Rabesime ACME medicine to treat gastroesophageal reflux, duodenal ulcer (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Rabeprazole
Ingredient
| Composition information | Content |
| Rabeprazole | 20mg |
Uses
Indications
Rabesime 20mg drug is indicated in the following cases:
ATC code: A02b C04.
Mechanism of action: Rabeprazole sodium belongs to the group of anti-excreted compounds (benzimidazole), has no antihistamine effect in H2 receptor or cholinergic resistance, but prevents gastric acid secretion due to inhibition of enamel H+-K+-Aatpase (acid or proton pump). The effect is related to the dose and leading to acid secretion in both normal conditions and when stimulated.
Animal research shows that after drinking Rabeprazole sodium quickly disappears both in the blood and in the stomach mucosa. As a weak base, Rabeprazole is absorbed quickly after all the doses and is concentrated in the acidic environment of the cell into the stomach. Rabeprazole is converted into activated sulfonamid through protons and then it links to cysteine available on the proton pump.
Other effects: The systemic effect of Rabeprazole sodium on the central nervous system, the cardiovascular and respiratory system is not known. Treatment with Rabeprazole sodium dose of 20mg in 2 weeks has no effect on the thyroid function, carbohydrate metabolism, or the level of circulating of the hormone, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretine, glucagon, fsh hormone, fsh hormon LH, renin, aldealon or growth hormone.
pharmacokinetic
absorption
Rabeprazole's absorption only starts after the tablet passes through the stomach. The rapid absorption, with the peak of rabeprazole plasma, occurs about 3.5 hours after taking the dose of 20mg. The peak concentration in plasma (CMAX) and AUC is linearly in the dose of 10 - 40mg. The absolute bioavailability of a 20mg 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 drug time do not affect the absorption and treatment effects of Rabeprazole.
Distribution
rabeprazole binding to plasma proteins is about 97%.
Metabolism and elimination
Rabeprazole as well as other drugs in the Proton pump inhibitors (PPI), are metabolized by Cytochrom P450 (CYP450), liver metabolism system. In human in vitro studies show that Rabeprazole is metabolized by the isenzyme of CYP450 (CYP2C19 and CYP3A4). In these studies, at the expected plasma concentration Rabeprazole does not cause induction and does not inhibit CYP3A4.
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 combined mercapturic acid (M5). Only Desmethyl metabolites (M3) have a weak excretion effect, but it is not detected in plasma.
After taking a single dose of 20mg Rabeprazole, no Rabeprazole is not detected in the unchanged form 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 pharmacokinetics parameters after taking the dose of 20mg Rabeprazole in both men and women.
Patients with renal dysfunction:
In stable patients, the end stage, renal failure requires cycle of cycle (clearinine clearance ≤ 5 ml/min/1.73 m2), the distribution of Rabeprazole is almost similar to in healthy volunteers. AUC and CMAX in these patients are lower than the corresponding parameters in healthy volunteers about 35%.
Rabeprazole's average selling time is 0.82 hours in healthy volunteers and 0.95 hours in patients with dialysis and 3.6 hours after dialysis. The clearance of the drug in patients with kidney disease requires dialysis cycle is approximately twice as high as in healthy volunteers.Patients with liver dysfunction:
After taking a single -dose of Rabeprazole for patients with chronic to moderate chronic liver failure, the AUC doubled and the sale time increased by 2-3 times more than a healthy volunteer. However, at a dose of 20mg daily in 7 days, AUC only increased by 1.5 times and CMAX increased by 1.2 times.
Rebeprazole's sale time in liver failure patients is 12.3 hours compared to 2.1 hours in healthy volunteers. Pharmacological response (gastric pH control) in two groups is clinically equivalent.
Old people:
Rabeprazole's elimination has somewhat decreased in the elderly. After 7 days of taking the drug at a dose of 20mg Rabeprazole daily, AUC has nearly doubled, CMAX increased by 60% and T ages increased to about 30% compared to healthy volunteers. However, there is no evidence of the accumulation of Rabeprazol.The polymorphic phenomenon of CYP2C19 gene:
After 7 days of taking the drug at a dose of 20mg of Rabeprazole daily, in people with poor metabolic CYP2C19 yeast, an increase of 1.9 times and t ½ increased by about 1.6 times compared to the corresponding parameters in people with strong metabolic yeast, while CMAX has increased only 40%.
Before taking Rabesime ACME medicine to treat gastroesophageal reflux, duodenal ulcer (3 blisters x 10 tablets)
How to use
Rabesime is used orally.
For treatments once a day, take Rabesime tablets in the morning, before eating about 30 minutes.
Patients have to swallow the tablet, do not chew, crush or break.
Dosage
Adults/Elderly
Active duodenal ulcer and benign stomach ulcer
recommended dose is 20mg, 1 time/day in the morning.
Most duodenal ulcer patients active within 4 weeks. However, a few patients may need 4 more 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/abrasive (GERD)
recommended dose is 20mg, 1 time/day for 4 - 8 weeks.
Long -term maintenance treatment of gastroesophageal reflux - esophagus
For long -term treatment, the recommended dose is 20mg or 10mg 1 time/day depending on the patient's response.
Symptomatic treatment in gastroesophageal reflux - esophagus from average to very severe
The recommended dose is 10mg, 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 diet required and the dose of 10mg x 1 time/day when necessary.Zollinger-Elison syndrome
The recommended starting dose is 60mg, 1 time/day. The dose may increase to 100mg, 1 time/day or 120mg/day 2 times based on the patient's needs. Treatment should continue according to clinical indications.
combined in H. pylori treatment regimen
H. pylori -infected patients should be treated with eradication therapy. The following combination is recommended in 7 days:
[Rabeprazole 20mg + Clarithromycin 500mg and amoxicillin 1 g] x 1 time/day.
Patients with kidney failure and liver failure
No need to adjust the dose in patients with renal failure or liver failure.
Children
Rabesime 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 to do when overdose? The maximum dose is set not exceeding 60mg 2 times/day, or 160mg x 1 time/day. 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 Rabeprazole. Rabeprazole is strongly linked to plasma proteins, therefore, there is no hemolysis. Like other overdose cases, symptomatic treatment and appropriate support measures should be taken.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
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 Rabesime 20mg, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Other: weakness, influenza syndrome.
Uncommon, 1/1000 Urinary kidney: Urinary infection. Other: chest pain, chills, fever, liver enzyme. Rare, 1/10,000 Other: weight gain. Unknown frequency Mental: Confusion. Skin and subcutaneous tissue: Diverse erythematosus, poisoned epidermal necrosis (Ten), Stevens-Johnson syndrome (SJS). Instructions on how to handle ADR Stop using the drug. With minor adverse reactions, usually just stop the drug. In case of severe sensitivity or allergic reactions, supportive treatment (airy keeping and using epinephrin, oxygen breathing, antihistamine, corticoid ...).
Warnings
Contraindicated
Rabesime 20mg drug is contraindicated in cases of sensitivity to Rabeprazole sodium, benzimidazole or any ingredients of the drug.
Caution when using
Rabeprazole 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 Rabeprazole and other proton pump inhibitors or benzimidazole derivatives.
Patients should be warned that Rabeprazole should be swallowed whole, should not chew or crush.
Rabesime 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, the 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. In most cases, other causes are not determined, the cases are without complications and treatment 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 Rabeprazole in patients with severe liver dysfunction, doctors prescribe should be cautious when treating Rabeprazole for the first time in these patients.
Do not use Atazanavir with Rabeprazole.
Treatment with proton pump inhibitors, including Rabeprazole, can increase the risk of gastrointestinal infections such as Salmonella infection, campylobacter and Clostridium difficile.
Proton pump inhibitors, especially when high doses and long -term (> 1 year), may increase the risk of hip, wrist and spine fractures, especially in elderly patients or when there is a 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 severe blood magnesium reduction in patients treated with proton pump inhibitors (PPI) like Rabesime for at least 3 months, and in most cases is for 1 year. Severe manifestations of blood magnesium reduced blood such as fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhyths may occur but silently and not concerned.
In the majority of patients, blood magnesium loss 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 Rabeprazole 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
Rabesime 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 the doctor should consider stopping Rabesime. SCLE after treatment with a proton pump inhibitor can increase the risk of SCLE with other proton pump inhibitors.
affect tests
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 Rabesime 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 pharmacokinetic properties and data on unwanted effects, not sure that Rabesime affects 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 Rabesime's safety during pregnancy.
Reproductive research conducted in rats and rabbits has shown no evidence of the ability to impair fertility or damage to the fetal of Rabeprazole sodium, although the drug is low through the mouse. Rabesime is contraindicated in women during pregnancy.
Breastfeeding period
It is unclear whether Rabeprazole will be excreted in breast milk. There has been no research on medication in breastfeeding women. However, Rabeprazole is excreted in the milk of the mouse. So Rabesime should not be used in women who are breastfeeding.
Drug interaction
Rabeprazole sodium causes strong and long -term inhibition to gastric acid secretion. It is possible to interact with absorption drugs depending on the stomach pH. Simultaneous use of sodium rabeprazole with ketoconazole or iTraconazole may significantly reduce antifungal concentration. Therefore, patients may need to be monitored to determine whether to adjust the ketoconazole or iTraconazole dose when using simultaneously with Rabeprazole.
Simultaneous use Atazanavir 300mg/ritonavir 100mg with omeprazole (40mg once a day) or Atazanavir 400mg with Lansoprazole (60mg once a day) on healthy volunteers has significantly reduced the contact time of Atazanavir.
The absorption of Atazanavir depends on pH. Although not studied, similar results are predicted with other proton pump inhibitors. Therefore, PPIs, including Rabeprazole, should not be used with Atazanavir.
Methotrexate: Cases of reporting and pharmacological research published, and regression analysis shows that simultaneous use of ppi and methotrexate (mainly at high doses) can increase and prolong its concentration
However, there has been no official medication interaction research of methotrexat with ppi.
Storage
In a dry place, avoid light, temperature below 30 ° C.
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