Esogas 40mg Bidiphar medicine for stomach acid secretion (1 bottle + 1 tube 5ml)

Dosage form Box
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	40mg

Uses

indications

Esogas drugs are indicated in the following cases:

In adults:

Treatment of stomach acid secretion when oral therapy is not appropriate, such as:

Gastroesophageal reflux disease (GERD) in patients with esophagitis and/or have severe reflux symptoms. Trang.

In children and adolescents from 1 to 18 years: Treatment of stomach acid secretion when oral therapy is inappropriate, such as gastroesophageal reflux disease (GERD) in patients with esophagitis due to reflux and/or severe symptoms.

Pharmacology

Pharmacological group: Gastroentric excretion inhibitors belong to Proton inhibitors.

ATC code: A02BC05.

Pharmacological and mechanism of action:

Esomeprazol is the S isomers of omeprazol, used similarly to Omeprazol in the treatment of gastrointestinal ulcers, gastroesophageal reflux disease and Zollinger - Ellison syndrome.

Esomeprazol is attached to H+/K+-Aatpase in the cell wall, which is inactivated this enzyme system, preventing the final step of the excretion of hydrochloride acid into the stomach. Therefore, Esomeprazol has the effect of inhibiting the stomach secretion of basic acid and even when stimulated by any agent. The drug works strongly, lasting.

Proton pump inhibitors have an inhibitory effect but do not deduct Helicobacter pylori, so it must be coordinated with antibiotics (such as amoxicillin, tetracycline and clarithromycin) to eradicate this bacterium effect.

Dynamic pharmacokinetics

about 97% Esomeprazol attached to plasma proteins. The drug is metabolized mainly in the liver thanks to the Cytochrom P450 enzyme system, the isenzyme CYP2C19 into hydroxy and desmethyl metabolites that are no longer active, the rest is metabolized through isenzyme CYP3A4 into osomeprazol sulfon.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 phenomenon of accumulation of drugs 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 in a person deficient in CYP2C19 enzyme increases about 2 times compared to people with enough enzymes. Selling time for plasma is about 1.3 hours. 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 is 2-3 times higher than that of people with normal liver function, so it may be necessary to reduce the dose of Esomeprazol in these patients.

Before taking Esogas 40mg Bidiphar medicine for stomach acid secretion (1 bottle + 1 tube 5ml)

How to use

for intravenous injection: The injection solution is prepared by reverting the powder jar with 5 ml of 0.9%NAC1 solution. Intravenous injection for at least 3 minutes.

For intravenous infusion:

intravenous solution (40 mg dose) for 10 - 30 minutes: Reconcalation of powder bottle with 5ml of 0.9% NaCl solution or Lactated Ringer or 5% Dextrose solution. Then dilute to the volume of 100 ml. After that, the solution in 2 vials is diluted in 100 ml of 0.9%NaCl solution. The solution after the preparation is transmitted in the corresponding time or speed as in the "dosage" section.

Only use the transparent solution so the mixed solution must be checked by the naked eye to detect strange molecules and discoloration before use.

The mixed solution should not be mixed or shared with the lines with other drugs.

Should use half phase volume if only use 20 mg of esomeprazol, should remove the unused solution.

Dosage

adults:

Treatment of stomach acid secretion when oral therapy is inappropriate:

Patients who cannot take oral medication may be treated with a dose of 20 - 40 mg, 1 time/day. Patients with reflux esophagitis should be treated at a dose of 40 mg, 1 time/day. To treat symptoms of reflux disease, patients should be used for 20 mg, 1 time/day.

To treat stomach ulcers due to NSAID, the usual dose is 20 mg, 1 time/day. To prevent stomach and esophagus due to NSAID in patients at risk, the dose is 20 mg, 1 time/day.

Trying time with intravenous sugar is usually short and should be switched to oral medication when possible.

Prevention of bleeding due to stomach and duodenum ulcers:

After acute endoscopy treatment due to stomach or duodenal ulcer, 80 mg high doses in 30 minutes, followed by continuous veins of 8 mg/hour for 3 days (72 hours).

After intravenous treatment, patients should continue to treat acid resistance.

Children and adolescents from 1 to 18 years old:

Treatment of stomach acid secretion when oral therapy is inappropriate.

Patients who cannot use oral medication can be treated with intravenous injections once a day as part of the full gerd treatment process (see in the table below).

Usually the time of intravenous treatment should be short and switch to oral as soon as possible.

recommended dose when using ecomeprazol by vein:

age group 10 mg or 20 mg, 1 time/day 10 mg, 1 time/day

12 - 18 years old 40 mg, 1 time/day 20 mg, 1 time/day Special:

People with renal failure: No need to reduce the dose in people with renal failure but caution in people with severe renal failure because the experience of using these people is limited.

Elderly: No need to reduce the dose in the elderly.

Hepatogens:

gerd: No dose adjustment in patients with mild to moderate liver failure. For patients with severe liver failure, maximum doses should not be used for 20 mg daily. For patients with severe hepatic failure, the starting of a high dose of 80 mg should be transmitted, followed by a continuous intravenous infusion of 4 mg/h in 71.5 hours may be sufficient to achieve efficiency. 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 do

do when using overdose? The described symptoms related to oral doses of 280 mg are digestive and weakened symptoms. Esomeprazol single doses of oral oral 80 mg and a 308 mg of venous Esomeprazol for 24 hours do not cause unwanted effects. No specific antidote. Esomeprazol is strongly connected to plasma proteins and therefore it is not easy to appraise. In case of overdose should treat symptoms and use general support measures.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 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 doses to compensate for missed dose.

Side Effects

When using the drug, there are common unwanted effects (ADR) such as:

Safety records:

headache, abdominal pain, diarrhea and nausea are one of the most unwanted effects in clinical trials (and also during the time the drug circulates in the market). Besides, this safety record is similar to different formulas, indicated treatment, age groups and patients. There are no unwanted effects related to the determined dose.

Unwanted effects are arranged according to the frequency: very common (≥ 1/10); or meet (≥ 1/100 to

frequency granulocytes, reduced all bloody blood. boundary. Blood magamic reduction can also lead to hypotension. Enlightenment. Eye

rarely blurred vision. > Gastrointestinal disorders often meet abdominal pain, constipation, diarrhea, bloating, nausea/vomiting. Clearly Micro colitis. There is liver disease. Morning. Meet hip fractures, wrist or spine bones. There are reports on renal failure accompanied by some patients. Foul.

The non -recovery visual lesions have been reported in a very rare number of severe patients with Omeprazol (racemat) intravenously. However, there is no establishment of the causal relationship between drug use and unwanted effects.

used for children: A multinational, open, random label is conducted to evaluate the pharmacokinetics of Esomeprazol, 1 time/day, for 4 days in patients from 0 to 18 years old. The total number of 57 patients (8 children in the age group 1-5 years old) has been assessed for safety. The results of safety are suitable for the known safety data of Esomeprazol and there is no new safety sign.

Instructions on how to handle ADR:

Notify the physician with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

anti -contraindications Esogas in the following cases:

Hypersensitivity to Esomeprazol or with other proton inhibitors, or hypersensitivity to any ingredients of the drug.

Be cautious when using

When there is the presence of any symptoms of vigilance (such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting blood or black feces) and when there is or suspected stomach ulcers, so eliminating malignant ability because treatment with Esomeprazol can reduce symptoms and slow diagnostic.

Gastrointestinal infections: Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal tract infections caused by Salmonella and Campylobacter.

Vitamin B12 absorption: Esomeprazol, as well as other antacids, can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced stomach acid. This should be considered in patients with reduced reserves or risk of reducing vitamin B12 absorption when long -term treatment.

Hypotension of blood: There have been reports on serious hypoglycemia in patients treated with proton pump inhibitors (PPI) such as Esomeprazol for at least three months and in most cases of using PPI for a year. The serious manifestations of the blood magnesi such as fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhyths may occur, but may be silently and not concerned. In most affected patients, the reduction of blood magnesium is improved after using magnesi replacement therapy and stopping using PPI. For patients who are expected to be treated for prolonged treatment with PPI or patients using PPT along with digoxin or other drugs that can lower blood magnesium (such as diuretics), health experts should consider measuring magnesium levels before starting treatment with PPI and periodically during treatment.

The risk of fracture: When using proton pump inhibitors, especially when taking high and prolonged doses (≥ 1 year), the risk of pelvic fractures, wrist bones or spine due to osteoporosis. 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. The lowest dosage recommendation works in the shortest possible time, suitable for clinical status. Patients at risk of osteoporosis should use enough calcium and vitamin D, assess bone condition and manage as instructed.

Lupus erythematosus (SCLE): Very rare cases of SCLE related to proton pump inhibitors. If the lesions occur, especially in the skin exposed to the sun and if accompanied by joint pain, patients should quickly find medical help and medical experts should consider stopping using Esomeprazol. SCLE occurs after treatment with a previous proton pump inhibitor may increase the risk of SCLE occurring with other proton pump inhibitors.

Coordinate with other drugs:

It is not recommended to use Esomeprazol with Atazanavir. If combined with Atazanavir with proton pump inhibitors is inevitable, clinically closely monitoring when increasing the dose of Atazanavir to 400 mg combined with 100 mg of ritonavir; Do not exceed 20 mg of esomeprazol.

Esomeprazol is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazol, it is necessary to consider the ability to interact with metabolic drugs through CYP2C19. The interaction between clopidogrel and esomeprazol. The clinical involvement of this interaction is uncertain. As a cautious measure, it is not recommended to simultaneously use Esomeprazol and Clopidogrel.

Interacts with tests: an increase in Chromographin A (CGA) level can interfere with the detection of endocrine nerve tumors. To avoid this intervention, Esomeprazol should be discontinued at least 5 days before quantifying CGA. If the CGA and Gastrin concentrations do not return to the scope of reference after the first quantification, this quantitative magazine should be repeated 14 days after stopping treatment with Proton pump inhibitors.

Before taking proton pump inhibitors, gastric cancer must be eliminated because the drug can cover symptoms, slow down the diagnosis of cancer.

Be cautious when used in people with liver disease, pregnant or nursing.The long -lasting

using ecomeprazol can cause gastric atrophy or an increased risk of infection (such as pneumonia in the community).

may increase the risk of diarrhea due to Clostridium dificile when taking proton pump inhibitors.

Esogas contains

The effect of the drug on the ability to drive and operate machines

Esomeprazol has the ability to drive and operate the machine. Side effects such as dizziness (rarely) and limited vision (rarely) have been reported. If the patient is affected, do not drive or operate machinery.

Using drugs for women during pregnancy and lactation

Pregnancy: There is no complete study when using Esomeprazol in pregnant people. Only use Esomeprazol during pregnancy when really necessary.

Breastfeeding period: It is unknown whether esomeprazol is excreted in breast milk or not. However, Omeprazol is distributed into human milk. Esomeprazol has the potential to cause ADRs in breastfed babies, so it is necessary to decide to stop breastfeeding or stopping the drug, depending on the importance of the medication for the mother.

Drug interaction

The effect of the above Esomeprazol is the kineticness of other drugs:

Protease inhibitors:

Omeprazol has been reported to interact with some protease inhibitors. It is unclear clinical importance and the mechanism of impact of the recorded interactions. Increasing stomach pH during treatment with omeprazol may change the absorption of protease inhibitors. Another possible interactive mechanism is through CYP2C19 enzyme inhibitors.

For Atazanavir and Nelfinavir, the serum concentration has been reported when used with omeprazol and is not recommended to simultaneously use these drugs. In healthy volunteers, simultaneous use of omeprazol (40 mg, 1 time/day) with Atazanavir 300 mg/ritonavir 100 mg significantly reduces contact with Atazanavir (reduced AUC, CMAX and Cmin by about 75%). Increasing the dose of Atazanavir to 400 mg has not compensated for the effects of omeprazol on contact with Atazanavir. Use combination omeprazol (20 mg, 1 time/day) with Atazanavir 400 mg/ritonavir 100 mg in healthy volunteers reduces about 30% of the contact with Atazanavir when compared to the contact in case of using Atazanavir 300 mg/ritonavir 100 mg, 1 time/day without using Omeprazol 20 mg, 1 time/day/day/day. Use combination omeprazol (40 mg once a day) reduces the average value of AUC, CMAX and CMIN of NELFINAVIR about 36 - 39% and decreases about 75 - 92% of the average AUC, CMAX and CMIN values of active metabolites with pharmacological effects M8. Due to the effects of pharmaceutical force and similar pharmacokinetic properties of omeprazol and esomeprazol, it is not recommended to simultaneously use Esomeprazol with Atazanavir and contraindicated to use Esomeprazol with Nelfinavir.

For Saquinavir (simultaneously used with Ritonavir), increasing serum concentration (80 - 100%) has been reported during simultaneous treatment with omeprazol (40 mg, 1 time/day). Treatment with omeprazol 20 mg, 1 time/day, does not affect the contact of Darunavir (when used simultaneously with Ritonavir) and Amprenavir (when used simultaneously with Ritonavir). Esomeprazol 20 mg, 1 time/day, does not affect the contact of Amprenavir (whether or not to use simultaneously with Ritonavir). Treatment with omeprazol 40 mg, 1 time/day, does not affect the contact of Lopinavir (simultaneously used with Ritonavir).

methotrexate:

When used with PPIs, increasing methotrexate levels have been reported in some patients. In the treatment of high doses of methotrexate, it may be necessary to consider and stop using Esomeprazol.

tacrolimus:

Concomitant use with Esomeprazol has been reported to increase the concentration of tacrolimus in serum. Need to increase monitoring tacrolimus concentration as well as kidney function (creatinine clearance) and tacrolimus dose are adjusted if necessary.

Drugs with absorption depend on pH:

Inhibition of stomach acid during treatment with ecomeprazol and other PPTs can reduce or increase the absorption of drugs that depend on the stomach pH. Like other drugs that reduce the gastric pH, the absorption of drugs such as ketoconazole, otraconazole and erlotinib may decrease and the absorption of digoxin may increase during treatment with ecomeprazol. Simultaneous use of omeprazol (20 mg/day) and digoxin in healthy objects that increase the bioavailability of digoxin about 10% (up to 30% in 2 of 10 research objects). There are rare reports on Digoxin toxicity. However, it is necessary to be cautious when using high doses of Esomeprazol in elderly patients. Need to increase monitoring treatment with digoxin.

Metabolic drugs by CYP2C19:

Esomeprazol inhibits CYP2C19, the main enzyme metabolizes Esomeprazol. Therefore, when Esomeprazol is combined with metabolic drugs by CYP2C19, such as Diazepam, Citalopram, Imipramin, Clomipramin, Phenytoin ... The plasma concentration of these drugs may increase and need to reduce the dose. No Interim interactive studies are done in high doses (80 mg + 8 mg/h) using intravenous lines. Esomeprazol's effects on metabolic drugs because CYP2C19 can be more clearly detected in this map and patients should closely monitor the unwanted effects of the drug during 3 days of intravenous treatment.

diazepam:

Simultaneous use of Esomeprazol 30 mg oral form reduces 45% of Diazepam's clearance (a substrate of CYP2C19).

phenytoin:

Simultaneous use of 40 mg oral Esomeprazol and phenytoin increases 13% of the bottom concentration of phenytoin in plasma in epilepsy patients. Should monitor phenytoin concentration in plasma when starting or stopping treatment with Esomeprazol.

voriconazole:

omeprazol (40 mg once a day) increases the cmax and auc of variconazol (a substrate of CYP2C19) to 15% and 11% respectively.

cilostazol:

Omeprazol as well as Esomeprazol acts as CYP2C19 inhibitors. In a cross study, Omeprazol used at a dose of 40 mg on healthy objects increased by 18% CMAX and 26% AUC of Cilostazol and increased 29% CMAX and 69% AUC of one of one of the active metabolites.

cisaprid:

In healthy volunteers, when using 40 mg of esomeprazol oral and cisaprid, the area under the curve shows Cisaprid concentration in plasma over time (AUC) increases to 32% and the semi -discharged time of Cisaprid (T1/2) extends by 31% but the Cisaprid peak concentration in plasma increases negatively. The QTC range is slightly prolonged after using a separate Cisaprid, not longer lasting when using Cisaprid in combination with Esomeprazol.

warfarin:

When concurrent 40 mg of esomeprazol oral form in patients being treated with warfarin in a clinical trial has shown that blood clotting time is in an acceptable range. However, after bringing the drug to the market, there were a very rare number of cases of significant Inr clinical increase when treated simultaneously on the above two drugs. The patient should be monitored at the beginning and at the end of treatment with warfarin or other cooumarin derivatives.

clopidogrel:

The results from studies on healthy subjects have shown pharmacokinetic interactions (PK)/Pharmacy (PD) between clopidogrel (300 mg of maintenance dose of 75 mg/day) and Esomeprazol (40 mg/day orally) lead to an average reduction ADF).

In a study on healthy objects, when concurrent Clopidogrel is used with a combination of Esomeprazol 20 mg + Asa 81 mg compared to the unique clopidogrel, the exposure to the active metabolites of Clopidogrel has decreased by nearly 40%. However, the maximum level of platelets inhibitors (caused by ADP) on these objects is the same in the single clopidogrel and the group uses Clopidogrel and Esomeprazol + ASA.

The inconsistent data on the clinical manifestation of Esomeprazol's PK/PD interaction on the main cardiovascular events has been reported from both clinical observation and research research. For careful purpose, simultaneous use with clopidogrel is not recommended.

Clinical non -clinical interactions:

amoxicillin or quinidine:

Esomeprazol has been shown to have no significant clinical impact on pharmacokinetics of amoxicillin or quinidine.

Naproxen or Rofecoxib:

Esomeprazol and Naproxen or Rofecoxib or Rofecoxibs do not show any clinical pharmacokinetic interactions in short -term studies.

The effect of other drugs on Esomeprazol pharmacokinetics:

CYP2C19 and/or CYP3A4 inhibitors:

Esomeprazol is metabolized by CYP2C19 and CYP3A4. When using Esomeprazol simultaneously oral Esomeprazol with a CYP3A4 inhibitor, Clarithromycin (500 mg, 2 times/day) double the AUC of Esomeprazol. Simultaneous use of Esomeprazol with an inhibitor of both CYP2C19 and CYP3A4 may increase the exposure to Esomeprazol. CYP2C19 and CYP3A4 Voriconazole inhibitors increase Esomeprazol's AUC to 280%. No need to adjust the dose of Esomeprazol regularly in these cases. However, it is necessary to consider adjusting the dose in patients with severe liver failure and if prescribed long -term treatment.

CYP2C19 and/or CYP3A4 induction drugs:

CYP2C19 or CYP3A4 induction drugs or both (such as rifampicin and st. John's grass) can cause reduction in serum ecomeprazole due to hypothermia Esomeprazol.

Blood -lowering drugs such as thiazid diuretics or diuretic: may increase the risk of hypoglycemia when used with ecomeprazol. Check the Magnesi concentration before starting to use proton pump inhibitors and then periodically.

Children: Medicinal interactive studies are only done in adults.

Storage

In a dry place, the temperature does not exceed 30 ° C, avoiding light.

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