Esomeprazol 20-US medicine for gastroesophageal reflux disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	20mg

Uses

indications

Esomeprazol 20-US drug is indicated in the following cases:

Treatment:

Gastroesophageal reflux syndrome.

Stomach - duodenal ulcer.

Treatment of gastric ulcer - duodenum contaminated with Helicobacter pylori and prevent the risk of recurrence in patients with stomach ulcer - duodenum infected Helicobacter pylori.

Prevention and treatment of enzyme - duodenal ulcer caused by nonsteroidal anti -inflammatory drugs.

Pharmacology

Esomeprazol 20-US containing Esomeprazol is the isomorphic form of Omeprazol that reduces gastric acid secretion under a high selective and non-recovery mechanism into Proton pump.

The drug has a specific affinity with H+/ K+- ATPase enzyme (proton pump) in the stomach mucosa cells. This enzyme controls the final stage of the process of gastric acid secretion, so Esomeprazol 20-US inhibits both the basic acid secretion as well as any stimulation.

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 hunger decreases from 33 - 53%. So drink Esomeprazol 1 hour before meals.

Distribution:

About 97% Esomeprazol is connected to plasma proteins.

Metabolism:

Esomeprazol is widely metabolized in the liver by the cytochrom P450 ISOENZYM CYP2C19 system into non -activated hydroxy and demethyl derivatives. The rest converts through isenzyme CYP3A4 into Esomeprazol Sulfon.

When used repeated, the initial metabolism through the liver and the clearance of the drug may be due to the inhibited ISOENZYM CYP2C19. However, there is no accumulated phenomenon when used once a day. In some Asians (15-20%) because of the lack of genetic ISOENZYMYMYMYMM, slowing down the metabolism of Esomeprazol, leading to an increase of 2 times compared to people with enough enzymes.

Era:

Esomeprazol's waste time is about 1-1.5 hours, about 80% of oral doses are eliminated in the form of non-activated metabolites in the urine, the rest is deducted from feces. Less than 1% of the mother 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 they must reduce the dose for these objects and should not be used more than 20 mg daily.

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

Before taking Esomeprazol 20-US medicine for gastroesophageal reflux disease (3 blisters x 10 tablets)

How to use

Take whole pills, do not chew or grind seeds. Drink before meals (preferably before breakfast).

Dosage

Dosage and duration of use for each specific case as prescribed by the treating doctor. The usual dose is as follows:

Gastroesophageal reflux syndrome:

The starting dose is recommended for the treatment of gastroesophageal reflux disease-esophagus is from 20 to 40 mg daily, which 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 may be used.

Stomach - duodenal ulcer has Helicobacter pylori:

In the trio combined with amoxicillin and clarithromycin, the common dose is 20 mg of esomeprazol x twice a day for 7 days or Esomeprazol 40 mg x 1 time / day for 10 days.

Stomach - duodenum ulcerative disease:

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

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.

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 specialist.

What to do when overdose and management? There is currently 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 a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Esomeprazol 20-US, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache, dizziness.

digestive: abdominal pain, diarrhea, flatulence, constipation.

Uncommon, 1/1000

Skin: Dermatitis, itching, urticaria.

nerve: dizziness. digestive: dry mouth.

Rare, ADR

Body: Sweating fever.

cardiovascular: peripheral edema.

Hypersensitivity reactions include: urticaria, angioedema, bronchospasm, anaphylactic shock.

Other: sensitive to light.

Hematology: Loss of granulocytes, leukopenia, thrombocytopenia liver: Increased liver enzymes, hepatitis, liver failure. kidney: interstitial nephritis.

Mechanical-muscle: muscle pain, joints.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using Esomeprazol 20-US, you need to read the user manual carefully and refer to the information below.

contraindicated

Esomeprazol 20-UST Contraindicated in the following cases:

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

Be cautious when using

When there is a presence of vigilant symptoms such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting blood, or defecation of black blood) and when there is a suspected stomach ulcer, should eliminate stomach cancer, because treatment with ecomeprazole can reduce symptoms and delay the diagnosis.

Be cautious when taking the drug for a long time because it can cause gastritis.

Be cautious when used for children under 18 years old.

Be cautious when used for people with liver disease, pregnant and lactating women.

For people with renal failure, do not need to adjust the dose, but be cautious when used for patients with severe renal impairment.

The ability to drive and operate machinery

Some cases of dizziness, headache, dizziness when using Esomeprazol, so be careful to use medication while driving or operating machinery.

Pregnancy

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

The period of breastfeeding

should not be used 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.

Simultaneous use of Esomeprazol, Clarithromycin and amoxicillin increases 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 30mg 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 the possible side effects of Saquinavir.

Esomeprazol reduces the activity of clopidogrel metabolic enzymes into a activity form, thus reducing the activity of clopidogrel, so recommend only use combining these two drugs when 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.

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