Goldesome 40mg Valpharma Treatment Treatment Treatment of benign peptic ulcer (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	40mg

Uses

Indications

Goldesome 40 mg of Valpharma 4x7 is indicated in the following cases:

Indications for treatment of gastric ulcer - benign duodenum.

Pharmacokology

Esomeprazol is the S isomers of omeprazol, used similarly to Omeprazol in the treatment of gastrointestinal ulcers and gastroesophageal reflux disease - esophagus. Esomeprazol is associated with H+/K+ - ATPase (also called proton pump) in the stomach wall cell, inhibiting this enzyme system, preventing the final step of acid secretion into the stomach. So Esomeprazol has the effect of inhibiting the basic acid secretion and even when stimulated by any agent.

Dynamic pharmacokinetics

Esomeprazol absorbed quickly after oral, 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 Esomeprazol 40mg at meals compared to when hunger drops from 33% to 53%. Therefore, Esomeprazol has to drink at least 1 hour before meals. About 97% Esomeprazol attaches to plasma proteins. The volume of distribution when the drug concentration is stable in healthy volunteers is 16 liters.

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in the liver thanks to isenzyme CYP2C19, cytochrom P450 enzyme system, into hydroxy and desmethyl metabolites that are no longer active.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. Half life eliminated 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 Goldesome 40mg Valpharma Treatment Treatment Treatment of benign peptic ulcer (4 blisters x 7 tablets)

How to use

oral medication. Use as directed by the treating doctor.

Esomeprazol tablets should be taken at least 1 hour before meals. Should swallow the whole ball with the liquid. Do not chew or crush capsules. The time for using proton pump inhibitors must be based on the level of safety and effectiveness of treatment with indications and dose as directed by instructions.

Dosage

adults

Treatment of stomach ulcer - duodenum with 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 (equivalent to 1 Goldesome tablet 20 mg), twice a day for 7 days, or 40 mg once a day (equivalent to 2 Goldesome 20 mg tablets) 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 every day 40 mg (equivalent to 2 Goldesome tablets 20 mg) for 4-8 weeks, can take another 4-8 weeks if there are still symptoms or manifestations of laparoscopic inflammation.

Maintenance treatment after gustary inflammation:

Take 20 mg once a day (equivalent to 1 Goldesome tablet 20 mg), can last up to 6 months.

Treatment of gastroesophageal reflux disease - symptoms but no esophagitis:

Take it once a day 20 mg (equivalent to 1 Goldesome 20 mg tablet) for 4 weeks, can take 4 more weeks if the symptoms have not completely cured.

Treatment of stomach ulcers due to nonsteroidal anti -inflammatory drugs (NSAID):

Take 20 mg once a day (equivalent to 1 Goldesome 20 mg) for 4-8 weeks.

Prevention of stomach - duodenal ulcer due to nonsteroidal anti -inflammatory drugs (NSAID) in patients of risk: 20 mg (equivalent to 1 Goldesome 20 mg tablet), 1 time/day.

Treatment of Zollinger-Eleson syndrome:

Depending on the individual and the level of acid secretion of the gastric juice, the daily dose is 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.

Patients with liver failure, renal failure

Severe liver failure: Do not use more than 1 tablet (20 mg) a day.

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

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. 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 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 Goldesome 40 mg Valpharma 4x7, 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.

Other: visual disorders.

Rare, 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: granulocytic loss, leukopenia, platelets. 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 bacterial infections in the gastrointestinal tract.

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

Goldesome 40 mg Valpharma 4x7 contraindications in the following cases:

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

Do not use Esomeprazol simultaneously with nelfinavir.

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 ecomeprazol for prolonged because it can cause gastric atrophy. The drug is not recommended for children.

When prescribing Esomeprazol to eliminate Helicobacter pylori, should consider drug interactions that may occur in the 3 -drug treatment regimen, Clarithromycin is a powerful CYP3A4 inhibitor and therefore should consider contraindicating and interactions for Clarithromycin when using 3 drugs for patients who are taking other drugs through CYP3A4 such as Cisaprid.

The ability to drive and operate machinery

should be cautious because Esomeprazol can cause adverse effects such as headache, dizziness.

Pregnancy

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

Nursing period

It is unknown whether esomeprazole will excrete in human milk or not. Esomeprazol has the ability to break out 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, Esomeprazole increases the gastric pH, affecting the bioavailability of the drugs dependent on pH: ketoconazole, iron salt, digoxin.

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

Esomeprazol interact with dynamic pharmacokinetics with metabolic drugs by the cytochrom P450 enzyme system, isenzyme CYP2C19 in the liver.

Storage

In closed containers at temperatures below 30 ° C.

Other drugs

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