Razo tab n / an kish.rastv. 10 mg 15 pcs

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Razo tab n / an kish.rastv. 10 mg 15 pcs

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Description

Composition
Active substance:
1 tablet contains: Rabeprazole sodium 10 mg;
Excipients:
Mannitol, low substituted giproloza, heavy magnesium oxide, hypromellose (5cps), sodium lauryl sulfate, talc, magnesium stearate. Sheath: zein, triethylcitrate. Sheath enteric: methacrylic acid-ethyl acrylate copolymer [1: 1] (methacrylic acid copolymer (type C)), triethyl citrate, talc. Coating: Opadry pink 03B54475 (hypromellose 6 cP, Titanium dioxide (E171), macrogol 400, iron oxide red dye (E172)). Composition of black ink for inscribing the tablet 10 mg: 45% shellac glaze, iron oxide black dye (E172), isopropyl alcohol, n-butanol, propylene glycol, concentrated ammonia solution 28%.
Description:
Round, biconvex tablets, coated from pink to brownish-pink color with black markings «RB10» colors on one side. The cross-sectional core from white to almost white color.
Product form:
The tablets, enteric-coated tablets, 10 mg.
15 tablets from a blister (PVC / AL / PA) foil / aluminum foil. 1 or 2 blisters together with instructions for use in a cardboard pack.
At 15 or 30 tablets of a high density polyethylene jars with screw neck provided with a membrane to control the first opening, sealed with plastic screw cap with a gasket and a package embedding a desiccant (silica gel) and polyester cotton swab. Each of the bank together with instructions for use in paper cartons.
Contraindications
Hypersensitivity to rabeprazole, substituted benzimidazoles or auxiliary components of the drug; pregnancy; breastfeeding; Children up to age 18 years.
Carefully.
Severe renal insufficiency.
Dosage
10 mg
Indications
The symptoms of dyspepsia associated with acidity of gastric juice, including symptoms of gastroesophageal reflux disease (heartburn, acid regurgitation).
Interaction with other drugs
450 cytochrome system.
Rabeprazole, as well as other proton pump inhibitors (PPI), is metabolized with the cytochrome P450 (CYP450) in the liver. In in vitro studies of human liver microsomes, it was shown that rabeprazole metabolized isozymes CYP2C19 and CYP3A4.
Studies in healthy volunteers have shown that rabeprazole has or clinically significant pharmacokinetic interactions with drugs that are metabolized by the cytochrome P450 system – warfarin, phenytoin, theophylline and diazepam (regardless of whether patients metabolize diazepam strongly or weakly).
A study of combination therapy with antibacterial agents. In this four-way crossover study involved 16 healthy volunteers who received 20 mg rabeprazole, 1000 mg amoxycillin 500 mg clarithromycin, or a combination of these three preparations (CANCER – rabeprazole, amoxicillin, clarithromycin). Indicators for AUC and Cmax of clarithromycin and amoxicillin were similar when compared to combined therapy with monotherapy. Indicators for AUC and Cmax rabeprazole increased by 11% and 34%, respectively, and for 14-hydroxy-clarithromycin (the active metabolite of clarithromycin) AUC and Cmax increased by 42% and 46%, respectively, for the combination therapy versus monotherapy. This increase in impact indicators for rabeprazole, and clarithromycin was found to be clinically significant.
Interactions due to the inhibition of gastric acid secretion.
Rabeprazole provides sustainable and long-lasting inhibition of gastric acid secretion. Thus, there may be an interaction with substances for which absorption is independent of pH. Together with the admission ketoconazole rabeprazole absorbance is reduced by 30% and the absorption of digoxin is increased by 22%. Consequently, for some patients, observation should be conducted to solve the problem of the need to adjust dosages, while the application of rabeprazole ketoconazole, digoxin or other medicinal preparations, for which the absorption is dependent on pH.
Atazanavir.
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 depends on pH. While the simultaneous reception rabeprasol not studied, similar results are expected also for other proton pump inhibitors. Thus, without the simultaneous application of atazanavir with proton pump inhibitors, including rabeprazole.
Antacids funds.
In clinical trials, antacids were used in conjunction with rabeprazole. Clinically relevant interaction of rabeprazole with aluminum hydroxide gel or magnesium hydroxide were observed.
Meal.
In a clinical study in the application of rabeprazole depleted in fats with clinically significant interaction with food was observed. Receiving rabeprazole simultaneously with food rich in fats may slow the absorption of rabeprazole up to 4 hours or more, but Cmax and AUC are not changed.
Cyclosporine.
The experiments in vitro using human liver microsomes showed that cyclosporin inhibits metabolism rabeprazole IC50 with 62 micromol, i.e. at a concentration 50 times higher than the Cmax for healthy volunteers after 20 days of 20 mg of rabeprazole. The degree of inhibition is similar to that of omeprazole for equivalent concentrations.
Methotrexate.
According to reports of adverse events, according to the published pharmacokinetic studies and retrospective analysis suggests that simultaneous reception of IPP and methotrexate (particularly in high dosage) may lead to increased concentrations of methotrexate / or its metabolite gidroksimetotreksata and increase half-life. However, special studies of drug interactions with methotrexate IPP was conducted.
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 did not require medical intervention.
Treatment. The specific antidote for rabeprazole is unknown. Rabeprazole well bound to plasma proteins so poorly displayed during dialysis. In case of overdose should be carried out is symptomatic and supportive treatment.
pharmachologic effect
Pharmacological group:
Means lowering the secretion of the glands of the stomach – a proton pump inhibitor.
Pharmacodynamics:
Mechanism of action.
Rabeprazole relates to a class of antisecretory agents which chemically are substituted benzimidazoles. Rabeprazole 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.
Rabeprazole has no anticholinergic properties.
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 was 62% and 82%, respectively, and lasts up to 48 hours. This duration pharmacokinetic activities far exceed predictable on half-life (T1 / 2), which is approximately 1 hours. This effect can be explained by binding of the drug with h + / K + ATPase of the parietal cells of the stomach. The magnitude of rabeprazole inhibitory effect on acid secretion reached a plateau after three days of rabeprazole. 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 enterochromaffin-like cell.
Study biopsies bottom and antrum in more than 500 patients receiving rabeprazole or drug comparisons for up to 8 weeks showed no change in the morphological structure of enterochromaffin-like (ECL) cells, severity of gastritis, incidence of atrophic gastritis, intestinal metaplasia or prevalence of Helicobacter pylori infection .
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.
Currently, 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, carbohydrate metabolism as well as on blood concentrations 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 the maximum plasma concentration (Cmax) is achieved after about 3.5 hours after ingestion of 20 mg. Changing the values ​​of Cmax and the area under the curve “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. Receiving rabeprazole with fatty food slows the absorption of rabeprazole for 4 hours or more, but no Cmax, nor the extent 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.
Withdrawal.
After a single oral administration of 20 mg of rabeprazole 14C-labeled about 90% of rabeprazole excreted by the kidneys, preferably in the form of a thioether carboxylic acid and its glucuronide as derivatives mercapturic acid. Rabeprazole unchanged in the urine is not defined. The remaining portion of the received rabeprazole displayed through the intestines. The total elimination of 99.8%.
End-stage renal failure.
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%, compared to 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 accumulation of rabeprazole were noted.
CYP2C19 polymorphism.
Patients with sustained metabolism by CYP2C19 isozyme 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 while 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. Razo® The drug 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 passes into 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 lactating women.
Conditions of supply of pharmacies
Without recipe.
side effects
Rabeprazole is usually well tolerated by patients. Side effects are generally mild to moderate and are transient in nature.
When receiving rabeprazole in clinical trials were observed following side effects: headache, abdominal pain, diarrhea, meteorism, constipation, dry mouth, dizziness, rash, peripheral edema.
The incidence of side effects is described according to the following gradation: very often (> 1/10); often (1/10 – 1/100); infrequently (1/100 – 1/1000); rarely (1/1000 – 1/10000); very rarely (
Violations by the 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 of the kidneys and urinary tract.
Very rarely – interstitial nephritis.
Violations of the skin and subcutaneous tissue.
Rare – bullous rash, urticaria; very rarely – erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Violations by musculoskeletal and connective tissue.
Rarely – myalgia, arthralgia.
Violations by the reproductive system.
Very rare – a gynecomastia.
Changes in laboratory parameters during the reception of rabeprazole was observed.
When receiving proton pump inhibitors may increase the risk of bone fractures (see. Section “Special Instructions”).
special instructions
the patient’s response to therapy rabeprasol not exclude the presence of malignancies in the stomach.
Tablets should not be chewed Razo® 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 a special study in patients with mild or moderate hepatic impairment did not have the side effects of frequency found significant differences rabeprazole from that of matched by sex and age healthy people, but despite this, it is advisable to use caution during the first use of rabeprazole in patients with severely impaired liver function. AUC of rabeprazole in patients with severe hepatic impairment is approximately two times higher than in healthy patients.
Patients with impaired renal or hepatic function rabeprazole dose adjustment is required.
Hypomagnesemia.
In the treatment of proton pump inhibitors for at least 3 months in rare cases it has been noted cases of symptomatic or asymptomatic hypomagnesemia. In most cases, these messages are received a year after therapy. Serious adverse events were tetany, arrhythmias and seizures. Most patients required treatment hypomagnesemia consisting of magnesium substitution, discontinuation proton pump inhibitors. Patients who will receive long-term treatment or who are taking proton pump inhibitors with agents such as digoxin or drugs that can cause hypomagnesemia (e.g. diuretics), medical personnel need to monitor magnesium levels before treatment with proton pump inhibitors and in the treatment period.
Patients should not receive simultaneously with other means rabeprazole, reducing acidity, e.g., H2 receptor blockers or proton pump inhibitors.
Fractures of the bones.
According to observational studies suggest that treatment with proton pump inhibitors may lead to an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients receiving high doses of PPIs long-term (one year or more).
Simultaneous application of rabeprazole with methotrexate.
According to the literature, simultaneous IPP with methotrexate (particularly in high dosage) may lead to increased concentrations of methotrexate and / or its metabolite gidroksimetotreksata and increase half-life, which can lead to the manifestation of toxicity of methotrexate. If necessary, use of high doses of methotrexate may be considered temporary cessation therapy IPP.
Clostridium difficile.
PPI therapy may lead to increase risk of gastrointestinal infections such as Clostridium difficile.
Patients taking rabeprazole for short-term symptomatic treatment of the manifestations of GERD and NERD (eg heartburn) without a prescription, you should consult your doctor in the following cases:
– application means for relieving symptoms of heartburn and indigestion for 4 weeks or more;
– the appearance of new symptoms or a change in the previously observed symptoms in patients over the age of 55 years;
– cases of involuntary loss of body weight, anemia, bleeding in the gastrointestinal tract, dysphagia, pain on swallowing, persistent vomiting or vomiting with blood, and the contents of epigastric, cases of stomach ulcers or operations on the stomach of a history of jaundice, and so on (including , the liver and kidney).
Patients suffering from long-term recurrent symptoms of indigestion or heartburn should be monitored regularly by a doctor. Patients over the age of 55 years, every day taking OTC drugs for relieving symptoms of heartburn and digestive disorders should inform their physician.
Patients should not receive simultaneously with other means rabeprazole, reducing acidity, e.g., H2-receptor blockers or proton pump inhibitors.
When using other medications patients should consult with a physician or pharmacist before rabeprazole therapy nonprescription.
If the patient is already scheduled endoscopy, the patient should consult a doctor before starting the use of rabeprazole without prescription.
Should avoid taking rabeprazole before the urea breath test.
Patients with severely impaired liver function should consult a physician before rabeprazole therapy nonprescription, for short-term symptomatic treatment of the manifestations of GERD and NERD (e.g., heartburn).
Effects on ability to drive and use machines.
Based on the features of the pharmacodynamics of rabeprazole and its profile of adverse effects, it is unlikely that rabeprazole has an impact on the ability to drive and perform other activities that require concentration and speed of psychomotor reactions. However, in case of drowsiness, dizziness, avoid these activities.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children!
Dosing and Administration
Inside, 10 mg (1 tablet) once daily.
Tablets should not be chewed Razo® drug or grind.
The tablets should be swallowed whole. It is recommended taking the drug in the morning before eating.
It was found that neither the time of day nor food intake does not affect the activity of rabeprazole, but the recommended time of taking the pills Razo® contributes to better patient compliance.
If no effect during the first three days of treatment requires specialist inspection. Maximum treatment without consulting a doctor – 14 days.
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

DR.REDDIS

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