Nesteloc 20 USP medicine for gastroesophageal reflux syndrome (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	20mg

Uses

Indications

Nesteloc 20 drugs are indicated in the following cases:

Gastroesophageal - esophagus syndrome.

Pharmacokology

Nesteloc 20 contains Esomeprazol as the isomorphic form of Omeprazole that reduces gastric acid secretion under high selective and non -recovery mechanism into the proton pump. The drug has a specific affinity for H+K+-Aatpase (proton pump) in the stomach lining cells. This enzyme controls the final stage of the process of gastric acid secretion, so Nesteloc 20 inhibits the basic acid secretion process as well as due to any stimulation.

pharmacokinetic

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 reminded, reaching about 68% when taking the dose of 20mg and 89% when taking the dose of 40mg. Food slows down and reduces the absorption, the area under the curve (AUC) after taking a single dose of 40mg at meals compared to when hunger decreases from 33 - 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 ISOENZE CYP2C19 system into hydroxy and demethyl derivatives. The rest is converted through isenzyme CYP3A4 to Esomeprazol Sulfon. The initial metabolism through the liver and the clearance of the drug may be due to the inhibited isoenzyme CYP2C19. However, there is no accumulated phenomenon when used once a day. Where some Asians (15 - 20%) because of the lack of isoenzyme CYP2C19 due to genetics should slow down the metabolism of Esomeprazol, resulting in AUC increasing 2 times compared to people with enzymes.

Elimination

Esomeprazol's waste sale time is about 1 - 1.5 hours, about 80% of oral doses are eliminated in the form of non -active metabolites in the urine, the rest is excreted through feces. Under 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 20mg daily.

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

Before taking Nesteloc 20 USP medicine for gastroesophageal reflux syndrome (3 blisters x 10 tablets)

How to use

Take oral, taken pills, do not chew or grind the micro -seeds. Drink before meals (preferably before breakfast).

Dosage

Dosage and medication time for each specific case as prescribed by the treating doctor. The usual dose is as follows:

Gastroesophageal reflux syndrome

The starting dose for the treatment of gastroesophageal reflux disease is from 20 to 40mg per day, 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, the daily dose of 20mg can be used.

Stomach ulcer - duodenum with HP

In the trio combined with amoxicillin and clarithromycin, the usual dose is 20mg Esomeprazol x 2 times/day for 7 days or Esomeprazol 40mg x 1 time/day for 10 days.

Stomach - duodenal ulcer due to non -steroid anti -inflammatory drugs

Required dose is 20mg or 40mg 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 20mg/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? 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 Nesteloc 20, you may experience unwanted effects (ADR).

Common side effects: headache, dizziness, abdominal pain, diarrhea, flatulence, constipation.

Less: Dermatitis, itching, urticaria, dizziness, dry mouth.

Rare: fever, sweating, peripheral edema, sensitive to light, hypersensitivity reactions including (urticaria, angioedema, bronchospasm, anaphylactic shock).

Very rare: granulocytosis, leukopenia, thrombocytopenia, hyper enzyme, hepatitis, liver failure, interstitial nephritis, muscle pain, joints.

Instructions on how to handle ADR:

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

Nesteloc 20 drugs are contraindicated in the following cases:

Hypersensitivity to the ingredients of the drug.

Prisable when using

When there is a vigilant symptom such as: significant weight loss, unintentional, recurrent vomiting, difficulty swallowing, vomiting, or defecation of black blood and when there is a suspected stomach ulcer, should eliminate the possibility of malignant stomach ulcer, because treatment with Esomeprazol can reduce symptoms and delay the diagnosis.

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

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, therefore, be careful to take the drug while driving or operating machinery.

Pregnancy

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

Breastfeeding period

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

Drug interaction

Esomeprazol 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-hydroxy clarithromycin 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 100mg twice a day to 50mg twice daily when used with Esomeprazol.

Storage

Store the drug in a dry place, the temperature below 30 ° C, avoiding light.

To be out of reach of children.

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