Radicad 10 cadila treatment for duodenal and stomach ulcer (1 blister x 10 tablets)
Dosage form Box of 1 blister x 10 tablets
Specifications Rabeprazole
Ingredient
| Composition information | Content |
| Rabeprazole | 10mg |
Uses
Indications
Radicad 10 is indicated in the following cases:
Antibiotic activity: After the dose of 20mg of sodium Rabeprazol, the onset effect of the secretion effect occurs within 1 hour, with the maximum impact occurring within 2 to 4 hours. The inhibition of acid secretion from the basal cell and by the stimulation of food 23 hours after the first sodium rabeprazole dose in order is 69% and 82% and the inhibitor time lasts up to 48 hours. The inhibitory effect of sodium Rabeprazol on acid secretion increases slightly with a repeated dose once a day, achieving inhibition in a stable state after 3 days. When stopping the drug, the activity of normal acid secretion after 2 to 3 days. The acidity of the stomach decreases due to any agent, including proton pump inhibitors such as Rabeprazol, which increases the amount of normal bacteria present in the gastrointestinal tract. The treatment with proton pump inhibitors may be able to increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
The effects on plasma gastrin: In clinical studies, patients are treated once a day with 10 or 20mg of sodium Rabeprazol, for a period of up to 43 months. The level of plasma gastrin increases during 2 to 8 weeks reflects the acid secretion effect and maintains stable while continuing treatment. Gastrin values return to levels before treatment, usually within 1 to 2 weeks after stopping treatment.
Stomach biopsy in humans from cave and stomach from more than 500 patients treated with rabeprazol or comparative treatment for up to 8 weeks has not detected changes in ECL cell learning, gastritis level, frequency of gastritis, small intestine or the distribution of H. pylori infection, in more than 250 patients being monitored during 36 months of continuous treatment, there is no change in the results at first results Okay.
Other effects: The systemic effects of the sodium rabeprazol in the nervous system, the cardiovascular system and the respiratory system have not been found yet. Rabeprazol sodium, taking oral doses of 20mg for 2 weeks, no effect on the thyroid function, carbohydrate metabolism, or circulating concentrations of thyroid hormones, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretin, glucagon, follicle stimulating hormone (FSH), Hormonal Hormone (LH) or vegetative hormone.
Studies in healthy objects show that sodium rabeprazol does not have significant clinical interactions with amoxicillin. Rabeprazole does not adversely affect the plasma concentrations of amoxicillin or clarithromycin when used these drugs for the purpose of thoroughly treating the gastrointestinal tract infection on H. pylori.
pharmacokinetic
absorption
Rabicad is a formula of the intestinal tablet (insoluble in the stomach) of the sodium Rabeprazol. This form of preparation is necessary because Rabeprazol is not durable in acid. Therefore, the absorption of Rabeprazol only starts after the tablet leaves the stomach. The absorption of drugs is fast, with a plasma rabeprazole concentration about 3.5 hours after 1 dose of 20mg. The peak plasma concentration (CMAX) of Rabeprazol and linear AUC is 10mg to 40mg.
Absolute bioavailability of a 20mg oral dose (compared to the injection line) is about 52% because most of the drug is metabolized before entering the general circulatory system. In addition, bioavailability does not seem to increase with repeated oral dose. In healthy subjects, plasma disposal time is about 1 hour (ranging from 0.7 to 1.5 hours), and the total clearance of the body is estimated at 283 ± 98ml/min. There is no clinical interaction with food. Food or duration of medication for the day does not affect the absorption of sodium Rabeprazol.
Distribution
rabeprazol attaches about 97% to plasma proteins.
Metabolism and elimination
Rabeprazol sodium, as well as in the case of other components of the Proton pump inhibitors (PPI), is transformed through the drug metabolism system in the cytochrome P450 (CYP450). In vitro studies in human mitochondria show that sodium rabeprazole is metabolized by the same enzymes of CYP450 enzymes (CYP2C19 and CYP3A4). In these studies, in humans predicted in humans, Rabeprazol does not touch nor inhibit the CYP3A4 enzyme and although in vitro studies may not always predict in vivo status, the results show that the prediction has no interaction between Rabeprazol and Cyclosporin. In the thioether (M1) and carboxylic acid (M6) are the main metabolites with sulphone (m2), Desmethyl-Tioether (M4) and Mercapturic Acid (M5), secondary metabolites observed at low concentrations. Only Desmethyl Metabolite metabolites (M3) have a small amount of anti -secretion activity, which it is not present in plasma.
Following the single dose of Rabeprazol sodium 20mg 14C marking radioactive isotope, no drug in the form of constant excretion of urine. About 90% of the dose is excreted mainly in urine in the form of 2 metabolites: 1 Mercapturic Acid (M5) and 1 carboxylic acid (M6), plus 2 other unknown metabolites. The rest of the dose is seen in feces.
Gender
Adjust according to the body mass index and height, there is no significant difference in gender in pharmacokinetic parameters following a single dose of 20mg Rabeprazol.
Kidney function
In patients with stable renal impairment, the end stage requires dialysis (Creatinine clearance
Liver dysfunction
Following the single dose of oral 20mg Rabeprazol for patients with mild to medium impaired renal function, AUC doubled and the half -life of Rabeprazol increased by 2-3 times compared to healthy volunteers. However, following 1 daily dose of 20mg in 7 days, the AUC level increased by only 1.5 times and CMAX increased by only 1.2 times. Rabeprazol's half -life in severe liver failure is 12.3 hours compared to 2.1 hours in healthy volunteers. Responding to the pharmaceutical force (controlled gastric pH) in two groups is the same in terms of clinical.
Elderly
The elimination is somewhat reduced in the elderly. After 7 days of treatment with daily doses of 20mg Rabeprazol sodium, AUC doubled, CMAX increased by 60% and T1/2 increased by about 30% when compared to healthy volunteers. However, there is no evidence of the accumulation of Rabeprazol.
CYP2C19 phenomenon
Following the single dose of 20mg Rabeprazol for 7 days, CYP2C19 slow metabolites, with AUC and T1/2 fold about 1.9 and 1.6 times the corresponding parameters in the expanded metabolites while CMAX only increased by 40%.
Before taking Radicad 10 cadila treatment for duodenal and stomach ulcer (1 blister x 10 tablets)
How to use
For indications that require treatment with Rabeprazol sodium-1 tablets every day in the morning, before eating and although the daily use of medication in the day or food used with medicine does not prove the effect of Rabeprazole sodium, this treatment mode will facilitate treatment.
Patients should be cautious as sodium rabeprazol tablets should not be chewed or broken, but should swallow the whole pill.
Dosage
Adults/Elderly
Active duodenal ulcer and benign stomach ulcer
Dosage recommended for both active duodenal ulcer and gastric ulcer is 20mg used once a day in the morning.
Most patients have active duodenal ulcer for 4 weeks. However, some patients may need additional 4 weeks to achieve treatment effect. Most patients with benign stomach ulcers are healthy within 6 weeks. However, once again, a few patients may need 6 weeks of additional treatment to heal the ulcer.
ulcerative or gastroesophageal reflux disease (Gord)
The recommended oral dose for this condition is 20mg, taken 1 time daily for 4 to 8 weeks. Long -term control of gastroesophageal reflux disease (Gord management): For long -term management, maintenance of Rabeprazol sodium 20mg or 10mg, 1 time per day can be used depending on the response of patients.
The treatment of gastroesophageal reflux disease - esophagus has symptoms from average to very severe (Gord symptoms): 10mg, 1 time daily in patients without esophagitis. If the symptom control is not achieved for 4 weeks, the patient should be considered more carefully. Once the symptoms are resolved, the control of symptoms can be achieved, using the required treatment regime, 10mg/1 time daily when necessary.
Zollinger-Elison syndrome
The recommended dose in adults is 60mg, 1 time daily. The dose can be increased to 120mg/day based on the needs of the patient's individual. Daily doses can be used up to 100mg/day. The dose of 120mg may need divided doses, 60mg/2 times daily. Should continue treatment longer if clinical indications.
thorough treatment H. pylori
H. pylori infected patients should be treated with thorough treatment. The following combination is recommended within 7 days.
Rabeprazol sodium 20mg/2 times daily + Clarithromycin 500mg/2 times daily and amoxicillin 1g/2 times daily.
kidney failure and liver failure
Unnecessary dose adjustment for patients with renal impairment or liver failure.
See in special warnings and caution in the use of sodium rabeprazol in the treatment of patients with severe liver function impairment.
Children
It is not recommended to use sodium rabeprazol in children, because there is no experience in using drugs on this patient.
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 using overdose? The maximum exposure is set not exceeding 60mg/2 times daily, or 160 mg/1 time daily. In general, these effects are mild, representing the known adverse effects and recovered without the need for drug intervention. There is no detoxified antidote. Rabeprazole sodium is largely mounted with protein and therefore, no separation is separated through dialysis. As in any case of overdose, symptomatic treatment and supportive measures should be applied.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using radicad 10 , you may experience unwanted effects (ADR).
The most frequent drug -reported adultery reactions, during the verified clinical trials with Rabeprazol are headaches, diarrhea, abdominal pain, weakness, bloating, redness and dry mouth. The majority of experiences of adultery reactions throughout the clinical studies are essentially light or medium, and fleeting.
The following adverse effects are reported from clinical trials and experiences in circulation.
The frequency is defined as follows: Common (1/100 1 includes swelling, hypotension and shortness of breath 2 eczema, blistering skin reactions and sensitive reactions are often over after treatment. 3 rare reports of liver disease received in patients with potential cirrhosis. In the treatment of serious liver dysfunction patients, the doctor should be cautious when the treatment starts with sodium Rabeprazol in 10 patients. 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.
Sinusitis. steam.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Radicad 10 contraindicated in the following cases:
rabeprazol sodium is contraindicated in pregnant women and during breastfeeding.
Be cautious when using
respond to symptoms when treated with sodium Rabeprazol does not prevent the presence of digestive or esophagus tumors, so the possibility of malignant diseases should be excluded when starting treatment with Rabeprazol sodium.
Patients with long -term treatment (especially patients treated for more than 1 year) should be monitored regularly.
Do not rule out the risk of cross -allergies with other proton pump inhibitors or replacement benzimidazoles.
Patients should be cautious that sodium Rabeprazol tablets should not be chewed or broken but should swallow whole tablets.
It is not recommended to use sodium rabeprazol for children, because there is no evidence of the use of this drug in this patient group.
There have been reports when circulating on hypertension (platelet loss and neutropenia). In most cases that cannot identify the cause of the disease, the events are not complicated and resolved by stopping rabeprazol.
Unusual cases of liver enzymes have been detected in clinical trials and are also reported due to market licenses. In most cases without identifying the cause of the disease, complicated events and resolved by stopping rabeprazol.
There is no evidence of significant safety issues related to drugs observed in a study in patients with mild to moderate liver failure compared to normal age and gender in the control group. However, because there is no clinical data on the use of sodium rabeprazol in the treatment of patients with severe liver dysfunction, the doctor prescribes should be cautious when the treatment starts with the sodium rabeprazol in these patients.
Concomitant use of Atazanavir with Sodium Rabeprazol is not recommended.
Treatment for proton pump inhibitors, including sodium Rabeprazol, can be likely to increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
The ability to drive and operate machinery
Based on the pharmaceutical properties and profile of adultery effects, sodium rabeprazol does not cause impaired car performance or machine operating capacity, but the alertness is impaired due to drowsiness, so it is recommended to avoid driving and operating complex machines.
Pregnancy
There is no data on Rabeprazol's safety in pregnant women. Studies on fertility in mice have shown no evidence of a fetal or fetal decline in fetal reproductive function due to sodium rabeprazol, although the percentage of drugs through the placenta in low mice. Rabeprazol Sodium 10 is contraindicated during pregnancy.
Breastfeeding period
It is unknown whether Rabeprazol sodium is secreted through breast milk. No research has been conducted in nursing women. However, sodium rabeprazol is excreted in the mouse. Therefore, sodium rabeprazol should not be used during breastfeeding.
Drug interaction
Rabeprazol sodium causes the effect of inhibiting the secretion of stomach acids for prolonged and completely. It is possible to interact with pH -dependent absorption drugs. The use of sodium rabeprazol with ketoconazole or iTraconazole can lead to a significant reduction in the concentration of antifungal drugs in plasma. Therefore, each individual patient may be monitored to determine whether or not to adjust the dose or not when Ketoconazole or Itraconazole is simultaneously used with Sodium Rabeprazol.
Concentrated use of Atazanavir 300mg/Ritonavir 10mg with omeprazole (40mg - 1 time per day) or Atazanavir 400mg with Lansoprazole (60mg - 1 time per day) for healthy volunteers leading to significant reduction in exposure with Atazanavir. The absorption of Atazanavir is pH dependent. Although it has not been studied, it is estimated that the results are similar to Proton Pump pump inhibitors. Therefore, proton pump inhibitors, including rabeprazol, should not be used with Atazanavir.
Storage
Storage below 30 ° C. Avoid light and damp.
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