Rabizol 20 Tablet ACME Treatment of stomach ulcer, duodenum (5 blisters x 10 tablets)
Dosage form Box of 5 blisters x 10 tablets
Specifications Rabeprazole
Ingredient
| Composition information | Content |
| Rabeprazole | 20mg |
Uses
indications
Rabizol 20 Tablet is indicated in the following cases:
Antibiotics: After taking a dose of 20 mg of sodium Rabeprazol, the acid secretion effect begins within 1 hour, the maximum efficiency is achieved within 2 - 4 hours. The acid secretion effect in the normal condition of the stomach and the condition is stimulated by the food of the sodium Rabeprazol at 23 hours after the first dose is 69% and 82% and the inhibitory time lasts up to 48 hours. The effectiveness of sodium Rabeprazol on a mild acid secretion with a repeated dose once a day, achieving stable inhibition state after 3 days. When the drug is stopped, normal acid secretion is back after more than 2-3 days.
Reducing stomach acid due to any form, including proton pump inhibitors like Rabeprazol, increases the number of permanent bacteria in the digestive tract. Proton pump inhibitors may increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
Effects on serum gastrin concentration: In clinical studies, patients are treated once a day with 10 or 20 mg of sodium Rabeprazol, for up to 43 weeks, serum galastin levels increase in the first 2-8 weeks reflect the acid secretion and stability during the next treatment period. Gastrin value returns to the level before treatment, usually within 1-2 weeks after stopping treatment.
Stomach biopsy in the caves and the bottom from more than 500 patients treated with Rabeprazol or comparative drug for 8 weeks shows no change in ECL cell tissue, gastritis level, the incidence of gastritis atrophy, intestinal transfer or the distribution of H. pylori bacteria. In more than 250 patients after 36 months of continuous treatment, observation shows no significant change.
Other effects: The systemic effect of the sodium rabeprazole on the central nervous system, the cardiovascular and respiratory system is not known. Treatment with Rabeprazol sodium dose of 20 mg for 2 weeks has no effect on the thyroid function, carbohydrate metabolism, or the level of circulation of parathyroid hormones, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretine, glucagon, fsh hormone, FSH Hormone LH, Renin, Aldosterone or growth hormone.
Studies in healthy people show that sodium Rabeprazol has no clinical interaction with amoxicillin. Rabeprazol does not adversely affect the plasma concentration of amoxicillin or clarithromycin when treated in combination to kill H. pylori bacteria in the above digestive tract.
During treatment with anti -secretions, serum galastin levels increased to respond to acid secretion. CGA also increased due to decrease in stomach acid levels. Increasing CGA levels can be imposed on diagnosis of endocrine nerve tumors.
The published evidence shows that proton pump inhibitors should be discontinued from 5 days to 2 weeks before CGA measurement. This is to increase CGA levels after treatment with PPI back to normal.
pharmacokinetics
absorption:
Rabeprazol's absorption only starts after the pills pass through the stomach. The rapid absorption, with the peak of rabeprazol plasma occurs about 3.5 hours after taking the dose of 20 mg. The peak concentration in plasma (CMAX) and AUC is linearly between 10 mg to 40 mg. The absolute bioavailability of a 20 mg of oral dose (compared to intravenous injection) is about 52% due to a large part of the liver transformed for the first time. In addition, bioavailability does not increase when the dose is repeated. In healthy people, the duration of plasma waste of the drug is about an hour (about 0.7 - 1.5 hours), and the total body clearance is 283 ± 98 ml/min. There is no clinical interaction related to food. Food and time of drug use does not affect the absorption and treatment effects of Rabeprazol.
Distribution:
rabeprazol binds to plasma proteins is about 97%.
Metabolism and elimination:
Rabeprazol as well as other drugs in the Proton pump inhibitors (PPI), metabolized by Cytochrom P450 (CYP450), liver metabolism system. In human in vitro studies show that rabeprazol is metabolized by isenzyme of CYP450 (CYP2C19 and CYP3A4). In these studies, at the plasma concentration of rabeprazol is not inductance and does not inhibit CYP3A4; And although in vitro studies may not always predict the condition that occurs in the body, these studies indicate that there is no interaction between Rabeprazol and Cyclosporin. In the human body, Thiioether (M1) and carboxylic acid (M6) are the main metabolites in plasma, along with secondary metabolites such as sulphon (M2), Desmethyl-Tioether (M4) and conjugated mercapturic acid (M5) observed at lower concentrations. Only Desmethyl metabolites (M3) have a weak excretion effect, but it is not detected in plasma.
After taking a single dose of 20 mg Rabeprazol, no Rabeprazol discovers in the form of unchanged form are excreted through the urine. About 90% of the dose is eliminated in the urine, mainly in the form of two metabolites: combined mercapturic acid (M5) and carboxylic acid (M6), plus two unknown metabolites. The rest of the dose is eliminated through feces.
Sex: Adjustment by body weight and height, there is no significant difference in pharmacokinetic parameters after taking the dose of 20 mg Rabeprazol in both men and women.
Patients with renal dysfunction: In stable patients, enduring stage, renal failure requires cycle of cycle (creatinine clearance
Patients with liver dysfunction: After taking a single dose of Rabeprazol's single 20 mg for patients with mild -up to moderate chronic liver failure, the AUC doubled and the sale time increased by 2-3 times higher than healthy volunteers. However, at a dose of 20 mg daily in 7 days, AUC only increased by 1.5 times and CMAX increased by 1.2 times. Rabeprazol's waste sale time in patients with hepatic impairment is 12.3 hours compared to 2.1 hours in healthy volunteers. Pharmacological response (gastric pH control) in two groups is clinically equivalent.
The elderly: Rabeprazol's excretion has somewhat decreased in the elderly. After 7 days of taking the drug at a dose of 20 mg of Rabeprazol daily, AUC has nearly doubled, CMAX increased by 60% and T1/2 increased to about 30% compared to healthy volunteers. However, there is no evidence of the accumulation of Rabeprazol.
The polymorphic phenomenon of the CYP2C19 gene: After 7 days of taking the drug at a dose of 20 mg of Rabeprazol daily, in people with poor metabolic CYP2C19 enzymes, with AUC increased by 1.9 times and T1/2 increased by 1.6 times compared to the corresponding parameters in people with strong metabolic yeast, while CMAX has only increased by 40%.
Before taking Rabizol 20 Tablet ACME Treatment of stomach ulcer, duodenum (5 blisters x 10 tablets)
How to use
oral medication, rabeprazol should be swallowed, not chewing, crushing or breaking.
Dosage
adults/the elderly:
Active duodenal ulcer and benign stomach ulcer: The recommended dose is 20mg, once a day in the morning.
Most duodenal ulcer patients active within 4 weeks. However, a small number of patients may need another 4 weeks of treatment for ulcers to be healed. Most patients with benign stomach ulcers are healthy within 6 weeks. However, a small number of patients may need an additional 6 weeks of treatment for ulcers to be healed.
Gastroesophageal reflux disease/erosion (Gord): The recommended dose is 20mg, once a day for 4 - 8 weeks.
Long -term maintenance treatment of gastroesophageal reflux - esophagus: For long -term treatment, the recommended dose is 20 mg or 10 mg x1 times/day depending on the response of the patient.
Treatment of symptoms in gastroesophageal reflux - very severe - very severe: recommended dose is 10 mg x 1 time/day in patients without esophagitis. If symptoms are not controlled for 4 weeks, patients need to be diagnosed again. Once the symptoms have been resolved, the symptom control can then be achieved by the required diet and the dose of L0 mg once daily when necessary.
Zollinger - Ellison syndrome: The recommended starting dose is 60 mg, once a day. The dose may increase to 100 mg x 1 time/day or 120 mg x 2 times/day based on the patient's needs. Treatment should continue according to clinical indications.
Combining in H. pylori treatment regimen: H. pylori infected patient should be treated with eradication therapy. The following combination is recommended in 7 days:
Rabeprazol 20 mg, twice daily + Clarithromycin 500 mg x 2 times/day and amoxicillin 1g x 2 times/day.
For treatment indications 1 time/day, should take Rabeprazol tablets in the morning, before eating.
Although the time to use drugs and food does not affect the effects of the drug, this regimen will help patients follow treatment.
Patients with kidney failure and liver failure:
No need to adjust the dose in patients with renal failure or liver failure.
Children:
Rabeprazol is not recommended for children, has no experience in using drugs in this patient group.
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 do
do when overdose? The maximum dose is set not exceeding 60 mg twice daily, or 160 mg once daily. The general effects are small, characterized by unwanted effects that have been known and can recover without medical intervention.
There is no specific antidote to Rabeprazol. Rabeprazole is strongly linked to plasma proteins, so it does not perform blood decomposition. Like other overdose cases, symptomatic treatment and appropriate support measures should be taken.
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. Do not drink twice as prescribed.
Side Effects
When using Rabizol 20 Tablet, you may experience unwanted effects (ADR).
Common, ADR> 1/100
General and on -site: weakness, influenza symptoms.
Uncommon, 1/1000 Skin and subcutaneous tissues: rash, erythema. Testing: increased liver enzymes. Rare (1/10,000 Skin and subcutaneous tissues: itching, sweating, water ball reaction. Very rare, ADR> 1/10,000 Unknown frequency Blood vessels: Foreign angioedema. Skin and subcutaneous tissues: Lupus erythematosus in skin. Instructions on how to handle ADR Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Rabizol 20 tablet drugs are contraindicated in the following cases:
Be cautious when used
Rabeprazol treatment response can cover the symptoms of stomach cancer. Therefore, it is necessary to rule out the possibility of cancer before using the drug.
Patients with long -term treatment (especially those who treat for more than a year) should be monitored regularly.
There is a risk of diagonal hypersensitivity between rabeprazol and other proton pump inhibitors or benzimidazol derivatives.
Patients should be warned that Rabeprazol tablets should be swallowed whole, should not chew or crush.
Rabeprazol is not recommended for children, has no experience in using drugs in this patient group.
There have been reports on hematopoietic disorders after the product to the market (platelets and leukopenia). In most cases, other causes are not determined, cases are without complications and treatment by stopping rabeprazol
Liver enzyme abnormalities have been seen in clinical trials and has also been reported since the product to the market. Of the majority of other schools, other causes are not identified, cases are unexplicated and managed by stopping rabeprazol.
There is no evidence of drug safety related to a clinical trial in patients with mild to moderate liver failure compared to normal people of the same age and gender. However, because there is no clinical data on the use of rabeprazol in patients with severe liver dysfunction, doctors should be careful when treating Rabeprazol for the first time in these patients.
Do not use Atazanavir at the same time with rabeprazol.
Treatment with proton pump inhibitors, including rabeprazol, may increase the risk of gastrointestinal infections such as Salmonella infection, campylobacter and clostridium difficile. Proton pump inhibitors, especially when taking high doses and for a long time (> 1 year), may increase the risk of hip, wrist and spine fractures, especially in elderly patients or when the presence of other risk factors. Observatory studies show that proton pump inhibitors may increase the overall risk of fractures by about 10 -40%. Part of this increase may be due to other risk factors. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and should be added with an appropriate amount of vitamin D and calcium. There have been reports on serious reduction of blood magnesium in patients treated with proton pump inhibitors (PPI) such as Rabeprazol for at least 3 months, and in most cases is for 1 year. The severe manifestation of blood magnesium reduced blood such as fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhythmia may occur but silently started and not concerned. In most patients, blood magnesium reduction is improved after using magnesium instead and stop using PPI.
For patients who need prolonged treatment or patients with simultaneous use of ppi and digoxin or other drugs that can cause blood magnesia (such as diuretics), medical staff should consider quantifying blood magnesium levels before starting PPI treatment and periodic monitoring during treatment.
Simultaneous use Rabeprazol with methotrexate
Documents show that the simultaneous use of ppi drugs with methotrexate (mainly at high doses) can increase and prolong its concentration of methotrexate and / or its metabolic substance, which can lead to methotrexate poisoning. While treating with high doses of methotrexate, temporary suspension of PPI may be considered in some patients.
affect the absorption of vitamin B12
Rabeprazol sodium as well as all antacids, which can reduce the absorption of vitamin B12 (cyanocobalamin) due to a reduction or lack of gastric acid. This should be considered in patients who have a reduction in vitamin B12 reserves or have risk factors for reducing vitamin B12 absorption when treated long -term or when clinical manifestations of vitamin B12 deficiency.
Select acute erythematosus lupus (SCLE)
Proton pump inhibitors are very frequent to SCLE cases. If the damage occurs, especially in the skin -exposed skin areas, and if it comes with joint pain, patients should see a doctor for timely help and a doctor should consider stopping Rabeprazol. SCLE after treatment with a proton pump inhibitor can increase the risk of SCLE with other proton pump inhibitors.
affects the test:
Increased chromographin A (CGA) concentration can interfere with the detection of endocrine nerve tumors. In order to avoid this intervention, should temporarily stop treatment with Rabeprazol at least five days before quantifying CGA. If CGA and Gastrin level do not return to the reference limit after the first measurement, the test should be repeated 14 days after stopping treatment with proton pump inhibitors.
The ability to drive and operate machinery
Based on the pharmacokinetics and data on unwanted effects, not sure that Rabeprazole has the ability to drive and operate machinery. However, if the patient feels sleepy, not awake, you should not drive or operate machinery.
Pregnancy
There is no data on Rabeprazol's safety during pregnancy.
Rice and rabbits have shown no evidence of the ability to impair fertility or damage to the fetal of sodium rabeprazol, although the drug is low in mice. Rabeprazol is contraindicated in women during pregnancy.
The period of breastfeeding
It is unclear whether Rabeprazole will be excreted in breast milk. There has been no research on medication in breastfeeding women. However, Rabeprazol is excreted in the milk of the mouse. So rabeprazol should not be used in women who are breastfeeding.
Drug interaction
Rabeprazole sodium causes strong and long -term inhibition to the secretion of stomach acid. It is possible to interact with absorption drugs depending on the stomach pH. Simultaneous use of sodium rabeprazole with ketoconazole or otraconazole can significantly reduce antifungal concentration. Therefore, patients may need to be monitored to determine whether to adjust the ketoconazole or iTraconazole dose when used simultaneously with rabeprazol.
In clinical trials, antacids are used simultaneously Rabeprazol and, in a specific drug interaction study - a specific drug, does not observe the interaction between Rabeprazol and liquid antacids.
Sometimes, Atazanavir 300 mg/ritonavir 100 mg with omeprazol (40 mg once a day) or Atazanavir 400 mg with Lansoprazol (60 mg once a day) on healthy volunteers has significantly reduced the blood concentration of Atazanavir. The absorption of Atazanavir depends on the pH. Although not studied, similar results are predicted with other proton pump inhibitors. Therefore, PP1, including Rabeprazol, should not be used with Atazanavir. Methotrexate: Cases of reporting, pharmaceutical research are added, and rescue analysis shows that simultaneous use of ppi and methotrexate (mainly at high doses) may increase and prolong its concentration However, there is no official drug interaction research of Methotrexate with PPI.
Storage
Store at temperatures below 30 ° C, avoiding light and humidity.
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