Somexwell-40mg microphone treatment of gastroesophageal reflux disease (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Esomeprazol
Ingredient
| Composition information | Content |
| Esomeprazol | 40mg |
Uses
indications
Somexwell 40 mg microphone 3x10 is indicated in the following cases:
Adults
Treatment of gastroesophageal reflux disease (GERD).
Combined with an appropriate antibacterial regimen to eradicate Helicobacter pylori.
Patients need to be treated with nonsteroidal anti -inflammatory drugs (NSAID) continuously.
Prolonged treatment after treatment for re -prevention of bleeding due to intravenous stomach ulcers.
Treatment of Zollinger Ellison syndrome.
adolescents 12 years and older
Treatment of gastroesophageal reflux disease (GERD).
Combined with antibiotics in the treatment of duodenal ulcer caused by Helicobacter pylori.
Pharmacokic
Esomeprazol is the isomorphic form S - Omeprazol and reduces the secretion of stomach acid with a specialized mechanism of action. The drug is a specific inhibitor of acid pump in the wall of the wall. Both areomers R - and S - of Omeprazol have similar pharmacological effects.
Esomeprazol is a weak base, focused and transformed into an active form in a high acidic environment in the sub -control tube of the secretion of the cell, where H+ K+ - Atpase inhibitors (acid pump) and inhibit both basic fluid and irritability.
Acting on gastric acid secretion
After taking the oral dosage of Esomeprazol 20 mg and 40 mg, the drug onset has an impact within 1 hour. After repeating the dose of Esomeprazol 20 mg, 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.
After 5 days of taking the oral dose of Esomeprazol 20 mg and 40 mg, the pH in the stomach> 4 has been maintained within the average time, respectively 13 and 17 hours within 24 hours in patients with symptoms of gastroesophageal reflux. The proportion of patients maintaining pH in the stomach> 4 minimum for 8, 12 and 16 hours respectively, equivalent 76%, 54% and 24% for esomeprazol 20 mg and 97%, 92% and 56% for Esomeprazol 40 mg.
When using AUC as a parameter representing the concentration of drugs in plasma, people have proven to have the relationship between acid secret inhibition and drug concentration and contact time.
The therapeutic effect of acid inhibition
When using Esomeprazol 40 mg, about 78% of esophagitis patients are healed after 4 weeks and about 93% are healed after 8 weeks.
Esomeprazol 20 mg, 2 times/day and appropriate antibiotics! The week has eradicated Helicobacter pylori success in about 90% of patients. After 1 week of eradication treatment, no additional anti -acid anti -acid drugs to heal ulcers and reduce symptoms in patients with uncomplicated duodenal ulcer.
Other effects related to acid inhibition
During the treatment with gastric acid -secreting drugs, the serum galastin concentration responds to a reduction in gastric acid. CGA concentration also increases due to reduced gastric acid. The increase in CGA levels can interfere with the detection of hormonal tumors. Medical reports indicate that it is advisable to stop treating with proton pump inhibitors at least 5 days before quantifying CGA. If the CGA and Gastrin concentrations do not return to normal after 5 days, the quantitative should be conducted after 14 days after not using Esomeprazol. Increasing the number of ECL cells is probably due to increased serum gastrin levels that have been recorded in both children and adults during long -term treatment with Esomeprazol.
This is considered to have no clinical significance. After a long period of treatment with gastric acid -secreting drugs, a slight increase in the frequency of gastric gland follicles. These changes, due to the inhibition of gastric acid excretion, is benign and can recover. Reducing stomach acid due to 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 tract infections caused by Salmonella and Campylobacter, and possibly Clostridium difficile on boarding patients.
Pharmacokinetics
absorption
Esomeprazol is easily destroyed in acidic environments and is taken in the form of grain soluble in the intestine. In animals (in vivo), the transition to the isomer r is negligible. Esomeprazol is quickly absorbed with peak concentration in plasma reaching about 1-2 hours after drinking. Absolute bioavailability is 64% after taking a single dose of 40 mg and increasing to 89% after the dose is repeated once a day.
For Esomeprazol 20 mg, these values correspond to 50% and 68%. Food slows down and reduces the absorption of Esomeprazol, although this does not significantly affect the effects of Esomeprazol on gastric acid secretion.
Distribution
Expected distribution integral in a healthy state is about 0.22 l/kg of body weight. Esomeprazol connects 97% to plasma protein.
Metabolism
Esomeprazol is completely metabolized through the Cytochrom P450 (CYP) system. The main part of the Esomeprazol metabolism depends on the morphological cyt CYP2CI19 enzyme, forming hydroxy and desmethyl metabolites of Esomeprazol. The rest of the metabolic process depends on a specific same name, CYP3A4, forming Esomeprazol Sulphon, the main specialized chemical in plasma.
Elimination
About 80% of esomeprazol oral doses are excreted in urine in the form of metabolites, the rest through feces. Less than 1% of constant drugs found in urine.
Before taking Somexwell-40mg microphone treatment of gastroesophageal reflux disease (3 blisters x 10 tablets)
How to use
Somexwell 40 mg microphone 3x10 oral.
Do not use other liquids because the cover helps to dissolve the intestinal tract.
Dosage
adults and adolescents aged 12 and older
Gastroesophageal reflux disease (GERD)
Treatment of esophageal scratches due to reflux: 40 mg, 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: 20 mg, 1 time/day.
Treatment of symptoms of gastroesophageal reflux disease (GERD): 20 mg, 1 time/day in patients without esophagitis. If the symptoms are not controlled after 4 weeks, patients should be closer to subclinical exploration to determine the diagnosis. Once the symptoms are over, symptomatic control can be maintained at a dose of 20 mg, 1 time/day. In adults, the treatment may be used when necessary at a dose of 20 mg, 1 time/day. In patients with gastroesophageal reflux disease (GERD), NSAID is at risk of developing peptic ulcer, do not recommend controlling symptoms by treatment when necessary.
Adults
Combined with an appropriate antibacterial regimen to treat Helicobacter pylori
Healing duodenal ulcer contaminated with Helicobacter pylori: Esomeprazol 20 mg, amoxicillin 1 g and Clarithromycin 500 mg, all used 2 times/day for 7 days.
Prevention of stomach -duodenal recurrence in patients with Helicobacter Pylori infected ulcer: Esomeprazol 20 mg, Amoxicillin 1 G and Clarithromycin 500 mg, all used 2 times/day for 7 days.
Patients need to be treated with nonsteroidal anti -inflammatory drugs (NSAID) continuously
Healing stomach ulcers caused by NSAID drugs: Normal dose 20 mg, 1 time/day. Treatment period is 4 - 8 weeks.
Prevention of stomach ulcers and duodenal ulcers due to NSAID drugs in patients are at risk: 20 mg, 1 time/day.
Prolonged treatment after treatment for re -hemorrhage due to intravenous peptic ulcer
40 mg, 1 time/day for 4 weeks after treatment for hemorrhage due to peptic ulcer with intravenous sugar.
Treatment of Zollinger Ellison syndrome
The recommended starting dose is Esomeprazol 40 mg, 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 80 mg, divide the dose into 2 times/day.
adolescents 12 years and older
Treatment of duodenal ulcerative by Helicobacter pylori
When choosing the appropriate combination therapy, it is necessary to consider the official guidance of the nation, the region and the locality on the resistance of bacteria, the treatment time (usually 7 days but sometimes it can be up to 14 days), and how to use appropriate antibacterial drugs. The treatment process should be monitored by medical experts.
The recommended dose is:
weight
Dosage
30 - 40 kg
Combined with two antibiotics: simultaneous use of Esomeprazol 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg weight, 2 times/day for 1 week.
40 kg
Combined with two antibiotics: simultaneous use of Esomeprazol 20mg, Amoxicillin 1 G and Clarithromycin 500 mg, 2 times/day for 1 week.
Use other forms of preparation as a more suitable powder package for children under 12 years old.
People with kidney function damage
No need to adjust the dose in patients with renal function damage. Due to less experience in using drugs in patients with severe renal impairment, caution when treating in these patients.
Liver function damage
No need to adjust the dose in patients with liver damage from mild to medium. In patients with severe liver failure, no overdose of Esomeprazol 20 mg.
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? The described symptoms that are related to the dose of 280 mg are symptoms on the gastrointestinal tract and fatigue. Esomeprazol 80 mg single doses are still safe to use.
Need to notify the doctor or pharmacist immediately if used overdose.
There is no specific detoxification. Esomeprazole is strongly connected to plasma proteins and thus not absorbing. In case of overdose, symptomatic treatment and use of general support measures.
What to do when you forget 1 dose? Do not use double dose to compensate for the missed willow.
Side Effects
When using Somexwell 40 mg microphone 3x10, you may experience unwanted effects (ADR).
The most common adverse reactions include: headache, abdominal pain, diarrhea and nausea (adjacent to after -sales study). Safety characteristics are similar to each other between drugs, indications, age groups and patient populations.
The following adverse reactions have been recorded or suspected in Esomeprazol's clinical research programs and monitored after the drug to the market. There is no reaction related to the dose.
Common, ADR> 1/100
Uncommon, 1/1000 Mental disorders: Insomnia. Digestive disorders: dry mouth. Liver disorders: Hyper enzyme. Skin and tissue disorders: Dermatitis, itching, rash, urticaria. musculoskeletal and connective tissue disorders: hip fractures, wrists and spine. Rare, 1/10000 Immune system disorders: Hypersensitivity reactions such as fever, angioedema, anaphylactic/anaphylactic reaction. Mental disorders: agitation, confusion, depression. Nervous system disorders: taste disorders. eye disorders: blurred vision. Gastrointestinal disorders: stomatitis, gastrointestinal candidiasis. Hepatitis: Hepatitis has or no jaundice. Skin and subcutaneous tissue disorders: baldness, light sensitivity. Very rare ADR Mental disorders: impatient, hallucinations. Liver disorders: Hepatic failure, brain disease in patients with liver disease. Unknown frequency Instructions on how to handle ADR Notify the doctor the unwanted effects when taking the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Somexwell 40 mg microphone 3x10 contraindications in the following cases:
Do not use Esomeprazol simultaneously with Nelfinavir, Atazanavir.
Be cautious when using
Need to notify your doctor or pharmacist before taking the drug if the patient:
Severe kidney failure. There was a skin allergy after treatment with a drug that reduced gastric acid similar to Somexwell 40 mg microphone 3x10. Somexwell 40 mg microphone 3x10 can hide symptoms of other diseases. Therefore, it is necessary to notify your doctor immediately if you encounter any of the following manifestations before starting or using Somexwell 40 mg Micro 3x10: Proton pump inhibitors, especially when taking high doses and for a long time (> 1 year), may increase the risk of hip, wrist and spine fractures, especially in elderly patients or when there is a presence of other risk factors. It is necessary to notify the doctor if the patient has osteoporosis or is taking corticosteroids (may increase the risk of osteoporosis). If you experience skin rash symptoms, especially in places that come into contact with the sun, it is necessary to notify your doctor as soon as possible because may need to stop treatment with Somexwell 40 mg micro 3x10. Remember to mention any other side effects encountered like joint pain. Somexwell 40 mg microphone 3x10 contains lactose monohydrate: Do not use this drug for patients with rare genetic problems such as galactose intolerance, lapp - lactase deficiency or malcose -galucose - galactose. Children under 12 years of age: Using other forms of preparation as a more suitable form of powder package for children under 12 years old. Esomeprazole has little influence on the ability to drive and operate machinery. Some adverse reactions such as dizziness (rare), blurred (rare) vision may occur. If these adverse reactions occur, patients should not drive and operate machinery. If the patient is pregnant, may be pregnant or planning to get pregnant, consult a doctor and pharmacist before taking this medication. The doctor will decide that the patient can use Somexwell 40 mg Micro 3 x 10 or not. It is unknown whether esomeprazole is secreted through breast milk or not. There are no studies on breastfeeding women. Therefore, do not use esomeprazol during breastfeeding. Notice to a doctor or pharmacist if used, recently used or may use any other drug, including non -prescribed drugs. Do not use Somexwell 40 mg microphone 3x10 while taking drugs containing Nelfinavir (used to treat HIV infection). Please inform your doctor if the patient is using any of the following drugs: cilostazol (used to treat pain in the foot when walking caused by anemia). cisaprid (for indigestion and heartburn). Somexwell 40 mg microphone 3x10 with food and beverage: can be used with or not food. The ability to drive and operate machinery
Pregnancy
The period of breastfeeding
Medicinal interaction
Storage
Store in a cool dry place, avoiding light. Temperature below 30 ° C.
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