Agimepzol 20 Agimexpharm Treatment Treated duodenal ulcer, prevent recurrence of duodenal ulcer (10 blisters x 10 tablets)
Dosage form Box of 10 blisters x 10 tablets
Specifications Omeprazol
Ingredient Agimexpharm Pharmaceutical Joint Stock Company
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Omeprazol | 20mg |
Uses
indications
Agimepzol 20 drugs indicated treatment in the following cases:
Adults
Treatment of duodenal ulcer.
Prevention of duodenal ulcer.
Treatment of stomach ulcers.
Prevention of stomach ulcers recurrence.
Combined with appropriate antibiotics, eliminating Helicobacter pylori (H. pylori) in stomach ulcers.
Treatment of stomach and duodenal ulcer is associated with nonsteroidal anti -inflammatory drugs (NSAID).
Prevention of stomach and duodenal ulcer is associated with nonsteroidal anti -inflammatory drugs (NSAID) in risks.
Treatment of reflux esophagitis.
Long -term treatment for patients with reflux healing to prevent recurrence.
Treatment of symptoms of gastroesophageal reflux disease.
Treatment of Zollinger-Elison syndrome.
Children:
Children over 1 year and ≥ 10kg:
Treatment of reflux esophagitis.
Treatment of heartburn and acid reflux in gastroesophageal reflux disease.
Children and adolescents over 4 years old:
Combined with antibiotics in the treatment of duodenal ulcer caused by H. pylori.
Pharmacokology
omeprazol is a benzimidazole that has attached the group, structured and similar to Pantoprazol, Lansoprazol, Esomeprazol.
Omeprazol is an inhibitor of the acid secretion of the stomach due to inhibiting the enzyme system hydrogen/potassium adenosin triphosphatase (H+/K+ ATPase) also known as the proton pump in the cell wall of the stomach wall. The maximum effect is achieved after 4 days of treatment. In patients with duodenal ulcer, it is possible to maintain a 80% reduction in gastric acid in 24 hours.
Omeprazol can restrain Helicobacter pylori bacteria in patients with duodenal ulcer and/or reflux esophagitis infected with this bacteria. Combining omeprazol with some antibacterial drugs (eg clarithromycin, amoxicillin) can be h.pylori with an ulcer.
pharmacokinetics
absorption:
Omeprazol is destroyed in acidic environment. The drug is prepared in the form of particles dissolved in the intestine and then closed into the capsule or stamping the tablet to avoid the destruction of the acid pH of the stomach. Omeprazol is quickly absorbed, with peak concentration in soy sauce reaching about 1-2 hours after taking the drug. Omeprazole is usually absorbed in the small intestine after drinking for 3 to 6 hours. Food does not affect biological use. Biological use from a single dose of omeprazol is about 40%. After drinking repeated once a day, bioavailability increases to about 60%.
Distribution:
Volume of options in healthy subjects is about 0.3 liters/kg body weight. Omeprazole binds to plasma proteins about 97%.
Metabolism:
Omeprazol is completely metabolized through the cytochrom paso (CYP) system. The main part of the metabolism of omeprazol depends on the morphological CYP2C19 enzyme, forming hydroxyl omeprazol metabolites, the main metabolite in plasma. The rest of the metabolic process depends on a specific same name, CYP3A4, forming Omeprazol Sulfon. As a result of Omeprazol's high affinity with CYP2C19, there is a possibility of competition inhibitors and drug-and-drug conversion with other substrates of CYP2C19. However, due to low affinity for CYP3A4, Omeprazol is not able to inhibit the metabolism of other substrates of CYP3A4. In addition, Omeprazol does not inhibit the main CYP enzymes. About 3% of the white population and 15-20% of the Asian population deficiency CYP2C19 enzyme function and are called poor metabolic people. In these people, the metabolism of omeprazol may be mainly catalyzed through CYP3A4. After repeating the dose of 20 mg of Omeprazol once daily, the average AUC in the metabolic person is 5 to 10 times higher than the person with the CYP2C19 enzyme (strong metabolic). The average peak concentration in plasma is also 3 to 5 times higher. These findings are not related to the dose of omeprazol.
Era:
Omeprazol's plasma sale time is usually shorter than 1 hour after taking the single dose and the dose is repeated daily. Omeprazol is completely eliminated from plasma between non -tendency to accumulate when taking the drug once daily. Almost 80% of omeprazol oral dose is excreted in the form of metabolites in urine, the rest in the feces, mainly derived from the secretion of bile.
Linear/non -linear:
Omeprazol's AUC increases with repeated medication. This increase depends on the dose and leads to the non-linear-negative dose-Auc involved after repeating drugs. This time and dosage dependence is due to the initial metabolism and total clearance may be caused by omeprazol and/or metabolites (for example, sulfon) inhibit the CYP2C19 enzyme. No metabolic is found to work on the secretion of stomach acid.
Special subjects
Hepatic failure:
Metabolism of omeprazol in patients with hepatic failure is reduced, resulting in an increase in AUC. Omeprazol does not show a tendency to accumulate at a daily dose.
kidney failure:
Omeprazol pharmacokinetics, including systemic biological and exhaust speed in patients with impaired renal function.
Elderly:
The metabolic speed of omeprazol is somewhat reduced in elderly objects (75 - 79 years old).
Children:
During treatment with recommended doses for children from 1 year of age, the concentration is in the same plasma when compared to adults. In children under 6 months, low omeprazol clearance due to low ability to metabolize omeprazol.
Before taking Agimepzol 20 Agimexpharm Treatment Treated duodenal ulcer, prevent recurrence of duodenal ulcer (10 blisters x 10 tablets)
How to use
should use Omeprazol capsules in the morning, hungry, drink whole tablet with 1 glass of water. Do not chew or crush capsules. For patients with difficulty swallowing and children can drink or swallow with snake food.
Patients can open the capsule cap and take the inner medicine with half a cup of water or after mixing with mild acid solution, such as fruit juice or pressed apples, or non -gas water. It should be advised that patients should disperse the drug immediately (or within 30 minutes) and always be stirred before drinking and coating with half a glass of water.
In addition, you can drink micro -follicles with half a glass of water. Do not chew the melting microids in the intestine.
Dosage
adults:
Treatment of duodenal ulcer:
recommended dose for patients with progressive duodenal ulcer is omeprazol 20 mg x 1 time/day. In most cases the patient recovered within two weeks. For patients who cannot recover completely after the first treatment, the healing is usually treated for another two weeks. In patients with duodenal ulcer, omeprazol 40 mg once daily is recommended and healing is usually achieved for four weeks.
Prevention of duodenal ulcer:
To prevent recurrence of duodenal ulcers in negative patients with H. pylori or when it is not possible to exclude H. pylori, the recommended dose is Omeprazol 20 mg x 1 time/day. In some patients, the 10 mg dose per day may be sufficient. In case of failure, the dose may increase to 40 mg.
Treatment of stomach ulcers:
The recommended dose is Omeprazol 20 mg x 1 time/day. In most cases the patient recovered within four weeks. For patients who may not recover completely after the first treatment, healing is often achieved during the treatment period for another four weeks. For patients with poor stomach ulcers in Omeprazol 40 mg once daily recommended and healing is usually achieved within 8 weeks.Prevention of stomach ulcers:
To prevent relapse in patients with poorly responded stomach ulcers, the recommended dose is 20 mg x 1 time/day. If necessary, the dose may increase to omeprazol 40 mg once a day.
eliminates H. pylori in stomach ulcers:
To eliminate H. pylori, the selection of antibiotics should consider the tolerance of each patient and must be done according to the national, regional and local drug resistance model and treatment guidance:
Omeprazol 20 mg + Clarithromycin 500 mg + Amoxicillin 1,000 mg, each drug used twice a day for a week, or Omeprazol 20 mg + Clarithromycin 250 mg (replaced 500 mg) + Metronidazol 400 mg (or 500 mg or Tinidazol 500 mg), each drug used twice a day in a week.
Omeprazol 40 mg once daily with amoxicillin 500 mg and Metronidazol 400 mg (or 500 mg or Tinidazol 500 mg), the following two types use three times a day a week.
In each regimen, if the patient is still positive for H. Pylori, the therapy can be repeated.
Treatment of stomach and duodenal ulcer is associated with nonsteroidal anti -inflammatory drugs (NSAID):
To treat peptic ulcer and duodenal ulcer caused by NSAID, the recommended dose is Omeprazol 20 mg x 1 time/day. Most patients recovered within four weeks. For patients who cannot recover completely after the first treatment, often recovering during the treatment period for another four weeks.
Prevention of stomach and duodenal ulcer is associated with nonsteroidal anti -inflammatory drugs (NSAID) in patients at risk:
To prevent peptic ulcer or duodenal ulcer in patients at high risk (> 60 years old, with a history of stomach and duodenal ulcer, with a history of gastrointestinal bleeding) recommended by the dose is Omeprazol 20 mg x 1 time/day.
Treatment of reflux esophagitis:
The recommended dose is Omeprazol 20 mg x 1 time/day. Most patients recovered within four weeks. For patients who cannot recover completely after the first treatment, healing is often achieved during the treatment period for another four weeks.In patients with serious esophagitis, omeprazol 40 mg 1 time/day is recommended and cure is usually achieved within 8 weeks.
Long -term treatment for patients with reflux esophagitis to prevent recurrence:
For long -term treatment, patients with reflux esophagitis patients have been healed, the recommended dose is Omeprazol 10 mg x1 times/day. If necessary, the dose can be increased to Omeprazol 20 - 40 mg once daily.
The recommended dose is 20 mg omeprazol daily. Patients can fully respond to a dose of 10 mg per day, so the dose adjustments for each individual should be considered.If the symptom control is not achieved after four weeks of treatment with 20 mg omeprazol daily, additional tests need to be conducted.
Treatment of Zollinger-Eleson syndrome:
For patients with zollinger-zellison syndrome, the individual should be adjusted separately and the treatment continues as long as it is clinically indicated. The starting dose is recommended as omeprazol 60 mg per day. All patients with serious illness and incomplete response to other therapies have been effectively controlled and more than 90% of patients maintain with the dose of omeprazol from 20 - 120 mg daily. When the dose exceeds omeprazol 80 mg daily, the dose should be divided and taken 2 times/day.
Dosage for children:
Children over 1 year and ≥ 10 kg:
Treatment of reflux esophagitis.
Treatment of heartburn and acid reflux in gastroesophageal reflux disease.
Treatment of symptoms of gastroesophageal reflux disease:
recommended dose is as follows:
| ≥ 1 year of age
≥ 2 years old | Treatment of heartburn and acid reflux in gastroesophageal reflux disease: Treatment period from 2-4 weeks. If the symptom control is not achieved after 2-4 weeks of treatment, patients need to be checked. Children and adolescents over 4 years old: Treatment of duodenal ulcer caused by H. pylori: When choosing appropriate combination therapy, it is necessary to consider the guidance of the nation, the region and the locality on the resistance of bacteria, the treatment time (usually 7 days but sometimes up to 14 days) and the use of appropriate antibiotics. Treatment must be supervised by experts. The recommendations of dosage are as follows:
|
Side Effects
The most common side effect (1 - 10% of patients) is headache, abdominal pain, constipation, diarrhea, flatulence and nausea/vomiting.
The following side effects are identified or suspected in clinical trials for omeprazol and after the drug is marketed. There is no side effects that are related to the dose. Side effects are classified by symptomatic organs.
Frequency is determined by conventions: Very common: ADR ≥ 1/10; Common: 1/100 ≤ ADR
Blood disorders and lymphatic systems:
Mental disorders:
The safety of omeprazol has been assessed among the 310 children from 0 to 16 years old with acid -related illness. There are limited data on long -term safety from 46 children treated with Omeprazol in a clinical study of serious esophagitis that lasts up to 749 days. Information about side effects in general is similar to adults in short -term and long -term treatment. There is no long -term data on the effects of Omeprazol treatment on puberty and growth.
Notify the physician with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Agimepzol 20 drug contraindicated in the following cases:
Be cautious when using
If there is any alarm symptom (for example, significantly losing weight, recurrent vomiting, difficulty swallowing, vomiting or bleeding) and when suspected or there is a phenomenon of stomach ulcers, it is necessary to eliminate the possibility of malignant tumor (the drug can cover symptoms, so it is late to diagnose).
Do not simultaneously use Atazanavir with proton pump inhibitors. If the combination of Atazanavir with proton pump inhibitors cannot be avoided, it is advisable to closely monitor clinical (for example, the amount of virus) combined with increased Atazanavir to 400 mg along with 100 mg of ritonavir; Do not exceed 20 mg omeprazol.
Omeprazole as well as all anti -acid drugs can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced or deficient gastric acid. This should be reminded in patients with reduced vitamin B12 reserves in the body or have risk factors for reducing vitamin B12 absorption when long -term treatment.
omeprazol is a CYP2C19 inhibitor. When starting or ending treatment with omeprazol, it is advisable to consider the ability to interact with metabolic drugs through CYP2C19. There has been an interaction between clopidogrel and omeprazol. It is unclear clinical related relationship of this interaction. As a cautious measure, it is not recommended to simultaneously use omeprazol and clopidogrel.
Magnesi blood:
There have been reports on severe blood magnesium reduction in patients treated with proton pump inhibitors (PPI) like omeprazol for at least 3 months and in most cases in one year. The severe manifestations of blood magnesi such as fatigue, lumbar pain, spasticity, gizzard, convulsions, dizziness and ventricular arrhyths may occur but may be silently and omitted. In most patients affected, reducing the amount of blood magnesium improved after applying magnesium replacement and ppi.
For patients expected to be treated for prolonged treatment or use of proton pump inhibitors with digoxin or drugs that can cause blood magnesium (eg diuretics), physicians should consider measuring magnesium levels before starting PPI treatment and periodic monitoring during treatment.
Proton pump inhibitors, especially if used in high doses and for a long time (> 1 year), can increase the risk of hip, wrist and spine fractures, mainly in the elderly or have other recognized risk factors. Observatory studies show that proton pump inhibitors may increase the overall risk of fractures by about 10 - 40%. Part of this increase may be due to other risks. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and they should eat enough vitamin D and calcium.
Interaction with tests:
Increased chromographin (CGA) concentration can interfere with the detection of endocrine nerve tumors. To avoid this intervention, Omeprazol should be stopped at least 5 days before quantitating CGA.
Some children with chronic diseases may need long -term treatment although this is not recommended.
Proton pump inhibitors may increase the risk of gastrointestinal infections such as Salmonella and Campylobacter.
Patients treated for a long time (especially when the treatment time exceeds 1 year) should be monitored regularly.
Lupus Skin Red Red Red Skin Skin Skin Skin Sells:
Proton pump inhibitors are related to very rare cases of SCLE (SCLE). If the lesions occur, 10 especially in the skin exposed to the sun, and if accompanied by joint pain, patients should quickly find medical assistance and doctors should consider stopping using omeprazol. SCLE after previous treatment with proton pump inhibitors can increase the risk of SCLE with other proton pump inhibitors.
The effect of the drug on the ability to drive and operate machinery
Caution when taking the drug for the driver or operating machinery because the drug can cause headaches, drowsiness, dizziness.
Use drugs for women during pregnancy and lactation
Pregnant women:
On experiments, omeprazol does not cause deformity and toxicity to the fetus, but the tracking time is not enough to eliminate all risks. Therefore, the use of omeprazol during pregnancy is only considered when really necessary.
breastfeeding women:
Because the drug is distributed in breast milk, it is advisable to consider stopping the drug or stop breastfeeding.
Drug interaction
The impact of omeprazol on the pharmacokinetics of other drugs
Drugs with absorption depend on pH:
Stomach acidity decreases during treatment with omeprazol may increase or decrease the absorption of drugs with a mechanism of absorption depending on the pH of the stomach.
nelfinavir, Atazanavir:
Plasma concentrations of Nelfinavir and Atazanavir decreased when used simultaneously with omeprazol. Contraindicated use at the same time Omeprazol and Nelfinavir.
Simultaneously used with omeprazol (40 mg once a day) reduces the average concentration of Nelfinavir by about 40% and the average concentration of active metabolites has a pharmacological impact decreased by about 75 - 90%. This interaction may also be related to CYP2C19 inhibition.
Do not use omeprazol simultaneously with Atazanavir. Simultaneous use of omeprazol (40 mg once daily) and Atazanavir 300 mg/ritonavir 100 mg for healthy volunteers reduces 75% of the concentration and time of Atazanavir contact. Increasing the dose of Atazanavir to 400 mg has not compensated for the effects of omeprazol on concentration and time of Atazanavir contact. Simultaneous use with and time of Atazanavir exposure. Increasing the dose of omeprazol (20 mg once daily) with Atazanavir 400 mg/ritonavir 100 mg for healthy volunteers has reduced about 30% of the concentration and time of Atazanavir contact when compared to Atazanavir 300 mg/ritonavir 100 mg once daily.
digoxin:
Simultaneous use of omeprazol (20 mg per day) and digoxin in healthy objects that increase the bioavailability of digoxin to 10%. The toxicity of digoxin is rarely reported. However, it is necessary to be cautious when using high -dose omeprazols in elderly patients to increase monitoring with Digoxin treatment.
clopidogrel:
Results from studies in healthy subjects show that pharmacokinetic interaction (PK)/Pharmacological (PD) between clopidogrel (dose of 300 mg/maintenance dose 75 mg/day) and omeprazol (80 mg oral daily) leads to the concentration of the active metabolites of clopidogrel the average decrease of about 46% and maximize the maximum of the average Coccidiom (due to ADP) is 16% of the ADP). The inconsistent data on the clinical impact of Omeprazol's pharmaceutical/pharmaceutical interactions on the main cardiovascular events has been reported from clinical and clinical studies. For the purpose of caution, the simultaneous use of clopidogrel is not recommended.
Other active ingredients:
The absorption of Posaconazole, Erlotinib, Ketoconazole and Itraconazole is significantly reduced and therefore clinical efficiency may be reduced.
For Posaconazol and Erlotinib to avoid simultaneous use.
The drug is metabolized by CYP2C19:
Omeprazol is a medium inhibitor CYP2C19, the main enzyme metabolizes omeprazol. Therefore, the metabolism of the drugs used simultaneously is also reduced by CYP2C19 and the concentration of these drugs in plasma increases. Examples of such drugs are R-Warfarin and other vitamin K antagonists, Cilostazol, Diazepam and Phenytoin.
cilostazol:
In a cross study, Omeprazol used at a dose of 40 mg on healthy objects increased CMAX and AUC of Cilostazol, both 18% and 26% and CM and AUC of a metabolic substance with its activity corresponding to 29% and 69%.
phenytoin:
Need to monitor phenytoin concentration in the first two weeks after starting treatment with omeprazol, and if the phenytoin dose is adjusted, the monitoring and adjustment of the additional dose occurs when stopping treatment with omeprazol.
Unknown mechanism:
The use of omeprazol along with saquinavir/ritonavir increases plasma concentration to about 70% for Saquinavir covered with good tolerance in HIV -infected patients.
tacrolimus:
There has been a report on simultaneous use with omeprazol increasing the concentration of tacrolimus in the serum. Tacrolimus concentration must be increased as well as renal function (creatinine clearance) and tacrolimus dose are adjusted if necessary.
methotrexate:
When used in combination with proton pump inhibitors, methotrexate concentration increases in some patients who have been reported. When using high doses of methotrexate, it may be necessary to consider stopping the temporary omeprazol.
The impact of other drugs on Omeprazol's pharmacokinetics
CYP2C19 and/or CYP3A4 inhibitors:
Because omeprazol is metabolized by CYP2C19 and CYP3A4, drugs are inhibited CYP2C19 or CYP3A4 (such as Clarithromycin and Voriconazol) that can increase the concentration of omeprazol in serum by reducing the metabolism rate of omeprazol. Simultaneous treatment with voriconazole increases more than twice the time and contact concentration of omeprazol. Due to the good high doses of Omeprazol, it is often not necessary to adjust the omeprazol dose. However, it is necessary to consider adjusting the dose in patients with severe liver failure and if long -term treatment is designated.
CYP2C19 and/or CYP3A4 induction drugs:
The drugs are known to cause CYP2C19 or CYP3A4 induction or both (such as rifampicin and st. John's grass) may cause reduced serum omeprazol levels due to increased omeprazol metabolism.
Storage
Store at a temperature not exceeding 30 ° C in the original packaging, avoid moisture and avoid light.
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