Ultop capsules 10 mg 28 pcs
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Active ingredients
Omeprazole
Release form
Capsules
Composition
Omeprazol 20 mg Auxiliary substances: sugar granules (sucrose, corn starch) - 80 mg, hyprolose - 4.8 mg, magnesium hydroxycarbonate (magnesium carbonate, heavy) - 20 mg, sucrose - 32.2 mg, corn starch - 26.5 mg, sodium lauryl sulfate - 2.5 mg, copolymer of methacrylic acid and ethyl acrylate (1: 1) 30% dispersion - 31 mg, talc - 6 mg, macrogol 6000 - 3.1 mg, titanium dioxide - 1.9 mg, sodium hydroxide - 0.21 mg. The composition of the capsule cap: iron dye oxide red (E172) - 0.6153%, titanium dioxide (E171) - 2%, gelatin - up to 100%. The composition of the capsule body: iron dye red oxide (E172) - 0.0875%, titanium dioxide (E171) - 3%, gelatin - up to 100%.
Pharmacological effect
Proton pump inhibitor
Pharmacokinetics
Absorption and distribution After taking the drug inside omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is achieved in 0.5-1 hours. Bioavailability is 30-40%. Plasma protein binding - 90%. Metabolism and elimination of Omeprazole is almost completely biotransformed in the liver. Excreted mainly by the kidneys (70-80%) and with bile (20-30%). Omeprazole is a CYP19 isoenzyme inhibitor. Pharmacokinetics in special clinical situations. In chronic renal failure, excretion decreases in proportion to the decrease in CC. In the elderly, the elimination of omeprazole is reduced, bioavailability increases. With liver failure, bioavailability increases to 100%, T1 / 2 - 3 hours.
Indications
Short-term treatment of non-ulcer dyspepsia; - long-term maintenance therapy in order to prevent recurrence of gastroesophageal reflux disease; - long-term maintenance therapy to prevent the recurrence of gastric ulcer and duodenal ulcer
Contraindications
- Childhood; - pregnancy; - lactation (breastfeeding); - hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrose / isomaltose deficiency; - hypersensitivity to the drug. Precautions should be prescribed the drug for renal or hepatic failure.
Use during pregnancy and lactation
The safety of the drug Ultop in pregnancy and lactation has not been studied. Therefore, it is not recommended to prescribe during pregnancy.If necessary, the appointment of the drug during lactation breastfeeding should be discontinued.
Dosage and administration
Inside, in the morning before a meal or during a meal, washed down with a small amount of water (the contents of the capsule can not be chewed). Duodenal ulcer. When exacerbation of duodenal ulcer is recommended to take 20 mg 1 time per day. The drug provides rapid elimination of symptoms. In most patients, ulcer healing occurs within 2 weeks. In cases where within 2 weeks. complete healing of the ulcer does not occur, healing is achieved with the subsequent 2-week intake of the drug Ultop. Patients with duodenal ulcer resistant to treatment are usually prescribed the drug Ultop40 mg once a day, ulcer healing usually occurs within 4 weeks. For the prevention of relapse in patients with peptic ulcer of the duodenum recommend the drug Ultop 10 mg 1 time per day. If necessary, the dose can be increased to 20-40 mg once a day. Stomach ulcer. When exacerbation of gastric ulcer, the recommended dose of the drug Ultop - 20 mg 1 time per day. The drug provides rapid elimination of symptoms. In most patients, the cure occurs within 4 weeks. In those cases when, after the first course of taking the drug, complete healing does not occur, it is usually prescribed a repeated 4-week course of treatment during which healing is achieved. Patients with gastric ulcer resistant to treatment are usually prescribed Ultop 40 mg 1 time per day, healing is usually achieved within 8 weeks. For the prevention of relapse, Ultop, 20 mg 1 time per day, is recommended for patients with gastric ulcer. If necessary, the dose can be increased to 40 mg 1 time per day. Reflux esophagitis. The recommended dose - 1 tab. drug Ultop 20 mg 1 time per day. The drug provides rapid elimination of symptoms. In most patients, the cure occurs within 4 weeks. In those cases when, after the first course of taking the drug, there is no complete cure, it is usually prescribed a repeated 4-week course of treatment during which the cure is achieved. Ultop 40 mg 1 time per day is recommended for patients with severe reflux esophagitis, cure usually occurs within 8 weeks.Patients with reflux esophagitis in remission are prescribed Ultop 10 mg 1 time per day in the form of long courses of maintenance therapy. If necessary, the dose can be increased to 20-40 mg once a day. Symptomatic GERD. The recommended dose of Ultop is 20 mg 1 time per day. The drug provides rapid elimination of symptoms. The therapeutic effect can be achieved with a daily dose of 10 mg, therefore, individual selection of the dose is not excluded. If after 4 weeks. treatment (drug Ultop 20 mg 1 time per day), the symptoms do not disappear, it is recommended additional examination of the patient. Dyspepsia associated with high acidity. To relieve pain and / or eliminate the feeling of discomfort in the epigastric region, with or without heartburn, prescribed Ultop 20 mg 1 time per day. The therapeutic effect can be achieved with a dose of 10 mg 1 time per day, so treatment can begin with this dose. If after 4 weeks. treatment (drug Ultop 20 mg 1 time per day), the symptoms do not disappear, it is recommended additional examination of the patient. Erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs. In the presence of erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs, the recommended dose of Ultop - 20 mg 1 time per day. The drug provides rapid elimination of symptoms, in most patients, the cure occurs within 4 weeks. In those cases when, after the first course of taking the drug, there is no complete cure, it is usually prescribed a repeated 4-week course of treatment during which the cure is achieved. For the prevention of erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs, the recommended dose of the drug Ultop - 20 mg 1 time per day. Helicobacter pylori eradication regimens for peptic ulcer Three-component treatment regimen - Ultop 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg. All drugs take 2 times a day for 1 week; - Ultop drug 20 mg, metronidazole 400 mg (or tinidazole 500 mg) and clarithromycin 250 mg. All drugs take 2 times a day for 1 week; - the drug Ultop 40 mg 1 time per day, as well as amoxicillin 500 mg and metronidazole 400 mg 3 times per day for 1 week. A two-component treatment regimen is Ultop 40–80 mg / day and amoxicillin 1500 mg / day (the dose should be divided into 2 parts) for 2 weeks. - during clinical studies, amoxicillin was used in a daily dose of 1500–3000 mg, omeprazole 40 mg once a day and clarithromycin 500 mg 3 times a day for 2 weeks.In cases where, after undergoing a course of treatment, the test for Helicobacter pylori remains positive, the course of treatment can be repeated. Zollinger-Ellison syndrome. Patients with Zollinger-Ellison syndrome, the drug is prescribed in an individual dosage. Treatment continues on clinical indications as long as necessary. The recommended starting dose is 60 mg daily. In all patients with a severe form of the disease, as well as in cases where other therapeutic methods did not lead to the desired result, the use of omeprazole was effective in more than 90% of patients when taken at a dose of 20-120 mg daily. In cases where the daily dose of omeprazole exceeds 80 mg, the dose should be divided into 2 parts and taken 2 times a day. Children. To ensure the following dosing regimen, it is possible to take the drug Ultop in another registered dosage (Ultop, enteric capsules, 10 and 40 mg). Children older than 2 years (body weight more than 20 kg) Gastroesophageal reflux disease. At 20 mg 1 time per day. If necessary, the dose can be increased to 40 mg 1 time per day. Reflux esophagitis. The duration of treatment is 4-8 weeks. Symptomatic treatment of heartburn and belching sour with GERD. The duration of treatment is 2-4 weeks. If the use of omeprazole for 2-4 weeks. symptoms of the disease do not disappear, further examination is recommended. Children older than 4 years old Duodenal ulcer associated with Helicobacter pylori (as part of combination therapy). When choosing an antibiotic for the appropriate combination therapy, the patient's individual tolerance of drugs must be considered. Drugs should be prescribed in accordance with the nature of resistance and treatment guidelines, taking into account the duration of treatment (usually 7 days, sometimes 14 days) and the appropriate use of antibacterial drugs. Treatment should be carried out under the supervision of a specialist. The following doses are recommended: Body weight 15–30 kg, dose: combination with two antibiotics: 10 mg of omeprazole, amoxicillin 25 mg / kg and clarithromycin 7.5 mg / kg are applied simultaneously 2 times a day for 1 week. Body weight 31–40 kg, dose: combination with two antibiotics: 20 mg of omeprazole, 750 mg of amoxicillin and clarithromycin 7.5 mg / kg are applied simultaneously 2 times a day for 1 week. Body weight> 40 kg, dose: combination with two antibiotics: 20 mg of omeprazole, 1000 mg of amoxicillin and 500 mg of clarithromycin are applied simultaneously 2 times a day for 1 week.Special patient groups Impaired renal function. In patients with impaired renal function dose adjustment is not required. Liver dysfunction. In patients with impaired liver function, bioavailability and T1 / 2 of omeprazole from blood plasma increase. In this regard, a dose of 10-20 mg / day is sufficient. Elderly patients. Dose adjustment is not required. In special cases, if you have difficulty in swallowing the whole capsule in adults and children, you can swallow its contents after opening or resorption of the capsule, and you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.
Side effects
In rare cases, the following, usually reversible, side reactions may occur. On the part of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, irritable bowel syndrome, heartburn, dry mouth, taste disorders, stomatitis, pancreatitis (including fulminant), loss of appetite, discoloration fecal masses, esophageal candidiasis, atrophy of the mucous membrane of the tongue, transient increase in liver enzymes and bilirubin in the plasma; in patients with previous severe liver disease - hepatitis (including jaundice), impaired liver function or hepatic encephalopathy. Nervous system disorders: headache, dizziness, aggressiveness, apathy, nervousness, agitation, drowsiness, insomnia, tremor, vertigo, paresthesia, depression, hallucinations, confusion; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy. Since the cardiovascular system: angina, tachycardia, bradycardia, palpitations, increased blood pressure, vasculitis, peripheral edema. On the part of the urogenital system: interstitial nephritis, urinary tract infections, microscopic pyuria, proteinuria, hematuria, glycosuria, increased serum creatinine concentration, gynecomastia, testicular pain. On the part of the musculoskeletal system: muscle weakness, myalgia, arthralgia, ossalgia (pain in the bones), muscle cramps. From the hemopoietic system: pancytopenia, agranulocytosis, anemia (includinghemolytic anemia), neutropenia, thrombocytopenia, leukocytosis, leukopenia. On the part of the skin: petechiae, pruritus, skin rash; in some cases - photosensitization, erythema multiforme exudative, hair loss, alopecia, dry skin, epidermal necrosis, Stevens-Johnson syndrome. On the part of the respiratory system: sore throat, cough, profuse nasal bleeding. From the senses: ringing in the ears, unexpressed visual and hearing impairment. Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever. Laboratory indicators: hypoglycemia, hyponatremia. Others: backache, increased sweating; rarely - the formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible), general fatigue, weakness, weight gain, fever.
Overdose
Patients tolerate the drug in a daily dose of up to 360 mg. Symptoms: abdominal pain, drowsiness, headache, dizziness, dry mouth, tachycardia, arrhythmia, blurred vision, agitation, confusion, increased sweating, nausea; in rare cases - seizures, shortness of breath, hypothermia. Treatment: conduct symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective.
Interaction with other drugs
Long-term use of omeprazole in a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their plasma concentration. No interaction of omeprazole with concomitant antacids was observed. Omeprazole can reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (because omeprazole increases the pH of the stomach). As an inhibitor of cytochrome P450, omeprazole can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin, which in some cases may require a reduction in doses of these drugs. With simultaneous reception increases the absorption of omeprazole and clarithromycin.
special instructions
Before starting treatment, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), since treatment, masking the symptoms, may delay the correct diagnosis. Eating slows down the absorption of omeprazole, so the drug is taken before meals. In special cases, if you have difficulty in swallowing a whole capsule, you can swallow its contents after opening or resorbing the capsule, and you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes. With caution it is necessary to take Ultop in patients with cirrhosis of the liver; daily dose should not exceed 20 mg. Also, caution is necessary to take the drug Ultop patients with impaired renal function. In patients on dialysis, the pharmacokinetic parameters of omeprazole do not change. Ultop contains sucrose, so the drug is not recommended for patients with malabsorption syndrome of glucose and / or galactose or sucrose / isomaltose deficiency. Impact on the ability to drive vehicles and control mechanisms When using the drug in recommended doses does not affect the ability to drive vehicles and control mechanisms.