Orieso 20mg capsules in the Southeast treat stomach - duodenal ulcer (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazole

Ingredient

Composition information	Content
Esomeprazole	20mg

Uses

indications

Orieso drugs are indicated in the following cases:

Gastric ulcer - benign duodenum.

Zollinger - Ellison syndrome.

Gastroesophageal reflux disease - severe esophagitis (scratched esophagitis, ulcers or stenosis is determined by laparoscopy).

Prevention and treatment of stomach - duodenal ulcer due to nonsteroidal anti -inflammatory drugs.

Pharmacokinus

Esomeprazol is the isomorphic form of Esomeprazol, used similar to omeprazol in the treatment of gastric ulcer and gastroesophageal reflux disease.

Esomeprazol is associated with H+/K+ - ATPase (also known as proton pump) in the stomach wall cell, inhibiting this enzyme system, preventing the final step of acidic secretion into the stomach. So Esomeprazol has the effect of inhibiting the basic acid secretion and even when stimulated by any agent.

Pharmacokinetics

absorption

Esomeprazol absorbs quickly after drinking, reaching the highest concentration in plasma 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 of Esomeprazol, the area under the curve (AUC) after taking a single dose of Esomeprazol 40 mg at meals compared to when hunger decreases from 33% to 53%. Therefore, Esomeprazol has to drink at least 1 hour before meals.

Distribution

About 97% Esomeprazol attaches to plasma proteins. The volume of distribution when the drug concentration stabilizes in a healthy condition of 16 liters.

Metabolism

Maximum metabolic drugs are mainly in the liver thanks to isenzyme CYP2C19, cytochrom P450 enzyme system, into hydroxy and desmethyl metabolites that are no longer active. The rest is converted through ISOENZYM CYP3A4 to Esomeprazol Sulfon. When used repeated, initially metabolized through the liver and the clearance of the drug reduced, possibly due to the inhibited ISOENZYM CYP2C19. However, there is no phenomenon of accumulation of drugs when used once a day. In some people because of the lack of CYP2C19 due to genetics (15-20% of Asians), they should slow down the metabolism of Esomeprazol, resulting in an increase in AUC value about 2 times compared to people with enough enzymes.

Elimination

Half lifetime elimination in plasma 1 - 1.5 hours. About 80% of oral doses are eliminated in the form of non -active metabolites in the urine, the rest is eliminated in the 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 Esomeprazol is reduced in patients, the dose does not exceed 20 mg a day.

Esomeprazol pharmacokinetics in people under 18 have not been studied.

Before taking Orieso 20mg capsules in the Southeast treat stomach - duodenal ulcer (3 blisters x 10 tablets)

How to use

Oral oral oral medication.

Esomeprazol is used in the form of magnesium or sodium salt, but the dose is calculated in esomeprazol.

Esomeprazol is not stable in acidic environment, so it is necessary to take the drug in the form of capsules containing the boweled particles in the intestine so as not to be destroyed in the stomach and increase bioavailability. Must swallow the tablet, not crushed or chewed. However, if the patient is difficult to swallow, it is possible to open the capsule, slowly pour the medicine inside the cyst into a tablespoon of boiled water to cool or apples, orange juice and swallow immediately.

Take the medicine at least one hour before meals.

Dosage

Adults

Treatment of stomach - duodenal ulcer has Helicobacter Pylori: Esomeprazol is a component in the treatment regimen along with antibiotics, for example 3 drug regimen (along with amoxicillin and clarithromycin). Take Esomeprazol at 20 mg, twice a day for 7 days, or 40 mg once a day for 10 days. (Amoxicilin at 1.0 g, twice a day and Clarithromycin at 500 mg, twice a day for 7 or 10 days).

Treatment of gastroesophageal reflux disease - serious esophagitis: Take 20 - 40 mg once a day for 4-8 weeks, can take 4-8 weeks more if there are still symptoms or manifestations of laparoscopic inflammation.

Treatment is maintained after gustary inflammation: taken once a day 20 mg, can last up to 6 months.

Preventive prevention of stomach ulcers in people with high risk of stomach - duodenal complications, but there is a requirement to continue treatment with nonsteroidal anti -inflammatory drugs: 20 mg daily.

Treatment of gastroesophageal reflux disease - symptomatic but not esophagitis: Take 20 mg once a day for 4 weeks, can take 4 more weeks if the symptoms are not completely.

Treatment of stomach ulcers due to nonsteroidal anti -inflammatory drugs: Take 20 mg once a day for 4-8 weeks.

Treatment of Zollinger - Ellison syndrome: Depending on the individual and the level of acid secretion of the gastric juice, immediately use higher daily in other cases, used one -time or divided into 2 times a day. When symptoms are controlled, surgery may be used to cut tumors. If the tumor is not completely removed, the medication must be used for a long time.

Severe liver failure does not use more than 20 mg a day.

There is no need to reduce the dose in mild and medium liver failure, people with kidney failure or elderly.

Children

Do not take medicine for children.

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 no specific antidote for Esomeprazol. Mainly treat symptoms and support. Blood separation does not have the effect of increasing the elimination of the drug because the drug is highly attached to the protein.

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 Orieso, you may experience unwanted effects (ADR).

Overall, Esomeprazol tolerates well when used in a short time and a long time.

Common, ADR> 1/100

Systemic: headache, dizziness, skin extra skin.

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

Uncommon, 1/1000

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

Eye: visual disorders.

Rare, 1/10000 ≤ ADR

Systemic: Fever, sweat, peripheral edema, sensitivity to light, hypersensitivity reactions (including urticaria, angioedema, bronchospasm, anaphylactic shock).

Central nervous system: agitation, depression, confusion with recovery, hallucinations in serious illness. Hematology: granulocytosis, leukopenia, thrombocytopenia. liver: Increased liver enzyme, hepatitis, jaundice, liver function. digestion: taste disorders.

Muscle muscle: joint pain, muscle pain.

Urinary tract: interstitial nephritis.

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 gastrointestinal infections.

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

Orieso drugs are contraindicated in the following cases:

Hypersensitivity to proton pump inhibitors or hypersensitivity to any ingredients of the drug.

Be cautious when used

Before taking proton pump inhibitors, it is necessary to eliminate 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 lactating people.

Be cautious when using Esomeprazol for prolonged because it can cause gastritis. Precautions must be used for children under 18 years of age because of their safety and efficiency. The drug is not recommended for children.

The ability to drive and operate machinery

No report.

Pregnancy

There is no adequate study when using Esomeprazol in pregnant women. On white rat animals Esomeprazol dose 280 mg/kg/day (57 times the dose on humans calculated on the body surface area) and the oral rabbit dose of 86 mg/kg/day (15 times the dose on humans calculated by the body surface area) did not see evidence of reproductive or toxic fetuses by Esomeprazol. However, only use Esomeprazol when really necessary during pregnancy.

Nursing period

It is unknown whether esomeprazole will excrete in human milk or not. However, the concentration of omeprazol in women's milk after taking 20 mg of omeprazol. Esomeprazol has the ability to cause serious unwanted effects in breastfed babies, so it is necessary to decide to stop breastfeeding or stopping the drug, depending on the importance of the medication for the mother.

Drug interaction

Due to the inhibition of acid excretion, Esomeprazol increases the gastric pH, affecting the bioavailability of pH -dependent absorption drugs: ketoconazol, iron salt, digoxin.

Simultaneous use of ecomeprazol, clarithromycin and amoxicilin increases the concentration of ecomeprazol and 14 -hydroxyclarithromycin in the blood.

Esomeprazol interact with pharmacokinetic pharmacokinetic drugs with metabolic drugs by the cytochrom P450 enzyme system, isenzyme CYP2C19 in the liver. Simultaneous use of 30 mg of Esomeprazol and Diazepam reduces 45% of Diazepam's clearance.

Storage

In a dry place, temperatures below 30 ° C, avoid light.

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