Omeraz 20 Boston capsules for treatment and recurrence of stomach ulcers, duodenum (5 blisters x 4 tablets)
Dosage form Omeprazol
Specifications Gastroesophageal reflux, heartburn
Ingredient
| Composition information | Content |
| Omeprazol | 20mg |
Uses
Indications
Omeraz 20 drugs are indicated in the following cases
Adults
Combined with antibiotics in the treatment of stomach ulcers caused by H.pylori infection.
Children
Children ≥ 2 years old and> 20kg
Adolescents and children ≥ 4 years old
Combined with antibiotics to treat H.pylori -infected stomach ulcers.
Pharmacokology
Omeprazol is a benzimidazole that has attached groups, structured and similar to Pantoprazol, Lansoprazol, Esomeprazol.
In the acidic environment in the cell wall of the stomach, omeprazol is converted into activity and inhibition of H+/K+ATPASE enzyme (proton pump), reducing the secretion of gastric acid in the background state and stimulating state.
Effects on the acid secretion of the stomach
After taking omeprazol once a day, the drug quickly promotes and achieves maximum effect after 4 days of treatment. With a dose of 20mg, omeprazol can reduce at least 80% of the total amount of acid secreted for 24 hours and maintain the stomach pH> 3 consecutive days for 17 hours a day in patients with duodenal ulcer.
The acid secretion effect is related to the total amount of drugs in contact with the body, performing through the area under the curve (AUC) of the blood concentration in the blood, rather than the drug concentration at a certain time.
Effects on Helicobacter pylori (H.pylori)
Omeprazol can restrain bacteria h. Pylori in patients with duodenal ulcer or esophagitis reflux contaminated with bacteria. Combining omeprazol with an antibacterial drug (clarithromycin, amoxicillin) can eradicate H. pylori attached to ulcers and remain from long -term disease.
Other effects related to acid inhibition
Long -term treatment with antacids of gastric secretion may slightly increase the frequency of gastric cysts. These changes are benign and can recover.
Reducing stomach acid due to any cause, including using proton pump inhibitors (PPI), may increase the number of permanent bacteria in the digestive tract.
During the treatment with gastric acid -secreting drugs, the serum galastin concentration responds to a reduction in gastric acid. Chromographin concentration (CGA) also increases due to reduced gastric acid. The increase in CGA levels can interfere with the detection of hormonal tumors. Medical reports recommend that PPI should be stopped at least 5 days before quantifying CGA. If CGA and Gastrin concentrations do not return to normal after 5 days, should conduct quantitative after 14 days of stopping PPI.
Increasing the number of ECL cells (enterchromaffin - likes) may be due to increased serum gastrin levels that have been recorded in both children and adults when long -term treatment with omeprazol. This is considered not clinical significance.
Children
In children's study from 1- 16 years old with gastroesophageal reflux, with the dose of omeprazol 0.7 - 1.4mg/kg can improve the level of esophagitis in 90% of cases and significantly reduce reflux symptoms. In a single blind study, children from 0 to 24 months of age suffering from gastroesophageal reflux treated with omeprazol dose from 0.5-1.5mg/kg. The results showed that at all frequency doses should be reduced by 50% after 8 weeks of treatment.
Combining omeprazol with two antibiotics (amoxicillin and clarithromycin) are safe and effective in killing H.pylori in children from 4 years of age.
pharmacokinetic
absorption
Omeprazol is not durable in the acidic environment, so the drug is prepared in the form of particles dissolved in the intestine and then closed into the cyst. Omeprazol is quickly absorbed, the plasma concentration is achieved after drinking about 1-2 hours. The absorption of omeprazol occurs in the small intestine and usually ends within 3-6 hours.
Food does not affect the bioavailability of the drug. Born the whole body after taking the dose is about 40% and increases about 60% after repeated use once a day.
Distribution
The distribution of healthy people is approximately 0.3 liters/kg of body weight. Omeprazol attaches to plasma proteins about 97%.
Metabolism
Omeprazol is almost completely metabolized in the liver by the enzyme system of Cytochrom P450. In which most omeprazol is metabolized through CYP2C19, a polymorphic enzyme, into hydroxyomeprazol. The rest is metabolized through CYP3A4 to form omeprazol sulfon.
Elimination
omeprazol is almost completely eliminated between doses and the selling time is usually less than 1 hour. About 80% of the oral dosage of omeprazol is excreted in the urine in the form of metabolites and the rest is excreted through feces.
Patients with liver failure
Omeprazol metabolism decreases in people with liver failure, leading to an increase in the AUC of the drug. However, omeprazol does not show the ability to accumulate when taking 1 dose per day.
Patients with renal failure
Omeprazol pharmacokinetics, including systemic use and excretion speed, unchanged in patients with renal impairment.
Elderly
Omeprazol's metabolic ratio decreases slightly in the elderly (75 - 79 years).
Children
Children over 1 year of age: Pharmacokinetics of the drug similar to adults.
Children under 6 months of age: The clearance of the drug is reduced due to the incomplete metabolism of children.
Before taking Omeraz 20 Boston capsules for treatment and recurrence of stomach ulcers, duodenum (5 blisters x 4 tablets)
How to use
Take oral use.
Omeraz 20 Boston is recommended to be used in the morning, taken whole tablets, must not chew or grind.
For patients with difficulty swallowing and children can drink or swallow solid food: Patients can open capsules and mix parts into half a cup of water or a weak amount of acidic water such as orange juice, apple juice and drink immediately.
Dosage
Adults
Treatment of stomach ulcer, duodenum
The recommended dose is 20mg x 1 time/day, may increase to 40mg x 1 time/day if necessary. The recovery time is usually 2 - 4 weeks for duodenal ulcer and 4 - 8 weeks for stomach ulcers.Preventive recurrence of stomach ulcers, duodenum
Dosage 20 mg x 1 time/day. In patients with poor response, the dose can be increased to 40 mg, 1 time/day.
Combined with antibiotics in the treatment of H.pylori -infected stomach ulcer
Omeprazol dose 20mg x 2 times/day can be combined with antibiotics in the treatment of eradication H. pylori. The selection of antibiotics must be based on the ability to tolerate drugs of each patient, the situation of antibiotic resistance in the area and the treatment regimens of reputable organizations.
Treatment of stomach and duodenum ulcers caused by NSAID
The dose is 20mg x 1 time/day. The ulcer usually recovers within 4 weeks. For patients with poor response, recovery time can be up to 8 weeks.
Stomach - duodenum prevention by NSAID
Dosage is 20mgx 1 time/day.
Treatment of reflux esophagitis
recommended dose is 20mg x 1 time/day.
For people with severe esophagitis, the beginning of treatment at a dose of 40mg x 1 time/day is recommended. The recovery time is usually 4 weeks for the majority of patients and can last up to 8 weeks for patients with severe or poorly respected inflammation.
Treatment of symptoms of gastroesophageal reflux disease
The usual dose is 20mg x 1 time/day.
In some cases, lower doses (10mg x 1 time/day) can also respond well. If symptoms are not controlled after 4 weeks at a dose of 20mg per day, patients should be tested more carefully to redefine diagnosis.
Treatment of Zollinger - Ellison syndrome
Normal starting dose is 60mg/day. Dosage should be personalized and maintained continuously until clinically indicated.
Severe and poor cases responding to other regimens can still be effectively treated and more than 90% of patients are maintained at the dose of Omeprazol 20 - 120mg daily. Doses of over 80mg should be divided into 2 times/day.
Children
Children ≥ 2 years and> 20 kg
Dosage 20mg x 1 time/day, can increase to 40mg x 1 time/day if necessary.
Treatment time:
Combined with antibiotics to treat H.pylori -infected stomach ulcers: Omeprazol 20mg x 1 time/day, antibiotic dose should be adjusted for each patient depending on weight.
Treatment time: 1 - 2 weeks.
Patients with renal failure
No dose adjustment.
Patients with liver failure
Dosage not exceeding 20mg/day.
Old people
No dose adjustment, if the liver function is still normal.
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
There is very little information about the effect of overdose Omeprazol on humans. In the literature, there are cases where the use of wastes is up to 560mg or 2400mg (100 times the recommendation). Symptoms include: nausea, vomiting, dizziness, abdominal pain, diarrhea and headache. In addition, indifferent, depressed, confused has also been encountered in some cases.
Treatment
Symptoms of overdose are temporary and do not cause serious effects. Omeprazol's excretion speed is not sometimes increasing the dose. Just treat symptoms if necessary.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Omeraz 20, you may experience unwanted effects (ADR).
Popular, ≥ 1/100 to
Not popular, ≥ 1/1000 to 100
Liver disorders: Increased liver enzyme. Skin disorders, subcutaneous tissue: Dermatitis, itching, rash, urticaria. Disorders of muscle - joints: fracture of hip, wrist bone and spine. Rare, ≥ 1/10,000 to 1,000 1 Mental disorders: agitation, confusion, depression. Respiratory disorders: bronchial spasm. Gastrointestinal disorders: dry mouth, stomatitis, gastrointestinal candidiasis. Hepatitis: Hepatitis has or no jaundice. Skin disorders, subcutaneous tissue: Hair loss, light sensitivity. Other disorders: increase sweating. Very rare, Mental disorders: impatient, hallucinations. Unknown Gastrointestinal disorders: Micro colitis. 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
Omeraz 20 drugs are contraindicated in the following cases:
Precautions when using
The conditions need to be cautious when taking the drug
When any alert symptoms appear (such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting of blood or black stool bowel) and when suspected or confirming gastric ulcer, patients should be eliminated the risk of malignant diseases before treatment because Omeprazol can cover symptoms and delay diagnostic.
It is not recommended to simultaneously use Omeprazol with Atazanavir. If it is required to coordinate, it is necessary to monitor patients closely clinically, and increase the dose of Atazanavir to 400mg and combine with 100mg of ritonavir, the dose of omeprazol should not exceed 20mg.
Omeprazol, as well as other antacids, can reduce the absorption of vitamin B12 (cyanocobalamin) due to a reduction or lack of gastric acid. Attention should be paid to patients who reduce vitamin B12 reserves or have risk factors for reducing vitamin B12 absorption when long -term treatment with omeprazol. Omeprazol is CYP2C19 inhibitor. At the beginning or end of treatment with omeprazol, the risk of interacting with other drugs should be considered through CYP2C19. Omeprazol has interact with clopidogrel. Although clinical influence is not sure, but in case it is not recommended to coordinate omeprazol and clopidogrel.
Prolonged treatment (over 3 months or annual) with proton pump inhibitors (PPI) such as omeprazol can cause severe loss of blood magnesi. The serious signs of hypoglycemia may occur such as fatigue, muscle spasms, delirium, convulsions, dizziness and ventricular arrhythmia, but can also silently start and be overlooked. In most patients, blood magnesium reduction is improved after using magnesium instead and stop using PPI.
For patients who need prolonged treatment or patients with simultaneous use of ppi with digoxin or other drugs that can cause bloodstream (such as diuretics), health workers should consider quantifying blood magnesium levels before starting treatment with PPI and periodic monitoring during treatment.
PPI drugs, especially when taking high and prolonged doses (> 1 year), may increase the risk of hip fractures, wrist bones and spine, especially in elderly patients or when the presence of other risk factors. Patients at risk of osteoporosis should be taken care of the kidneys, and adequate vitamin D and calcium.
PPIs are related to a very rare number of semi -exponent lupus skin lesions (SCLE). If the lesions occur, especially in the skin exposed to the sun and if the symptoms of joint pain are accompanied by symptoms of joint pain, patients should go to the nearest medical facility to be cared for. The patient had a history of SCLE with a PP drug that could increase the risk of SCLE occurring when using other PPIs.
Increasing CGA levels can affect the detection of endocrine nerve tumors. To avoid influence, it is recommended to be used with omeprazol treatment for at least 5 days before the quantification of CGA.
Can be used for long -term treatment in children with chronic diseases although not recommended.
Proton pump inhibitors may increase the risk of gastrointestinal tract infections caused by Salmonella and Campylobacter.
The ability to drive and operate machinery
Omeprazole often does not significantly affect the ability to drive or operate machinery, unwanted reactions of the drug such as dizziness and visual disorders may occur.
If affected, patients should not operate machinery, train trains or work on high.
Pregnancy
has not observed the harmful reaction of omeprazol in pregnant women or on the health of the fetus/infant. Therefore, omeprazol can be used for pregnant women.
Breastfeeding period
omeprazol is excreted in breast milk but does not affect children when used at the dose of treatment.
Drug interaction
The effect of omeprazol on pharmacokinetics of other drugs
For drugs that depend on pH
The drugs are metabolized through CYP2C19
omeprazol is a CYP2C19 inhibitor, so omeprazol can increase the concentration of other drugs that also metabolizes through CYP2C19 such as warfarin and antagonistic substances against vitamin K, cilostazol, diazepam and phenytoin.
Other drugs (unknown mechanisms)
CYP2C19 or CYP3A4 inhibitors
Omeprazol is metabolized by CYP2C19 and CYP3A4, so CYP2C19 or CYP3A4 inhibitors (such as clarithromycin and voiconazol) can increase omeprazol levels in plasma due to reduced metabolism of omeprazol. Simultaneous use of omeprazol along with voriconazole may increase more than twice the AUC of omperazol. Omeprazol dose should be considered in patients with severe hepatic failure or long -term indicators.
CYP2C19 or CYP3A4 induction drugs
CYP2C19 or CYP3A4 induction drugs (such as rifampicin and st.john’s wort) can reduce the plasma concentrations of omeprazol due to metabolic increase of omeprazol.
Other interactions
Omeprazol does not have a serious interaction clinically when used with food.
Storage
Store drugs in dry, temperatures not exceeding 300C, avoiding light.
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