Prazopro 20 TV.Pharm Treatment Treatment of Stomach ulcer, benign duodenum (2 blisters x 7 tablets)

Dosage form Box of 2 blisters x 7 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	20mg

Uses

indications

Prazopro 20 drugs are indicated in the following cases:

Treatment of stomach ulcers - colon, gastroesophageal reflux disease, zollinger -endison syndrome, gastrointestinal bleeding, severe colonoscopy (prevent recurrent bleeding). Learning

Esomeprazole is the S isomers of Omeprazole, used similar to omeprazole in the treatment of stomach ulcers, gastroesophageal reflux disease and zollinger -endison syndrome.

Esomeprazole is associated with H+/K+-Aatpase (also called proton pump) in the cell wall of the stomach, inhibiting this enzyme system, preventing the final step of the excretion of hydrochloride acid secretion into the stomach heart. Therefore, Esomeprazole has the effect of inhibiting the stomach secreting basic acid and even when stimulated by any factor. 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.

Dynamic pharmacokinetics

absorption

Esomeprazole quickly absorbed after drinking, reaching the highest concentration in plasma after 1–2 hours.

Esomeprazole's bioavailability increases according to the dose and when used repeated, reaching about 68% when taking the dose of 20 mg and 89% when taking the dose of 40 mg.

Esomeprazole slowed and reducing the absorption of Esomeprazole, but does not change the effect of the drug's effect on the acidity in the stomach, the area under the curve (AUC) after taking a single dose of Esomeprazole 40 mg at meals compared to 33–53%. Therefore, Esomeprazole has to drink at least 1 hour before meals.

distribution

About 97% Esomeprazole attaches to plasma proteins.

The distribution volume when the drug concentration is stable in healthy volunteers about 0.22 l/kg.

transformation

Maximum metabolic drugs are mainly in the liver thanks to the isoenzyme CYP2C19, the cytochrome p450 enzyme system, into hydroxy and desmethyl metabolites.

The rest is converted through isenzyme CYP3A4 to Esomeprazole Sulfon.

When used repeated, initially metabolized through the liver and the clearance of the drug reduced, possibly due to the inhibited isoenzyme 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 Esomeprazole, resulting in an increase in AUC value about 2 times compared to people with enough enzymes.

Elimination

Selling time is about 1.3 hours. About 80% of oral doses are eliminated in the form of non -active metabolites in the urine, the rest is eliminated in feces.

less than 1% of the drug is eliminated in urine.

In people with severe liver failure, AUC value is 2–3 times higher than that of people with normal liver function, so Esomeprazole do not reduce the dose of Esomeprazole in these patients.

Before taking Prazopro 20 TV.Pharm Treatment Treatment of Stomach ulcer, benign duodenum (2 blisters x 7 tablets)

How to use

Prazopro 20 tablets hard capsules for oral. Swallow of pills with water, not chewed or grinded.

Dosage

adults and children> 12 years old

Dosage in the treatment of stomach ulcers - rosaries due to Helicobacter pylori infection:

Esomeprazole is a component in the treatment regimen along with antibiotics, for example a regimen 3 or 4 drugs (along with amoxicillin and clarithromycin or clarithromycin, metronidazole and bismuth).

Oral Esomeprazole 20 mg/time (1 tablet) x 2 times/day x 7 days. bismuth).

Take 20 mg daily (1 tablet) for 4–8 weeks.

Take 20 mg every day (1 tablet).

Dosage in the treatment of gastroesophageal reflux disease

Take 20 mg daily (1vien) for 4–8 weeks, can take 4–8 weeks for another if the injury is not healed.

Dosage in treatment for maintenance after gustary inflammation or symptomatic treatment in case of no esophagitis:

Take 20 mg daily (1 tablet).

Depending on the individual and the level of acid secretion of the gastric juice, the daily dose is higher daily in other cases, once used or divided into 2 times a day.

The starting dose of oral 40 mg (2 tablets) x 2 times/day, then adjust the dose when necessary.

Most patients can control the disease at the dose of 80–160 mg daily, although there are cases where 240 mg must be used daily.

Doses greater than 80 mg/day must be divided into 2 times.

Children under 12 years old

Should use another form of preparation more suitable.

Other objects

People with liver failure: Do not reduce the dose in mild and medium liver failure. People with severe liver failure do not use more than 20 mg/day.

Persons of renal failure: No need to reduce the dose in people with renal failure but be cautious in people with kidney failure because the experience used in these patients is limited.

Elderly: No need to reduce the dose in the elderly.

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 overdose? Mainly treat symptoms and support. Hemorrhage does not have the effect of increasing the elimination of drugs 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 Prazopro 20, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Body: headache, dizziness.

Skin: Ban on the skin.

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

rarely, 1/1000

Body: fatigue, insomnia, drowsiness.

Skin: rash, itching.

Eye: visual disorders.

rare, ADR

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

Central nerve: agitation, depression, confusion with recovery, hallucinations in serious patients.

Hematology: granulocytosis, leukopenia, thrombocytopenia.

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

Digestive: taste disorders, stomatitis.

Metabolism: hypoglycemia, hypoglycemia, porphyrin metabolic disorders.

Bone muscle: joint pain, muscle pain.

urinary tract: interstitial nephritis.

Endocrine: Big breasts in the South.

Skin: puffiness, 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.

Instructions on how to handle ADR

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

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Prazopro 20 drugs are contraindicated in the following cases:

Hypersensitivity to Esomeprazole, other proton pump inhibitors or any ingredients of the drug.

Do not use simultaneously with nelfinavir.

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 mothers.

Be cautious when using Esomeprazole prolonged because it can cause gastritis or increase the risk of bacterial infections (such as community pneumonia). The risk of diarrhea may be increased due to clostridioides varesile when using proton pump inhibitors.

When using proton pump inhibitors, especially when taking high and prolonged doses (> 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 reduction in unanimidated calcium absorption due to gastric increased pH.

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.

Esomeprazole may reduce the absorption of vitamin B12 (cyanocobalamin) due to a reduction or lack of gastric acid. It is advisable to consider when long -term treatment with Esomeprazole in patients with vitamin B12 deficiency or at risk of reducing vitamin B12 absorption.

There has been a report on serious blood maggesi in patients treated with proton pump inhibitors (PPI) such as Esomeprazole for at least 3 months and most cases of PPI for 1 year.

Serious symptoms of bloody blood like fatigue, muscle spasms, delirium, convulsions, dizziness and ventricular arrhyths may occur, but may be silently and not noticed. The majority of patients who have a magnesi hypoglycemic condition will be improved after supplementing Magnesi and stopping ppi.

For patients for long -term treatment with PPI or patients who have to use PPI along with digoxin or other drugs that may cause blood magomesi (such as diuretics), medical experts should consider quantifying magnesium concentration in the blood before starting treatment with PPI and periodic testing during treatment.

The ability to drive and operate machinery

may experience unwanted effects such as dizziness and visual disorders. Do not drive or operate machinery if there are these signs.

Pregnancy

There is no adequate study when using Esomeprazole in pregnant people. However, only use Esomeprazole during pregnancy when really necessary.

Nursing period

It is unknown whether esomeprazole is excreted in breast milk or not. However, omeprazole is distributed into human milk.

Esomeprazole has the ability to cause unwanted effects in breastfed babies, so it is necessary to decide to stop breastfeeding or stop the drug, depending on the importance of the medication for the mother.

Interactive drug

Due to the inhibition of acid excretion, Esomeprazole increases the stomach pH, affecting the bioavailability of the absorbing drugs depending on the pH: ketoconazole, iron salt, digoxin.

Esomeprazole interact with pharmacokinetic pharmacokinetic drugs with metabolic drugs by the cytochrome p450 enzyme system, ISOenzyme CYP2C19 in the liver. Simultaneous use of Esomeprazole with Gilostazol increases the level of Cilostazol and active metabolites, considering reducing the dose of Cilostazol.

Simultaneous use of Esomeprazole with voricononale may increase the concentration of Esomeprazole 2 times, considering in patients with high doses of Esomeprazole (240 mg/day) when treating Zollinger - Elison syndrome.

Use Esomeprazole with CYP2C19 and CYP3A4 induction drugs such as Rifampin reduces Esomeprazole levels, should be avoided simultaneously.

may increase the risk of hypoglycemia when taking Esomeprazole with drugs that also causes blood magomesi such as thiazide diuretics or diuretic. Check the Magnesi concentration before starting to use proton pump inhibitors and then periodically.

Atazanavir: can change the absorption when taking Atazanavir, reducing this concentration of drugs in plasma, which can reduce antiviral effects. Do not simultaneously inhibit the Proton and Atazanavir inhibitors.

Clopidogrel: Use the same proton pump inhibitors that reduce the concentration of metabolites that are active of clopidogrel in plasma, reducing platelet resistance.

Digoxin: Lowering blood magnesia due to prolonged use of proton pump inhibitors that cause heart muscle to increase sensitivity to digoxin, which can increase the risk of toxicity to Digoxin's heart. In patients who are using digoxin, check the magnesium concentration before starting to use proton pump inhibitors and periodically.

Sucralfate: Inhibition of absorption and reducing the bioavailability of proton pump inhibitors. Use proton pump inhibitors at least 30 minutes before using sucralfate.

tacrolimus: Increased serum concentration of tacrolimus.

Warfarin: Inrang and prothrombin time when using warfarin simultaneously with proton pump inhibitors, can cause abnormal bleeding and death. Follow the INR and prothrombin time when using Esomeprazole and Warfarin simultaneously.

Simultaneous use of Esomeprazole and Clarithromycin increases the concentrations of ecomeprazole and 14-hydroxyclarithromycin in the blood.

Simultaneous use of Esomeprazole and Diazepam reduces diazepam metabolism and increases the plasma diazepam concentration.

Storage

To be out of reach of children.

Store in a dry place, the temperature does not exceed 30ºC, avoiding light.

Other drugs

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