Esomeprazole EG 40mg Pymepharco medicine for stomach and esophagus treatment (20 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	40mg

Uses

indications

Esomeprazole EG drugs are indicated in the following cases:

Treatment of gastroesophageal reflux disease. Pylori.

Esomeprazole is a proton pump inhibitor that reduces the secretion of gastric acid by attaching H+/K+-AatPase (also known as proton pump) in the cell wall of the stomach, inactivating 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 secretion of basic acid and even when stimulated by any factor.

Dynamic pharmacokinetics

absorption: Esomeprazole is 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 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 Esomeprazole.

Distribution: about 97% Esomeprazole attaches to plasma proteins.

Metabolism: The drug is mainly metabolic in the liver thanks to the isoenzyme CYP2C19, the cytochrome p 450 enzyme system into hydroxy and desmethyl metabolites is no longer active. The rest is converted through isenzyme CYP3A4 to Esomeprazole sulfon. When used repeated, initially metabolized through the liver and the clearance of the drug decreased, possibly due to the inhibited isoenzyme CYP2C19. However, there is no phenomenon of accumulation of drugs when used once a day.

Elimination: Semi -selling time in plasma is about 1–1.5 hours. About 80% of oral doses are eliminated in the form of metabolites in urine, the rest is eliminated in feces.

Before taking Esomeprazole EG 40mg Pymepharco medicine for stomach and esophagus treatment (20 tablets)

How to use

oral medication. Take the medicine at least 1 hour before meals and should swallow the pill with water, do not chew or crush.

Dosage

Adults and adolescents 12 years or older:

Treatment of gastroesophageal reflux disease - serious esophagitis: 20 - 40 mg/time x 1 time/day, for 4–8 weeks, can take 4–8 weeks for more than more symptoms or inflammation through endoscopy. Severe cases may increase the dose to 80 mg/day divided 2 times. Treatment is maintained after gustary inflammation: 20 mg x 1 time/day, can last up to 6 months.

Treatment of gastroesophageal reflux disease is symptomatic but not esophagitis: 20 mg x 1 time/day for 4 weeks, can take 4 more weeks if the symptoms have not completely cured.

Treatment and prevention of recurrence of stomach ulcers - rosary with helicobacter pylori:

Esomeprazole is a component in the treatment regimen along with antibiotics, for example 3 drug regimen (along with amoxicillin and clarithromycin). Take Esomeprazole 20 mg x 2 times/day for 7 days or 40 mg x 1 time/day for 10 days.

Prevention and treatment of stomach ulcers due to nonsteroidal anti -inflammatory drugs:

Preventive gastric ulcerative prophylaxis in people with high risk of stomach complications, but there is a requirement to continue treatment with nonsteroidal anti -inflammatory drugs: 20 mg x 1 time/day.

Treatment of stomach ulcers due to nonsteroidal anti -inflammatory drugs: 20 mg x 1 time/day for 4–8 weeks.

Treatment of Zollinger - Ellison syndrome: The recommended starting dose is 40 mg x 1 time/day. Then adjust the dose according to the response of each patient and continue treatment when it is indicated clinically. Clinical data shows that most patients are controlled at a dose of 80–160 mg/day. When the daily dose is greater than 80 mg, the dose should be divided into 2 times/day.

Children under 12 years of age: Do not use it because there is no data.

People with renal failure and the elderly: No dose adjustment.

Patients with hepatic impairment: No need to adjust the dosage in mild and medium liver failure people, people with severe liver failure do not overdose for a maximum of 20 mg of esomeprazole.

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?

Management: There is no specific antidote for Esomeprazole. Mainly treat symptoms and support. Hemorrhage does not have the effect of increasing the elimination of drugs because Esomeprazole is fitted with plasma proteins.

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 Esomeprazole EG, you may experience unwanted effects (ADR).

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.

visual disorders.

Rare, ADR

Body: Fever, sweat, peripheral edema, sensitive to light.

Hypersensitivity reaction: urticaria, angioedema, bronchospasm, anaphylactic shock.

Central nerve: agitation, depression, confusion with recovery, hallucinations in serious illnesses. Hematology: granulocytic loss, leukopenia, platelets. liver: Increased liver enzyme, hepatitis, jaundice, liver failure. digestive: taste disorders, increased risk of bacterial infections in the gastrointestinal tract.

Muscle muscle: joint pain, muscle pain.

urinary: interstitial nephritis.

Skin: bumper, Stevens - Johnson syndrome, poisoned epidermal necrosis, dermatitis.

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

Esomeprazole EG is contraindicated in the following cases:

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

Be cautious when using

before using Esomeprazole must 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.

Be cautious when using Esomeprazole prolonged because it can cause gastric atrophy or increase the risk of bacterial infections (such as community -suffering pneumonia).

may increase the risk of diarrhea due to Clostridioides Difficile when taking proton pump inhibitors.

When using proton pump inhibitors, especially if high doses and prolonged doses (≥ 1 year), the risk of pelvic fractures, wrist bone or spine due to osteoporosis. The mechanism of this phenomenon has not been explained, but it may be due to reducing unanimidated calcium absorption due to gastric pH hypoglycemia. 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.

Hypotension (with or asymptomatic) rare in patients using prolonged proton pump inhibitors (at least 3 months or in most cases lasting over 1 year).

Be cautious when used for children under 18 years of age because of safety and effectiveness. The drug is not recommended for children.

The ability to drive and operate machinery

Patients with hallucinations or dizziness while taking Esomeprazole should not drive or operate machinery.

Pregnancy

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

Nursing period

It is unknown whether esomeprazole will excrete in human milk or not. However, Omeprazole's concentration has been measured in women's milk after taking 20 mg of omeprazole.

Esomeprazole has the potential to cause serious 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.

Drug interaction

Due to the inhibition of acid excretion, omeprazole increases the gastric pH, affecting the bioavailability of the absorption drug dependent 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 Cilostazol increases the concentration of Cilostazol and its active metabolites, considering reducing the dose of Cilostazol.

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

Use Esomeprazole with CYP2C19 and CYP3A4 induction drugs such as rifampin reduces Esomeprazole levels, avoiding simultaneous use.

In addition to increasing the risk of hypoglycemia when taking Esomeprazole and drugs also causes hypotension such as thiazide diuretics or straps. Check the Magnesi concentration before starting to use proton pump inhibitors and then periodically.

Atazanavir: Omeprazole can change the absorption of Atazanavir, reducing the concentration of this drug 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 plasma concentration of the active metabolites of clopidogrel, 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 later.

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

Store to avoid moisture, avoid light, temperature below 30 ° C.

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