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Esomeprazole is an active ingredient commonly indicated in gastroesophageal reflux disease and some diseases related to peptic ulcers. Esomeprazole is also the main active ingredient in Arazol-tab 40.1. What is Arazol-Tab 40?
Arazol-tab 40 of Apimed Pharmaceutical Joint Stock Company has the active ingredient Esomeprazole 40mg. Arazol tab 40mg is used in the treatment of gastroesophageal reflux disease (GERD), Zollinger - Ellison syndrome, eradication of Helicobacter pylori in combination with antibiotics or prevention of stomach side effects in people treated with anti-inflammatory long-term non-steroidal anti-inflammatory drugs (NSAIDs).
The product Arazol tab 40 is available in the form of enteric-coated film-coated tablets, round, yellow, smooth on both sides, with edges and healthy members. Packing specifications for each box of 3 blisters, each blister corresponds to 10 tablets.
2. Indications of the drug Arazol-tab 40
In adults and adolescents 12 years of age and older, Arazol tab 40 is indicated in the following cases:
Treatment of gastroesophageal reflux disease (GERD), including cases of erosive esophagitis caused by reflux or prolongation to prevent recurrent esophagitis or simply to relieve symptoms caused by gastroesophageal reflux; Combination of antibiotics in Helicobacter pylori eradication regimen, including treatment of duodenal ulcer or prevention of recurrence of peptic ulcer in people with Helicobacter pylori (+) test; Use in humans requiring prolonged NSAID therapy for the treatment or prevention of drug-induced peptic ulcers in high-risk patients; Treatment of Zollinger-Ellison syndrome.
3. Pharmacological characteristics of the drug Arazol-tab 40
3.1. Pharmacodynamics Active ingredient Esomeprazole is the S-isomer of Omeprazole, so it has similar effects in the treatment of peptic ulcer disease, gastroesophageal reflux disease and Zollinger-Ellison syndrome.
Esomeprazole in Arazol tab 40mg binds to H+/K+ ATPase (also known as proton pump) in parietal cells of the stomach, thereby inactivating this enzyme system and inhibiting the final step of HCl secretion into the stomach. Arazol tab 40 has the effect of inhibiting gastric acid secretion both basal and stimulated by any agent with long duration of action and strong intensity. At the same time, active ingredients belonging to the proton pump inhibitor group such as Arazol tab 40mg also inhibit but do not kill Helicobacter pylori bacteria, thus requiring combination with suitable antibiotics (such as Amoxicillin, Tetracycline). and Clarithromycin).
3.2. Pharmacokinetics Absorption: Arazol tab 40 is rapidly absorbed after oral administration, peak plasma concentrations are achieved after 1-2 hours. The bioavailability of Esomeprazole increases with dose and with repeated administration, reaching approximately 68% at 20 mg and 89% at 40 mg. Food is a factor that can slow and reduce the absorption of Esomeprazole, but does not affect the effect of the drug on gastric acid. Distribution: Arazol tab 40 is approximately 97% bound to plasma proteins. Metabolism: Arazol tab 40 is metabolised primarily in the liver by CYP2C19 and the cytochrome P450 enzyme system to inactive hydroxy and desmethyl metabolites. The remainder is metabolized via the CYP3A4 isoenzyme to Esomeprazole sulfone. Elimination: Approximately 80% of an oral dose of Arazol tab 40 is excreted as inactive metabolites in the urine, the remainder in the feces.
4. Dosage of the drug Arazol-tab 40mg
Patients when taking Arazol tab 40 should swallow the tablet whole, do not crush or chew it. The best time to take Arazol tab 40 is 1 hour before meals and can be combined with stomach antacids to relieve pain.
Dosage of Arazol tab 40 specifically as follows:
Treatment of esophagitis caused by reflux: 1 tablet of Arazol tab 40mg / time / day for 4 weeks, can be used for an additional 4 weeks if the esophagitis has not healed or symptoms persist; Treatment of Zollinger - Ellison syndrome: The initial dose is Arazol tab 40mg each time, 2 times a day, then adjust according to the patient's response and can continue treatment as long as it is clinically indicated. Special attention should be paid to the subjects when using Arazol tab 40:
Children under 12 years: Not recommended to use Arazol-tab 40 mg; Patients with renal impairment: No dose adjustment of Esomeprazole is required in this patient; Patients with hepatic impairment: No dose adjustment of Arazol tab 40 is required in patients with mild and moderate hepatic impairment. In case of severe liver failure may consider taking 1⁄2 tablets of Arazol tab 40 per day; People over 65 years old: No need to adjust the dose of Arazol tab 40.
5. Side effects of the drug Arazol tab 40mg
Patients should immediately stop using Arazol tab 40, then quickly contact a doctor, pharmacist or go directly to the nearest hospital when there are symptoms of a severe allergic reaction such as wheezing, swelling of the lips, tongue, throat or whole body, skin rash, difficulty swallowing... In addition, people using Arazol tab 40 and appear red skin, sores or peeling skin, bleeding in lips, eyes , mouth, nose or genitals... need special attention, because it can be a manifestation of Stevens-Johnson syndrome or toxic epidermal necrolysis.
Some other unwanted effects of Arazol tab 40mg:
Headache, dizziness, skin rash; Nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, dry mouth; Peripheral edema; Tired; Insomnia or drowsiness; Itching, paresthesia; Fractures of the hip, wrist or spine; Increase liver enzymes ; Depression, confusion; Visual disturbances; Bronchospasm; Decrease in white blood cell or platelet count; Hepatitis, jaundice; Taste disorder, stomatitis; Hyponatremia; Joint pain, muscle pain; Hair loss; Skin increased sensitivity to light; Myasthenia; Interstitial nephritis; gynecomastia in men; Gastric colitis; Lupus erythematosus subcutaneous.
6. Contraindications of Arazol tab 40mg
Contraindicated to use Arazol tab 40mg in the following cases:
People who are allergic to Esomeprazole or other ingredients in Arazol tab 40; People allergic to other proton pump inhibitors; People who are being treated with nelfinavir (a medicine to treat HIV infection).
7. Some cautions when using Arazol-tab 40mg
Care should be taken when appointing Arazol-tab 40 for the following cases:
Unusual weight loss; Vomiting blood; Black pepper; Liver failure. Some other cautions of Arazol tab 40:
Patients who need to use Arazol tab 40 for a long time (more than 1 year) should be monitored regularly; When prescribing Arazol tab 40 for the eradication of Helicobacter pylori, the physician needs to consider possible drug interactions in a 3-drug regimen. The antibiotic Clarithromycin is a strong inhibitor of CYP3A4, therefore contraindications and interactions should be considered in patients receiving other drugs metabolised by CYP3A4; Treatment with proton pump inhibitors such as Arazol tab 40 may slightly increase the risk of gastrointestinal infections due to Salmonella and Campylobacter; The combination of Esomeprazole with Atazanavir is not recommended. If the combination is mandatory, the patient should be closely monitored clinically, when the dose of Atazanavir has to be increased to 400mg in combination with 100mg of Ritonavir, Esomeprazole should not be used with a dose of more than 20mg; Arazol tab 40 may reduce the absorption of vitamin B12 due to a decrease or lack of gastric acid. Therefore, it should be considered in patients with reduced vitamin B12 stores or risk factors for reduced vitamin B12 absorption during long-term therapy; Esomeprazole in Arazol tab 40 is an inhibitor of CYP2C19, which warns to consider the risk of interactions between Esomeprazole and drugs metabolised by CYP2C19; Proton pump inhibitors such as Arazol tab 40, if taken in high doses and for a long time (> 1 year) can increase the risk of hip, wrist, and spine fractures. This effect occurs mainly in the elderly and in people with special risk factors; Subacute lupus erythematosus (SCLE): Proton pump inhibitors have been associated with cases of SCLE (very rare). If this damage occurs, especially in areas exposed to the sun, and is accompanied by joint pain, the patient should consider discontinuing Arazol Tab 40; Arazol tab 40 has little influence on the ability to drive and use machines. However, this preparation can cause dizziness or vision loss side effects, so care should be taken when patients have to drive and operate machinery; Pregnancy has not been adequately studied with the use of Arazol tab 40. In animals, rat Esomeprazole 280 mg/kg/day (57 times the human dose based on body surface area) and rabbits 86 mg/kg/day (35 times the human dose). body surface area) showed no evidence of impaired fertility or fetotoxicity with esomeprazole. However, because it has not been studied in humans, the use of Arazol tab 40 for pregnant women must be cautious and only used when absolutely necessary; Lactation: It is not known whether Arazol tab 40 is excreted in human milk. Although omeprazole is known to be distributed into human milk. Esomeprazole has the potential to cause ADRs in nursing infants, so a decision should be made whether to discontinue nursing or to discontinue Arazol tab 40, depending on the importance of the drug to the mother.
8. Drug interactions of Arazol tab 40
Due to the inhibitory effect on acid secretion, esomeprazole will increase gastric pH, thereby affecting the bioavailability of pH-dependent absorbed drugs: such as reducing the absorption of ketoconazole, itraconazole and increasing the absorption of digoxin . Esomeprazole has the potential to cause pharmacokinetic interactions with drugs metabolised by the cytochrome P450 enzyme system, isoenzyme CYP2C19 in the liver, so the concomitant use of Arazol tab 40 with cilostazol will increase the concentration of cilostazol and its active metabolite. its dose, cilostazol dose should be reduced. Cisapride when co-administered with Arazol tab 40 resulted in a 32% increase in AUC and a 31% prolongation of the plasma half-life of cisapride. Administration of Arazol tab 40 with inducers of CYP2C19 and CYP3A4 such as rifampicin will reduce esomeprazole concentrations, so concomitant use should be avoided. There may be an increased risk of hypomagnesaemia when Arazol Tab 40 is used with drugs that also cause hypomagnesaemia, such as thiazide diuretics or loop diuretics. Arazol Tab 40 may alter absorption after oral administration of atazanavir, reducing drug concentrations. plasma, reduce antiviral effect, so do not use proton pump inhibitor and atazanavir concurrently. Clopidogrel when used with Arazol tab 40 proton pump inhibitors will reduce plasma concentrations of the active metabolite of clopidogrel, thereby reducing the antiplatelet effect. Hypomagnesemia due to prolonged use of Arazol tab 40 proton pump inhibitors makes the myocardium sensitive to digoxin, increases the risk of digoxin cardiotoxicity, magnesium levels should be checked before using proton pump inhibitors. and check periodically afterwards. Sucralfate can inhibit absorption and reduce bioavailability of proton pump inhibitors, Arazol tab 40 should be taken at least 30 minutes before taking sucralfate. Arazol tab 40 will increase the serum concentration of tacrolimus. When co-administered with Arazol tab 40, methotrexate levels will increase in some patients, so when treated with high-dose methotrexate, esomeprazole should be temporarily discontinued. May lead to increased INR and prothrombin time when warfarin is used concomitantly with the proton pump inhibitor Arazol tab 40 causing abnormal bleeding and death. Concomitant administration of Arazol tab 40 and diazepam reduces the metabolism of diazepam, thereby increasing plasma concentrations of diazepam. Co-administration of esomeprazole increases plasma phenytoin concentrations in epileptic patients, so phenytoin levels should be monitored at the initiation and discontinuation of treatment with Arazol Tab 40. Arazol-tab 40 of Apimed Pharmaceutical Joint Stock Company has the active ingredient Esomeprazole 40mg. Arazol tab 40mg is used in the treatment of gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and many other gastrointestinal conditions. To ensure the effectiveness of treatment and avoid unwanted side effects, patients need to strictly follow the instructions of the doctor, professional pharmacist.
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