Effect on serum gastrin: clinical trials in patients received rabeprazole at 10 or 20 mg once a day for up to 43 months.Serum gastrin concentration increased during the first 2-8 weeks of receiving, reflecting the inhibitory effect on the secretion of hydrochloric acid and then remained stable with continued therapy. Indicators masteron propionate gastrin concentrations returned to baseline values typically within 1-2 weeks after discontinuation of therapy.
Biopsy samples of antral stomach and bottom, obtained in more than 500 patients receiving rabeprazole or comparative treatment for up to 8 weeks showed no change in the ECL -kletochnom and histological structure, the degree of gastritis, incidence of atrophic gastritis, intestinal metaplasia or the prevalence of infection with H. pylori in more than 250 patients followed for 36 months of therapy, there was no significant change in baseline of existing conditions.
Other effects: systemic effect and rabeprazole in relation to the central nervous system, cardiovascular and respiratory systems are not identified to date. Rabeprazole, is applied orally at a dose of 20 mg for 2 weeks, had no effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid hormone, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretin, glucagon, follicle stimulating hormone (FSH), luteinizing hormone (LH), renin, aldosterone or growth hormone.
Clinical studies have shown that rabeprazole does not enter into a clinically significant interaction with amoxicillin, no adverse effect on the plasma concentrations of amoxicillin or clarithromycin, while the use of these drugs for eradication of H. pylori from the upper sections gastrointestinal tract.
Absorption: drug is rabeprazole tablets, enteric-coated (gastric resistant) shell. This form is due to instability in the acidic environment of rabeprazole. Therefore, rabeprazole absorption begins only after the tablet has exited the stomach. Rapid absorption; the maximum concentration (C max ) of rabeprazole in plasma is reached after about 3.5 hours after ingestion of 20 mg. C max and AUC “concentration-time» (AUC) are linear over a dose range from 10 mg to 40 mg. The absolute bioavailability of an oral dose of 20 mg (as compared to intravenous administration) is about 52%, mostly due to presystemic metabolism. Repeated application of the bioavailability, presumably, does masteron propionate not increase. In healthy individuals, the half-life (Tu,) from the blood plasma of about 1 hour (from 0.7 to 1.5 hours), a total clearance – 283 ± 98 ml / min. Clinically significant interaction associated with eating there. Neither food nor the time of reception of the drug does not affect the absorption of rabeprazole.
Sex: taking into account the corrections for the growth and body weight showed no sex differences in the pharmacokinetic parameters of rabeprazole 20 mg.
Renal impairment: in patients with renal failure requiring hemodialysis (creatinine clearance (CC) of less than 5 mL / min / 1.73 m 2 ) of rabeprazole distribution was similar to its distribution in healthy volunteers. AUC and C max in these patients was about 35% lower than the corresponding parameters in healthy volunteers. Average T 1/2 , rabeprazole was 0.82 hours in healthy volunteers, 0.95 hours in patients on background hemodialysis and 3.6 hours – after hemodialysis. QC rabeprazole in patients with impaired renal function, requiring maintenance hemodialysis was approximately two times higher than in healthy volunteers.
Abnormal liver function: after a single application of rabeprazole 20mg patients with light or moderate liver disease 2 times increased AUC, and 2-3 times increased T 1/2 , rabeprazole compared with healthy volunteers. However, after oral administration of daily doses of 20 mg in 7 days only AUC increased 1.5 times, and C max – 1.2 times only. Tu, rabeprazole in patients with hepatic impairment was 12.3 hours compared to 2.1 chu healthy volunteers. The pharmacodynamic response (gastric pH control) in the two groups was clinically comparable.
Elderly patients: elderly patients slightly reduced excretion of rabeprazole. After application of rabeprazole for 7 days at a daily dose of 20 mg AUC increased approximately two-fold, and C max is increased by 60%, T 1.2 was increased by 30% as compared with healthy young volunteers. No signs of accumulation were observed rabeprazole. Polymorphism CYP2C19: rabeprazole after oral administration at a dose of 20 mg in humans sustained CYP2C19 – metabolism AUC and T 1/2 are approximately 1.9 and 1.6 times higher than the corresponding parameters in patients with active metabolism, while C max It increased by only 40%.
- Gastric ulcer and duodenal ulcer in the acute stage;
- Gastroesophageal reflux disease (GERD): erosive reflux esophagitis (healing), symptomatic treatment of GERD, including long-term maintenance therapy;
- Zollinger-Ellison syndrome;
- In the combined therapy: the eradication of Helicobacter pylori in patients with gastric ulcer and 12 duodenal ulcer and chronic gastritis;
- Treatment and prevention of relapse of peptic ulcer associated with Helicobacter pylori.
Hypersensitivity to the active substance or auxiliary components of the drug, pregnancy, breast-feeding, child age (no application experience).
Severe renal impairment.
Application of pregnancy and during breastfeeding
There are no data on the safety of rabeprazole in human pregnancy. Reproductive studies in rats and rabbits revealed no evidence of impaired fertility or harmful effects on the fetus of rabeprazole.
The drug Zulbeks not used during pregnancy.
It is not known whether rabeprazole secreted in breast milk, but is secreted in the milk of rats. Studies in lactating women have not been conducted.
If necessary, use Zulbeks during lactation, breast-feeding should be discontinued.
Dosing and Administration
Inside, the whole without chewing and without breaking.
Peptic ulcer and 12 duodenal ulcer in the acute stage
of 20 mg 1 time a day, in the morning.
In most patients, active ulcer 12 duodenal ulcer heal within four weeks. However, some patients may need 4 more weeks for complete healing of the ulcer. Active benign gastric ulcer healing in most patients within six weeks. However, a small number of patients still six weeks may be required for complete healing.
Gastroesophageal reflux disease (GERD): erosive reflux esophagitis (healing), symptomatic treatment of GERD is
20 mg 1 time a day for four to eight weeks. Prolonged therapy Zulbeks maintenance dose preparation may be used – 10-20 mg once a day, depending on the patient’s response to treatment.
Symptomatic treatment of GERD:
10 mg 1 once daily in patients without esophagitis. If 4 weeks fails to achieve control of symptoms, it is necessary to conduct further examination of the patient. After the improvement of the patient’s condition further symptom control can be carried out while taking 10 mg 1 time per day, on request.
The recommended starting dose for adults is 60 mg 1 time per day. The dose may be increased to 120 mg a day depending on the individual patient’s needs. You can assign a daily dose of 100 mg 1 time per day. The dose of 120 mg six times may require acceptance, 60 mg 2 times a day. The therapy is carried out as long as there are appropriate clinical indications.
Eradication of H. pylori in patients with gastric ulcer and 12 duodenal ulcer or chronic gastritis:
patients with AN pylor, should undergo eradication therapy. We recommend the following combination regimens course 7 days: ® drug Zulbeks 20 mg 2 times daily + clarithromycin 500 mg 2 times daily and amoxicillin 1 g, 2 times a day.
If eradication schemes require masteron propionate the use of drugs 1 time per day, Zulbeks drug must taken in the morning before breakfast; time and food intake does not affect the activity of rabeprazole.
Renal dysfunction and / or hepatic impairment:
dosage adjustment Zulbeks preparation is required.
Children’s age: due to the lack of efficacy and safety data rabeprazole drug Zulbeks not used in children.
Classification of the incidence of side effects of the World Health Organization (WHO):
very common> 1/10
often by> 1/100 to <1/10
uncommon from> 1/1000 to <1/100
rarely from> 1/10000 to <1 / 1000
is very rare on the <1/10000, including isolated reports.
In each group, adverse events are listed in order of decreasing seriousness.
From hemopoiesis system:
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-rare: neutropenia, leukopenia, thrombocytopenia, leukocytosis, the part of the immune system: -rare: hypersensitivity reactions 1 , metabolic disorders and nutrition: -rare: anorexia, weight gain; Very rare: gnponatriemiya; Co nervous system: -Frequently: headache, dizziness, insomnia, -nechasto: drowsiness, nervousness; -rare depression; Very rare: confusion; From the senses: -rare: visual disturbances,cardio – vascular system : Very rare: peripheral edema; The respiratory system: -Frequently: cough, pharyngitis, rhinitis, -nechasto: bronchitis, sinusitis, part of the digestive system: -Frequently: diarrhea, vomiting, nausea, abdominal pain, constipation, flatulence ; -nechasto: dyspepsia, dry oral mucosa, belching; -rare: gastritis, stomatitis, changes in taste, hepatitis, jaundice, hepatic encephalopathy 3 ; For the skin: -nechasto: rash, erythema; -rare: itching, sweating , bullous rash 2 – very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, the part of the musculoskeletal system:-Frequently: nonspecific pain, back pain; -nechasto: myalgia, leg cramps, arthralgia, From the urinary system: -nechasto: urinary tract infection; -rare: interstitial nephritis reproductive system: Very rare: gynecomastia; Laboratory findings: -nechasto: increased activity of liver enzymes Other: -Frequently: asthenia, flu-like illness. bodybuilding supplements uk
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