Rabeto 40mg Fiamingo medicine for gastroesophageal reflux treatment (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Rabeprazole

Ingredient

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Composition information	Content
Rabeprazole	40mg

Uses

Indications

Rabeto - 40 is indicated in the following cases:

Treatment of gastroesophageal reflux disease, esophagus or ulcerative (GERD)

Rabeto - 40 is indicated for short -term treatment (4 to 8 weeks) to heal and all symptoms of gastroesophageal reflux disease - esophagus or ulcer (GERD). For patients with pain after 8 weeks of treatment, an additional treatment can be considered with Rabeto-40 in 8 weeks.

Maintain gastroesophageal reflux disease - esophagus or ulcer (GERD)

Rabeto - 40 is indicated to maintain healing and reduce the rate of heartburn symptoms in patients with gastroesophageal reflux disease - esophagus or ulcer (GERD).

The verified studies do not last for more than 12 months.

Treatment of gastroesophageal reflux disease (GERD)

Rabeto - 40 is indicated for adults and teenagers 12 years or older to treat heartburn day and night and other symptoms combined with gastroesophageal reflux - esophagus or ulcer.

Heals duodenal ulcers

Rabeto - 40 is indicated for short -term treatment (maximum 4 weeks) to heal and all symptoms of duodenal ulcer. Most patients cure within 4 weeks.

Treatment of pathological secretion, including Zollinger - Ellison syndrome

Pharmacokology

Rabeprazol belongs to the anti -secreting compound group (replaced Benzimidazol Proton Benzimidazol pump) has no anti -cholinergic or antagonistic effect of Histamine H2 but blocked stomach acid secretions due to H+/K+ ATPase in the secret surface of the stomach cell.

Because this enzyme is considered a pump (proton) acid in the wall of the wall, Rabeprazol is identified as a type of stomach proton pump inhibitor. Rabeprazol sealed the final step of gastric acid secretion.

In the stomach wall, Rabeprazol is protonized, accumulated and transformed into an active sulfenamid. In research in test tubes, Rabeprazol is activated in chemicals at pH 1,2 with half a lifetime of 78 seconds. It inhibits the transportation of acid in pig gastric bags with half a 90 seconds.

Anti -secret activity

Anti -secreting effect begins within 1 hour after taking 20 mg Rabeprazol. The average inhibitory effect of rabeprazol on gastric acid acidity for 24 hours is 88% of the maximum level after the first time. Rabeprazol 20 mg inhibits acid secretion by peptone meal and is basically compared to Placebo with 86% and 95%, corresponding and increasing the percentage of the 24 -hour period and stomach pH> 3 is from 10% to 65%. Pharmacological effects are relatively extended compared to half a life of short pharmacokinetics (1-2 hours) reflecting the prolonged inactivity of H+, K+ ATPASE.

Effects on the exposure to acid in the esophagus

In patients with thick reflux disease and medium -sighted acid exposure, Rabeprazol 20 mg and 40 mg daily reduces exposure to the esophagus for 24 hours. After 7 days of treatment, the rate of 65% of the time when the esophagus pH

The normalization of exposure to acid in the esophagus for 24 hours is correlated with the stomach pH> 4 in at least 35% of the 24 -hour period: This level is achieved in 90% of patients using Rabeprazol 40 mg. With Rabeprazol 20 mg and 40 mg per day, it has seen meaningful effects on the stomach and esophagus after a day of treatment and more obvious effect after 7 days of treatment.

Effects on serum gastrin

In patients with daily dose Rabeprazol for up to 8 weeks to treat ulcerative or scratches, and in patients for a maximum of 52 weeks to prevent recurrence, gastrin average concentration rises depending on the dose. The average value of the group is still within normal range.

In a daily group of treatments with Rabeprazol 20 mg for 4 weeks, there has been a doubling of Gastrin's average concentration in serum. About 35% of these treatment subjects develop serum levels higher than the upper limit of normal.

In a study on Genotyp CYP2C19 objects in Japan, those who are less developed in serum levels are significant than strong metabolic people.

Effect on ECL cells (chromium -style cells in the intestine, enterochromaffin - like cells)

Secondary serum increase with anti -secret drugs that stimulate the proliferation of ECL cells in the stomach, over time can lead to hyperplasia ECL cells in rats and white rats and stomach carcinoid in white mice, especially in Cai mice.

In more than 400 patients treated with rabeprazol (10 or 20 mg/day) to 1 year, the rate of ECL cell hyperplasia increases over time and with doses. This is consistent with the pharmacological effects of pump inhibitors. No patient develops tumor, dysplasia or cancer changes of ECL cells in the gastric mucosa. No patient develops Carcinoids to comment in white rats.

Endocrine effects

Human research for up to 1 year does not detect clinical significance on the endocrine system. In a healthy male volunteer for treatment with Rabeprazol for 13 days, not good changes are clinically related to the following endocrine parameters: 17 β - estradiol, hormone stimulating thyroid, thyroxin, triiodothyronin, protein gin thyroxin, hormones of the Armor, Insulin, Glucagon, Renin, Aldostoston, Hoc Hoc Huoc Hu Loil Follure, Human Follure Human Follure Follure, Loll Follure Human Human Foll ProLactin, growth hormone, dehydroepiandrosteron, globulin mounted cortisol, 6 β- hydroxycortisol urine, serum testosterone and cortisol for 24 hours.

Other effects

In treatment with rabeprazol for up to 1 year, the whole body effect on the central nervous system, lymphatic systems, hemorrhage, kidney, liver, cardiovascular or respiratory.

pharmacokinetics

After taking 20 mg Rabeprazol, the plasma peak concentration (CMAX) of Rabeprazol occurs in a range of 2 - 5 hours ~ 9 t max). CMAX and AUC of Rabeprazol linearly within the dose range of 10 mg to 40 mg every 24 hours; Rabeprazol's pharmacokinetics do not change when using many doses. Half a life of plasma moves from 1 to 2 hours.

absorption and distribution

The absolute biological use of gear intravenous drugs is 100%. Rabeprazol is attached to human plasma proteins at 96.3%.

Metabolism

rabeprazol metabolizes strongly. Thioether and suffon are the main metabolites measured in human serum. These metabolites have no significant anti -secret activity. Research in test tubes shows that Rabeprazol is metabolized in the liver mainly by cytochrom P450 3A (CYP 3A) into a SULLFON metabolic, and by CYP450, 2C19 (CYP2 C19) into Desmethyl Rabeprazol. Hioether metabolites are created without enzyme due to Rabeprazol reduction. CYP2C19 shows a genetic diversity due to a shortage in some population groups (such as 3-5% of people, white skin and 17-20% of Asians). The metabolism of rabeprazol is slow in these population groups, so they are slow metabolic.

Elimination

After 1 single dose of 20 mg of Rabeprazol marked 14 degrees radioactive C, about 90% of the drug is excreted in urine, mainly of its carboxylic acid, glucuronid, and mercapturic acid metabolites. The rest is discharged in feces. The entire recovery of radioactive activity is 99.8%. No rabeprazol has not changed in urine or feces.

Special population

Elderly

In 20 healthy elderly people after taking Rabeprazol 20 mg/day/time for 7 days, the AUC value is doubled and CMAX increases about 60% compared to the value of the young people's control group in parallel. There is no evidence of drug accumulation after use/time.

Children

There is no pharmacokinetic research of Rabeprazol in children under 18 years old.

Sex and race

In analysis that is adjusted according to the weight and height, Rabeprazol's pharmacokinetics does not show the clinical difference between men and women. In the study using different types of rabeprazol, AUC value for healthy Japanese men is about 50 - 60% larger than the value of healthy men in the US.Kidney disease

In 10 patients with kidney disease in the end stable stage, the hemorrhage should be maintained.

There is no clinical difference in pharmacokinetics of Rabeprazol after a dose of 20 mg when compared to 10 healthy volunteers.

Liver disease

In the study of a dose of more than 10 patients with mild chronic cirrhosis, which has just been adjusted for a dose of 20 mg of Rabeprazol, AUC 0 - 24 about double, half -life eliminated about 2-3 times higher and the whole body clearance drops below half of the value in healthy people.

Before taking Rabeto 40mg Fiamingo medicine for gastroesophageal reflux treatment (10 blisters x 10 tablets)

How to use

Rabeto medicine is used for oral.

must swallow Rabeto - 40 intact, not chewed, crushed or broken tablets.

Can drink Rabeto - 40 with or not with food.

Dosage

Heals gastroesophageal reflux disease - esophagus or ulcer (GERD)

The recommended dose for adults is a Rabeto tablet once a day for four to eight weeks. For patients who do not recover after 8 weeks of treatment, it is possible to consider treatment for another 8 weeks with Rabeto.

Maintain healing of gastroesophageal reflux disease - esophagus or ulcer

The recommended dose for oral for adults is a rabeto once a day.

Treatment of gastroesophageal reflux disease (GERD)

The recommended dose for adults is a rabeto tablet once a day for 4 weeks. If the symptoms do not go completely after 4 weeks, it is possible to consider treating one more batch.

Heals duodenal ulcers

The recommended dose for adults is a Rabeto tablet once a day after breakfast for a maximum of 4 weeks. The majority of patients with duodenal ulcer within 4 weeks. A few patients need additional treatment to heal.

Treatment of disease secretion, including Zollinger - Ellison syndrome

Rabeto dose for patients with diseases increased disease secretion with each patient. The recommended dose starts oral for adults is 60 mg, once a day. The dose must be adjusted depending on the needs of each patient and must continue to continue in time as directed by the clinical.

Some patients need to use smaller doses. The doses have been used up to 100 mg once a day and 60 mg twice a day. Some patients with ZoHinger - Ellison syndrome have been treated continuously with Rabeprozol for a maximum of a year.

Short -term treatment for thick skin reflux disease (GERD) in teenagers 12 years old and older

The recommended dose for oral for teenagers is 12 years old and older is a Rabeto tablet once a day for a maximum of 8 weeks.

Elderly patients, impaired renal and liver function

No dose adjustments for elderly patients, patients with renal disease or patients with mild to moderate liver function impairment. The use of rabeprazol for patients with mild liver function decreased to medium leads to an increase in exposure and reduced excretion. Due to the lack of clinical data on rabeprazol in patients with severe liver failure, caution must be cautious for these patients.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Do not know specific antidote with rabeprazol. Rabeprazole is a large part of protein and is not easy to separate in case of overdose, symptomatic treatment and support.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Rabeto - 40, you may experience unwanted effects (ADR).

around the world, there are 2,900 patients treated with Rabeprazol oral in clinical trials of stage I - II with different doses and treatment time.

An analysis of unwanted effects occurs at> 2% of patients with Rabeprazol and with a greater frequency than Placebo, showing the following unwanted effects: pain, sore throat, flatulence, bacterial, and constipation. Other undesirable effects see in clinical trials that do not respond to the above standards (> 2% of patients treated with rabeprazol and> placebo) and may be related to rabeprazol including: headache, sore throat, diarrhea, dry mouth, dizziness, peripheral edema, hepatitis, hepatitis, hepatitis, muscle pain and joint pain.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Rabeto medicine - 40 contraindicated in the following cases:

rabeprazole is contraindicated in patients with hypersensitivity to rabeprazol, replacement benzimidazols or any ingredients of the drug form.

Caution when using

responding to symptoms with Rabeprazol therapy does not prevent the presence of stomach cancer.

The presence of stomach cancer

Symptoms response to Rabeprazol therapy do not rule out the presence of stomach cancer. The patient is healed with gastroesophageal reflux disease to be treated for up to 40 months with Rabeprazol and is monitored with a series of gastric biopsy. Patients are not infected with H.pylori (221 of 326 patients) without clinical important pathological changes in the stomach mucosa.

Patients with H. Pylori infected at the beginning (105 in 326 patients) have mild inflammation to fit the stomach or mild inflammation in the gastric caves. Patients with a level of infection or mild inflammation in the stomach tend to turn to medium, while the patient is classified as the original tendency to be stable.

Patients with infections or mild inflammation in stomach cave tend to remain stable. In the beginning, 8% of patients had atrophy of stomach glands and 15% of patients with stomach atrophy. At the end, 15% of patients have atrophy of glands in the stomach and 11% have atrophy in the stomach cave. About 4% of patients have intestinal abnormalities at some points while continuing but not noticing a consistent change.

Used for the elderly

In general, there is no difference in safety and effectiveness between the elderly and young people.

Renal function impairment

No dose adjustment in patients with renal function impairment.

Liver function impairment

No dose adjustments in patients with mild liver function impairment are needed. Due to the lack of clinical data on rabeprazol in patients with severe liver function, it is necessary to be cautious for these patients.

The ability to drive and operate machinery

No report.

Pregnancy

There is no adequate and good test in pregnant women. Because animal reproduction research does not always predict response on humans, only use this medication during pregnancy if necessary.

Breastfeeding period

Because the drug is secreted in breast milk, be cautious when using Rabeprazol for breastfeeding women.

Drug interaction

The drug is metabolized by CYP 450

Rabeprazol is metabolized by Cytochrom P450 (CYP 450) which is an enzyme system that metabolizes drugs. Research on healthy objects shows that Rabeprazol does not have clinical interactions with other drugs metabolized by CYP450, such as Warfarin and Theophyllin with single dose, diazepam using single -vein injection dose, and phenytoin using single intravenous doses (for supplemental oral use). There is no drug interactive research in the stable state of rabeprazol and other drugs metabolized by this enzyme in patients.

warfarin

There is a report on Inr and Prothrombin 6 patients who use proton pump inhibitors, including rabeprazol and warfarin simultaneously. The increase in Inr and the time of prothrombin can lead to abnormal bleeding and even death.

cyclosporin

Into in vitro using microsom liver shows that rabeprazol inhibits the metabolism of cyclosporin with IC 50 (50%inhibitor concentration) is 62 mircomol, a concentration of 50 times higher than CMAX (maximum concentration) in healthy volunteers after 14 days using 20 mg Rebeprazol with equivalent concentration.

The compound depends on the stomach pH to absorb

Rabeprazol causes prolonged inhibition of stomach acid secretion. An interaction with compounds depends on the stomach pH to absorb due to high level of acid secretion by Rabeprazol. For example, in normal objects, simultaneous use of Rabeprazol 20 mg/day gradually led to a reduction of about 30% of ketocomazol's bioavailability and increasing AUC and CMAX with 19% and 29%, respectively. Therefore, it is necessary to monitor patients when using these drugs simultaneously with rabeprazol. The simultaneous use of rabeprazol and antacids does not change the plasma rabeprazol levels related to clinical.

It is not recommended to simultaneously use Atazanavir and proton pump inhibitors. The simultaneous use of Atazanavir with proton pump inhibitors can reduce plasma acanavir concentrations and thus reduce treatment effects.

Metabolic drug by CYP2C19

In a clinical study in Japan, to evaluate Rabeprazol in patients classified as genotyp CYP2C19 (n = 6 According to genotyp type), gastric acid blockers are higher than people with poor metabolic people than in strong metabolic people. This may be due to a higher plasma rabeprazole in poor metabolic people. There is no drug interactive study of sodium Rabeprazol with other drugs metabolized by CYP2C19 to see if there is a vary in strong metabolic and weak metabolic people.

Storage

in a dry place, temperatures below 30 ° C, avoiding light.

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