Esomaxcare 40 drugs treat gastroesophageal reflux (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	40mg

Uses

indications

Esomaxcare 40mg drug is indicated in the following cases:

Adults:

Treatment of gastroesophageal reflux syndrome (GERD). Prevention of pepticular bleeding by intravenous peptic ulcer.

Treatment of gastroesophageal reflux syndrome (GERD). The drug inhibits gastric acid secretion by inhibiting the enamel system H+/K+ ATPASE (acid pump) leading to inhibition of basic acid secretion and acid secretion when stimulated by any stimulus.

pharmacokinetics

absorption:

Esomeprazol is quickly absorbed with peak plasma concentrations reaching about 1-2 hours after drinking. Absolute bioavailability is 64% after taking a single dose of 40mg and increased to 89% after the dose is repeated 1 time/day.

For the 20mg Esomeprazol, these values are 50% and 68% respectively. Food slows down and reduces the absorption of Esormeprazol, although this does not significantly affect the effects of ecomeprazol on stomach acid secretion.

Distribution:

Expected distribution integral in a healthy state is about 0.22 l/kg of body weight, Esomeprazol binds 97% to plasma protein.

Metabolism:

Esomeprazol is completely metabolized through the Cytochrom P450 (CYP) system. The main part of the metabolism of Esomeprazol depends on the polymorphic CYP2C19 enzyme, forming the metabolites of hydroxy and desmethyl of esomeprazol. The rest of the metabolic process depends on another specific same, CYP3A4, forming Esomeprazol Sulfon, the main metabolite in plasma.

Era:

The following parameters mainly reflect pharmacokinetics in individuals with CYP2C19 function yeast, a group of strong metabolic people.

The total plasma clearance is about 17 l/hour after the single dose and about 9 l/hour after the dose is repeated.

Sell waste time in plasma is about 1.3 hours after the dose is repeated once a day. Esomeprazol's pharmacokinetics have been studied at a dose of up to 40mg, 2 times/day.

The main metabolites of Esomeprazol does not affect stomach acid secretion. About 80% of Esomeprazol oral dose is excreted in the urine in the form of metabolites, the rest through feces. Less than 1% of constant drugs found in urine.

Special patient groups:

Poor metabolic objects:

about 2.9 ± 1.5% of patients do not have CYP2C19 function enzyme and are called poor metabolic people. In these individuals, the metabolism of Esomeprazol is catalyzed mainly by CYP3A4.

After the dose repeats Esomeprazol 40mg, 1 time/day, the average AUC in the metabolic person is about 100% lower than that of patients with CYP2C19 function enzymes (strong metabolic people). The average peak concentration in plasma increased by about 60%. These records do not affect the dose of Esomeprazol.

Sex:

After taking the single dose of Esomeprazol 40mg, the average AUC in women is about 30%higher than that of men. There is no difference in AUC between gender after the dose is repeated once a day. These records do not affect the dose of Esomeprazol.

Hepatic failure:

Esomeprazol's metabolism may be impaired in patients with mild to medium liver dysfunction. The metabolic rate decreases in patients with severe liver dysfunction, resulting in double the AUC of Esomeprazol.

Therefore, do not overdose up to 20mg in patients with severe liver dysfunction. Esomeprazol or main metabolites do not tend to accumulate when used 1 time/day.

kidney failure:

No studies have been conducted in patients with renal function. Because the kidney is responsible for the excretion of the metabolites of Esomeprazol but not responsible for the elimination of drugs in a constant form, it is considered that the metabolism of esomeprazol is unchanged in patients with impaired kidney function.

Elderly:

Esomeprazol's metabolism has not changed significantly in elderly patients (71-80 years old).

Children:

adolescents 12-18 years old. After using the repeated dose of 20mg and 40mg Esomeprazol, the total concentration and contact time (AUC) and the maximum concentration time in plasma (TMAX) in children 12-18 years old are similar to adults for both doses of Esomeprazol.

Before taking Esomaxcare 40 drugs treat gastroesophageal reflux (3 blisters x 10 tablets)

How to use

Take oral use. The drug should be taken in whole and should not be ground or chewing, should be taken at least 1 hour before meals.

Dosage

Dosage for adults:

Treatment of gastroesophageal reflux disease: Treatment of esophageal scratches due to reflux.

Take a 40 mg per day for 4 weeks, can take 4 more weeks if the symptoms are not completely cured.

Treatment of stomach ulcer - duodenum with Helicobacter pylori:

Esomeprazol is an ingredient in the treatment regimen along with antibiotics, for example 3 drug regimen (along with amoxicillin and clarithromycin). (Amoxicillin 1g x 2 times/day and Clarithromycin 500mg x 2 times/day for 7 or 10 days).

Healing stomach ulcers due to nsaids: Normal dose 20mg x 1 time/day. Treatment period is 4-8 weeks.

Prevention of stomach ulcers and duodenal ulcer due to NSAID drugs in patients at risk: 20mg x 1 time/day.

Prolonged treatment after medical treatment for hemorrhage due to intravenous gastrointestinal ulcers:

40mg x 1 time/day for 4 weeks after the treatment of hemorrhage due to intravenous gastrointestinal ulcer.

The recommended starting dose is Esomeprazol 40mg x 2 times/day. The clinical data shows that most patients are controlled with Esomeprazol doses of 80-160 mg/day.

Treatment of gastroesophageal reflux:

Take a 40mg tablet every day for 4 weeks, can take 4 more weeks if the symptoms are not completely cured.

Do not take medicine for children under 12 years old.

People with kidney function:

No need to adjust the dose in patients with renal function damage. Due to less experience in using drugs in patients with severe renal impairment, caution should be careful when treating in these patients.

People with liver function damage:

No need to adjust the dose in patients with liver damage from mild to medium.

In patients with severe liver failure, maximum overdose should not be used for 20mg Esomeprazol.

Elderly:

No dose adjustment in the elderly.

Note: For 20mg doses, the 40mg tablet form is not suitable for the dose. Refer to the form of melting tablets in the intestine 20 mg.

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 expert

What do

do when using overdose? The described symptoms related to the use of 280mg dose are symptoms on the gastrointestinal tract and fatigue.

Esomeprazol 80mg single doses are still safe to use. There is no specific detox. Esomeprazol is strongly connected to plasma proteins and therefore it is not easy to fertilize. In case of overdose, symptomatic treatment and use of general support measures.

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 dose to compensate for missed dose.

Side Effects

When taking Esomaxcare 40mg may experience some of the following side effects:

Common

Headache, abdominal pain, diarrhea and nausea.

Less:

Peripheral edema, insomnia, dizziness, paresthesia, chicken sleep, dizziness, dry mouth, liver enzyme, dermatitis, itching, hives, hives, hip fractures, wrists and spine.

Rare:

leukopenia, thrombocytopenia, blood sodium, agitation, confusion, depression, taste disorders, blurred vision, bronchospasm, stomatitis.

Candida infection with gastrointestinal tract, hepatitis with or no jaundice, baldness, light sensitivity, muscle pain, joint pain, increased sweating.

Very rare:

Loss of grain leukemia, reducing all bloody, reducing blood magnesium, impatient, hallucinations, taste disorders, liver failure, brain disease in patients with liver disease.

Diverse roses, Stevens-Johnson syndrome, toxic epidermal necrosis (ten), muscle weakness, female mammary glands.

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.

Warnings

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

Contraindicated

sensitive to Esomeprazol, other benzimidazol derivatives (such as Lansoprazol, Pantoprazol, Rabeprazol) or any ingredients of the drug.

Do not coordinate with Nelfinavir, Atazanavir.

Caution when using

If the patient has symptoms such as heavy weight loss, prolonged vomiting, difficulty swallowing, vomiting of blood or black stools), suspicion or gastric ulcer, it is necessary to eliminate the possibility of malignant tumor because the treatment may mitigate symptoms and make late diagnosis.

Long -term treatment: Patients with long -term treatment (especially those who have been treated for more than 1 year) should be monitored regularly.

Proton pump inhibitors may increase the risk of gastrointestinal tract infections caused by Salmonella and Campylobacter.

Esomeprazol, as well as other antacids, can reduce the absorption of vitamin B12 (cyanocobalamin) due to a reduction or lack of gastric acid.

Magnesium reduction.

The risk of fractures: high doses and for a long time (> 1 year), may increase the risk of hip, wrist and spine fractures. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and should be added with an appropriate amount of vitamin D and calcium.

Proton pump inhibitors are related to very frequent cases of multi -level lupus.

Esomeprazol is CYP2C19 inhibitor. When starting or ending treatment with Esomeprazol, the risk of drug interaction with metabolic drugs should be considered through CYP2C19. There has been an interaction between clopidogrel and omeprazol.

The ability to drive and operate machinery

Esomeprazol almost does not affect the ability to drive or operate machinery. Be careful because some cases of Esomeprazol can cause adverse effects such as headache, dizziness.

Pregnancy

does not have enough clinical data on the use of esomeprazol in pregnant women. Be careful when prescribing pregnant women.

The period of breastfeeding

It is unknown whether esomeprazole is secreted through breast milk or not. Therefore, you should not use esomeprazol during breastfeeding.

Drug interaction

Esomeprazole increasing gastrointestinal pH can lead to decrease or increase the absorption of other drugs with the absorption mechanism of gastric pH (the absorption of ketoconazole, iTraconazole, erlotinib can decrease and of digoxin can increase).

Increasing gastric pH in the treatment virgin with Esomeprazol can also lead to a change in the absorption of protease inhibitors, another possible interaction mechanism is through the inhibition of CYP2C19 enzyme inhibitors (Atazanavir and Nelfinavir reduces drug concentration in serum blood, should not be used simultaneously these drugs)

When using ppis with methotrexat, tarcolimus. Methotrexate, Tarcolimus concentration is reported to increase in some patients. Adjustment should be considered if necessary.

Esomeprazol inhibits CYP2C19, the main enzyme metabolizes Esomeprazol. Therefore, when Esomeprazol is used with metabolic drugs with CYP2C19 such as Diazepam, Citalopram, Imipramin, Clomipramin, Phenytoin, Clopidogrel ..., the concentration of these drugs in plasma can increase and need to decrease the dose.

Esomeprazol is metabolized by CYP2C19 and CYP3A4. Should be cautious when used simultaneously with induction drugs or inhibiting these enzymes.

Storage

In closed packaging, cool dry place, avoid light, avoid moisture temperature not exceeding 30⁰C.

To be out of reach of children.

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