Ameprazol 40mg OPV medicine to treat gastroesophageal reflux disease, esophagus (2 blisters x 7 tablets)

Dosage form Box of 2 blisters x 7 tablets
Specifications Esomeprazol
Ingredient OPV Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Esomeprazol	40mg

Uses

indicated

Ameprazol is indicated in the following cases:

Gastroesophageal reflux disease (GERD)

Treatment of esophageal scratches due to reflux.

Heals the duodenal ulcer with Helicobacter pylori.

Heal stomach ulcers due to nonsteroidal anti-inflammatory drugs

Prevent stomach-colitis due to nonsteroidal anti-inflammatory drugs in patients at risk.

Treatment of Zollinger Ellison syndrome.

Pharmacokology

Esomeprazol is the S-Omeprazol isomers and reduces the secretion of gastric acid with a specialized mechanism of action. The drug is a specific inhibitor of acidic pump in the stomach wall. Both types of isomers R-and S- of Omeprazol have similar pharmacological effects.

Position and impact mechanism

Esomeprazol is a weak base, concentrated and transformed into an active form in a high acidic environment in the sub-tanning of the cell's secretion, where the drug will inhibit H+K+K+-atpase (acid pump) and inhibit both basic fluid and stimulating fluid.

Dynamic pharmacokinetics

Esomeprazol is quickly absorbed with peak concentration in plasma reaching about 1 to 2 hours after drinking. The drug is easily destroyed in the acidic environment in the stomach and is taken in the form of a micro -granular form in the intestine. Absolute bioavailability is 64 % after taking a single dose of 40 mg and increasing by 89 % after the dose is repeated once a day. For the dose of Esomeprazol 20 mg, these values correspond to 50 % and 68 %. Food slows down and reduces the absorption of ecomeprazol, but this does not significantly change the effects of the drug on the secretion of stomach acid. About 97 % Esomeprazol binds to plasma proteins.

The drug is widely metabolized in the liver thanks to the P450 Isoenzyme enzyme system CYP2C19, forming hydroxyl and desmethyl metabolites, these substances do not affect gastric acid secretion. The rest is metabolized by Cytochrome P450 Isoenzyme CYP3A4 to form Esomeprazol Sulfon. When the dose is repeated, there is a metabolic reduction in the early stages and reducing the body clearance, perhaps due to the inhibition of CYP2C19. However, there is no tendency to accumulate when taking the drug once/day.

Semi -cancellation time in plasma is about 1.3 hours. About 80 % of oral doses are eliminated through urine in the form of metabolites, the rest is eliminated through feces.

Before taking Ameprazol 40mg OPV medicine to treat gastroesophageal reflux disease, esophagus (2 blisters x 7 tablets)

How to use

Take the whole pill with water or liquid drinks. Do not chew or crush the seeds.

Dosage

Adults and adolescents aged 12 and older:

Gastroesophageal reflux disease (GERD)

Treatment of esophageal scratches due to reflux:

40 mg x 1 time/day for 4 weeks. Should treat 4 more weeks for patients with untreated esophagitis patients or still symptoms.

Treatment for recurrent prevention of healed esophagitis:

20 mg x 1 time/day.

Treatment of symptoms of gastroesophageal reflux disease (GERD):

20 mg x 1 time/day in patients without esophagitis. If the symptom control is not achieved after 4 weeks, the patient should be tested more carefully to determine the diagnosis. Once the symptoms are out of symptoms, the control of symptoms can then reach a dose of 20 mg x 1 time/day.

In adults, the treatment regimen of 20 mg x 1 time/day can be used, when necessary.

Adults:

Combined with an appropriate antibacterial regimen to eradicate Helicobacter pylori

Healing duodenal ulcer has Helicobacter pylori and prevention of recurrence of stomach ulcers in patients with Helicobacter pylori infected ulcer:

Esomeprazol 20 mg, Amoxicillin 1 g and Clarithromycin 500 mg, all used 2 times/day for 10-14 days.

Patients need to be treated with nonsteroidal anti -inflammatory drugs

Healing stomach ulcers due to nonsteroidal anti -inflammatory drugs:

Normal dose 20 mg, 1 time/day. Treatment period is 4-8 weeks.

Prevention of stomach ulcers and duodenal ulcers due to nonsteroidal anti -inflammatory drugs in patients at risk:

20 mg, 1 time/day.

Serial treatment after preventing stomach bleeding with intravenous drugs.

40 mg, 1 time/day for 4 weeks after the prevention of stomach bleeding with intravenous drugs.

Treatment of Zollinger Ellison syndrome

The recommended starting dose is Esomeprazol 40 mg x 2 times/day. Then adjust the dose according to the response of each patient. Most patients respond to the dose from 80 to 160 mg Esomeprazol/day. When taking daily dose greater than 80 mg, the dose should be divided into 2 times/day.

Children under 12 years old:

Do not use esomeprazol for children under 12 years old because there is no adequate data.

People with kidney function:

No need to adjust the dose in patients with mild and medium renal function.

People with liver function damage:

No need to adjust the dose in patients with liver damage from mild to medium. In patients with severe liver failure, not more than 20 mg/day.

Elderly:

No dose adjustment in the elderly.

What do

do when using overdose? The described symptoms related to the use of 280 mg oral dose are symptoms on the digestive tract and weak. The single doses of Esomeprazol 80 mg have not caused any events. There is no specific antidote. Esomeprazol is strongly linked to plasma proteins and therefore cannot be easily separated. In case of overdose, symptomatic treatment and general support treatment.

What to do when you forget 1 dose?

Side Effects

headache, abdominal pain, constipation, diarrhea, bloating, nausea or vomiting.

Less: Peripheral edema, insomnia, dizziness, paresthesia, Sleeping, dizziness, dry mouth, liver enzyme, dermatitis, itching, rash, urticaria.

Rare: leukopenia, thrombocytopenia, hypersensitivity reactions (such as fever, angioedema, anaphylactic/anaphylactic reaction), hypoglyc sodium, agitation, confusion, depression, taste disorders, blurred vision, bronchial spasm, stomatitis, gastrointestinal fungal infection, hepatitis or no jaundice, hair loss, sensitive to light, muscle pain, muscle pain.

Very rare: granulocytosis, reduction of blood cell lines, impatient, hallucinations, liver failure, brain disease in patients who have liver disease, diverse roses, Stevens-Johnson syndrome, poisoned epidermis, muscle weakness, interstitial nephritis, large breasts in men.

Notice the doctor with unwanted effects when using the drug.

Warnings

contraindicated

History of hypersensitivity to Esomeprazol, drugs with benzimidazol groups and other ingredients in the formula.

Be cautious when using

When there is any alert symptom (such as significant weight loss, unintentional, recurrent vomiting, difficulty swallowing, vomiting of blood or black defecation) and when it is or suspected of stomach ulcers, eliminating malignant diseases because Esomeprazol treatment can obscure stomach cancer symptoms Thick. When prescribing Esomeprazol, it is necessary to consider the interaction with other drugs due to the concentration of Esomeprazol in plasma that may change. Consider contraindications and drug interactions with clarithromycin when using 3 drugs for patients who are taking other drugs metabolized through CYP3A4 such as Cisapride.

The effect of the drug on driving and operating machinery

does not affect the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women:

There is no enough clinical data on the use of Esomeprazol in pregnant women. In animal research, Esomeprazol does not directly or indirectly on the development of the embryo. Should be cautious when prescribing pregnant women.

breastfeeding women:

It is not known whether esomeprazole will produce breast milk or not. No research on breastfeeding women has been conducted. Therefore, Esomeprazol should not be used during breastfeeding.

Drug interaction

Reducing gastric acid levels during Esomeprazol treatment may increase or reduce the absorption of other drugs if the absorption mechanism of these drugs is affected by gastric acid levels.

The absorption of ketoconazole and iTraconazole may decrease during treatment with ecomeprazol.

Do not simultaneously use Esomeprazol with Atazanavir because it can significantly reduce the concentration of Atazanavir (reducing the area under the curve, maximum and minimum concentration).

In healthy volunteers, simultaneous use of Esomeprazol and Cisaprid, resulting in increasing the area under the curve and prolonging the half -life, but does not significantly increase the peak concentration in the plasma of Cisaprid.

When Esomeprazol is used with metabolic drugs through CYP2C19 such as diazepam, citalopram, imipramin, clomipramin, phenytoin, ..., the concentration of these drugs in plasma can increase and need to decrease the dose of these drugs.

Esomeprazol is metabolized by CYP2C19 and CYP3A4. When used simultaneously, Esomeprazol with CYP3A4 inhibitors will double the area under the curve of Esomeprazol. Simultaneous use of Esomeprazol along with inhibitors both CYP2C19 and CYP3A4 may increase the concentration of Esomeprazol. No need to adjust the dose of Esomeprazol regularly in these situations. However, the adjustment adjustment should be considered in patients with severe liver failure if long -term treatment is indicated.

Esomeprazol treatment in patients taking warfarin shows blood clotting time. Follow the request at the beginning and end of Esomeprazol treatment in patients taking warfarin or other Coumarin derivatives.

Storage

Store at temperatures below 30 ° C, in a dry place, avoid light.

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