Hairabesol pills 20 mg 30 pcs
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Active ingredients
Rabeprazole
Release form
Pills
Composition
1 tab. rabeprazole sodium 20 mg. Excipients: magnesium oxide - 69 mg, mannitol - 40 mg, corn starch - 2.
Pharmacological effect
The antiulcer drug from the group of proton pump inhibitors (H + / K + -ATP-ase), is metabolized in the parietal cells of the stomach to active sulfonamide derivatives, which inactivate the sulfhydryl group H + / K + -ATP-ase. Blocks the final stage of secretion of hydrochloric acid, reducing the content of basal and stimulated secretion, regardless of the nature of the stimulus. It has a high lipophilicity, easily penetrates into the parietal cells of the stomach and concentrates in them, providing a cytoprotective effect. The antisecretory effect after oral administration of 20 mg occurs within 1 hour and reaches a maximum after 2-4 hours; Inhibition of basal and food-stimulated acid secretion 23 hours after the first dose is 62% and 82%, respectively; duration of action - 48 hours. After the end of reception, secretory activity is normalized within 2-3 days. In the first 2-8 weeks of therapy, the concentration of gastrin in the serum increases and returns to baseline levels within 1-2 weeks after discontinuation of the drug. It does not affect the central nervous system, cardiovascular and respiratory systems.
Pharmacokinetics
Absorption and distribution: Absorbed from the small intestine (due to the presence of acid-resistant enteric shell). The absorption is high, the time to reach Cmax is 3.5 hours. The values of Cmax and AUC are linear in the dose range from 10 to 40 mg. Bioavailability - 52%, does not increase with repeated use. Communication with plasma proteins - 97%. Metabolism and excretion: Metabolized in the liver with the participation of cytochrome P450 isoenzymes (CYP 2C19 and CYP 3A4). T1 / 2 - 0.7-1.5 h, clearance - 283 ± 98 ml / min. Excreted by the kidneys - 90% in the form of two metabolites: a mercapturic acid conjugate (M5) and a carboxylic acid (M6); intestine - 10%. Pharmacokinetics in special clinical situations: In patients with chronic or moderate hepatic insufficiency, after taking a single dose, the AUC increases by 2 times, T1 / 2 - by 2-3 times. After taking 20 mg of rabeprazole for 7 days, the AUC increases 1.5 times, T1 / 2 - 1.2 times. In patients with stable end-stage renal disease requiring hemodialysis (CC less than 5 ml / min / 1.73 m2), the distribution of rabeprazole sodium is close to that in healthy individuals. Elderly patients after taking rabeprazole for 7 days AUC is 2 times more, Cmax - 60% more than young.In patients with delayed CYP2C19 metabolism after 7 days of taking rabeprazole at a dose of 20 mg per day, the AUC increases 1.9 times, and T1 / 2 1.6 times compared with the same parameters in “fast metabolisers”, while Cmax increases by 40 %
Indications
- gastric ulcer and duodenal ulcer in the acute stage - gastroesophageal reflux disease - hypersecretory conditions, including Zollinger-Ellison syndrome - stressful ulcers of the gastrointestinal tract. As part of complex therapy: - Helicobacter pylori eradication in patients with gastric ulcer and duodenal ulcer or chronic gastritis - treatment and prevention of recurrence of peptic ulcer associated with Helicobacter pylori.
Contraindications
- pregnancy - breastfeeding - children and adolescents under 18 years of age - hypersensitivity to rabeprazole, benzimidazoles or other components of the drug. Precautions should be prescribed the drug in severe liver failure, severe renal failure.
Use during pregnancy and lactation
Rabeprazole should not be prescribed during pregnancy (there are no data on the safety of using rabeprazole during pregnancy). It is not known whether rabeprazole is excreted in breast milk. Relevant studies in nursing women have not been conducted. At the time of treatment should stop breastfeeding.
Dosage and administration
The drug is prescribed 20 mg 1 time / day. Tablets should be taken orally, in the morning before meals, swallowing whole, not chewed or crushed. In case of duodenal ulcer and gastric ulcer in the acute stage, 20 mg is prescribed (1 tab.) 1 time per day in the morning for 4-6 weeks. For gastroesophageal reflux disease (GERD), 20 mg (1 tab.) Is prescribed 1 time / day for 4-8 weeks. For maintenance therapy for GERD - at a dose of 10 or 20 mg 1 time / day, depending on the response of the patient. For symptomatic treatment of GERD in patients without esophagitis - at a dose of 10 mg 1 time / day for 4 weeks. For the treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion, the dose is selected individually. For the treatment of duodenal ulcer or chronic gastritis associated with infection with Helicobacter pylori, a treatment course of 7 days is recommended for one of the following combinations of drugs: Hairabesol 20 mg 2 times / day + clarithromycin 500 mg 2 times / day and amoxicillin 1 g 2 times / day. Hairabesol 20 mg 2 times / day + clarithromycin 500 mg 2 times / day and metronidazole 400 mg 2 times / day.
Side effects
WHO classification of undesirable side reactions according to the frequency of development: very often - 1/10 prescriptions (10%), often - 1/100 prescriptions (1%, but less than 10%), rarely - 1/1000 prescriptions (0.1%, but less than 1 %), rarely - 1/10 000 appointments (0.01%, but less than 0.1%), very rarely - less than 1/10 000 appointments (less than 0.01%). On the part of the digestive system: often - diarrhea, nausea; infrequently - vomiting, abdominal pain, flatulence, constipation; rarely - dry mouth, belching, dyspepsia; very rarely - a violation of taste, anorexia, stomatitis, gastritis, increased transaminase activity. From the nervous system and sensory organs: often - headache; rarely - dizziness, asthenia, insomnia; very rarely - nervousness, drowsiness, depression, visual impairment, taste disturbances. On the part of the musculoskeletal system: rarely - myalgia; very rarely - arthralgia, cramps of the calf muscles. On the part of the respiratory system: rarely - inflammation or infection of the upper respiratory tract, severe cough; very rarely - sinusitis, bronchitis. On the part of the blood-forming organs and the hemostasis system: rarely - thrombocytopenia, leukopenia; very rarely - leukocytosis. Allergic reactions: rarely - rash, skin itching. Other: rarely - pain in the back, chest, limbs, edema, urinary tract infection, fever, chills, flu-like syndrome; very rarely - excessive sweating, weight gain.
Overdose
Symptoms: not described. Treatment: for suspected overdose, supportive and symptomatic therapy is recommended. Dialysis is ineffective.
Interaction with other drugs
Rabeprazole slows down the excretion of certain drugs that are metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants). Reduces the concentration of ketoconazole by 33%, digoxin - by 22%. Does not interact with liquid antacids. Compatible with drugs metabolized by the CYP 450 system (warfarin, phenytoin, theophylline, diazepam).
special instructions
Before and after treatment with rabeprazole, endoscopic control is necessary to exclude a malignant neoplasm, since treatment may mask the symptoms and delay the correct diagnosis. It is recommended to use caution when first administering rabeprazole to patients with severely impaired liver function.The drug has no effect on thyroid function, metabolism of carbohydrates in the blood concentration of the parathyroid hormone, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretin, glucagon, follicle stimulating hormone, luteinizing hormone, renin, aldosterone, and growth hormone. Patients with impaired renal or hepatic function do not require dose adjustment. Discontinuation of the drug is not accompanied by rebound phenomenon, recovery of secretory activity occurs within 2-3 days as new enzyme molecules synthesize. Use in pediatrics The drug is not recommended for children and adolescents, because there is no experience of using rabeprazole in pediatric practice. Impact on the ability to drive motor vehicles and control mechanisms In the case of drowsiness during the treatment process, you should abandon driving and other activities that require increased concentration of attention and speed of psychomotor reactions.