Mepilori hard capsules 40 OPC treat gastroesophageal reflux disease, peptic ulcer (2 blisters x 7 tablets)
Dosage form Box of 2 blisters x 7 tablets
Specifications Esomeprazol
Ingredient
| Composition information | Content |
| Esomeprazol | 40mg |
Uses
Indications
Mepilori medicine are indicated in the following cases:
Adults
Gastroesophageal reflux disease (GERD):
Treatment of esophageal inflammation due to reflux. Long -term treatment for patients with healed esophagitis to prevent recurrence.
Prolonged treatment after treatment for bleeding due to stomach - duodenal ulcer with vein. Treatment of Zollinger Ellison syndrome.
Children aged 12 years and older
Gastroesophageal reflux disease (GERD):
Treatment of esophageal inflammation due to reflux. Long -term treatment for patients with healed esophagitis to prevent recurrence.
Combined with antibiotics in the treatment of duodenal ulcer caused by Helicobacter pylori.
Pharmacokology
Esomeprazole is the isomorphic form S - Omeprazole and reduces the excretion of gastric acid with a specialized mechanism of impact. The drug is a specific inhibitor of acidic pump in the stomach wall. Both types of isomers R - and S - of Omeprazole have similar pharmacological effects.
Mechanism of action
Esomeprazole is a weak base, concentrated and transformed into an active form in a high acidic environment in the cellular tip of the cell, where the drug will inhibit the H+/K+ ATPase enzyme (acid pump) and inhibit the basic secretion of the secretion due to stimulation.
Capacity of Hoc Hoc
After taking the oral dosage of Esomeprazole 20mg and 40mg, the drug onset has an impact within 1 hour. After repeating the dose of Esomeprazole 20mg, 1 time/day for 5 days, the maximum maximum acid secretion after stimulation with Pentagastrin decreases 90% when measured at 6 - 7 hours after taking the drug on the 5th day. The esophagus has symptoms.
The rate of patients maintaining pH in the stomach> 4 minimum for 8.12 and 16 hours equivalent is 76%, 54% and 24% for Esomeprazole 20mg and 97%, 92% and 56% for Esomeprazole 40mg. When using AUC as a parameter representing the concentration of drugs in blood, the relationship between acid secret inhibition and drug concentration and the time of contact has been proven.
pharmacokinetic
absorption
Esomeprazole is easily destroyed in the acidic environment and is taken in the form of micro -granules in the intestine, in vivo the conversion to isomer R is negligible.
Esomeprazole is quickly absorbed with peak plasma concentrations reaching about 1 to 2 hours after drinking. Absolute bioavailability is 64% after taking a single dose of 40mg and increased to 89% after the dose is repeated 1 time/day.
For Esomeprazole 20mg dose, these values correspond to 50% and 68%. The food slows down and reduces the absorption of Esomeprazole, but this does not significantly change the effect of the drug on the acidity in the stomach.
Distribution
The distribution of the stable state in healthy people is about 0.22L/kg of body weight, 97% Esomeprazole binds to plasma proteins.
Metabolism
Esomeprazole is completely metabolized through the Cytochrome P450 (CYP) system. The main part of Esomeprazole metabolism depends on the polymorphic CYP2C19, responsible for the formation of hydroxy and desmethyl metabolites of Esomeprazole.
The rest depends on another specific homogeneous substance, CYP3A4, under armpit for the formation of Esomeprazote Sulfon, the main metabolite in plasma.
Elimination
The following parameters mainly reflect the pharmacokinetics of individuals with enzymes CYP2C19. The total plasma clearance is about 17 l/hour after the single dose and about 9l/hour after the dose is repeated.
Selling time for plasma is about 1.3 hours after the dose is repeated once a day.
Esomeprazole is completely eliminated from plasma between doses without tend to accumulate during the one -time drug.
The main metabolites of Esomeprazole do not work on gastric acid secretion. Nearly 80% of oral doses of Esomeprazole are excreted in the form of metabolites in urine, the rest in the feces. Under 1% of unchanged drugs found in urine.
Before taking Mepilori hard capsules 40 OPC treat gastroesophageal reflux disease, peptic ulcer (2 blisters x 7 tablets)
How to use
Mepilori medicine Used orally. Should swallow all pills with water. Do not chew or crush medicine.
Dosage
Adults
Gastroesophageal reflux disease (GERD):
Treatment of symptoms of thick skin diseases - esophagus (gerd):
Combined with appropriate antibacterial regimens to exorcise Helicobacter pylori, heal duodenal ulcers contaminated with Helicobacter pylori and prevent recurrence of thick skin ulcers - duodenum in Helicobacter pylori infection:
Heal stomach ulcers due to nonsteroidal anti -inflammatory drugs:
Special subjects
Patients with renal failure: No need to adjust the dose in patients with renal impairment. Due to limited experience in patients with severe renal failure, caution should be cautious in this patient.
Patients with liver failure: No need to adjust the dose in patients with mild and medium liver failure. Esomeprazol dose for patients with severe liver failure must not exceed 20mg/day.
Children aged 12 years and older
Gastroesophageal reflux disease (GERD):
Treatment of duodenal ulcer caused by Helicobacter pylori:
When choosing appropriate coordination therapy, it is necessary to consider the official guidance of the nation, the region and the locality on bacterial resistance, treatment time (usually 7 days but sometimes up to 14 days), and the rational use of antibacterial agents. The treatment should be monitored by a doctor. The recommendations of the dose are:
Children under 12 years old
Do not use Esomeprazole for children under 12 years old because there is no data.
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?
Symptoms
So far has very little experience in intentional overdose. The described symptoms related to the use of 280mg dose are symptoms on the gastrointestinal tract and weakness. Single doses Esomeprazole 80mg have not caused any events.
How to handle
There is no specific antidote. Esomeprazole 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 forgetting a dose? However, if the time is near the next dose, skip the forgotten dose. Do not double the dose (2 doses at 1 time) to compensate for the forgotten dose.
Side Effects
When using Mepilori , you may experience unwanted effects (ADR).
The reactions are classified by frequency: Very common (> 1/10), common (1/100 to 1/1000 to 1/10000 to
Very rare
Stop using Esomeprazole and see a doctor immediately if: Suddenly wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (serious allergic reaction). Red rash with blistering and peeling.
There may also be heavy blisters and hemorrhage in the lips, eyes, mouth, nose and genitals. This may be "Stevens - Johnson syndrome" or "poisoned epidermal necrosis (ten)".
jaundice, dark urine and fatigue may be a symptom of liver problems. These unwanted effects are very rare and can affect 1 over 1000 people.
Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Mepilori drugs in the following cases:
Precautions when used
When there is any warning symptom (such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting or black feces) and when it is or suspected of stomach ulcers, it is recommended to eliminate malignant diseases because Esomeprazole can reduce the symptoms and delay the diagnosis.
Long -term treatment: Patients with long -term treatment (especially those who have been treated for more than 1 year) should be monitored regularly.
Treatment by needs: Patients with demand should be contacted with a doctor if there are symptoms that vary in characteristics.
Helicobacter pylori: When prescribing Esomeprazole to eradicate Helicobacter pylori, it is necessary to consider the possible interactions in the 3 -drug treatment regimen.
Gastrointestinal infections: Proton pump inhibitors can lead to a slight increase in the risk of gastrointestinal infections such as Salmonella and Campylobacter.
Vitamin B12 absorption: Esomeprazol can reduce the absorption of vitamin B12 due to reduced or deficient gastric acid.
Magnesi blood decrease: Serious blood magnesia is reported in patients treated with proton pump inhibitors such as Esomeprazole for at least 3 months, and in most cases is 1 year.
Increased risk of fractures: Proton pump inhibitors, especially when high doses and long -term (> 1 year), may increase the risk of broken muscle fractures of hip, neck, hands and spine, mainly in the elderly or when there are other recognized risk factors.
Concentrated with other drugs: Non -recommended simultaneous use of Esomeprazole with other drugs such as Atazanavir, Clopidogrel.
The ability to drive and operate machinery
Esomeprazole has a small impact on driving or operating machinery. Unwanted effects such as dizziness (rare) and blurred vision (rare) have been reported. If the patient is affected, do not drive or operate machinery.
Pregnancy
do not have enough clinical data on the use of Esomeprazole during pregnancy. Should be cautious when prescribing pregnant women.
Breastfeeding period
It is unknown whether esomeprazole will produce breast milk or not. There is not enough information about the effects of Esomeprazole in infants/young children. Therefore, Esomeprazole should not be used during breastfeeding.
Drug interaction
Esomeprazole has interactive pharmacokinetics of drugs: Protease inhibitors, metholtrexate, tacrolimus, pH -dependent drugs, pH -dependent drugs, drugs metabolized by CYP2C19, diazepam, phenytoin, voriconol, cilostazol, cilostazol, cilostazol, cilostazol cisapride, warfarin, clopidogrel.
Effects of other drugs on Esomeprazole: CYP2C19 inhibitors or CYP3A4, CYP2C19 induction drugs or CYP3A4.
Cavalry: Not applicable.
Storage
Store: At temperatures below 30 ° C, in a dry place, avoiding light.
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