Product name: Losik-SZ
Active substance (INN): Omeprazole
Dosage form: Capsules, 20 mg, in the blister packaging.
Pharmacotherapeutic group: anti-ulcer drugs (inhibitors of the H +, K + ATPase).
Storage conditions: In a dry, dark place at a temperature no higher than 25 ° C.
Shelf life: 3 year
Conditions of supply of pharmacies: With recipe
Lowers the secretion of hydrochloric acid from the parietal cells of the gastric mucosa by inhibiting H +, K +, ATP proton pump aznogo – the enzyme that catalyzes the final step of acid secretion. In this preparation it promotes inhibition of both basic and stimulated (regardless of the nature of the stimulus) of acid secretion. Inhibition of acid secretion after a single dose lasts for 24-72 hours. Upon termination of the drug secretory activity is gradually returning to the initial 3-5 days. Does not inhibit pepsin secretion, increases serum gastrin, which is returned to the initial value, usually within 1-2 weeks after cessation of drug therapy.
Rapidly absorbed from the gastrointestinal tract and peak plasma concentration is reached within 0.5-3.5 hours. In healthy individuals the half-life (T1 / 2) in plasma of 0.5-3 hours. Bioavailability is 30-40%. Binding to plasma proteins is approximately 90%.
It is metabolized in the liver, and the majority (70-80%) of the dose is excreted in the urine and the rest – with the feces.
Prevention and treatment of gastric and duodenal ulcers (including those resistant to therapy, H2-receptor antagonists), erosive and ulcerative lesions caused by therapy with NSAIDs, reflux esophagitis, Zollinger-Ellison syndrome. Destruction of Helicobacter pylori (in combination with antibiotics) in patients suffering from gastric ulcer and duodenal ulcer.
Dosing and Administration
Inside, before a meal (usually in the morning), with a small amount of liquid. The capsule should be swallowed whole without chewing or breaking. In gastric ulcer and reflux esophagitis the recommended dose is 20 mg daily doses for 4 weeks. For patients not fully cured after the initial rate and are resistant to other forms of treatment dose increased to 40 mg per day and the treatment continues for 4 weeks. In duodenal ulcer usual dose is 20 mg daily for 2 weeks. For patients who are not fully cured after the initial course of treatment is prolonged for another 2 weeks. When bad zazhivlyaemosti ulcers recommended starting dose of 40 mg, and 4-week treatment duration. For the prevention of relapse of ulcer and reflux esophagitis recommended dose of 10-40 mg per day.
Long uninterrupted drug treatment is not recommended.
With Zollinger-Ellison syndrome the recommended initial dose is 60 mg daily. Individual dosage can be increased to 80-180 mg per day (in this case, it is divided into two stages), and the duration of treatment depends on the dynamics of the disease symptoms.
pylori drug to achieve eradication of Helicobacter take a dose of 20 mg twice a day with the corresponding antibiotic (amoxicillin, clarithromycin, tetracycline, etc.) in various schemes, which last 7 or 14 days. For complete curing ulcers, after a double or triple combination therapy may require additional treatment antacids.
The recommended dose of ulcer caused by non-steroidal anti-inflammatory drugs is 20-40 mg per day.
The drug is usually well tolerated. In some cases (about 1%) are possible:
From the nervous system: headache, dizziness, somnolence, insomnia, malaise, paresthesia, in some cases – depression and hallucinations (in predisposed patients).
On the part of the gastrointestinal tract, liver, diarrhea, constipation, abdominal pain, nausea, vomiting, bloating, change in taste sensitivity, disease, increase in liver enzymes to increase and without raising the level of bilirubin.
With the respiratory system: rarely – bronchospasm.
From the musculoskeletal system: arthralgia, myalgia, muscle weakness.
From hemopoiesis system: in some cases – leukopenia, thrombocytopenia.
Skin reactions: skin rash, hives and / or itching, erythema multiforme.
Other reactions: in some cases – peripheral edema, blurred vision, sweating, fever.
The drug inhibits the release of diazepam, warfarin and phenytoin and other drugs that are metabolized by microsomal oxidation in the liver, with the participation of cytochrome P450.
Against the background of the drug may reduce the absorption of certain drugs for which gastric pH is an important determinant of bioavailability (eg, ketoconazole, ampicillin esters, iron salts).
It was found that while the use of the drug with antacids, metoprolol, theophylline, lidocaine, quinidine, and no change of action of drugs.
Before treatment to rule out malignancy in the stomach, as the drug can mask symptoms, making it difficult and postpones the correct diagnosis.
Note that with a decrease in gastric acidity increases the risk of oral disease transmitted infection (salmonellosis), as the hydrochloric acid of the stomach is a major barrier for these bacteria and possibly viruses. Therefore, when taking the drug should take precautions for patients with disorders of the immune system (immunosuppressants applying et al.).
During treatment with omeprazole should refrain from smoking and drinking alcohol as it irritates the mucous membrane of the stomach, violates the absorption of the drug, its effect weakens and delays healing.
No special selection of doses for elderly patients and patients with impaired hepatic or renal function.
The drug when used in recommended doses does not affect the ability to drive vehicles and management mechanisms.
The drug should be stored out of reach of children and do not use after the expiration date.
Symptoms: blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: gastric lavage and symptomatic therapy. No specific antidote.
Hypersensitivity to the drug, pregnancy, lactation, children’s age (due to lack of clinical experience with the drug in children).
Precautions should be prescribed the drug for hepatic or renal insufficiency.