Esomeprazol 40-HV medicine for gastroesophageal reflux treatment (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazole

Ingredient

Composition information	Content
Esomeprazole	40mg

Uses

indications

Esomeprazol 40 HV drug is indicated in the following cases:

Gastroesophageal reflux syndrome.

Stomach - duodenal ulcer.

Coordinate with other appropriate antibiotics to treat or prevent relapse of peptic ulcer caused by Helicobacter pylori.

Prevention and treatment of stomach ulcers - duodenum caused by nonsteroidal anti -inflammatory drugs.

Increased stomach acid secretion, including Zollinger - Ellison syndrome.

Pharmacokology and mechanism of action

Esomeprazol 40 HV containing Esomeprazol is the S isomers of omeprazol, used similar to omeprazol in the treatment of gastric - duodenal ulcer, gastroesophageal reflux disease and Zollinger - Ellison syndrome. Esomeprazol is attached to H+/K+ - ATPase (also known as the proton pump) the cell wall of the stomach, inactivating this enzyme system, preventing the final step of the secretion 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 eradicate Helicobacter pylori, so it must be coordinated with antibiotics (such as amoxicillin, tetracycline and clarithromycin) to effectively eradicate this bacteria.

In two studies to compare activity with ranitidin, Esomeprazol shows good effects in treating stomach ulcers in patients using NSAIDs, including NSAIDs selected on COX - 2.

In two studies with placebo, Esomeprazol shows good effects in prevention of stomach and duodenal ulcers in patients using NSAIDs (over 60 years old and/or have a history of ulcer), including NSAIDs selective on COX - 2.

Pharmacokinetics

absorption

Esomeprazol is quickly absorbed after drinking, the peak concentration in plasma is achieved after 1-2 hours. Esomeprazol's bioavailability increases according to the dose and when used to repeat, reaching about 68% when taking the dose of 20 mg and 89% when taking the dose of 40 mg.

Food slows down and reduces the absorption, the area under the curve (AUC) after taking a single dose of 40 mg at a meal compared to the time of hunger decreases from 43% - 53%. So drink Esomeprazol 1 hour before meals.

Distribution

About 97% Esomeprazol binds to plasma proteins.

Metabolism

Esomeprazol is widely metabolized in the liver thanks to the Cytochrome P450 ISOENZYM CYP2C19 system into hydroxy and desmethyl derivatives. The rest is converted through isenzyme CYP3A4 to Esomeprazol Sulfon. When repeated, initially metabolized through the liver and the clearance of the drug may be due to the inhibited ISOENZYM CYP2C19.

However, there is no accumulation phenomenon when used once a day. In some Asians (15 - 20%) because of the lack of genetic isoenzyme, the genetics should slow down the metabolism of Esomeprazol, leading to an increase in AUC to 2 times compared to people with enough enzymes.

Elimination

Esomeprazol's waste sale time is about 1.5 hours, about 80% of oral doses except in the form of non -active metabolites in the urine, the rest is excreted through feces.

less than 1% of the mother substance is eliminated in the urine.

Patients with liver failure

In people with severe liver failure, AUC value is 2-3 times higher than that of people with normal liver function, so they must reduce the dose for these objects and should not be used more than 20 mg per day.

Patients with renal failure

There has been no research conducted in patients with renal failure. Because the kidney is responsible for the excretion of Esomeprazol metabolites but is not responsible for the removal of the mother, the metabolism of Esomeprazol is expected to not change in patients with renal impairment.

Elderly

Esomeprazol's metabolism does not change significantly in the elderly (71-80 years old).

Children (12 - 18 years old)

After the repeated dose of 20 mg and 40 mg Esomeprazol, the total AUC and the time to achieve the maximum plasma concentration (TMAX) for children aged 12-18 are similar to adults, corresponding to both the Esomeprazol doses.

Pharmacokinetics in people under 18 years of age have not been studied.

Before taking Esomeprazol 40-HV medicine for gastroesophageal reflux treatment (3 blisters x 10 tablets)

Dosage and duration of use of Esomeprazol 40 HV for each specific case as prescribed by the treating doctor.

How to use

Take whole pills, do not chew or grind seeds.

Take before meals (preferably before breakfast).

Dosage

adults

Gastroesophageal reflux syndrome

The starting dose is recommended for the treatment of gastroesophageal reflux disease - esophagus is from 20 to 40 mg daily, can last for more than 4-8 weeks for patients who do not heal after 4-8 weeks of treatment.

In the case of maintenance or diseases without symptoms of esophageal erosion, a daily dose of 20 mg.

Stomach ulcer - duodenum with Helicobacter pylori

In the trio combined with amoxicillin and clarithromycin, the usual dose is 20 mg Esomeprazol x 2 times/day of the day or Esomeprazol 40 mg x 1 time/day for 10 days.

Stomach - duodenal ulcerative disease is nonsteroidal anti -inflammatory drugs

The required dose is 20 mg or 40 mg x 1 time/day for 6 months.

Patients with gastric acid secretion, including Zollinger - Ellison syndrome

The initial dose is recommended to be 40 mg of esomeprazol x 2 times/day.

After that, the dosage should be adjusted according to the location of each patient and continue treatment as clinically indicated.

Based on clinical data that has been studied, most patients may be controlled the symptoms at a dose of 80 - 160 mg of Esomeprazol daily. With a dose of over 80 mg daily, the dose should be divided into 2 times/day.

Patients with renal failure

No dose adjustment for patients with mild and medium renal failure. Due to the limited treatment in patients with treatment patients, it is necessary to be careful to monitor on this object (see the pharmacokinetic part in patients with renal impairment).

Patients with liver failure

No dose adjustment for patients with mild and medium liver failure. Esomeprazol dose for patients with severe liver failure must not exceed 20 mg/day.

Elderly

No dose adjustment for the elderly.

Children over 12 years old

Treatment of gastroesophageal reflux syndrome: 40 mg Esomeprazol x once a day, for 4 weeks. An additional 4 -week treatment process is recommended for untreated esophagitis patients or patients with persistent symptoms.

Children under 12 years old

Esomeprazol should not be used in children under 12 years old because there is no clinical data.

What to do when overdose? There is no specific antidote, in case of overdose should treat symptoms and use general support measures.

Hemorrhage does not have the effect of eliminating drugs.

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 using Esomeprazol 40 HV, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Systemic: headache, dizziness, skin rash.

Digestive: Nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, dry mouth.

Uncommon, 1/1000

Body: fatigue, insomnia, drowsiness, rash, itching, abnormalities.

visual disorders.

Rare, ADR

Systemic: Fever, sweating, peripheral edema, sensitive to light, hair loss, hypersensitivity reaction (including urticaria, angioedema, bronchospasm, anaphylaxis).

Central nerve: agitation, depression, confusion, hallucinations.

Respiratory: Respiratory infections.

Hematology: Reducing all bloody, leukopenia, platelet decline.

Liver: Increased liver enzyme, hepatitis, jaundice, liver failure.

Digestive: taste disorders, stomatitis.

Metabolism: hypoglycemia, hypoglycemia, porphyrin metabolism disorders.

Muscle muscle: joint pain, muscle pain, osteoporosis, fracture.

urinary tract: interstitial nephritis.

Endocrine: Big breasts in men.

Skin: bullous rash, Stevens - Johnson syndrome, poisoned epidermal necrosis, dermatitis.

Due to reducing the acidity of the stomach, proton pump inhibitors may increase the risk of bacterial infections in the gastrointestinal tract.

How to handle ADR

Must stop the drug when there is a heavy ADR manifestation.

Notify the doctor 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

Esomeprazol 40 HV contraindications in the following cases:

Hypersensitivity to Esomeprazol, benimidazols or any ingredients of the drug.

Do not coordinate with Nelfinavir, Atazanavir.

Be cautious when used

Before taking proton pump inhibitors, it is necessary to eliminate the possibility of stomach cancer 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 difficile when using proton pump inhibitors.

When using proton pump inhibitors, especially when taking high and prolonged doses (over 1 year), it may increase the risk of pelvic fractures, wrist or spine due to osteoporosis. The mechanism of this phenomenon has not been explained, but it may be due to reducing unanimidated calcium absorption due to gastric pH hypoglycemia. 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.

Hypotension (with or asymptomatic) rarely encountered in patients using prolonged proton pump inhibitors (at least 3 months or in most cases that last for more than 1 year).

Due to the micro -seed composition containing sucrose, patients with rare genetic diseases in galactose tolerance, or poorly absorbing Glucose - Galactose should not use this drug.

Be cautious when used for patients with diabetes.

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

Some cases of dizziness, headache, dizziness when using Esomeprazol, therefore, be careful to use the drug while driving or operating machinery.

Using drugs for pregnant and lactating women

The drug does not affect the development of fetuses in humans and animals, but should only be used for pregnant women when necessary.

Do not use medication for women during breastfeeding. In case of medication, it is necessary to stop breastfeeding.

Drug interaction

Esomeprazole inhibits acid secretion, increases gastric pH, so the drug can affect the bioavailability of some pH -dependent absorption drugs such as ketoconazole, digoxin, iron salt.

Simultaneously use Esomeprazol, Clarithromycin and Amoxicillin, increasing the concentration of ecomeprazol and 14 - Hydroxyclarithromycin in the blood.

Esomeprazol interact with dynamic pharmacokinetics with metabolic drugs by the cytochrom P450 enzyme system P450 isoenzyme CYP2C19 in the liver.

Simultaneously use 30 mg of Esomeprazol and Diazepam, reducing Diazepam's 45% of clearance.

Esomeprazol may increase the blood concentration of Saquinavir and reduce the concentration of Nelfinavir and Atazanavir through an unclear mechanism. Therefore, it is advisable to consider reducing the dose of Saquinavir when used with Esomeprazol to avoid unwanted effects of Saquinavir.

Esomeprazol reduces the activity of clopidogrel metabolic enzymes into an active form, thus reducing the activity of clopidogrel, so it is recommended to use only the combination of these two drugs when it is really necessary.

Esomeprazol increases the concentration of cilostazol and its metabolites. The dose of cilostazol should be reduced from 100 mg twice a day to 50 mg twice daily when used with Esomeprazol.

Storage

Store drugs in a dry place, temperatures below 30 ° C, avoiding light.

To be out of reach of children.

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