Hard capsules Mepraz 20mg Sanofi treat gastroesophageal reflux (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Omeprazol
Ingredient
| Composition information | Content |
| Omeprazol | 20mg |
Uses
indications
Mepraz® 20mg drug is indicated in the following cases:
Adults
Long -term treatment in patients with reflux esophagitis.
Children
Pharmacology
Omeprazol is a optical removal mixture of two copiers of the image, reducing gastric acid secretion through a highly effective impact mechanism. This is a specific inhibitor of acid pump in the cell wall of the stomach. The drug has a quick impact and controls the inhibition that can recover from gastric acid secretion when used once a day.
Omeprazoi is a weak base, concentrated and transformed into an active form in the highly acidic environment of intracellular channels in the cells, where it inhibits the enzyme H+ K+ - ATPase - Acid pump (or proton pump).
The process of impact on the final step of this stomach acid formation depends on the dose and provides highly effective inhibition on basic acid secretion and even when stimulated, regardless of stimuli.
Pharmacological effects
can explain all the pharmacological effects with the effect of omeprazol on acid secretion.
Effects on the inhibition of stomach acid secretion
Omeprazol drink once a day brings a quick and effective inhibition on the inhibition of gastric and night stomach secretions, with the maximum effect achieved within 4 days of treatment. With 20 mg Omeprazol, the average decrease of at least 80% of the 24 -hour stomach acid is maintained in the duodenal ulcer patient, with the average reduction of the maximum acid extraction after Pentagastrin stimulating about 70% 24 hours after the drug.
In patients with duodenal ulcer, the 20 mg omeprazol waste maintains pH in the stomach ≥ 3 in an average period of 17 hours of the 24 -hour period of medication.
Due to reducing acid secretion and acidity in the stomach, omeprazole reduces/normitizes acidic exposure in the esophagus in a dosage-dependent-style type of dosage on patients with gastroesophageal reflux disease. The inhibition of acid secretion is associated with an area under the concentration curve over time (AUC) of omeprazol and is not related to plasma concentrations at a given time.
There is no fast -familiar drug phenomenon during treatment with omeprazol.
Effects on H. Pylori
h. Pylori causes digestive ulcers, including gastric and duodenal ulcer. H. Pylori is an important factor in the development of gastritis. H. Pylori, along with stomach acid, are the main factors in the development of digestive ulcers. H. Pylori is an important factor in the development of gastric mucosal atrophy, which is a disease associated with increasing the risk of developing stomach cancer.
H. pylori with omeprazol and antibiotics increase the healing rate of ulcers and long -term retreat for digestive ulcers.
Two -drug therapy has been tested and showed less effective than three drugs. However, they may be considered in cases where the hypersensitivity history cannot be used any three drugs.
Other effects associated with acidic inhibition
The frequency of gastric gland cysts is reported somewhat increasing during long -term treatment. These changes are the physiological consequences of strong inhibition on acidic secretion, benign nature and self -recovery.
Reducing stomach acid levels due to any way, including proton pump inhibitors, increasing the number of normal bacteria present in the digestive tract. Treatment with acid secretion can lead to a slight increase in the risk of stomach infections like Salmonella and Campylobacter.
Chromogranin A (CGA) also increases due to decrease in stomach acid. The effect of changing this CGA disappears after stopping the treatment of proton pump inhibitors for 5 days.
Use in children
In a non -control study in children (1 to 16 years old) suffered from severe reflux esophagitis, omeprazol at the dose of 0.7 to 1.4 mg/kg improved the level of esophagitis in 90% of cases and reducing significant reflux symptoms.
In single blind study, children from 0-24 months old with gastroesophageal reflux disease are clinically diagnosed with treatment with 0.5, 1.0 or 1.5 mg omeprazol/kg. The frequency of vomiting/reflections decreased by 50% after 8 weeks of treatment regardless of the dose.
Extraction of H. pylori in children
A random, double clinical study (Héliot research) concluded that omeprazol in combination with two antibiotics (amoxicillin and clarithromycin) showed that it was safe and effective in treating H. pylori infection in children from 4 years old and older with gastritis: H. Pylori except ratio of 74.2% (23/3/31 of Nhi) with Omeprazol + Amoxicillin + Clarithromycin compared to 9.4% (3/32 children) with amoxicillin + clarithromycin.
However, there is no evidence of clinical benefits of indigestion. This research has no information for children under 4 years old.
Pharmacokinetics
absorption
Omeprazol and omeprazol Magnesi are not durable in the acidic environment and so the oral medication must be in the form of nuggets in the intestine container in capsules or tablets. Omeprazol is quickly absorbed, reaching the peak concentration in plasma about 1-2 hours after drinking.
Omeprazol absorption occurs in the small intestine and usually completed within 3-6 hours. Taking medicine at meals does not affect bioavailability. Birth is about 40% after using a single dose. Birth increases about 60% after the dose repeated once a day.
Distribution
The apparent distribution volume on healthy objects is about 0.3 l/kg of weight. Omeprazol ratio with plasma proteins is 97%.
Metabolism
Omeprazol is completely metabolized by the Cytochrom (CYP) P450 system. The main part of this metabolism depends on CYP2C19, which is manifested in a polymorphic, creating hydroxyomeprazol, the main metabolite in plasma.
The rest depends on another specific closed form, CYP3A4, creating Omeprazol Sulphon. Because Omeprazol has high affinity for CYP2C19, there is a potential for competitive inhibition and drug-drug interaction with other substrates of CYP2C19.
However, due to low affinity with CYP3A4, Omeprazole has no potential to inhibit the metabolism of other substrates of CYP3A4. In addition, omeprazol has no inhibitory effect on the main CYP enzymes.
About 3% of whites and 15-20% of Asians do not have an active CYP2C19 enzyme and are called poor metabolic. On these objects, omeprazol metabolism is probably mainly catalyzed by CYP3A4.
After taking Omeprazol 20 mg repeated once a day, the average AUC on the person metabolizes is 5 to 10 times less than the person with the enzyme CYP2C19 active (people with strong metabolism).
Average peak concentration in plasma is also 3 times higher than 3 times. These findings do not affect the dose of omeprazol.
Excretion
Omeprazol's semi -waste time is usually shorter than 1 hour after taking the single dose and drinking repeated once a day. Between doses, omeprazol is completely eliminated from plasma without accumulating when taking the drug once a day.
Nearly 80% of the oral dose of omeprazol is excreted in the form of metabolites in urine, the rest is excreted in feces, mainly through bile.
ome of omeprazol increases when the dose is repeated. This increase depends on the dose and leads to non-linear dosage-Auc relationship after repeated dose. This time and dosage dependence is due to the reduction of metabolism for the first time and the body clearance, perhaps because of Omeprazol and/or its floral transfer substances (for example, sulphon) that inhibits CYP2C19 enzyme inhibitors.
There is no metabolite that has any effect on gastric acid secretion.
Special subjects
Hepatic failure: Omeprazole metabolism decreases in patients with liver failure, resulting in an increase in AUC. Omeprazol does not show any accumulation trends when taking the drug once a day.
renal failure: pharmacokinetics of omeprazol, including body bioavailability and elimination speed, unchanged on patients with reduced renal function.
Old people: The metabolism speed of omeprazoi is somewhat reduced on the elderly (75-79 years old).
Children: When treating with high -advanced doses for children aged 1 and older, the concentration measured in plasma is similar to adults. In children under 6 months of age, low omeprazol clearance because of low ability to metabolize Omeprazol.
Before taking Hard capsules Mepraz 20mg Sanofi treat gastroesophageal reflux (4 blisters x 7 tablets)
How to use
should take Mepraz® 20mg gastric resistance capsules in the morning, preferably at hunger, and should swallow the tablet with half a glass of water. Do not chew or crush capsules.
For patients with difficulty swallowing and children can drink or swallow with thick food.
Can open capsules and take the medicine inside with half a glass of water or after mixing with a mild acidic liquid, such as fruit juice or apple juice, or with non -carbonated drinks. Should drink immediately after the mixing (or within 30 minutes) and always have to stir before drinking and rinse with half a glass of water.
Patients can also suck capsules and swallow internal drugs with half a glass of water. Do not chew these seeds.
Dosage
adults
Treatment of duodenal ulcer
The dose is recommended in patients with duodenal ulcer, which is 20 mg of omeprazol once a day. Most patients will heal ulcers within 2 weeks. For patients who do not heal completely after the original course, usually the ulcer will heal after a 2 -week treatment.
In patients with poor duodenal ulcer, it is recommended to use 40 mg of omeprazol once a day and usually the ulcer will heal for 4 weeks.
Preventing the recurrence of duodenum ulcers
To prevent recurrence of duodenal ulcers in negative patients with H. pylori or when it is impossible to eradicate H. pylori, the recommended dose is 20 mg of omeprazol once a day. In some patients, 10 mg dose daily is enough to work. In case of treatment failure, the dose can be increased to 40 mg.
Treatment of stomach ulcers
The recommended dose is 20 mg of omeprazol once a day. Most patients will heal ulcers within 4 weeks. For patients who do not heal completely after the original course, usually the ulcer will heal after a 4 -week treatment.In patients with poor stomach ulcers, 40 mg of omeprazol should be used once a day and usually the ulcer will heal for 8 weeks.
Preventing stomach ulcers
To prevent ulcers recurrence in patients with poor stomach ulcers, the recommended dose is 20 mg of omeprazol once a day. If necessary, the dose can be increased to 40 mg of omeprazol once a day.
Dexterity H. pylori in digestive ulcer
To eradicate H. pylori, it is advisable to consider the tolerance of each patient when choosing antibiotics, and should use antibiotics according to the national, regional and local drug resistance and treatment guidance.
To treat stomach and duodenum ulcers caused by NSAID drugs, the recommended dose is 20 mg of omeprazol once a day. Most patients will heal ulcers for 4 weeks. For patients who do not heal completely after the original course, usually the ulcer will heal after a 4 -week treatment.
Preventing stomach and duodenum ulcers caused by NSAID drugs in patients at risk
To prevent stomach and duodenal ulcer due to NSAID drugs in patients at risk (age> 60, history of stomach ulcer, a history of gastrointestinal bleeding), the recommended dose is 20 mg of omeprazol once a day.
Treatment of reflux esophagitis
The recommended dose is 20 mg of omeprazol once a day. Most patients will heal ulcers within 4 weeks. For patients who do not heal completely after the original course, usually the ulcer will heal after a 4 -week treatment.On patients with severe esophagitis, 40 mg of omeprazol should be used once a day and usually the ulcer will heal for 8 weeks.
Long -term treatment patients with reflux esophagitis patients
For long -term treatment for patients with reflux esophagitis, the recommended dose is 10 mg of omeprazol once a day. If necessary, the dose can be increased to 20-40 mg Omeprazol once a day.
Treatment of gastroesophageal reflux disease with symptoms
The recommended dose is 20 mg of omeprazol once a day, the patient can respond well for a dose of 10 mg/day, and thus consider adjusting the dose depending on the patient.
If the symptoms are not controlled after 4 weeks of treatment with omeprazol 20 mg/day, additional testing should be tested.
Treatment of Zollinger-Elison syndrome
On patients with Zollinger-Eleson syndrome, the dose should be adjusted depending on the person and continue treating on the condition that there is clinical indications. The initial dose recommended is 60 mg of omeprazol per day.
All patients with severe and poorly responded to other therapies are effectively controlled and more than 90% of patients have maintained Omeprazol at the dose of 20-120 mg/day. When the dose of omeprazol exceeds 80 mg/day, it is divided into drinking twice a day.
Dosage in children
Children over 1 year of age and weight> 10 kg.
Treatment of reflux esophagitis
Treatment of heartburn and acidic chemistry in gastroesophageal reflux disease
The dose is recommended as follows:
Age
weight
Dosage
10-20 kg
10 mg once a day, may increase to 20 mg once a day if needed
≥ 2 years old 20 kg
20 mg once a day, may increase to 40 mg a day if necessary
Treatment of heartburn and acidic vesicles in gastroesophageal reflux disease: The treatment time is 2-4 weeks. If the symptoms are not controlled after 2-4 weeks, patients need to be examined.
Children over 4 years old and teenagers
Treatment of duodenal ulcer caused by H. pylori
When choosing the appropriate combination therapy, it is advisable to consider the official guidance of the nation, the region and the locality on drug -resistant bacteria, treatment time (usually 7 days but sometimes up to 14 days), and use antibiotics appropriately.
Treatment must be monitored by a specialist.
The dose is recommended as follows:
weight
Dosage
15-30 kg
Combined with 2 antibiotics: Omeprazol 10 mg, amoxicillin 25 mg/kg weight and Clarithromycin 7.5 mg/kg weight, all drink twice a day a week.
31-40 kg
Combined with 2 antibiotics: Omeprazol 20 mg, Amoxicillin 750 mg and Clarithromycin 7.5 mg/kg weight, all drink twice a week a week.
40 kg
Combined with 2 antibiotics: Omeprazol 20 mg, Amoxicillin 1 g and Clarithromycin 500 mg, all drink twice a week a week.
Renal function
No need to adjust the dose in patients with renal function {see pharmacokinetics section).
Liver function
On patients with hepatic failure, the dose of 10-20 mg/day is enough {see pharmacokinetics section).
Elderly (65 years old)
No need to adjust the dose on the elderly (see pharmacokinetic section).
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 do
do when using overdose? In literature, at a dose of 560 mg has been recorded, and occasionally reports with the only doses when taking omeprazol reaches 2400 mg (120 times the recommended doses of clinical recommendations). Nausea, vomiting, dizziness, diarrhea and headache have been reported. Similarly, indifferent, depression and confusion have been described in single cases.
Handling: Omeprazol overdose symptoms described fleeting properties, and no serious consequences were reported. The speed of excretion does not change (first -order dynamic) when increasing the dose. If needed, symptomatic treatment only.
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 Mepraz® 20mg, you may experience unwanted effects (ADR).
The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence and nausea/vomiting.
The following unwanted effects have been recorded or suspected in Omeprazol's clinical trial and drug circulation experience. There is no case that is noticed to the dose.
The undesirable effects below are classified as the following frequency and system system: Very common (≥ 1/10); Common (1/100 ≤ ADR Agency/ frequency system rare: leukopenia, thrombocytopenia Very rare: immune system disorders rare: Hypersensitivity reactions, for example fever, angioedema and anaphylactic/shocking reaction rare: Sodium-lowering Unknown: Lower Magnesi-Causes (see caution) Mental disorders Insomnia rare: agitated, confused, depressed Very rare: aggression, hallucinations Headache Dizziness, paresthesia, drowsiness rare: Intense disorders Feeling of loss of balance Bronchospasm abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting dry mouth, stomach stomatitis, stomach candidiasis, colitis liver enzyme Hepatitis with or without jaundice Hepatic failure, brain disease in patients with liver disease Dermatitis, itching, rash, urticaria Hair loss, sunlight Diverse roses, Stevens-Johnson syndrome, poisoned epidermal necrosis (Ten) Broken hip, wrist or backbone (see caution) joint pain, muscle pain Weakness interstitial nephritis Big breasts in men Difficult to live, edema Surgery a lot The safety of omeprazol has been rated on a total of 310 children from 0 to 16 years old with acid -related disease. Existing data has a limited long -term safety of up to 749 days from 46 children being maintained with Omeprazol in a clinical study with severe esophagitis. The adverse events generally occur like adults when treated short -term and long -term. There is no long -term data on the effects of omeprazol treatment on puberty and growth. Instructions on how to handle ADR Notify the doctor with unwanted effects when using the drug. Must stop the drug when there is an unwanted effect.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Mepraz® 20mg contraindications in the following cases:
Caution when using
when there is any alarm symptom (for example, significant weight loss, constant vomiting, swallowing pain, vomiting of blood or Black stools) and when there is or suspected stomach ulcers, it is necessary to eliminate malignant diseases, because this treatment can overshadow symptoms and make diagnostic delay.
Do not use Atazanavir simultaneously with Proton pump inhibitors {see drug interactions). If it is found that the combination of Atazanavir with a proton pump inhibitor, should be closely monitored (for example, loading virus amounts) in combination with increased Atazanavir to 400 mg with 100 mg of ritonavir; Omeprazol dose should not exceed 20 mg.
Like all other acid inhibitors, omeprazol reduces the absorption of vitamin B12 (cyanocobalamin) due to reduction or non -secretion of chlohydric acid. It should be noted this on patients with reduced reserves in the body or have risk factors for reducing vitamin B12 absorption when long -term treatment.
omeprazol is a CYP2C19 inhibitor. When caught or ending Omeprazol treatment, it is advisable to consider the potential to interact with drugs specialized in CYP2C19. The interaction between dopidogrel and omeprazol has been recorded (see the drug interaction), the clinical significance of this interaction is not known. For prevention, should not be used simultaneously omeprazol and dopidogrel.
Some children with chronic diseases may need long -term treatment although this is not recommended.
Mepraz® 20mg stomach resistance capsules contain sucrose and anhydrous lactose. Patients with rare genetic disorders such as galactose tolerance or fructose, Lactase Lapp deficiency, Glucose-Galactose malabsorption or Sucrase-Isomaltase deficiency should not be taken.
Treatment with proton pump inhibitors can lead to a slight increase in the risk of gastric infections like Salmonella and Campylobacter (see the pharmacological section).
Patients with long -term treatment (especially patients who have been treated for more than 1 year) should be monitored regularly.
Proton pump inhibitors, especially when taking high doses for a long time (> 1 year), can increase the risk of hip, wrist and backbone fractures, mainly on the elderly or when the presence of known risk factors.
Observing studies suggest that proton pump inhibitors may increase 10-40% of the risk of fractures in general. Part of this increase is due to other risk factors. Patients at risk of osteoporosis need to be treated under the current clinical instructions and they must be provided with adequate vitamin D and calcium.
Severe Magnesi-Lowering has been reported in patients treated for proton pump inhibitors such as Meprazol for at least 3 months and most cases are 1 year.
The heavy manifestations of the lower Magnesi-like fatigue, muscle spasms, frenzy, convulsions, dizziness and ventricular arrhyths may occur but they can start silently and be missed. On the majority of patients with Magnesi-symptoms improved after compensation for magnesi and stop using Proton pump inhibitors.
For patients who are expected to treat prolonged treatment or use proton pump inhibitors with digoxin or drugs that can cause Magnesi-matte (e.g. diuretics), medical staff should consider measuring magnesium levels before starting the treatment of proton pump inhibitors and periodic measurement during treatment.
Subclinical jamming
Increasing CGA levels can cause interference with the exploration of economic-secret tumors. To avoid this interference, it is recommended to suspend the treatment of omeprazol five days before CGA measurement.
The ability to drive and operate machinery
Mepraz® 20mg gastric resistance capsules does not seem to significantly affect the ability to drive and operate machinery. Side effects such as dizziness, visual disorders can occur {see unwanted effect section). If affected, patients should not drive and operate machinery.
Pregnancy
Results from three pre -rescue epidemiological studies (more than 1,000 drug use results) show that there is no disadvantage of omeprazol in pregnancy or on the health of the fetus/infant. Omeprazol can be used during pregnancy.
breastfeeding period
omeprazol is excreted in breast milk but does not have the ability to affect the baby when using the dose of treatment.
Drug interaction
The effect of omeprazol on pharmacokinetics of other drugs
The drug has a pH absorption.
Reducing acidity in the stomach when treated with omeprazol, which can increase or reduce the absorption of active ingredients with gastric absorption.
nelfinavir, atazanavir.
The concentration of Nelfinavir and Atazanavir decreases when drinking in time with Omeprazol.
Contraindicated use Omeprazol with nelfinavir (see the control item).
Concomitance use Omeprazol (40 mg once a day) reduces about 40% of NELFINAVIR's average contact concentration and decreases by about 75-90% of the average contact concentration of metabolites with M8 pharmacological activity. The interaction can also cause CYP2C19 inhibitors.
Do not use simultaneously Omeprazol with Atazanavir {see caution). Simultaneous use Omeprazol (40 mg once a day) and Atazanavir 300mg/ritonavir 100 mg on a healthy vow reduces 75% of Atazanavir contact concentration.
Increased atazanavir dose to 400 mg does not compensate for the effects of omeprazol on Atazanavir contact concentration. Simultaneous use Omeprazol (20 mg once a day) with Atazanavir 400 mg/ritonavir 100 mg on healthy volunteers reduces about 30% of Atazanavir contact concentration compared to Atazanavir 300 mg/ritonavir 100 mg once a day.
digoxin
Simultaneous treatment with omeprazol (20 mg/day) and healthy digoxin increases 10% of the bioavailability of digoxin. Rare Digoxin toxicity is reported.
However, caution should be used when using high -dose omeprazol in elderly patients. At that time, it is necessary to increase monitoring the therapeutic effect of Digoxin.
clopidogrel
In a cross -clinical clinical study, Clopidogrel (the next 300 mg load is 75 mg/day) is used single -dose and combined with omeprazol (80 mg oral at the same time as dopidogrel) is used for 5 days.
The contact concentration of the active metabolites of Clopidogrel decreased by 46% (day 1) and 42% (day 5) when clopidogrel and omeprazol are shared. Average inhibition of plateletic (IPA) decreases 47% (24 hours) and 30% (day 5) when Clopidogrel and Omeprazol are shared.
Another study showed that drinking clopidogrel and omeprazol at different hours could not prevent their interaction, which is likely to be dominated by the inhibitory effect of omeprazol on CYP2C19.
This inconsistent data on clinical significance of pharmaceutical force (PK/PD) for important cardiovascular events has been reported in clinical observation and clinical research studies.
Other active ingredients
The absorption of Posaconazole, Erlotinib, Ketoconazole and Itraconazole decreases significantly and therefore can impair clinical effect. For Posaconazol and Erlotinib, it is recommended to be used with omeprazol.
The drugs are metabolized by CYP2C19
Omeprazol is an average inhibitor for CYP2C19, the main metabolic enzyme of omeprazol. Therefore, the metabolism of active ingredients is simultaneously metabolized by CYP2C19 will decrease and the concentration of body contact with these substances will increase. For example, for such drugs are R-Warfarin and other vitamin K antagonists, Cilostazol, Diazepam and Phenytoin.
cilostazol
Omeprazol is used at 40 mg for healthy people in a cross -study, increasing CMAX and AUC of Cilostazol, 18% and 26% respectively, and of its metabolites respectively, respectively, respectively 29% and 69%.
phenytoin
Should monitor the phenytoin concentration in plasma in the first two tuan tuan after starting Omeprazol and, if the phenytoin dose has been adjusted, you should monitor and adjust again at the end of Omeprazol treatment.
Unknown mechanism
saquinavir: Concomitant use of omeprazol with saquinavir/ritonavir increases the concentration of saefinavir in plasma to about 70%, combined with good tolerance in HIV -infected patients.
tacrolimus: simultaneous use of omeprazol increases the concentration of tacrolimus in serum. Tacrolimus concentration should be strengthened as well as kidney function (creatinine clearance), and adjust the dose of tacrolimus if needed.
Methotrexate: When used with proton pump inhibitors, methotrexate levels increase in some patients. When using high doses of methotrexate, it is necessary to consider temporary suspension of Omeprazol.
The effect of other drugs on omeprazol pharmacokinetics
CYP2C10 and CYP3A4 inhibitors
Because omeprazol is metabolized by CYP2C19 and CYP3A4, the active ingredients inhibitors CYP2C19 and CYP3A4 (such as Clarithromycin and Voriconazol) can lead to increased serum omeprazol levels by reducing the speed of Omeprazol metabolism.
Simultaneous treatment with voriconazole increases the concentration of omeprazole exposure more than twice. The high dose of omeprazol is well tolerated so it usually does not need to adjust the dose. However, the dose adjustment should be considered on patients with severe liver failure and when prescribed long -term treatment.
CYP2C19 and/or CYP3A4 induction
CYP2C19 or CYP3A4 touch active ingredients or both (such as Rifampicin and St John Wort) can reduce serum omeprazol levels by increasing the speed of omeprazol metabolism.
Storage
Store at a temperature not exceeding 30 ° C, in the original packaging to avoid moisture.
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