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Arazol- Tab 20 has the main active ingredient is Esomeprazole. Arazol- Tab 20 is used to treat gastroesophageal reflux disease - oesophagitis, in combination with an appropriate antibiotic regimen to eradicate Helicobacter pylori, treatment of Zollinger - Ellison syndrome, patients on continuous anti-inflammatory drug therapy. non-steroid.
1. What is the drug Arazol- Tab 20?
Arazol- Tab 20 has the main active ingredient is Esomeprazole, the drug is prepared in the form of round film-coated tablets that dissolve in the intestine. Arazol- Tab 20 is an inhibitor of gastric acid secretion of the proton pump inhibitor class. Esomeprazole is the S-isomer of Omeprazole, used similarly to Omeprazole in gastroesophageal reflux disease, treatment of peptic ulcers and Zollinger-Ellison syndrome. Esomeprazole binds to the proton pump H+/K+ ATPase in the parietal cells of the stomach, inactivating this enzyme system, then blocking the final step of gastric secretion of hydrochloric acid. Esomeprazole therefore inhibits gastric acid secretion both basal and stimulated. Arazol-Tab 20 has a strong and long-lasting effect. Arazol- Tab 20 has the effect of inhibiting gastric acid secretion but not eradicating Helicobacter pylori, so Arazol- Tab 20 must be combined with antibiotics (such as Tetracycline, Amoxicillin and Clarithromycin) in the treatment of this bacteria.
2. Uses of the drug Arazol- Tab 20
2.1 Indications Arazol-Tab 20 film-coated tablets are indicated for use in the following cases:
Adults
Gastroesophageal reflux disease (GERD): erosive reflux esophagitis, long-term treatment Healed esophagitis to prevent recurrence and symptoms of gastroesophageal reflux disease. In combination with an appropriate antibiotic regimen to eradicate Helicobacter pylori: treatment of peptic ulcers with Helicobacter pylori infection; Prevention of recurrent peptic ulcers in patients with Helicobacter pylori infection. Continuous treatment of non-steroidal anti-inflammatory drugs: gastric ulcer caused by the use of NSAIDs, prevention of peptic ulcer caused by the use of NSAIDs in patients at risk. Treatment of Zollinger-Ellison syndrome. Adolescents 12 years of age and older
Gastroesophageal reflux disease (GERD): erosive reflux esophagitis, symptoms of gastroesophageal reflux disease and long-term treatment of cured esophagitis to prevent disease recurrence. In combination with other antibiotics in the treatment of peptic ulcers caused by Helicobacter pylori. 2.2 Contraindications Allergy or hypersensitivity to Esomeprazole or any component of Arazol- Tab 20 or other proton pump inhibitors. Patient is taking medicine containing Nelfinavir (medicine used to treat HIV infection).
3. How to use and dose Arazol- Tab 20
Swallow the Arazol-Tab 20 tablet whole, do not crush or chew the tablet.Take Arazol- Tab 20 at least one hour before meals. The same medication can be used as needed for pain relief.
3.1 Adults, adolescents 12 years of age and older Gastroesophageal reflux disease (GERD) Reflux esophagitis: 1 tablet/time/day for 4 weeks. Patients with untreated esophagitis or with persistent symptoms should be treated for an additional 4 weeks.
Long-term treatment of healed esophagitis to prevent recurrence: 1 tablet/time/day.
Symptoms of gastroesophageal reflux disease - esophageal: 1 tablet / time / day. If symptoms are not controlled after 4 weeks of medication, further laboratory investigation is recommended to confirm the patient's diagnosis.
3.2 Adults In combination with an appropriate antibiotic regimen for eradication of Helicobacter pylori and peptic ulcer; Prevention of recurrence of peptic ulcer in patients with Helicobacter pylori infection: Esomeprazole 20mg in combination with Amoxicillin 1g and Clarithromycin 500mg, administered twice daily for 1 week.
Continuous treatment of non-steroidal anti-inflammatory drugs (NSAIDs): Stomach ulcers caused by taking NSAIDs: 1 tablet/time/day for 4-8 weeks.
Prevention of peptic ulcers caused by the use of NSAIDs in patients at risk: 1 tablet/time/day.
Treatment of Zollinger - Ellison syndrome Initial dose is 2 tablets x 2 times/day, adjust dose according to patient's response and continue treatment as long as clinically indicated.
Most patients can control the syndrome at a dose of 80-160 mg/day. When using Arazol-Tab 20 dose greater than 80mg/day divided into 2 times/day.
3.3 Adolescents 12 years of age and older Treatment of peptic ulcers caused by Helicobacter pylori The recommended dose is determined by body weight: Children aged 30-40 kg: Esomeprazole 20mg in combination with Amoxicillin 750mg and Clarithromycin 7.5mg/ kg body weight, used twice a day for 1 week.
Children from 40 kg or more: Esomeprazole 20mg combined with Amoxicillin 1g and Clarithromycin 500mg, used twice a day for 1 week.
3.4 Special populations Children under 12 years of age: Arazol- Tab 20 is not recommended.
Renal impairment: No dose adjustment of Arazol- Tab 20 is required in patients with renal impairment.
Hepatic impairment: No dose adjustment of Arazol-Tab 20 is required in patients with mild and moderate hepatic impairment, patients with severe hepatic impairment may consider taking 1 tablet/day.
Patients > 65 years old: No dose adjustment of Arazol- Tab 20 is required.
3.5 Overdose of Arazol- Tab 20 and management There are currently no reports of an overdose of Esomeprazole in humans.
Treatment is mainly symptomatic supportive treatment. Hemodialysis has no effect on increasing the elimination of Arazol- Tab 20 because the drug is highly protein bound. There is no specific antidote for Esomeprazole.
4. Undesirable effects of the drug Arazol- Tab 20
Stop taking the drug Arazol- Tab 20, go to a medical facility immediately and contact a doctor if the user has the following symptoms:
Severe allergic reaction: swelling of the lips, tongue, throat; rash, wheezing, generalized edema, difficulty swallowing. Manifestations of liver disease: fatigue, jaundice, dark urine. Redness of the skin, skin sores, peeling, possibly severe sores and bleeding in the eyes, lips, nose, mouth or genitals. This could be a symptom of Stevens-Johnson syndrome or toxic epidermal necrolysis. Other undesirable effects:
Systemic: headache, dizziness, fatigue, peripheral edema, insomnia, somnolence, itching, paresthesia, sweating, fever, rare hypersensitivity reactions. Gastrointestinal: abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation. Dry mouth, stomatitis or taste disturbances are uncommon. Musculoskeletal: fracture, arthralgia, myalgia. Liver: increased liver enzymes, hepatitis, jaundice. Neurological uncommon: depression, confusion. Respiratory: bronchospasm. Hematology: leukopenia, thrombocytopenia. Metabolic: hyponatremia and hypomagnesemia Skin: rash, alopecia, photosensitivity, Stevens - Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, subcutaneous lupus erythematosus. Some other side effects: interstitial nephritis, gynecomastia in men.
5. Note when using the drug Arazol- Tab 20
Use caution when using Arazol- Tab 20 in the following patients: abnormal weight loss, vomiting blood, black stools, liver failure.
Patients using Arazol-Tab 20 for longer than 1 year should be monitored regularly.
Patients on medication regimens should contact their doctor if unusual symptoms occur.
When prescribing Arazol- Tab 20 for the treatment of Helicobacter pylori, it is necessary to evaluate possible drug interactions in the treatment regimen.
Therapeutic use of proton pump inhibitors may slightly increase the risk of gastrointestinal infections such as Salmonella and Campylobacter infections.
Co-administration of Arazol-Tab 20 with Atazanavir is not recommended. If concomitant use is necessary, close clinical monitoring is required when increasing the dose of Atazanavir to 400 mg in combination with 100 mg of Ritonavir, not more than 20 mg of Esomeprazole should be used.
Arazol- Tab 20 may reduce the absorption of vitamin B12 due to a decrease or lack of gastric acid. Caution should be exercised in patients with reduced stores or risk factors for reduced vitamin B12 absorption during long-term therapy.
Esomeprazole is an inhibitor of CYP2C19. When starting or ending treatment with Arazol-Tab 20, the risk of interactions with drugs metabolised by CYP2C19 should be assessed.
Hypomagnesaemia: There have been reports of patients treated with proton pump inhibitors such as Esomeprazole for at least 3 months and in most cases for one year. Hypomagnesemia was reversible after magnesium supplementation and discontinuation of proton pump inhibitors. Patients who will be on long-term treatment or in combination with a proton pump inhibitor with digoxin or a hypomagnesaemic agent should monitor magnesium levels before initiating therapy and periodically during pump inhibitor therapy. protons.
Arazol-Tab 20, especially in high doses and for a long time > 1 year, may increase the risk of fracture mainly in the elderly and in patients with known risk factors. Monitor and provide adequate calcium and vitamin D when taking Arazol- Tab 20 in patients at risk of osteoporosis.
Effect of Arazol-Tab 20 on laboratory tests: Using drugs to increase Chromogranin A (CgA) levels interferes with the diagnosis of neuroendocrine tumors. Stop taking esomeprazole at least 5 days before the CgA test.
Arazol- Tab 20 has little influence on the ability to drive and use machines. Some side effects may occur such as dizziness, blurred vision. If these side effects appear while taking Arazol- Tab 20, patients should not drive or operate machinery.
Pregnant women: There are currently no adequate studies on the safety of using Esomeprazole in pregnant women. Use esomeprazole during pregnancy only when clearly needed, weigh the benefits and risks when using Esomeprazole in this population.
Lactation: It is not known whether Esomeprazole is excreted in human milk. However, Omeprazole is secreted into human milk. Esomeprazole can cause adverse effects in nursing infants, so a decision should be made whether to discontinue nursing or discontinue the drug, depending on the importance of Arazol-Tab 20 administration to the mother.
6. Drug interactions
Arazol- Tab 20 increases gastric pH by inhibiting gastric acid secretion, which may affect the bioavailability of drugs that are absorbed depending on gastric pH such as reducing absorption of Itraconazole, Ketoconazole and increasing absorption of Digoxin.
Esomeprazole, the main active ingredient of Arazol- Tab 20 interacts with drugs metabolised by isoenzyme CYP2C19, cytochrome P450 enzyme in the liver. Cilostazol: Concomitant administration of Arazol-Tab 20 with Cilostazol increases the concentration of Cilostazol and its active metabolite. Voriconazole: Concomitant administration of Arazol-Tab 20 may increase exposure to Esomeprazole more than 2-fold, considering in patients receiving high doses of Esomeprazole (240mg/day) as in the treatment of Zollinger-Ellison syndrome.
Use of Esomeprazole with inducers of CYP2C19 and CYP3A4 such as rifampin reduces esomeprazole concentrations, avoid concomitant use.
Rifampin: avoid concomitant use with Arazol- Tab 20 because it may reduce the concentration of Esomeprazole.
Thiazide diuretics or loop diuretics: There may be an increased risk of hypomagnesaemia when Esomeprazole is used with these drugs.
Atazanavir: alters absorption after oral administration of Atazanavir and reduces plasma concentrations of Atazanavir, reducing the antiviral effect.
Clopidogrel: Arazol-Tab 20, when administered concurrently, reduces plasma concentrations of the active metabolite of Clopidogrel, thereby reducing the antiplatelet effect.
Digoxin: hypomagnesemia due to prolonged use of proton pump inhibitors, thereby sensitizing the myocardium to digoxin and increasing the risk of digoxin cardiotoxicity.
Sucralfate : inhibits absorption, reduces the bioavailability of Arazol- Tab 20. Take Arazol- Tab 20 at least 30 minutes before taking Sucralfate.
Tacrolimus: increased serum concentrations of the drug when used concomitantly with Arazol- Tab 20.
Methotrexate: increased concentrations of methotrexate have been reported in some patients receiving Esomeprazole. Temporarily discontinue use of Esomeprazole during treatment with high-dose methotrexate.
Warfarin: increased INR and prothrombin time when warfarin is used concomitantly with proton pump inhibitors. Monitor INR and prothrombin time when the patient is taking these two drugs concurrently.
Clarithromycin: increases the concentration of esomeprazole and 14-hydroxyclarithromycin in the blood.
Diazepam: Esomeprazole when administered with Diazepam reduces the metabolism of Diazepam and increases the plasma concentration of Diazepam.
Phenytoin: increased plasma concentrations of phenytoin in epileptic patients receiving concomitant esomeprazole.
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