Nexium mups 20mg Astrazeneca tablets treat gastroesophageal reflux - esophagus, gastric ulcer (2 blisters x 7 tablets)

Dosage form Box of 2 blisters x 7 tablets
Specifications Esomeprazol

Ingredient

Composition information	Content
Esomeprazol	20mg

Uses

Indications

Nexium mups 20mg is indicated in the following cases:

Adults

Gastroesophageal reflux disease (GERD)

Treatment of esophageal scratches due to reflux. Pylori.

Heals stomach ulcers due to NSAID. 12 years and older

Gastroesophageal reflux disease (GERD)

Treatment of esophageal scratches due to reflux.

Long -term treatment for patients with healed esophagitis to prevent recurrence.

Treatment of symptoms of gastroesophageal reflux disease (GERD).

Combined with antibiotics in the treatment of duodenal ulcer caused by Helicobacter pylori.

Pharmacokological

Esomeprazole is the isomorphic form S - Omeprazole and reduces the secretion of stomach acid with a specialized mechanism of action. The drug is a specific inhibitor in the acid pump in the cell.

Both forms of isomers R - and S - of omeprazole have similar pharmacological effects.

Location and mechanism of action

Esomeprazole is a weak base, concentrated and transformed into an active form in a high acidic environment in the sub -trailer of the cell's secretion, where H+/K+ - ATPase inhibitors and inhibit both basic fluid and stimulating fluid.

Acting on gastric acid secretion

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.

After 5 days of taking the oral dose of Esomeprazole 20mg and 40mg, the pH in the stomach> 4 has been maintained within an average time of 13 and 17 hours in 24 hours in patients with symptomatic gastroesophageal reflux. The proportion 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 plasma, people have proven to have the relationship between acid secretion and drug concentration and contact time.

The therapeutic effect of acid inhibition

When using Esomeprazole 40mg, about 78% of patients with esophagitis due to reflux are healed after 4 weeks and about 93% are healed after 8 weeks.

Esomeprazole treatment 20mg, 2 times/day and appropriate antibiotics for 1 week have eradicated Helicobacter Pylori successfully in about 90% of patients. After treatment for 1 week, no additional anti -acid anti -acid medications to heal ulcers and reduce symptoms in patients with uncomplicated duodenal ulcer.

In a random, double -blind, follower of a place of placebo, the patient has diagnosed the gastrointestinal bleeding through endoscopy according to the classification of Forrest IA, IB, IIA or IIB (accounting for the corresponding rate of 9%, 43%, 38%and 10%) to be randomly treated with Nexium infusion solution (N = 375) or placebo (N = 389).

After endoscopic treatment for hemostasis, the patient is given placebo or 80mg Esomeprazole high -dose intravenous infusion for 30 minutes and followed by continuous intravenous infusion 8mg/hour for 72 hours. After the first 72 hours of treatment, all patients were continued to treat acid secretion with Nexium 40mg oral, opened label for 27 days.

The ratio of hemorrhage occurred within 3 days is 5.9% in the group treated with Nexium compared to the placebo group of 10.3%. On the 30th day after treatment, the ratio of hemorrhage in the Nexium treatment group compared to the placebo is 7.7% compared to 13.6%.

Other effects related to acid inhibition

During treatment with gastric acid -secreting drugs, serum galastin concentration responds to a reduction in gastric acid. CGA concentration also increases due to reduced gastric acid. Increasing CGA levels can interfere with endocrine tumors.

The medical reports show that it is advisable to stop treating with proton pump inhibitors at least 5 days before the CGA quantification. If CGA and Gastrin concentrations do not return to normal after 5 days, should conduct quantitative after 14 days after stopping using Esomeprazole.

Increasing the number of ECL cells is probably due to increased serum gastrin levels that have been recorded in both children and adults when treated with long -term with Esomeprazole. This is considered not clinical significance. After a long period of treatment with antacids of gastric acid secretion has recorded a slight increase in the frequency of the appearance of the gastric gland cyst. These changes are due to the inhibition of gastric acid excretion, which is benign and recovered.

Reducing stomach acid for 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.

In two studies using Ranitidine as a comparative drug, Nexium Mups proves to be better effective to heal stomach ulcers in patients taking NSAIDs, including NSAID drugs selected on COX - 2.

In two control studies with placebo, Nexium Mups shows a better effect in preventing stomach and duodenal ulcers in patients taking NSAID drugs (aged> 60 or previous ulcer), including NSAID selected drugs on COX - 2.

Children

In a study on children with gastroesophageal reflux disease (

pharmacokinetic pharmacokinetics

absorption and distribution

Esomeprazole is easily destroyed in an acidic environment and is taken in the form of grain soluble.

In animals (in vivo), the transition to isomer R is negligible. Esomeprazole 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 40mg and increased to 89% after the dose is repeated once a day. For Esomeprazole 20mg dose, these values correspond to 50% and 68%). The indicator distribution is in a healthy state of about 0.22L/kg of body weight. Esomeprazole binds 97%) to plasma proteins.

Slow food and reduce the absorption of Esomeprazole, although this does not significantly affect the effects of Esomeprazole on gastric acid secretion.

Metabolism and excretion

Esomeprazole is completely metabolized through the Cytochrome P450 (CYP) system. The main part of the Esomeprazole metabolism depends on the morphological CYP2C19 enzyme, forming Esomeprazole hydroxy and desmethyl metabolites. The rest of the metabolic process depends on a different specific substance, CYP3A4, forming Esomeprazole sulphone, the main metabolite in plasma.

The following parameters mainly reflect pharmacokinetics in individuals with CYP2C19 function enzymes, a group of strong metabolic people.

Total plasma clearance is about 17L/hour after 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's pharmacokinetics have been studied at a dose of up to 40mg, 2 times/day. The area under the curve shows the plasma concentration over time (AUC) increases after repeated use of Esomeprazole. This increase depends on the dose and the increase in AUC rise than the dose ratio after the dose is repeated.

The dependence of this time and dosage is due to the early metabolism decrease in the liver and reducing the body clearance is probably due to the inhibition of Esomeprazole's CYP2C19 enzyme or sulphone metabolites. Esomeprazole completely eliminated from plasma between doses without a tendency to accumulate when used 1 time/day.

The main metabolites of Esomeprazole does not affect stomach acid secretion. About 80%, Esomeprazole oral dose is excreted in urine in the form of metabolites, the rest through feces. Less than 1% of constant drugs found in urine.

Special patient groups

about 2.9 ± 1.5% of patients do not have CYP2C19 function enzymes and are called poor metabolic people. In these individuals, the metabolism of Esomeprazole is catalyzed mainly by CYP3A4. After the dose repeated Esomeprazole 40mg, 1 time/day, the average AUC in the metabolic person is about 100% lower than that of patients with CYP2C19 function enzymes (strong metabolic people). The average peak concentration in plasma increased by about 60%. These records do not affect the dose of Esomeprazole.

Esomeprazole's metabolism has not changed significantly in elderly patients (71 - 80 years old). After using the single dose of Esomeprazole 40mg, the average AUC in women is about 30%higher than that of men. There is no difference in AUC between gender after the dose is repeated once a day. These records do not affect the dose of Esomeprazole.

Patients with functional impairment of organs

Esomeprazole metabolism may be impaired in patients with mild to medium liver dysfunction. The metabolic rate decreases in patients with severe liver dysfunction, resulting in double the AUC of Esomeprazole. Therefore, do not overdose up to 20mg in patients with severe liver dysfunction. Esomeprazole or main metabolites do not tend to accumulate when used 1 time/day.

No studies have been conducted in patients with renal function. Because the kidney is responsible for the excretion of Esomeprazole metabolites but is not responsible for the elimination of drugs in a constant form, it is considered that the metabolism of Esomeprazole has not changed in patients with impaired kidney function.

Children

Teenage children 12 - 18 years old.

After using the repeated dose of 20mg and 40mg Esomeprazole, the total concentration and contact time (AUC) and the maximum concentration time in plasma (TMAX) in children 12-18 years old are similar to adults for both doses of Esomeprazole.

Before taking Nexium mups 20mg Astrazeneca tablets treat gastroesophageal reflux - esophagus, gastric ulcer (2 blisters x 7 tablets)

How to use

Nexium mups 20mg orally.

Should swallow the whole ball with the liquid. Do not chew or crush capsules.

For patients with difficulty swallowing, it is possible to disperse the drug in half a glass of water without carbonate. Do not use other liquids because the upholstery helps to dissolve the intestinal tract to be dissolved. Stir until the pill is completely dispersed and disperse the disperse fluid containing this micro -seed immediately or for 30 minutes. Rinse with half a glass of water and drink. Do not chew or crush these micro.

For patients who cannot swallow, the 20mg Nexium Mups medicine can be dispersed in water without carbonate and used through gastric catheter. It is important to carefully check the suitability of the type of syringe and selected catheter.

Dosage

Adults and minors aged 12 and older

Gastroesophageal reflux disease (GERD):

Treatment of esophageal scratches due to reflux: 40mg, 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: 20mg, 1 time/day.

Treatment of symptoms of gastroesophageal reflux disease (gerd): 20mg, 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 20mg, 1 time/day. In adults, the treatment may be used when necessary at a dose of 20mg, 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 eradicate Helicobacter pylori

Healing duodenal ulcer contaminated with Helicobacter pylori: Nexium mups 20mg, amoxicillin 1g and clarithromycin 500mg, all used 2 times/day for 7 days.

Prevention of stomach -duodenal recurrence in patients with ulcerative Helicobacter pylori: Nexium mups 20mg, amoxicillin 1g and clarithromycin 500mg, 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 20mg, 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: 20mg, 1 time/day.

Prolonged treatment after the prevention of re -prevention of hemorrhage due to peptic ulcer with intravenous tract 40mg, 1 time/day for 4 weeks after treatment for re -hemorrhage due to intravenous gastrointestinal ulcers.

Treatment of Zollinger Ellison syndrome: The recommended starting dose is Nexium Mups 40mg, 2 times/day. Then adjust the dose according to the response of each patient and continue treatment when clinically indicated. Clinical data shows that most patients are controlled with Esomeprazole dose of 80 - 160mg/day. When the daily dose is greater than 80mg, it is advisable to use it into 2 times/day.

Adolescents 12 years and older

Treatment of duodenal ulcerative ulcerative ulcerative pylori: When choosing appropriate combination therapy, it is necessary to consider the official instructions of the nation, region and localities about bacterial resistance, treatment time (usually 7 days but sometimes 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 week. Age

Regarding the dosage for patients from 1 to 11 years old, please refer to the user manual ofNium MUPS in the package containing stomach resistant nuggets.

Person of kidney function

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 should be careful 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, maximum overdose should not be used for Nexium Mups 20mg.

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 using overdose? The described symptoms related to the use of 280mg dose are symptoms on the gastrointestinal tract and fatigue. Single doses of Esomeprazole 80mg are still safe to use. There is no specific detox. Esomeprazole is strongly connected to plasma proteins and thus not easily fertilized. In case of overdose, symptomatic treatment and use of general support measures.

What to do when forgetting 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 Nexium 20mg, you may experience unwanted effects (ADR).

The most common adverse reactions include: headache, abdominal pain, diarrhea and nausea (including after -sales research). 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 Esomeprazole clinical research programs and monitored after the drug to the market. There is no reaction related to the dose.

Blood disorders and lymphatic systems

Rare: leukopenia, platelet reduction.

Very rare: loss of granulocytes, reducing all blood cells.

immune system disorders

Rare: Hypersensitivity reactions such as fever, angioedema, anaphylaxis/anaphylactic reaction.

Metabolic and nutrition disorders

Less: peripheral edema.

Rarely: Hematrum reduction.

Unknown

Unknown: reducing blood magnesium, severe hypotension may be associated with hypocalcemia. Lose magnesia can also lead to hypotension.

Mental disorders

Less: insomnia.

Rare: agitation, confusion, depression.

Very rare: impatient, hallucinations.

Nervous system disorders

Common: headache.

Less: dizziness, paresthesia, chicken sleep.

Rare: taste disorders.

Eye disorders

Rare: blurred vision.

Disorders of ears and mesmerizing

Less: dizziness.

Respiratory, chest and mediastinum disorders

Rare: Bronchospasm.

Gastrointestinal disorders

Common: abdominal pain, constipation, diarrhea, bloating, nausea/vomiting.

Less: dry mouth.

Rare: stomatitis, gastrointestinal candidiasis.

Unknown: Micro colitis.

Liver disorders

Less: increased liver enzymes.

Rare: Hepatitis has or no jaundice.

Very rare: liver failure, brain disease in patients with liver disease.

Skin and tissue disorders

Uncommon: Dermatitis, itching, rash, urticaria.

Rare: baldness, light sensitivity.

Very rare: Diverse roses, Stevens - Johnson syndrome, toxic epidermal necrosis (ten).

Musculoskeletal and connective tissue disorders

Uncommon: hip, wrist and spine fractures.

Rare: joint pain, muscle pain.

Very rare: weak muscle.

Kidney and urinary disorders

Very rare: interstitial nephritis, in some patients with the accompanying kidney failure.

Reproductive and mammary disorders

Very rare: female mammary glands.

General and local disorders

Rare: Difficult to live, increase sweating.

Instructions on how to handle ADR

When experiencing the side effects of Nexium Mups 20mg, 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

Nexium mups 20mg contraindicated in the following cases:

Hypothesis hypersensitivity to Esomeprazole, Benzimidazole or other ingredients in the formula.

Do not use Esomeprazole simultaneously with Nelfinavir, Atazanavir.

Precautions when used

When there is any alert symptom (such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting or black defecation) and when suspected or stomach ulcers should eliminate malignant diseases because Nexium MUPS 20mg treatment can reduce symptoms and delay diagnosis.

Patients with long -term treatment (especially those who have been treated for more than 1 year) should be monitored regularly.

Patients treated according to the regime when necessary should contact the doctor if there are symptoms that change in characteristics. When prescribing Esomeprazole according to the treatment regime when necessary, it is advisable to consider interaction associated with other drugs due to the concentration of Esomeprazole in plasma that may change.

When prescribing Esomeprazole to eliminate Helicobacter pylori, drug interactions should be considered in the 3 -drug treatment regimen. Clarithromycin is a strong CYP3A4 inhibitor and therefore should consider contraindicated and interact with clarithromycin when taking 3 drugs for patients who are taking other drugs metabolized through CYP3A4 as Cisapride.

This drug contains sucrose. Patients with rare genetic problems such as fructose intolerance, malventia - galactose or lack of sucrase - Visomaltase should not be used. Proton pump inhibitors may increase the risk of gastrointestinal tract infections caused by Salmonella and Campylobacter.

It is not recommended to simultaneously use Esomeprazole with Atazanavir. If the combination of Atazanavir with proton pump inhibitors is inevitable, it is necessary to closely monitor clinically when increasing the dose of Atazanavir to 400mg combined with 100mg of ritonavir, should not use more than 20mg Esomeprazole.

Esomeprazole, as well as other antacids, can reduce the absorption of vitamin B12 (cyanocobalamin) due to reduced or deficient gastric acid. This should be considered in patients with reduced vitamin B12 reserves or have risk factors for reducing vitamin B12 absorption when long -term treatment.

Esomeprazole is CYP2C19 inhibitor. When starting or ending treatment with Esomeprazole, the risk of drug interaction with metabolic drugs should be considered through CYP2C19. There has been an interaction between Clopidogrel and Esomeprazole. It is unclear clinical related relationship of this interaction. As a cautious measure, it is not recommended to simultaneously use Esomeprazole and Clopidogrel.

There have been reports on severe blood magnesium reduction in patients treated with proton pump inhibitors (PPI) such as Esomeprazole for at least 3 months, and in most cases is for 1 year. The severe manifestation of blood magnesium decreased such as fatigue, spasticity, delirium, convulsions, dizziness and ventricular arrhyths may occur but silently started and not concerned. In the majority of patients, blood magnesium reduction is improved after using magnesium therapy instead and stop using PPI.

For patients who need prolonged treatment or patients with simultaneous use of ppi and digoxin or other drugs that can cause blood magnesium (such as diuretics), health workers should consider quantifying blood magnesium levels before starting PPI treatment and periodic monitoring during treatment.

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. 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 risk factors. Patients at risk of osteoporosis should be taken care of under the current clinical instructions and should be added with an appropriate amount of vitamin D and calcium.

Interaction with tests

Increased chromographin A (CGA) concentration can interfere with the detection of endocrine nerve tumors. In order to avoid this intervention, it is recommended to stop treating with Esomeprazole at least 5 days before quantifying CGA.

The ability to drive and operate machinery

Esomeprazole has little influence on driving and operating 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.

Pregnancy

There is no clinical data on the use of Nexium Mups 20mg in pregnant women. When using omeprazole racemic stimulus mixture, a large number of pregnant women use drugs from epidemiological studies proves that the drug does not cause defects or toxicity on the fetus. Esomeprazole studies on animals do not show that the drug has a direct or indirect harmful effect on the development of embryo/fetus. Animal studies with Racemic mixture do not show that there is a direct or indirect effect on pregnancy, birth or postpartum development. Should be cautious when prescribing pregnant women.

Breastfeeding period

It is not known whether esomeprazole is secreted through breast milk or not. There are no studies on breastfeeding women. Therefore, do not use Nexium Mups 20mg during breastfeeding.

Medicinal interaction

Studies on Nexium MUPS 20mg drug interaction only performed in adults.

Esomeprazole's impact on pharmacokinetics of other drugs:

For drug absorption drugs dependent

Reducing stomach acid when treated with Esomeprazole and other PPIs may reduce or increase the absorption of other drugs with a mechanism of absorption dependent on the stomach pH. Like other drugs that reduce other stomach acid, the absorption of drugs such as ketoconazole, iTraconazole and erlotinib may decrease and the absorption of digoxin may increase during treatment with ecomeprazole.

Simultaneous use Omeprazole (20mg/day) and Digoxin in healthy objects that increase the bioavailability of digoxin about 10% (up to 30% in 2 out of 10 research objects). There are rare reports on Digoxin toxicity. However, caution should be used when using high doses of Esomeprazole in elderly patients. Need to increase monitoring treatment with digoxin.

There has been reported that Omeprazole interacts with some protease enzyme inhibitors. It is unclear clinical importance and mechanism of action of the recorded interactions. Increasing stomach pH during treatment with omeprazole can lead to changes in the absorption of enzyme inhibitors. Another possible interactive mechanism is through the inhibition of CYP2C19 enzyme. For Atazanavir and Nelfinavir, the serum concentration has been recorded when used with omeprazole, so it is not recommended to simultaneously use these drugs.

In healthy volunteers, simultaneous use of omeprazole (40mg, 1 time/day) and Atazanavir 300mg/ritonavir 100mg significantly reduces the concentration and time of Atazanavir contact (reducing AUC, CMAX and CMIN by about 75%). Increasing the dose of Atazanavir to 400mg has not compensated for the effects of omeprazole on concentration and time of contact Atazanavir.

Use combined omeprazole (20mg, 1 time/day) with Atazanavir 400mg/Ritonavir 100mg in healthy volunteers reduces about 30% of the concentration and time of Atazanavir contact when compared to the concentration and contact time recorded in the case of using Atazanavir 300mg/Ritonavir 100mg, 1 time/day, without Omeprazole 20mg 1 time/day. Used in combination with omeprazole (40mg, 1 time/day) reduces the average value of AUC, CMAX and CMIN of Nelfinavir by 36 - 39% and decreases about 75 - 92% of the average AUC, CMAX and CMin values of active metabolites with pharmacological effects M8.

For Saquinavir (simultaneously used with ritonavir), increasing serum medication (80-100%) when used simultaneously with omeprazole (40mg, 1 time/day). Treatment with omeprazole 20mg, 1 time/day, does not affect the contact of Darunavir (when used simultaneously with Ritonavir) and Amprenavir (when used simultaneously with Ritonavir).

Treatment with Esomeprazole 20mg, 1 time/day, does not affect the contact of Amprenavir (whether or not to use simultaneously with Ritonavir). Treatment with omeprazole 40mg, 1 time/day, does not affect the contact of Lopinavir (simultaneously used with Ritonavir). Due to the pharmaceutical effects and similar pharmacokinetic properties of Omeprazole and Esomeprazole, it is not recommended to use Esomeprazole simultaneously with Atazanavir and contraindicated using Esomeprazole simultaneously with Nelfinavir.

Metabolic drugs through CYP2C19

Esomeprazole inhibits CYP2C19, the main enzyme metabolizes Esomeprazole. Therefore, when Esomeprazole is used with metabolic drugs with CYP2C19 such as Diazepam, CitalPram, Imipramine, Clomipramine, Phenytoin ..., the concentration of these drugs in plasma can increase and need to decrease the dose. This should be paid special attention when prescribing Esomeprazole according to the treatment regime when necessary. Simultaneous use with Esomeprazole 30mg reduces 45% of Diazepam clearance (a substrate of CYP2C19).

When used simultaneously with Esomeprazole 40mg increases the bottom of the bottom (trough) of phenytoin in plasma in epilepsy patients. Should monitor phenytoin concentration in plasma when starting or stopping treatment with Esomeprazole. Omeprazole (40mg, 1 time/day) increased by 15% cmax and 45% AUCT of Voriconazole (a substrate of CYP2C19).

When using 40mg of Esomeprazole in the same time, people who are being treated with warfarin in a clinical trial have shown that blood clotting time is in an acceptable range. However, after a period of circulation of the drug, there were a very rare number of cases of significant Inr clinical increase when treated simultaneously on the two drugs. The patient should be monitored at the beginning and when the treatment is terminated simultaneously Esomeprazole with Warfarin or other substances of Coumarine.

Omeprazole, as well as Esomeprazole, acts as CYP2C19 inhibitors. In a cross study, Omeprazole used at a dose of 40mg on a healthy object increased CMAX and AUC of Cilostazol, both 18% and 26% and CMAX and AUC of a metabolic metabolites have its activity, both 29% and 69%.

In healthy volunteers, when used with 40mg of Esomeprazole, the area under the curve shows Cisapride concentration in plasma over time (AUC) increased to 32% and the selling time of Cisapride excretion lasted by 31% but the cisapride peak concentration in plasma increased negligible. The QTC range is slightly extended after using individual cisapride, not longer lasting when using Cisapride with Esomeprazole.

Esomeprazole has been proved to have no significant clinical impact on pharmacokinetics of amoxicillin or quinidine.

Short -term studies assess the simultaneous use of Esomeprazole with Naproxen or Rofecoxib has not identified any clinical pharmacokinetics interactions. The results from studies on healthy subjects have shown that pharmacological/pharmaceutical interactions (PK/PD) between clopidogrel (daily dose of 30mg/daily maintenance dose 75mg) and esomeprazole (40mg oral 1 time/day) lead to reduction in exposure to metabolic metabolites of clopidogrel average 40% and reduce the maximum inhibition of platelet. 14%.

In a healthy person study, when using Clopidogrel simultaneously, Esomeprazole 20mg + ASA 81mg, concentration and contact time of Clopidogrel's active metabolites decrease by nearly 40% compared to using clopidogrel. However, the maximum level of platelets inhibitors (caused by ADP) on these objects is the same in the clopidogrel group and Clopidogrel group in combination with (Esomeprazole + ASA).

The inconsistent data on clinical manifestations of pharmacokinetic/pharmaceutical interactions of Esomeprazole on the main cardiovascular events have been reported from clinical observation and research studies. For the purpose of caution, the simultaneous use of clopidogrel is not recommended.

Unknown mechanism

Concomitant use with Esomeprazole has been reported to increase serum concentration of Tacrolimus.

When using simultaneously PPIs, methotrexate levels are reported to increase in some patients. When using methotrexate height, it is recommended to temporarily pause Esomeprazole.

Effect of other drugs on pharmacokinetics of Esomeprazole

Esomeprazole is metabolized by CYP2C19 and CYP3A4. When using Esomeprazole simultaneously with a CYP3A4 inhibitor, Clarithromycin (500mg, 2 times/day) double the area under the curve (AUC) of Esomeprazole. Simultaneous use of Esomeprazole along with an inhibitor of both CYP2C19 and CYP3A4 may increase the concentration and contact time of Esomeprazole. CYP2C19 and CYP3A4 Voriconazole inhibitors increase the AUCT of Omeprazole to 280%.

No need to adjust the Esomeprazole dose regularly in these situations. However, the dose adjustment should be noted in patients with severe hepatic or long -term dedication. CYP2C19 or CYP3A4 induction drugs or both (such as Rifampicin and St. John’s) can cause a decrease in serum Esomeprazole due to an increase in Esomeprazole metabolism.

Storage

Do not store at temperatures above 30 ° C. Store in the original packaging to avoid moisture.

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