Esomeprazol Stada 40mg Treatment of gastroesophageal reflux, esophagus (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Esomeprazole

Ingredient

Composition information	Content
Esomeprazole	40mg

Uses

Indications

Esomeprazol 40 Stada is indicated in the following cases:

Gastroesophageal reflux disease (Gerd). Long -term treatment for patients with healed esophagitis to prevent recurrence; Treatment of symptoms of gastroesophageal reflux disease (gerd).

Heals stomach ulcers due to NSAID drugs; Prevention of gastric ulcer and duodenal ulcer due to NSAID drugs in patients at risk. Thick.

Esomeprazol is the isomorphic S of omeprazol, which is protonized and transformed in the acidic compartment of the cell into an active inhibitor, an air -to -air sulphenamide inhibitor.

Due to a special effect on proton pumps, Esomeprazol blocks the final step in the production of acid, thereby reducing stomach acid.

This effect depends on the daily dose of 20 - 40 mg and leads to inhibition of gastric acid secretion.

pharmacokinetics

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 used to repeat, reaching about 68% when taking the dose of 20mg and 89% when taking the dose of 40mg.

Esomeprazol slow and reducing foods, but not significantly changing the effects of ecomeprazol on the acidity in the stomach. Esomeprazol binds to plasma proteins about 97%.

The drug is metabolized mainly in the liver thanks to the isoenzyme CYP2C2 Cytochrom P450 enzyme system into hydroxy and desmethyl metabolites.The rest is converted through isenzyme CYP3A4 to Esomeprazol Sulfon. When used repeated, initially metabolized through the liver and the clearance of the drug, possibly due to the inhibited ISOENZYM CYP2C19.

However, there is no accumulation when used once a day. Selling time for plasma is about 1.3 hours.

Most 80% of the oral dose are eliminated in the form of metabolites in the urine, the rest is excreted through feces.

Before taking Esomeprazol Stada 40mg Treatment of gastroesophageal reflux, esophagus (4 blisters x 7 tablets)

How to use

Esomeprazol Stada should be swallowed with a water. Do not chew or crush capsules.

Dosage

adults and adolescents aged 12 and older

Gastroesophageal reflux disease (GERD)

Treatment of esophageal scratches due to reflux: 40mg x 1 time/ day for 4 weeks. Should treat 4 more weeks for patients with untreated esophagitis patients or persistent symptoms.

Long -term treatment for patients with healed esophagitis to prevent recurrence: 20mg x 1 time/day.

Treatment of symptoms of gastroesophageal reflux disease (GERD): 20mg x 1 time/day in patients without esophagitis. If the symptoms are not controlled after 4 weeks, patients should be diagnosed with further diagnosis. Once the symptoms are over, it is possible to maintain the control of symptoms at a dose of 20mg x 1 time/day, in adults can use the treatment regime when necessary at a dose of 20mg x 1 time/day, in patients with gastroesophageal reflux (GERD) is using NSAIDs at risk of developing gastroenter ulcer, not recommended to control symptoms by treatment regime when necessary.

Combined with an appropriate antibacterial regimen to eradicate Helicobacter pylori, heal duodenal ulcer due to Helicobacter pylori infection and prevent recurrence of peptic ulcer in patients with Helicobacter Pylori infection

20mg Esomeprazol, 1g Amoxicillin and 500mg Clarithromycin, all used 2 times/day for 7 days.

Patients need to be treated with anti-inflammatory drugs (NSAID) continuously

Healing stomach ulcers due to NSAID drugs: Normal dose 20mg x 1 time/day. Treatment period is 4 - 8 weeks.

Prevention of stomach ulcers and duodenal ulcer due to NSAID drugs in patients at risk: 20mg x 1 time/day.

Treatment of Zollinger - Ellison syndrome

The recommended starting dose is Esomeprazol 40mg x 2 times/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 with Esomeprazol dose of 80 - 160 mg/day. When the daily dose is greater than 80mg, the dose should be divided into 2 times/day.

Children under 12 years old

Do not use Esomeprazol capsules for children under 12 years old because there is no data.

People with kidney function damage

No dose adjustment in patients with kidney function damage. Due to less experience in using drugs in patients with severe renal impairment, caution should be careful when treating in these patients.

Liver function damage

No dose adjustment in patients with liver damage from mild to medium, in patients with severe liver failure, should not overdose for a maximum of 20mg of Esomeprazol.

Elderly

No dose adjustment 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 to do when overdose?

What to do when forgetting 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 Esomeprazol 40 Stada, you may experience unwanted effects (ADR).

Very common, common, ADR> 1/100

Systemic: headache, dizziness, skin extra skin.

Body: fatigue, insomnia, rash, itching, visual disorders.

Rare: 1/10000

Body: Fever, sweating, peripheral edema, sensitive to light, hypersensitivity reactions (including urticaria, angioedema, bronchospasm, anaphylactic shock). Hepatitis, hepatitis, jaundice, liver function. can increase the risk of gastrointestinal infections.

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

Esomeprazol 40 Stada is contraindicated in the following cases:

Patients with hypersensitivity to Esomeprazol, benzimidazol derivatives or any ingredients of the drug.

Precautions when using

when there is any alert symptom (such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting of blood or black defecation) and when suspected or stomach ulcers should eliminate malignant diseases because treated with Esomeprazol can reduce symptoms and delay diagnosis.

Using proton pump inhibitors, especially when taking high doses and for a long time (> 1 year), may increase the risk of hip, wrist and backbone fractures, mainly occurs in the elderly or when there are other risk factors. Observations show that proton pump inhibitors increase the risk of fractures from 10 to 40%. Some of these increase may be due to other risk factors. Patients at risk of osteoporosis must be cared for under the current clinical instructions and need adequate vitamin D and calcium.

When prescribing Esomeprazol to eliminate Helicobacter pylori, drug interactions should be considered in the 3 -drug treatment regimen. Clarithromycin is a strong CYP3A4 inhibitor and therefore should consider contraindicated and interact with Clarithromycin when using a 3 -drug regimen for patients who are taking other drugs metabolized through CYP3A4 as Cisaprid.

Symptomic and asymptomatic magnesi has been reported rare in patients treated with proton pump inhibitors for at least 3 months, most cases on patients after 1 year treatment. Serious unwanted effects include muscle spasm, arrhythmia and epilepsy. Most patients need to supplement Magnesi to treat blood magnesium or stop using proton pump inhibitors, need to consider monitoring blood magnesium levels while starting treatment with proton pump inhibitors and periodically in patients who have to treat long -term or use proton pump inhibitors with other drugs such as Digoxin or drugs that cause blood reduces (for example, for example, diuretic.

Reducing stomach acid for any cause, including using proton pump inhibitors, increasing the number of permanent bacteria in the digestive tract. Proton pump inhibitors may slightly increase the risk of gastrointestinal infections caused by Salmonella and Campylobacter.

The ability to drive and operate machinery

Patients with dizziness or hallucinations while using Esomeprazol should not drive or operate machinery.

Pregnancy

There has been no adequate and controlled research on pregnant women. Only use drugs for pregnant women when really necessary.

Breastfeeding period

It is unknown whether esomeprazol is excreted through breast milk or not. There is no research on breastfeeding women. Therefore, Esomeprazol should not be used while breastfeeding.

Interactive drug

drugs with a pH dependent of the stomach:

The absorption of ketoconazol, iTraconazole may decrease during treatment with ecomeprazol.

Use combinations of omeprazol (40mg x 1 time/day) with Atazanavir 300mg/Ritonavir 100mg in healthy volunteers reducing the response of Atazanavir.

Metabolic drug thanks to CYP2C19:

Esomeprazol is a CYP2C19 inhibitor. When starting or stopping treatment with Esomeprazol, it is necessary to consider the ability to interact with metabolic drugs through CYP2C19. An interaction is observed between clopidogrel and omeprazol. It is unclear clinical significance of this interaction. To prevent, should not use Esomeprazol and Clopidogrel simultaneously.

When Esomeprazol is used with drugs metabolized by CYP2C19, such as diazepam, citalopram, imipramin, clomipramin, phenytoin ..., the concentration of these drugs in plasma can increase and need to decrease the dose. Should monitor phenytoin concentration in plasma when starting or stopping treatment with Esomeprazol.

In a clinical trial, when using 40mg of Esomeprazol for patients who used Warfarin shows that blood clotting time is still within the allowed limit. However, some cases of high clinical increase Inr have been reported when used in combination with warfarin and esomeprazol.

Storage

In closed packaging, dry place, avoiding light. The temperature does not exceed 30 ° C.

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