completely metabolized in the liver and it excreted with urine by kidney in the form of metabolites.
Omeprazole is indicated for the treatment of the following conditions:
- Gastric and duodenal ulcer, including resistant to treatment by other antiulcer drugs;
- Gastro-oesophageal reflux, reflux esophagitis (erosive and ulcerative), including resistant to therapy of H2-antihistamines;
- NSAID-gastroenteropathy, erosive and ulcerative lesions of gastric and duodenal ulcers associated with NSAIDs use (nonsteroidal anti-inflammatory drugs);
- Duodenal and gastric ulcer developing in HIV-infected patients;
- Peptic ulcers caused by Helicobacter pylori (in combination with antibacterial agents);
- Elimination (eradication) of Helicobacter pylori in complex treatment
- Erosive and ulcerative changes in the upper gastrointestinal tract, occurred in patients with liver cirrhosis
- Pathological hypersecretory conditions: Zollinger-Ellison syndrome, multiple endocrine adenomatosis, systemic mastocytosis, stress ulcer;
- Prevention of acid aspiration during anesthesia (Mendelson syndrome)
Omeprazole 20mg comes in the form of capsules taken orally. Omeprazole is recommended to take once daily in the morning, swallowing omeprazole capsules 10mg or 20mg whole, without chewing, crushing an empty stomach or just before eating (it is possible dietary).
In cases where the daily dose exceeds 80 mg omeprazole, the dose should be divided into two parts and taken twice daily (every 12 h). The daily dose exceeding 120 mg should be split into 3 doses.
Omeprazole provides rapid elimination of symptoms, within the first two weeks of admission.
Omeprazole capsules 20mg are contraindicated in:
- Increased sensitivity to omeprazole, other components of the preparation or other proton pump inhibitors.
- Chronic liver diseases
The application of Omeprazole during pregnancy is possible only in case when presumptive benefit for mother overweighs potential risk for fetus. Omeprazole belongs to a pregnancy category C. This means that the medication may cause damage to the fetus. Make sure to inform your doctor if you are planning to become pregnant.
Omeprazole 20mg can pass through breast milk. Therefore the application of Omeprazole capsules during breastfeeding should be avoided.
The following Omeprazole side effects can occur during the treatment:
- Digestive system: diarrhea, constipation, abdominal pain, nausea, vomiting, anorexia, flatulence, rarely - dry mouth, taste disturbances, stomatitis, candidiasis of the gastrointestinal, atrophic gastritis, elevated levels of liver transaminases.
- In some cases - encephalopathy, aggravation of liver disease, hepatitis with jaundice or without liver dysfunction.
- Hemopoietic system: leucopenia, thrombocytopenia, agranulocytosis, pancytopenia.
- CNS: dizziness, headache, anxiety, depression, malaise, fatigue, paresthesia, somnolence, insomnia, reversible mental confusion, visual disturbances.
- Musculoskeletal system: arthralgia, myalgia, muscular weakness.
- Urogenital system: rarely - hematuria, proteinuria, peripheral edema, urinary tract infections
- Dermatological reactions: photosensitivity, alopecia, erythema multiform.
- Allergic reactions: hives, skin rash, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock.
- Other: gynecomastia, increased sweating. Among these omeprazole side effects, the most common and frequently observed include: headache, stomach pain, diarrhea, infections of the upper respiratory tract, dizziness, constipation, back pain
Omeprazole slows down the metabolism drugs metabolized livers cytochrome P450, and may increase the plasma concentrations of diazepam, carbamazepine, phenytoin, warfarin.
When Omeprazole is indicated with warfarin it is recommended to monitor the concentration of anticoagulant in the blood serum. Omeprazole enhances the effects of coumarins and difenine. Omeprazole decreases the absorption of certain medications which absorption depends on stomach acidity: antibiotics, ketoconazole.
Omeprazole can interact with antacids, disulferam, escitalopram, hiv medications, iron containing supplements and drugs, tacrolumus, voriconazole, clopidogrel and others.
Omeprazole 20mg capsules stored be stored at dry place out of reach of children. Shelf-life is 2 years. Do not take the medication after expiration date indicated on the pack.
This info corresponds to official PIL provided by legal manufacturer and reviewed by: Dr. Rohit Bansali N.