Arazol -tab 40 Apimed Treatment of Gastroesophageal reflux disease (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazol
Ingredient Apimed Pharmaceutical Joint Stock Company
Ingredient
| Composition information | Content |
| Esomeprazol | 40mg |
Uses
Indications
Arazol-Tab 40 is indicated for adults in the following case:
Adults
Gastroesophageal reflux disease (GERD)
Combined with an appropriate antibiotic regimen to eradicate Helicobacter pylori
Treatment of duodenal ulcer with infectionshelicobacter pylori.
Patients with continuous treatment of non -steroid anti -inflammatory drugs (NSAIDs)
Treatment of stomach ulcers caused by NSAIDs.
Treatment of Zollinger - Ellison syndrome
teenagers aged 12 and older
Gastroesophageal reflux disease (GERD)
Combined with antibiotics in the treatment of duodenal ulcer caused by Helicobacter pylori.
Pharmacokology
Esomeprazol is the isomorphic form of omeprazol, used similar to omeprazol in the treatment of gastric ulcer - duodenum, gastroesophageal reflux disease and Zollinger - Ellison syndrome.
Esomeprazol is attached to H+/ K+ ATPase (also known as proton pump) in the stomach wall cell, inactivating this enzyme system, preventing the final step of the excretion of hydrochloric acid into the stomach heart. Therefore, Esomeprazol has the effect of inhibiting the stomach secretion of basic acid and even when stimulated by any agent. The drug works strongly, prolonged. Proton pump inhibitors are inhibited but not exposed to the pylori, so they must be coordinated with antibiotics (such as amoxicillin, tetracycline and clarithromycin) to effectively eradicate this bacteria.
pharmacokinetic
absorption
Esomeprazol absorbs quickly after drinking, reaching the highest concentration in plasma after 1-2 hours. Esomeprazol's bioavailability increases according to the dose and when reminded, reaching about 68% when taking the dose of 20mg and 89% when taking the dose of 40mg. Food slows down and reduces the absorption of Esomeprazol, but does not change the effect of the effect of the drug on the acidity in the stomach. The area under the curve (AUC) after taking a single dose Esomeprazol 40mg at meals compared to the hunger decreased from 43% to 53%. Therefore, Esomeprazol should drink at least 1 hour before meals.
Distribution
The drug is attached to about 97% to plasma proteins.
Metabolism
The drug is metabolized mainly in the liver thanks to the isenzy CYP2CM CYP2C, Cytochrom P450 enzyme system into hydroxy and desmethyl metabolites are no longer active. The rest is converted through ISOENZYM CYP3A4 to Esomeprazol Sulfon. When used repeated, initially metabolized through the liver and the clearance of the drug reduced, possibly due to the inhibited ISOENZYM CYP2C19. However, there is no accumulation when used once a day. In some people, because of the lack of CYP2C19 due to genetics (15-20% of Asians), Esomeprazol's transformation is slowed down. In a stable state, the AUC value of a CYP2C19 enzyme is increased by 2 times compared to people with enough enzymes. Half life in plasma is about 1.3 hours.
Elimination
About 80% of oral doses are eliminated in the form of non -active metabolites in the urine, the rest is eliminated in the feces. Under 1% of the drug is eliminated in the urine.
In people with severe liver failure
AUC value in a stable state is 2-3 times higher than people with normal liver function, so may need to consider reducing the dose of Esomeprazol in these patients.
Before taking Arazol -tab 40 Apimed Treatment of Gastroesophageal reflux disease (3 blisters x 10 tablets)
How to use
must swallow the tablet, not crushed or chewed.
Take the medicine at least one hour before meals. Can be used with antacids when necessary to relieve pain.
Dosage
Adults and teenagers aged 12 and older
Gastroesophageal reflux disease (GERD)
Treatment of esophageal scratches due to reflux: 1 tablet/day/day for 4 weeks. Should treat 4 more weeks for patients with untreated esophagitis patients or persistent symptoms.
Treatment of Zollinger - Ellison syndrome
The starting dose of oral 40mg, 2 times/day, then adjust the dose according to the response of each patient day and continue treatment when clinically indicated.
Most patients can control the disease at the dose of 80 - 160mg per day. When the dose is greater than 80mg/ day, it must be divided into 2 times.
Special subjects
Patients with renal impairment: No dose adjustment in patients with renal impairment. Patients with liver failure: No dose adjustment in patients with mild and medium liver failure. In patients with severe liver failure may consider taking 20mg a day. What to do when overdose? There is no specific antidote for Esomeprazol. Mainly treat symptoms and support. Hemorrhage does not have the effect of increasing the elimination of drugs because the drug is highly attached to the protein. What to do when forgetting a dose? However, if near the next dose time, skip the forgotten dose. Do not take double the dose to compensate for the forgotten dose. There is no special requirement on drug treatment after use.
Side Effects
Stop taking the drug and contact the doctor, pharmacist or go to the hospital immediately if the drug users have the following symptoms: wheezing, swelling of the lips, tongue, throat or body edema, rash, difficulty swallowing (severe allergic reactions). Skin redness, ulcers or peeling, may have severe ulcers and bleeding in the lips, eyes, mouth, nose or genitals. This may be a manifestation of Stevens-Johnson syndrome or epidermal necrosis due to poisoning. Jaundice, dark urine, fatigue (manifestation of liver disease).
Other undesirable effects:
Common, 1/100 Uncommon, 1/1000 Rare, 1/10 000 Hematology: leukopenia, thrombocytopenia. Very rare, ADR Muscle muscle: Myasthenia. Endocrine: Big breasts in the South. Not determined frequency Skin: Lupus erythematosus under the skin.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Patients with allergies to Esomeprazol, any component of the drug or other proton pump inhibitors.
Patients are taking drugs containing Nelfinavir (drug used in HIV infection).
Precautions when using
Precautions when indicating Arazol-Tab 40 for the following patients:
Other cautious cases
If using Esomeprazol for treatment for a long time (more than 1 year), patients should be monitored regularly.
Patients treated according to the regime when necessary should contact the doctor if abnormal symptoms appear.
When prescribing Esomeprazol to eliminate Helicobacter pylori, drug interactions should be considered in the 3 -drug treatment regimen. Clarithromycin is a powerful CYP3A4 inhibitor and therefore should consider contraindicated and interact with clarithromycin when taking 3 drugs for patients who are taking other drugs metabolized through CYP3A4.
Proton pump inhibitors may increase the risk of gastrointestinal tract infections (for example, Salmonella, Campylobacter infection).
It is not recommended to simultaneously use Esomeprazol with Atazanavir. If the combination of Atazanavir with proton pump inhibitors is inevitable, clinically closely monitoring when increasing the dose of Atazanavir to 400mg combined with 100mg of ritonavir, should not use more than 20mg Esomeprazol.
Esomeprazol as well as other 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 reduced vitamin B12 reserves or have risk factors for reducing vitamin B12 absorption when long -term treatment.
Esomeprazol is CYP2C19 inhibitor. When starting or ending treatment with Esomeprazol, the risk of drug interaction with metabolic drugs should be considered through CYP2C19.
Hematemia: Magnesi decreased in severe blood has been reported in patients treated with proton pump inhibitors (PPIS) such as Esomeprazol for at least 3 months and most cases used for a year. The serious manifestations of blood magnesia reduced blood include: fatigue, muscle spasms, delirium, convulsions, dizziness, and ventricular arrhythmia. They reduce blood magnesium recovered after replacing magnesi and stop using PPI. In patients who will be treated for prolonged treatment or combination of ppis with digoxin or drugs that reduce blood magnesium (such as diuretics), need to monitor magnesi levels before starting PPI treatment and periodically during the use of the drug.
Proton pump inhibitors, especially if high doses and for a long time (> 1 year), can increase the risk of hip fractures, wrist bones and spine, mainly in the elderly and patients with known risk factors. Patients at risk of osteoporosis should be monitored and supplemented with calcium and vitamin D.
Lupus erythematosus (SCLE): Proton pump inhibitors are related to very rare SCLE cases. If the damage occurs, especially in the skin exposed to the sun, and if it comes with joint pain, it is recommended to stop using Esomeprazol.
affect tests: Increased chromographin A (CGA) concentration hindrances to the diagnosis of endocrine nerve tumors. Therefore, it is necessary to stop using Esomeprazol for at least 5 days before CGA measurement.
The ability to drive and operate machinery
Esomeprazole has little influence on the ability to drive and operate machinery. Some adverse reactions such as dizziness, blurred vision may occur. If these adverse reactions occur, patients should not drive and operate machinery.
Pregnant women
There is no adequate study when using ecomeprazol in pregnant women. On animals, white rats drink Esomeprazol 280mg/kg/day (57 times the dose on humans calculated according to the body surface area) and the oral rabbit dose 86mg/kg/day (35 times the dose on humans calculated by the body surface area) did not see evidence of reproductive or toxic fetus for Esomeprazol. However, only use Esomeprazol during pregnancy when really necessary.
breastfeeding women
whether esomeprazol is not excreted in milk or not. However, Omeprazol is distributed into human milk. Esomeprazol has the ability to cause ADRs in breastfed babies, so they must decide to stop breastfeeding or stop taking the drug, depending on the importance of the medication for the mother.
Medicinal interaction
Due to acid excretion inhibition, Esomeprazol increases the gastric pH, affecting the bioavailability of pH -dependent absorption drugs: reducing the absorption of ketoconazol, iTraconazol, increasing Digoxin absorption.
Esomeprazol interact with dynamic pharmacokinetics with metabolic drugs by the cytochrom P450 enzyme system, ISOENZYM CYP2C19 in the liver. Simultaneous use of Esomeprazol with Gilostazol increases the concentration of cilostazol and its active metabolites, considering reducing clostazol dose. Concomitant use of Esomeprazol with voriconazole may increase contact with ecomeprazol more than twice as much as considered in patients with high doses of Esomeprazol (240mg/day) like Zollinger - Ellison syndrome.
Cisaprid: simultaneous use of Esomeprazol increases 32% of the area under the curve and lasts 31% of the sale time but does not significantly increase the peak concentration of Cisaprid in plasma. Use Cisaprid alone to extend the QTC, but do not extend when used simultaneously with Esomeprazol.
Use Esomeprazol with CYP2C19 and CYP3A4 induction drugs such as rifampin reduces Esomeprazol levels, avoiding simultaneous use.
may increase the risk of hypoglycemia when taking ecomeprazol and drugs that also causes hypoglycemia such as thiazid diuretics or diuretic. Check the Magnesi concentration before starting to use proton pump inhibitors and then periodically.
Atazanavir: may change the absorption after taking Atazanavir, reducing this concentration of drugs in plasma, which can reduce antiviral effects. Do not simultaneously inhibit the Proton and Atazanavir inhibitors.
Clopidogrel: Use the same proton pump inhibitors that reduce the plasma concentration of the active metabolites of clopidogrel, reducing platelet resistance.
Digoxin: Lowering blood magnesia due to prolonged use of proton pump inhibitors that make the heart muscle sensitive to digoxin, which can increase the risk of toxicity to the heart of digoxin, can increase the risk of toxicity to the heart of digoxin. In patients who are using digoxin, check the magnesium concentration before taking proton pump inhibitors and periodically.
Sucralfate: Inhibition of absorption and reducing the bioavailability of proton pump inhibitors. Use proton pump inhibitors at least 30 minutes before using sucralfat.
tacrolimus: Increasing serum concentration of tacrolimus when used simultaneously with Esomeprazol.
Methotrexate: When used with proton pump inhibitors, methotrexate levels have been reported to increase in some patients. When treated with high doses of methotrexate, temporarily stop using Esomeprazol.
wafarin: Inrang and prothrombin time when using wafarin simultaneously with proton pump inhibitors, can cause abnormal bleeding and death. Follow the INR and prothrombin time when using simultaneously Esomeprazol and wafarin.
Simultaneous use of ecomeprazol and clarithromycin increases the concentrations of ecomeprazol and 14-hydroxyclarithromycin in the blood.
Simultaneous use of Esomeprasol and Diazepam reduces diazepam metabolism and increases the plasma diazepam concentration.
Phenytoin: simultaneously use ecomeprazol, increasing the level of phenytoin in plasma in epilepsy patients. Should track phenytoin concentration when starting and stopping treatment with Esomeprazol.
Storage
In a cool, dry place, avoid light, temperatures below 30 ° C. To be out of reach or children's vision.
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