Hayrabezol tab n / an kish.rastv. 20mg 15 pc

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Hayrabezol tab n / an kish.rastv. 20mg 15 pc

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Description

Composition
Active substance:
1 tablet contains: rabeprazole sodium – 10 mg or 20 mg.
Excipients:
Magnesium oxide, mannitol, corn starch, povidone K30, giproloza low substituted sodium stearyl fumarate.
Sheath: tsellatsefat, titanium dioxide, iron oxide red dye or a yellow dye of iron oxide.
Description:
Dosage 10 mg: Round biconvex tablets, coated from light pink to reddish pink. The cross-sectional core of a white or white color with a yellowish tinge.
Dosage 20 mg: Round biconvex tablets, coated from light yellow to yellow. The cross-sectional core of a white or white color with a yellowish tinge.
Product form:
The tablets coated with enteric film coating of 10 mg, 20 mg.
For pharmacies: 10, 14, 15 tablets in Al / Al blister or Al / Al strip.
1 or 10 strips / blisters with 10 tablets of 1, 2 or 10, the strip / blisters of 14 tablets 1, 2, 10 or strips / blisters of 15 tablets together with instructions for use in a cardboard pack.
By the Strip 1 / blister 14 or 15 tablets, together with instructions for use in a pack with a cardboard valve and perforation protected PVC film to the inner side of the pack (7 perforations in a circle).
Contraindications
Hypersensitivity to rabeprazole, substituted benzimidazoles or other auxiliary components of the drug; pregnancy; lactation (lactation); Children up to age 12 years.
Carefully
Severe hepatic failure, severe renal failure, children’s age (over 12 years).
Dosage
20 mg
Indications
Peptic ulcer in the acute stage and anastomotic ulcer;
Duodenal ulcer in the acute stage;
Erosive and ulcerative gastroesophageal reflux disease or reflux esophagitis;
Supportive therapy of gastroesophageal reflux disease;
Non-erosive gastroesophageal reflux disease;
Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;
In combination with appropriate antibiotic therapy for Helicobacter pylori eradication in patients with gastric ulcer and duodenal ulcer or chronic gastritis.
Interaction with other drugs
In in vitro studies on human liver microsomes, it was shown that rabeprazole metabolized in the liver and SYR3A4 SYR2S19 isoenzymes.
Rabeprazole not enter into clinically significant interactions with amoxicillin and other drugs metabolized by cytochrome P450 isozymes system in the liver: warfarin, phenytoin, theophylline and diazepam. Due to the fact that the rabeprazole causes pronounced and prolonged decline in production of hydrochloric acid, it was noted the interaction while receiving with the drugs, the absorption of which depends on the acidity of gastric contents. In healthy volunteers receiving rabeprazole caused a decrease in the concentration of ketoconazole in blood plasma by 30% and increase of the minimum concentration of digoxin by 22%. At the same time taking rabeprazole with ketoconazole or digoxin need to adjust their dose. When simultaneous administration of atazanavir 300 mg / 100 mg ritonavir with omeprazole (40 mg once a day 1) or atazanavir 400 mg lansoprazole (60 mg 1 time per day) to healthy volunteers showed significant lowering effects of atazanavir. Absorption atazanavir is pH dependent. Thus, it is not recommended simultaneous reception of atazanavir with proton pump inhibitors, including rabeprazole.
When the joint application of rabeprazole with clarithromycin parameters AUC and Cmax as compared to a monotherapy for rabeprazole increased by 11% and 34%, and for the active metabolite of clarithromycin by 42% and 46% respectively.
This effect is used during the eradication of Helicobacter pylori.
Simultaneous treatment with rabeprazole and methotrexate can lead to increased concentrations of methotrexate and its metabolite gidroksimetotreksata and increase the time of their removal.
There were no clinically significant interaction with rabeprazole sodium antacid preparations containing aluminum hydroxide or magnesium hydroxide. No clinically significant interaction with food rabeprazole.
Overdose
symptoms:
Data on intentional or accidental overdose is minimal. Reported taking the drug at a dose of 60 mg 2 times a day, or 160 mg dose, the side effects were minimal and reversible and require medical intervention.
Treatment: the specific antidote for rabeprazole is unknown. Rabeprazole well bound to plasma proteins, and therefore poorly displayed during dialysis. In case of overdose should be carried out is symptomatic and supportive treatment.
pharmachologic effect
Pharmacological group:
Decreasing the secretion of the glands of the stomach – a proton pump inhibitor.
Pharmacodynamics:
Mechanism of action. Rabeprazole relates to a class of antisecretory compounds which chemically are substituted benzimidazoles. The drug inhibits the enzyme activity of H + / K + -ATPase ( “proton pump”), thereby blocking the final step of the synthesis of hydrochloric acid. This effect is dose dependent and leads to inhibition of both basal and stimulated acid secretion irrespective of stimulus. As a weak base in any dose rabeprazole is rapidly absorbed and concentrated in the acidic environment of the parietal cells.
Antisecretory activity. After ingestion of 20 mg of rabeprazole antisecretory effect occurs within one hour. Inhibition of basal and stimulated acid secretion 23 h after the first dose of rabeprazole sodium is 62% and 82%, respectively, and extends up to 48 hours. Such pharmacokinetic duration of action is much greater than for a predictable period of half-life (T1 / 2), which is approximately one hour. This effect can be explained by binding of the drug with H + / K + -ATP-ase gastric parietal cells. The magnitude of the inhibitory effect of sodium rabeprazole in acid secretion reached a plateau after three days of rabeprazole sodium. When a reception secretory activity is restored in 1-2 days.
Influence on concentrations of serum gastrin. At the beginning of therapy rabeprasol gastrin concentration in serum is increased, which is a reflection of an inhibitory effect on the secretion of hydrochloric acid. gastrin concentration returned to its initial level usually within 1-2 weeks after cessation of treatment.
Effect on enterohromafinnopodobnye cells. Study biopsies bottom and antrum in more than 500 patients treated with sodium rabeprazole or drug comparisons for up to 8 weeks showed no change in the morphological structure enterohromafinnopodobnyh (ECL) cells, severity of gastritis, incidence of atrophic gastritis, intestinal metaplasia or prevalence of Helicobacter infection pylori.
In a study of 400 patients treated with rabeprazole 10 mg / day or 20 mg / day for up to 1 year, the incidence of hyperplasia was low and comparable with that of patients receiving omeprazole 20 mg / day. It was not registered a single case of adenomatous changes or carcinoid tumors observed in rats.
Other effects. At the present time there is no evidence that rabeprazole cause systemic effects on the central nervous system (CNS), cardiovascular and respiratory systems. When administered orally at a dose of 20 mg for 2 weeks rabeprazole no effect on thyroid function, metabolism of carbohydrates, as well as the blood concentration of parathyroid hormone, cortisol, estrogen, testosterone, prolactin, secretin, glucagon, follicle stimulating hormone, luteinizing hormone, renin, aldosterone, and growth hormone.
Pharmacokinetics:
Absorption
Rabeprazole is rapidly absorbed from the intestine, and its peak plasma concentration (Cmax) is achieved after about 3.5 hours after ingestion of 20 mg. Changing the peak plasma concentration and area under the curve values ​​”concentration – time” (AUC) of rabeprazole are linear over a dose range from 10 to 40 mg. The absolute bioavailability after oral administration of 20 mg (as compared to intravenous administration) is about 52%. Moreover, bioavailability is not changed during multiple dose rabeprazole. Neither the timing of the doses during the day or antacids do not affect the absorption of rabeprazole. The drug with fatty food slows the absorption of rabeprazole in 4 hours or more, but neither Cmax nor the degree of absorption is not changed.
Distribution
In humans, the extent of binding of rabeprazole plasma protein is about 97%. Metabolism
Rabeprazole is metabolized in the body in two ways. Much of it is metabolized systemically non-enzymatically to form a thioether derivative. Rabeprazole are also metabolised in the liver by cytochrome P450 to form the sulfone and desmetilovy derivatives.
In healthy volunteers the plasma half-life is around 1 hour (range from 0.7 to 1.5 hours) and the total clearance is 3.8 ml / min / kg.
breeding
After a single oral administration of 20 mg of rabeprazole 14C-labeled about 90% of the drug excreted in the urine, mainly as a thioether carboxylic acid and its glucuronide as derivatives mercapturic acid. Unchanged drug in urine is not defined. The remaining portion of the received rabeprazole displayed through the intestines. The total elimination of 99.8%.
End stage renal disease
Patients with stable renal insufficiency in the terminal stage, which requires maintenance hemodialysis (creatinine clearance
Chronic compensated cirrhosis
Patients with chronic compensated cirrhosis rabeprazole well tolerated at a dose of 20 mg 1 time per day, although the AUC is doubled and Cmax increased by 50% as compared with healthy volunteers.
elderly patients
In elderly patients, elimination of rabeprazole has slowed somewhat. After 7 days of rabeprazole in a dose of 20 mg 1 time per day in the elderly AUC was approximately twice as large, and Cmax increased by 60% compared with young healthy volunteers; signs of drug accumulation was observed.
SYR2S19 polymorphism
Patients with sustained metabolism by isozyme SYR2S19 after 7 days of rabeprazole in a dose of 20 mg per day AUC increased 1.9 times, and the half-life of 1.6 times compared with the same parameters in the “fast metabolizers”, while both Cmax increased by 40%.
Pregnancy and breast-feeding
Safety data application rabeprazole during pregnancy does not. Reproduction studies in rats and rabbits revealed no evidence of impaired fertility or fetal development defects caused by rabeprazole; however the rat small quantities of the drug penetrates the placental barrier. Rabeprazole, should not be used during pregnancy except in cases where the expected positive effect for the mother outweighs the potential harm to the fetus. It is not known whether rabeprazole is excreted in breast milk. Appropriate studies in lactating women have not been conducted. However rabeprazole detected in the milk of lactating rats, and the drug can not be applied during breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
Based on the experience of the clinical studies it can be concluded that the rabeprazole generally well tolerated by patients. Side effects are generally mild to moderate and are transient in nature.
Adverse reactions systematic with respect to each of the organ systems using the following classification Frequency of occurrence:
Very common (> 1/10)
Often (1/10 – 1/100)
Infrequently (1/100 – 1/1000)
Rarely (1/1000 – 1/10000)
Very rarely (
Disorders of immune system: rarely – acute systemic allergic reaction.
Blood disorders and lymphatic system: rarely – thrombocytopenia, neutropenia, leukopenia.
Violations by the Metabolism and nutrition: rarely – hypomagnesemia.
Violations by the hepatobiliary system: rarely – increased activity of “liver” enzymes, hepatitis, jaundice, hepatic encephalopathy.
Violations by the kidneys and urinary tract: very rarely – interstitial nephritis.
Violations of the skin and subcutaneous tissue disorders: rare – bullous rash, urticaria, very rarely – erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Violations of the musculoskeletal and connective tissue disorders: rarely – myalgia, arthralgia.
Violations of the reproductive system: very rare – a gynecomastia.
Changes in other laboratory parameters during the reception of rabeprazole sodium was not observed.
When receiving proton pump inhibitors (PPIs) may increase the risk of bone fractures (see. Section “Special instructions”).
special instructions
Patient response to therapy sodium rabeprazole not exclude the presence of malignancies in the stomach.
Before and after treatment required endoscopic examinations to rule out malignancy, as treatment may mask the symptoms and defer the correct diagnosis.
Caution is recommended at the first appointment rabeprazole patients with severe hepatic impairment.
Patients with impaired renal or hepatic function dose adjustment is required Hayrabezol preparation. AUC rabeprazole sodium in patients with severe impairment of liver function is approximately two times higher than in healthy patients.
The drug has no effect on thyroid function, carbohydrate metabolism, concentration in blood parathyroid hormone, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretin, glucagon, follicle stimulating hormone, luteinizing hormone, renin, aldosterone, and growth hormone.
According to observational studies of treatment with proton pump inhibitors may lead to an increased risk of osteoporosis-related fractures of the hip, wrist and spine. The risk of fracture was increased in patients receiving high doses of proton pump inhibitors year or more.
The content of a minimum amount of carbohydrates is to assign the drug to patients with diabetes.
Effects on ability to drive and perform other activities that require concentration and speed of psychomotor reactions
Based on the features of the pharmacodynamics of rabeprazole and its profile of adverse effects, it is unlikely that the drug Hayrabezol affects the ability to drive and perform other activities that require concentration and speed of psychomotor reactions. However, in case of drowsiness, vertigo should avoid these activities.
Storage conditions
In a dry place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Dosing and Administration
Tablets should not be chewed Hayrabezol drug or grind. The tablets should be swallowed whole. It was found that neither the time of day nor food intake does not affect the activity of rabeprazole.
In gastric ulcer in the acute stage and anastomotic ulcer recommended ingest 20 mg once a day. Typically, recovery occurs after 6 weeks of treatment, but in some cases the duration of treatment can be extended for 6 weeks.
When duodenal ulcer in the acute stage is recommended to be taken orally 20 mg once a day. The duration of treatment is from 2 to 4 weeks. If necessary, the duration of treatment can be extended for another 4 weeks.
In the treatment of erosive gastroesophageal reflux disease (GERD) or reflux esophagitis recommended to ingest 20 mg once a day. The duration of treatment is from 4 to 8 weeks. If necessary, the duration of treatment can be extended for another 8 weeks.
When maintenance therapy of gastroesophageal reflux disease (GERD) is recommended to ingest 10 mg or 20 mg once a day. The duration of treatment depends on the patient’s condition.
When non-erosive gastroesophageal reflux disease (NERD) recommended ingest 10 mg or 20 mg once a day.
If after four weeks of treatment, the symptoms do not disappear, it should be further study of the patient. After the relief of symptoms in order to prevent their further occurrence should take the drug orally at a dose of 10 mg once daily on demand.
For the treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion, dose picked individually. Starting dose – 60 mg a day, and then increase the dose administered drug dose to 100 mg per day in single or receiving 60 mg twice a day. For some patients, the fractional drug dosing is preferred. Treatment should continue as clinically necessary. Some patients with Zollinger-Ellison rabeprazole treatment duration of up to one year.
For the eradication of Helicobacter pylori, it is recommended to be taken orally 20 mg twice a day in a specific pattern with the appropriate combination of antibiotics. Treatment duration was 7 days.
Patients with renal and hepatic impairment
Dose adjustment for patients with renal failure is required.
Patients with mild to moderate hepatic impairment rabeprazole concentration in blood is generally higher than in healthy patients.
In appointing Hayrabezol drug to patients with severe hepatic insufficiency Caution should be exercised.
elderly patients
correction dose is not required.
Children
Safety and efficacy of rabeprazole in children aged 12 years and over is set for short-term (up to 8 weeks) treatment of GERD. The recommended dose for children aged 12 years and older is 20 mg 1 time per day for up to 8 weeks. The safety and efficacy of rabeprazole for use in other indications has not been established for pediatric patients.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

HAYGLANS

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