Stadnex 20 cap Stella treatment of gastroesophageal reflux disease (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	20mg

Uses

indications

Stadnex 20 cap drug is indicated in the following cases:

Treatment of gastroesophageal reflux disease (GERD)

Treatment of esophageal scratches due to reflux; Long -term treatment for patients with healed esophagitis to prevent recurrence; Treatment of symptoms of gastroesophageal reflux disease (GERD).

Combined with an appropriate antibacterial regimen to eradicate Helicobacter pylori, heal duodenal ulcers caused by Helicobacter pylori infection and prevent recurrence of peptic ulcer in patients with Helicobacter infection pylori.

Treatment of stomach ulcers due to nonsteroidal anti -inflammatory drugs (NSAID), prevention of stomach ulcers and duodenal ulcers due to the use of NSAID drugs in patients at risk but need to treat drugs (NSAID) continuously.

Treatment of Zollinger - Ellison syndrome.

Pharmacology

Pharmacological group: Treatment of stomach - duodenal ulcer and gastroesophageal reflux disease; Proton pump inhibitors.

ATC code: A02BC05.

Esomeprazole is a proton pump inhibitor that reduces gastric acid secretion by inhibiting the enzyme enzyme H+/K+-Aatpase in the wall of the stomach wall.

Esomeprazole is the isomorphic S of Omeprazol, which is protonized and transformed in the acidic cavity of the cell into an active inhibitor, an air -optical sulphenamide form. Due to the special effect on the proton pump, Esomeprazole 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 stomach acid secretion.

Dynamic pharmacokinetics

absorption: Esomeprazole is quickly absorbed after drinking, the peak concentration in plasma is achieved after 1-2 hours. Esomeprazole's bioavailability increases with the dose and when reminded, reaching about 68% when taking the dose of 20 mg. The food slows down and reduces the absorption of ecomeprazol, but does not significantly change the effect of Esomeprazole on the acidity in the stomach.

Distribution: Esomeprazole is linked to plasma proteins about 97%.

Metabolism: The drug is metabolized mainly in the liver thanks to isenzyme CYP2C19 into hydroxy and desmethyl metabolites. The rest is converted through isenzyme CYP3A4 to Esomeprazole Sulfon.

Elimination: Semi -selling time in plasma is about 1.3 hours. 80% of oral dose is eliminated in the form of metabolites in urine and the rest through feces.

Before taking Stadnex 20 cap Stella treatment of gastroesophageal reflux disease (4 blisters x 7 tablets)

How to use

swallow the whole pill with a little water. Do not chew or crush capsules.

Dosage

adults and adolescents ≥ 12 years old

Gastroesophageal reflux disease (GERD):

Active inflammation due to reflux:

2 tablets (40 mg) x 1 time/day x 4 weeks.

1 tablet (20 mg) x 1 time/day.

1 tablet (20 mg) x 1 time/day in patients without esophagitis.

If the symptoms do not control after 4 weeks, patients should be further diagnosed.

When symptoms are over, the symptom control can be maintained at a dose of 1 tablet (20 mg) x 1 time/day.

in adults can be used for treatment when necessary at a dose of 1 tablet (20 mg) x 1 time/day.

In patients with gastroesophageal reflux disease (GERD), NSAID is at risk of developing peptic ulcer, not recommended to control symptoms by treatment when necessary.

Combining the appropriate antibacterial regimen to eradicate Helicobacter pylori and room recurrent stomach ulcer due to Helicobacter pylori infection:

1 tablet (20 mg) Stadnex 20 cap + 1 g amoxicillin + 500 mg clarithromycin x 2 times/day x 7 days.

1 tablet (20 mg) x 1 time/day x 4 - 8 weeks.

1 tablet (20 mg) x 1 time/day.

Zollinger - Ellison syndrome:

Initial dose: 2 tablets (40 mg) x 2 times/day, then adjust the dose according to the response.

Maintenance dose: 4 - 8 capsules (80 - 160 mg)/day (dose> 80mg/day should be divided into 2 use).

Not recommended.

Patients with kidney function damage:

No dose adjustment in patients with kidney damage. Precautions when indicated for patients with severe renal failure.

Patients with liver function damage:
No dose adjustment in patients with mild - medium liver damage. The maximum dose for patients with severe liver failure is 1 tablet (20 mg).

Elderly patients:
No dose adjustment. 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?
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
There is no specific detoxification. It is difficult to eliminate blood from the bloodstream because the esomeprazole is strongly connected to plasma proteins. Should treat symptoms and use general support measures.
What to do when you forget 1 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 Stadnex 20 cap, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Systemic: headache, dizziness, skin extra skin.

Body: fatigue, sleeping eyes, rash, itching, visual disorders.

Rare, ADR

Systemic body: Fever, sweat, peripheral edema, sensitive to light, hypersensitivity reaction (including urticaria, angioedema, bronchospasm, anaphylactic shock). Hepatitis, jaundice, liver function.

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

Stadnex 20 cap contraindicated in the following cases:

hypersensitively to Esomeprazole, benzimidazole derivatives or any ingredients of the drug.

Women in the first 3 months of pregnancy.

Be cautious when using

When the presence of any alarm symptoms (such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting blood or black defecation) and when suspected or stomach ulcers should eliminate malignant diseases because Esomeprazole treatment can reduce symptoms and delay diagnostic.

Using proton pump inhibitors, especially when taking high doses and for a long time (> 1 year), may increase the risk of fracture of the thigh, wrist and backbone, mainly occurs in the elderly or when there are 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 Esomeprazole to eradicate Helicobacter pylori, drug interactions may occur in a 3 -drug treatment regimen. Clarithromycin is a strong CYP 3A4 inhibitor, so it is advisable to consider contraindicated and interact with clarithromycin when using a triple medication regimen for patients who are taking other drugs metabolized through CYP 3A4 as Cisaprid.

Hypotension may be found in patients treated with proton pump inhibitors after 3 months - 1 year, which can lead to serious unwanted effects including muscle spasm, arrhythmia and epilepsy. Periodic monitoring of blood magnesium concentration, especially patients, must take long -term drugs, patients are indicated simultaneously digoxin or other Magnesi -causing drugs such as diuretics.

Reducing gastric acid due to any cause (including using proton pump inhibitors) also increases the number of bacteria in the gastrointestinal tract, which can slightly increase the risk of Salmonella and Campylobacter infections.

The drug contains sucrose, so it should not be used for patients with fructose intolerance, glucose-galactose malabsorption or enzyme deficiency.

The ability to drive and operate machinery

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

Pregnancy

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

The period of breastfeeding

It is unknown whether Esomeprazole is excreted through breast milk or not. Therefore, esomeprazole should not be used while breastfeeding.

Interactive drug

The drug has a pH dependent of the stomach

The absorption of ketoconazole, iTraconazole may decrease during treatment with esomeprazole.

Use combined omeprazol (40 mg x 1 time/day) with Atazanavir 300 mg/ritonavir 100 mg in healthy volunteers reduces the response of Atazanavir.

Metabolic drug thanks to CYP2C19

Esomeprazole is a CYP2C19 inhibitor. When starting or stopping treatment with Esomeprazole, 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 Esomeprazole and Clopidogrel simultaneously.

When Esomeprazole is used with metabolic drugs 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 Esomeprazole.

In a clinical trial, when using 40 mg of Esomeprazole 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 esomeprazole.

Storage

Store drugs in closed packaging, in a dry place, away from light. The temperature does not exceed 30 ° C.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.