Esonix 20mg Incepta Treatment of esophageal reflux (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Esomeprazole

Ingredient

Composition informationContent
Esomeprazole20mg

Uses

indications

Esonix 20 drugs are indicated in the following cases:

Treatment of esophageal reflux disease (GERD)

Treatment of esophageal reflux symptoms.

Reduce the risk of stomach ulcers associated with anti -inflammatory drugs NSAID

Esonix is ​​indicated that reduces the risk of stomach ulcers associated with the use of NSAID anti -inflammatory drugs in patients at risk of gastric ulcer. Patients are thought to be at risk as older patients (≥ 60) and/or have a history of stomach ulcers. Clinical trials not exceeding 6 months.

Eliminating H. pylori to reduce the risk of duodenal ulcer

Combining 3 drugs: Esomeprazole + Amoxicillin + Clarithromycin. If the treatment fails, it is recommended to conduct sensitive tests. If any, clarithromycin is proven to be proven or cannot be sensitive, alternative antibiotic therapies need to be conducted.

Cases of increased diseases include Zollinger - Ellison syndrome

Esonix IV is indicated for short -term treatment (up to 10 days) GERD disease has a history of esophageal ulcer such as oral substitute treatment in patients when Esonix tablets are not suitable.

When can be taken orally, stop Esonix IV and continue oral treatment.

Pharmacokic

Esomeprazole is the isomorphic form of omeprazole and reduces the excretion of gastric acid with a specialized mechanism of action. The drug is a specific inhibitor of acid pump in the wall of the wall. Both types of isomers R-and S- of Omeprazole have similar pharmacological effects.

Position and impact mechanism

Esomeprazole is a weak alkaline, concentrated and transformed into an active form in a high acidic environment in the sub -trailer of the cell's secretion, where H+/K+ - ATPase inhibitors (acid pump) and inhibit both basic fluid and irritability.

Acting on gastric acid secretion

After 5 days of taking the oral dose of Esomeprazole 20 mg and 40 mg, the pH in the stomach> 4 has been maintained within an average time of 13 and 17 hours in 24 hours in patients with symptoms of gastroesophageal reflux. This effect is the same regardless of whether eSomeprazole is used orally or intravenously.

The therapeutic effect of acid inhibition

When using Esomeprazole 40 mg oral, about 78% of esophagitis patients are healed after 4 weeks and 93% are healed after 8 weeks. Other impacts are related to acid inhibition during treatment with gastric acid -secreting drugs, increased serum levels in response to gastric acid reduction.

Increasing the number of ELC cells is probably due to increased serum gastrin levels that have been recorded in some patients when long -term treatment with oral esomeprazole.

Microbiology

Combining 3 drugs: Esomeprazole, Amoxicillin and Clarithromycin have been shown to be active with H. pylori on in vitro and on clinical infections. Sensitive tests of amoxicillin and clarithromycin with H. pylori should be conducted when suspected of anti -drug bacteria.

pharmacokinetics

Distribution

Expected distribution voltage in a healthy state in a healthy person is about 0.22 l/kg body weight. Esomeprazole connects 97% to plasma proteins.

Metabolism and excretion

Esomeprazole is completely metabolized through the Cytochrome P450 (CYP) system. The main part of the Esomeprazole metabolism depends on the morphological polymorphic CYP2C19 enzyme, forming hydroxy and desmethyl metabolites of Esomeprazole. The rest of the metabolic process depends on a different specific substance, CYP3A4, forming Esomeprazole sulphoric, the main metabolite in plasma.

Sell waste time in plasma is about 1.3 hours.

The main metabolites of Esomeprazole does not affect gastric acid secretion. About 80% of Esomeprazole oral doses are excreted in the urine as metabolites, the rest through feces. Less than 1% of constant drugs found in urine.

Before taking Esonix 20mg Incepta Treatment of esophageal reflux (5 blisters x 10 tablets)

How to use

Tablet form: Should take medicine at least 1 hour before meals.

Dosage

Dosage recommended instructions in the following table:

indicated

Dosage

Number of times/day

Gerd reflux disease (

40 mg or 20 mg

1 time/day for 4 - 8 weeks.

20 mg

1 time/day.

20 mg

1 time/day for 4 weeks.

20 mg or 40 mg

1 time/day for 6 months.

40 mg

1 time/day for 10 days.

1000 mg

2 times/day for 10 days.

Clarithromycin

500 mg

2 times/day for 10 days.

40 mg

2 times/day.

20 mg or 40 mg

1 time/day for 8 weeks.

For the elderly and patients with renal impairment: No dose reduction.

Patients with mild and moderate liver failure do not need dose adjustment. Patients with severe liver failure, should not use more than 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 do

do when using overdose? The described symptoms related to the use of 280 mg oral dose are symptoms on the gastrointestinal tract and weakness. Esomeprazole single types of 80 mg oral and 100 mg veins are still safe to use.

There is no specific detoxification. Esomeprazole is strongly connected to plasma proteins and therefore not easily separated. 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 using Esonix 20, you may experience unwanted effects (ADR).

The following medication side effects have been recorded or suspected in the clinical trials of Esomeprazole oral or intravenously and after circulating the oral form of the drug on the market.

Blood and lymphatic disorders

Rare: leukopenia, thrombocytopenia.

Very rare: loss of granulocytes, reducing all bloody hematopleus.

immune system disorders

Rare: Hypersensitivity reactions such as fever, angioedema and anaphylactic shock.

Metabolic and nutrition disorders

Uncommon: Foreign eagles.

Rare: Hypoglyc sodium.

Mental disorders

Less: Sleep.

Rare: agitation, loss of temper, depression.

Very rare: illusion.

Nervous system disorders

Perfect, sleepy, insomnia, dizziness. Mental confusion can recover, agitated, impatient, depression and hallucinations mainly in patients with serious illness.

Endocrine

female mammary glands.

digestive

Gastrointestinal stomatitis and gastrointestinal fungal disease.

Hematology

leukopenia, thrombocytopenia, grain leukemia and all blood cells.

liver

Patients with severe liver disease; Hepatitis has or without jaundice, liver failure.

skeletal muscle

joint pain, muscle weakness.

DA

Rashes, light sensitivity, poisoned epidermal necrosis (ten), hair loss.

Other adultery reactions

tired.

Hypersensitivity reaction

Fever, bronchospasm, interstitial nephritis. Increase sweating, peripheral edema, taste disorders and hypoglycet. The non -recovery visual lesions have been recorded in a very rare number of cases where patients with serious illness have used omeprazole intravenously, especially when high doses, but have not yet identified the causal relationship between the use of drugs and adultery events.

Notify the doctor with unwanted effects when using the drug.

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

Esonix 20 drug contraindicated in the following cases:

Hypothesis hypersensitivity to the main active ingredient Esomeprazole or other substances belonging to the Benzimidazoles division or any excipients of this drug.

Be cautious when using

When there is a vigilant symptom (such as: significant weight loss, recurrent vomiting, difficulty swallowing, vomiting blood or defecation of black blood) and when there is a suspected stomach ulcer, eliminating the possibility of evil in Esomeprazole can cover symptoms and delay diagnosis.

Preliseors

Esomeprazole's cancer -causing ability is rated based on Omeprazole studies, in which Esomeprazole is a counter -image.

Esomeprazole is negative in the ames gene mutations, in the experiment on Vivo in the wrong chromosome of the mouse bone marrow cells and the reproductive humanity on the mouse.

The ability to influence the fertility of Esomeprazole is based on the studies of omeprazole, omeprazole oral doses of up to 138 mg/kg/day in mice (about 56 times of human dose based on the body surface) and 69 mg/kg/day in rabbits (about 56 times the dose of humans -based body surface shows no effect on animal fertility.

Use in children

Use Esomeprazol in patients from 12 to 17 years old during the short -term treatment as directed by the doctor. Using drugs in children under 12 years of age has not been established.

Older people

Of the total number of elderly patients using Esomeprazole in clinical trials, there are no differences in safety and effectiveness that are observed compared to young patients. And there are no reports on the difference in drug response between the elderly and the young, but the ability to be more sensitive to the drug in the elderly is not excluded.

The ability to drive and operate machinery

There is no research on the ability to use machinery and labor. Treatment should be done if really necessary.

Pregnancy

There was a few data on Esomeprazole on pregnant animals. Esomeprazole studies do not show that the drug has a direct or indirect effect on the development of embryos/fetus. Studies on animals with Ticemic mixture do not show that the drug has a direct or indirect effect on pregnancy, birth or postpartum development. Should be cautious when prescribing Esomeprazole for pregnant women.

The period of breastfeeding

It is unknown whether esomeprazole will produce breast milk or not. Research on breastfeeding women has not been conducted. Therefore, you should not use Esomeprazole during breastfeeding.

Drug interaction

The effect of the above Esomeprazole is the kinetics of other drugs

The reduction of stomach acid when treated with Esomeprazole may increase or reduce the absorption of other drugs if the absorption mechanism of these drugs is affected by gastric acid, like other gastric acid secretions or antacids, the absorption of ketoconazole and iTraconzole may decrease during treatment with Esomeprazole.

Esomeprazole inhibits CYP2C19, the main enzyme metabolizes Esomeprazole. Therefore, when Esomeprazole is used with metabolic drugs through CYP2C19 such as diazepam, citalopram, imipramine, clomipramine, phenytoin ..., the concentration of these drugs in plasma can increase and need to decrease the dose. When simultaneously used with Esomeprazole 40 mg orally 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 Esomeprazole.

When simultaneously use 40 mg of esomeprazole oral oral form in people being treated with warfarin in a clinical trial has shown that the time of blood clotting is in an acceptable range. However, after bringing the medication to the market, there were several cases of significant Inr clinical increase when treated simultaneously the above two drugs. The patient should be monitored at the beginning and when the treatment is terminated simultaneously Esomeprazole with Warfarin and the Coumarine derivatives.

In healthy volunteers, when used with 40 mg of esomeprazole oral and cisapride form, the area under the curve shows cisapride concentration in plasma according to the plasma cisapride peak concentration is negligible. The QTC range is slightly extended after using individual cisapride, not longer lasting when used simultaneously Cisapride with Esomeprazole.

Esomeprazole has been clinically proven to be not significantly supported to amoxicillin or quinidine pharmacology.

Effect of other drugs on pharmacokinetics of Esomeprazole

Esomeprazole is metabolized by CYP2C19 and CYP3A4. When used simultaneously oral Esomeprazol with CYP3A4 Clarithromycin inhibitor (500 mg, 2 times/day), double the area under the curve (AUC) of Esomeprazole.

Do not regularly adjust the dose of Esomeprazol in these cases.

However, it is necessary to consider adjusting the dose for patients with severe liver failure and have long -term indications for drugs.

Cavalry

There is no report on taboos with other drugs. However, do not use with other drugs.

Storage

Store in a dry place, avoid light, temperatures below 30 ° C

To be out of reach of children.

Other drugs

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