Approval Date:
Date of revision:
Omeprazole Enteric Capsules Instructions
Please read the instruction manual carefully and use under the guidance of a physician
[Drug Name]
Generic Name: Omeprazole Enteric Capsules
English name:Omeprazole Enteric Capsules
Hanyu Pinyin:Aomeilazuo Changrong Jiaonang
[Ingredients]
The main ingredient of this product is: omeprazole.
The chemical name is:5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-dimethyldimethyl span>pyridinyl)methyl]thiocarbonyl]-1H-benzimidazole
Chemical structure formula:
Molecular Formula:C17H19N3O3S
Molecular weight:345.42
[Properties] The contents of this product are white or off-white enteric granules.
[Application
Applicable
See ]
For gastric ulcers, duodenal ulcers, gastroesophageal reflux disease and Zhuo. span style=”font-family:Times New Roman”>-Elder’s syndrome (gastrinoma).
[Specification] 20mg
[Dosage]
To be taken orally, not chewed.
1.Gastric ulcer, duodenal ulcer: once20mg a day1to2times a day. Swallow once daily in the morning or once in the morning and once in the evening. The course of treatment for gastric ulcer is usually 4 to 8weeks, and duodenal ulcers are usually treated for2 to 4 weeks. For patients with milder symptoms, use 10mg or as prescribed by the physician.
2.Gastroesophageal reflux disease: once20mg a day1to2times a day. Swallow once daily in the morning or once in the morning and once in the evening. The duration of treatment is as prescribed by the doctor. After symptoms are controlled, use 10mg or as directed by physician.
3.Zhuo-Elder’s syndrome (gastrinoma): once 60 mg a day1 time, and later daily The total dose can be adjusted to 20mg to 120mg. If the total daily dose needs to exceed80mg, it should be divided into two doses.
Hepatic impairment
Daily dosage for patients with severe hepatic impairment 10mg-20mg.
Renal impairment.
Patients with renal impairment do not require dose adjustment.
[Adverse Reactions]
The most common adverse reactions (occurring in1-10%of patients) were headache, abdominal pain, constipation, diarrhea, flatulence and nausea/vomiting. Gastric mucosal cell hyperplasia and atrophic gastritis can occur in some long-term treatment cases.
Adverse reactions that have been identified or suspected during clinical trials and post-marketing use of omeprazole are listed below. No dose correlation was found. The adverse reactions listed below are classified according to frequency of occurrence and human organ system (SOC). The frequency classification is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), occasionally (≥ 1/1,000,< 1/100), rare (≥ 1/10,000, < 1/1,000), very rare
(< 1/10,000) , unknown frequency (cannot be estimated from available data).
System organ class/frequency Adverse effectsDiseases of the Blood and Lymphatic Systemrare Leukopenia, thrombocytopeniaVery rare
Granulocyte Deficiency, PancytopeniaImmune System Disordersrarehypersensitivity reactions (e.g., fever), angioedema, and tachyphylaxisshockMetabolic and Nutritional DisordersrareHyponatremiaunknown frequencyhypomagnesemia, severe hypomagnesemia may lead to hypocalcemia, and hypomagnesemia may also be associated with hypokalemiaPsychiatric class occasionalInsomniarare rareagitation, blurred consciousness, depressionvery rareAttacks, hallucinationsAll types of neurological disordersCommonHeadache Occasionaldizziness, abnormal sensation, drowsiness
rare Abnormal tasteOcular organ diseaserare Blurred visionEar and Labyrinth Class DiseasesEventually GlareRespiratory, Thoracic and Mediastinal Diseasesrare BronchospasmGastrointestinal Disorders Common abdominal pain, constipation, diarrhea, gastrointestinal bloating, nausea/Vomiting
Gastric fundic gland polyp (benign)Gastric fundic gland polyp (benign)rareDry mouth, oral mucositis, gastrointestinal candidiasisunknown frequencyMicroscopic colitisDiseases of the hepatobiliary systemoccasionalelevated liver enzymesrareHepatitis with or without jaundicevery rareEncephalopathy in patients with liver failure, previous history of liver diseaseDermal and subcutaneous tissue disordersoccasionalDermatitis, pruritus, rash rare Hair loss, photosensitivityvery rareErythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis relaxans(TEN)unknown frequencySubacute cutaneous lupus erythematosusVarious musculoskeletal and connective tissue disordersoccasional Hip, wrist or spine fracturerareJoint pain, myalgiaVery rareMyasthenia gravisKidney and urinary tract disordersrareInterstitial nephritisReproductive and Breast Diseasesvery rareMale Breast DevelopmentSystemic diseases and various reactions at the site of administrationoccasionaldiscomfort, peripheral edemarare Increased sweating
[Contraindicated]
1. Discontinued in persons with known hypersensitivity to omeprazole, other benzimidazoles, or any other component of this product. Hypersensitivity reactions may include tachyphylaxis, anaphylaxis, angioedema, bronchospasm, interstitial nephritis, and urticaria.
2. As with other proton pump inhibitors, omeprazole should not be combined with nelfinavir and rilpivirine.
[Precautions]
1. Gastric malignancy
When a gastric ulcer is suspected or confirmed and alarm symptoms are present(such as significant weight loss, recurrent vomiting, difficulty swallowing, vomiting blood or black stools)when malignancy should be ruled out first.
CompletePPIAdult patients who experience poor remission or early symptom recurrence after treatment, consider additional follow-up and diagnostic testing. In older patients, endoscopy needs to be considered.
The presence of gastric malignancy cannot be ruled out in adult patients whose symptoms are relieved by this treatment.
2. Acute interstitial nephritis
In takingPPI(including this product) in patients with acute interstitial nephritis observed. Acute interstitial nephritis may occur at any time point during PPItreatment and is usually attributed to idiopathic hypersensitivity reactions. If acute interstitial nephritis occurs, discontinue treatment with this product.
3. Clostridium difficile-associated diarrhea
Published observational studies suggest thatPPItreatment (such as this product) may increase Clostridium difficile-associated diarrhea (CDAD) risk, especially in hospitalized patients. This diagnosis should be considered if diarrhea does not improve.
4. Cyanocobalamin (vitamin) B-12) deficiency
Long-term (e.g. more than3years) of daily treatment with certain antacids may result in a decrease or deficiency of gastric acid and cause cyanocobalamin (vitamin B-12) malabsorption. Rare reports of cyanocobalamin deficiency in acid suppression therapy have been reported in the reference literature. This diagnosis should be considered if clinical signs consistent with cyanocobalamin deficiency are observed in patients treated with this product.
5. combined clopidogrel
The combination of this product and clopidogrel should be avoided. Clopidogrel is a precursor drug. The platelet agglutination inhibition produced by clopidogrel can be attributed solely to its active metabolite. Combined use of drugs that inhibit CYP2C19 activity (e.g., omeprazole) can impair the metabolism of clopidogrel into its active metabolite. Combined use of clopidogrel and 80 mgomeprazole decreases the pharmacological activity of clopidogrel, even if the two are spaced12hours between doses. Therefore, other antiplatelet therapy should be considered when using this product.
6. Combination with St. John’s wort or rifampin
inductionCYP2C19 orCYP3A4 drugs (such as St. John’s wort or rifampin) May significantly reduce omeprazole blood levels (see [Drug Interactions]). This product should be avoided in combination with St. John’s wort or rifampin.
7. Combination of methotrexate
The literature suggests thatPPIand methotrexate (mainly at high doses) combined may increase the risk of methotrexate and/ family:isoline”>or its metabolites in serum concentrations and prolong the duration of high serum concentrations, which may lead to methotrexate toxicity. Temporary discontinuation of PPI may be considered in some patients on high doses of methotrexate.
8. Co-administration of atazanavir
Co-administration of proton pump inhibitors with atazanavir is not recommended. If combination use is unavoidable, close clinical monitoring (e.g., viral load) is recommended, along with increasing the dose of atazanavir to 400 mg, add100mg of ritonavir and the omeprazole dose should not exceed20mg.
9. Low magnesiumemia
In patients receivingPPItreatment for at least3months(Most treatments1 years after treatment), rare cases of asymptomatic and symptomatic hypomagnesemia have been reported in patients with 1. blood reported in cases of hypomagnesemia. Serious adverse events included hand and foot twitching, cardiac arrhythmias, and seizures. For most patients, correction of hypomagnesemia requires magnesium supplementation and discontinuation of PPI.
Expected need to extendPPItreatment or with comorbid medications such as digoxin or medications that may cause hypomagnesemia(such as diuretics), regular monitoring of blood magnesium concentration needs to be considered.
10. Fracture. span style=”font-family:Times New Roman”>
Several published observational studies have shown that proton pump inhibitors (PPI) treatment may put people at increased risk of fractures in the hip, wrist, or spine due to osteoporosis. For patients receiving high-dose therapy (defined as multiple daily doses) and long-termPPI therapy (1year or longer) patients are at increased risk of fracture. Patients should be treated with the lowest dose and shortest course of PPI appropriate for the treatment situation. Patients who are at risk for osteoporosis-related fractures should be treated according to existing guidelines.
11. Skin and systemic lupus erythematosus
In takingPPI(including this product) in patients with pre-existing cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) were reported, whereCLE thanSLEis more common. Such events are both new onset and worsening of existing autoimmune disease. The most common type in CLE is subacuteCLE (SCLE), often occurring weeks to years after continuous drug therapy, with an onset population ranging from infants to elderly patients. In general, histologic findings are observed without organ involvement.
PPIRelatedSLEis usually more severe than non-drug-inducedSLE. Roman”>SLEis less severe than non-drug-induced. SLE episodes usually occur within days to years after starting treatment, and occur mainly in young to elderly patients. Most patients present with only a rash, but arthralgia and hemocytopenia have been reported.
PPI should be avoidedclass of drugs longer than clinically necessary if observed in patients treated with this product consistent withCLEorSLE signs or symptoms, discontinue the drug and refer the patient to the appropriate specialist for evaluation . PPISingle drug discontinuation4to12weeks. Most patients will have improved symptoms. Elevated serologic findings may take longer to resolve than the clinical presentation.
12. Interaction with diagnostic tests for neuroendocrine tumors Interactions
Serum chromograninA (CgA)levels can be elevated secondary to drug-induced lowering of gastric acid. Elevated CgA levels can lead to false-positive diagnostic tests for neuroendocrine tumors. Healthcare professionals should withhold omeprazole until bloodCgAlevels are evaluated for at least family:Times New Roman”>14days if the initial assayCgAlevels are elevated, a retest of this indicator should be considered. As normal reference values may vary from laboratory to laboratory, a series of tests(such as monitoring), it should be performed in the same laboratory.
13. This product contains lactose. If you have galactose intolerance, Lapplactase deficiency or glucose-galactose malabsorption and other rare genetic disorders should not take this product. –
14. For patients who have been taking this product for a long time In particular, those who use 1year or more should be monitored regularly.
15. Treatment with proton pump inhibitors may lead to a slightly increased risk of gastrointestinal infections (e.g., Salmonella and Campylobacter).
16. This product is an enteric capsule. When taking it, be careful not to chew it to avoid premature release of the drug in the stomach and affect its efficacy.
17. Effect on driving and mechanical ability Effects on driving and mechanical handling: This product basically does not affect driving or mechanical handling ability. Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machinery.
[For pregnant and lactating women]
Pregnant women: There are no adequate and well-controlled controlled studies of this product in pregnant women. The available epidemiologic data fail to demonstrate that omeprazole use in early pregnancy increases the risk of significant congenital teratogenicity or leads to other adverse pregnancy outcomes. Because of the effects of high-dose esomeprazole magnesium on the developing skeleton observed in rat studies, it should be used during pregnancy only if the potential benefit to the fetus outweighs the potential risk.
Lactation: Omeprazole can be secreted into breast milk, but there are no clinical data on the effect of omeprazole on breastfed infants or on lactation. The clinical need of the mother for this product and the potential adverse effects of this product or the underlying maternal disease on the breastfed infant should be weighed against the development and health of the infant while considering breastfeeding, and this product should be used only if the benefit outweighs the potential risk.
[Pediatric Use]
No domestic trials have been conducted and no reliable references are available.
[Geriatric use]
No dose adjustment is required in elderly patients.
[Drug Interactions]
1. Omeprazole’s effect on Effect of other active substances on pharmacokinetics
(1)pHdependent absorption of active substances:
During omeprazole treatment, a decrease in gastric acid may promote or inhibit the presentation of gastricpHdependent absorption of the active substance.
Nelfinavir, atazanavir:
The blood levels of nelfinavir and atazanavir are reduced when combined with omeprazole.
The combination of omeprazole and nelfinavir is contraindicated. Co-administration of omeprazole (40 mgonce daily) reduced mean nelfinavir exposure by approximately40%, pharmacologically active metaboliteM8 The average exposure to M8 decreases by approximately75%-90%. Interactions may also include inhibition of CYP2C19.
Co-administration of omeprazole and atazanavir is not recommended. In healthy volunteers, the combination of omeprazole (40 mg once daily) and atazanavir =”font-family:Times New Roman”>300mg/ritonavir100mg. span>reduces atazanavir exposure by 75%. An increase in atazanavir dose to 400 mg did not compensate for the effect of omeprazole on atazanavir exposure. In healthy volunteers, the same effect as with atazanavir300 mg/ritonavir100mg (once daily) compared with co-administration of omeprazole (20mg once daily) and atazanavir400mg/Ritonavir100mg, reducing atazanavir exposure by approximately30%.
Digoxin:
Healthy subjects taking concomitant omeprazole (20 mgonce daily) with digoxin resulted in an increase in digoxin bioavailability10%. Digoxin toxicity has rarely been reported. However, caution should be exercised when high doses of omeprazole are given to elderly patients. If a combination is necessary, therapeutic drug monitoring of digoxin should be intensified.
Clopidogrel:
Studies in healthy subjects have shown that clopidogrel (300 mgload dose/75 mgdaily maintenance dose) and omeprazole (daily80 mgorally) between the pharmacokinetics (PK)/ pharmacodynamic (PD) interactions, resulting in clopidogrel activity metabolite exposure decreased by an average of 46% and resulted in a maximal inhibition of platelet aggregation (ADPinduced) decreased on average16% .
About Omeprazole and ClopidogrelPK/PD interactions in major cardiovascular events, inconsistent data have been reported from both observational and clinical studies. Concomitant use of omeprazole and clopidogrel should be avoided.
Other drugs:
In combination with omeprazole, the absorption of posaconazole, erlotinib, ketoconazole, and itraconazole is significantly reduced, which may affect their clinical efficacy. The combination of posaconazole and erlotinib with this product should be avoided.
(2) Active substances metabolized byCYP2C19:
Omeprazole is a moderately potent CYP2C19inhibitor, CYP2C19is the major metabolizing enzyme of omeprazole. Therefore, the combination of active substances also metabolized via CYP2C19 decreases their metabolism, which in turn increases systemic exposure to these substances. Such drugs includeR-warfarin and other vitaminsK antagonists, cilostazol, diazepam, and phenytoin.
Cilostazol:
In a crossover study, healthy subjects received40 mg40 mgdose of omeprazole, resulting in a CmaxandAUCincreased respectively by family:Times New Roman”>18% and 26%, with one active metabolite increasing by 29% and 69%.
Phenytoin:
Phenytoin blood levels are recommended to be monitored during the first two weeks after initiation of omeprazole therapy, and if phenytoin dose adjustment is performed, it should be monitored after the end of omeprazole therapy and further dose adjustment.
(3)Unknown mechanism
Saquinavir:
Omeprazole with saquinavir/Ritonavir combination resulted in an increase in saquinavir blood levels of approximately70%, which correlates with good tolerability in patients withHIV infection.
Tacrolimus:
Co-administration of omeprazole can elevate tacrolimus blood levels. Monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be intensified, and the tacrolimus dose adjusted if necessary.
Methotrexate:
Increased methotrexate levels have been reported in some patients when combined with proton pump inhibitors. Temporary discontinuation of omeprazole may be considered when high doses of methotrexate are administered.
2. Other active substances on omeprazole pharmacokinetics kinetics
(1)CYP2C19and =”font-family:Times New Roman”>/orCYP3A4Inhibitors:
Since omeprazole is inhibited by CYP2C19andCYP3A4metabolism, which is known to inhibit CYP2C19or orCYP3A4 active drugs (e.g., clarithromycin and voriconazole) may decrease the metabolic rate of omeprazole, which in turn may lead to increased omeprazole blood levels. The combination of voriconazole may at least double the exposure to omeprazole. Because high doses of omeprazole are well tolerated, no adjustment of omeprazole dose is generally necessary. However, in patients with severe hepatic impairment, dose adjustment should be considered if long-term therapy is required.
(2)CYP2C19and =”font-family:Times New Roman”>/orCYP3A4Inducer:
known to induceCYP2C19and/orCYP3A4 active drugs (such as rifampin and St. John’s wort) can increase the rate of omeprazole metabolism, which in turn leads to a decrease in omeprazole blood levels.
[Drug overdose]
There is limited information on the effects of omeprazole overdose in humans. Doses as high as560 mg have been reported in the literature, with occasional single oral doses up to2400mg (this dose is 120 of the clinically routinely recommended dosage) span>fold) has been reported. Clinical manifestations of omeprazole overdose are highly variable and include nausea, vomiting, dizziness, abdominal pain, diarrhea, headache, apathy, depression, confusion, drowsiness, blurred vision, tachycardia, sweating, flushing, and dry mouth.
The symptoms described were all transient, and no cases of serious clinical outcome were reported. With increasing dose, clearance(level 1 pharmacokinetics) remains unchanged. There is no known specific antidote for omeprazole overdose. Because omeprazole is extensively bound to plasma proteins in the body, an overdose of omeprazole is not readily cleared by dialysis. If an overdose occurs, symptomatic treatment and supportive therapy should be given.
[Pharmacologic Toxicology]
Pharmacological effects
Omeprazole is a benzimidazole compound that specifically inhibits gastric lining cells byH+-K+ ATPenzyme system and blocking the final step of gastric acid secretion. The effect is dose-dependent and results in inhibition of both basal gastric acid secretion and gastric acid secretion in the stimulated state.
Microbiology
Omeprazole in diphasic combination with clarithromycin, or omeprazole, clarithromycin and amoxicillin in triple combination, is effective in most strains of H. pylori in in vitro trials as well as in clinical settings.
Toxicological studies
Genotoxicity:
OmeprazoleAmesassay, mouse lymphoma cell assay and rat liverDNAdamage Negative results in the in vitro human lymphocyte chromosome aberration assay, 2mice micronucleus assays in the =”font-family:Times New Roman”>1times and in vivo mouse bone marrow cell chromosome test results were positive.
Reproductive toxicity:
Rats given orally omeprazole138 mg/ kg/day (approximately the human oral dose based on body surface area40 mg of 34fold), no significant abnormalities in fertility or reproductive behavior were observed.
Pregnant rats given orally omeprazole 138 mg/kg/day (approximately the human oral dose based on body surface area40 mgof34fold), given orally to pregnant rabbits69 mg/kg/day (approximately the human oral dose based on body surface area40 mg of 34 times), omeprazole was not found to have potential teratogenic effects.
Rabbits were given omeprazole6.9-69.1 mg/kg/day (approximately the human oral dose based on body surface area40 mgof3.4-34fold), dose-dependent elevated rates of embryonic death, fetal resorption, and abortion were seen.
Parental rats given omeprazole13.8- 138.0 mg/kg/day (approximately the human oral dose based on body surface area40 mg) = “font-family:isoline”> of 3.4-34fold), with dose-dependent embryos visible in the offspring/ fetotoxicity and postnatal developmental toxicity.
Carcinogenicity:
Two in rats2year carcinogenicity tests in rats with omeprazole doses of1.7,,3.4, 13.8,44.0and span>140.8mg/kg/day (approximately the human oral dose based on body surface area40 mg of0.4-34fold), with dose-dependent appearance of gastrointestinal chromophobic (ECL) cell carcinoids; in which the incidence was significantly higher in females than in males, and the blood concentration of omeprazole was higher in females than in males. Gastric carcinoid tumors were rarely seen in unadministered animals, while ECL cell proliferation was seen in both female and male administered groups.
In another experiment, female rats were continuously1yearly administration of omeprazole13.8 mg/kg/day (based on body surface area, approximately the human oral dose40 mg of3.4times), after which the drug was discontinued1year, no carcinoids were seen to arise. However, in rats administered 1year, drug-relatedECLcell proliferation (94% in the drug administration group, control group10%), the difference between the dosing group and the control group narrowed at the second year, but the difference between the dosing group The incidence of ECL cell hyperplasia was still higher in the administered group (46%/26%). 1 rat (2%) developed gastric adenocarcinoma, while at dosing2Not seen in both male and female rats at age. From historical data, no similar tumors have been documented in rats of this species genus, and since only one case has occurred, its significance is difficult to judge.
In aSD rat 52week toxicity test with omeprazole at a dose of0.40.4,2,16 mg/kg/day (approximately the human oral dose based on body surface area40 mgof0.1-3.9fold), a small number of brain astrocytomas in males, and no occurrence in females. In SDrats2year carcinogenicity test, the highest dose140.8 mg/kg/day (based on body surface area, which is approximately the human oral dose40 mg of34fold), and no astrocytomas were seen in both males and females.
Omeprazole mice78week carcinogenicity test did not show an increase in tumor incidence, but the results of this test were inconclusive. p53 (+/-)Transgenic mice26week negative carcinogenicity test results.
Juvenile animal test:
Young rats were given esomeprazole magnesium at a dose of70-280 mg/kg/day (approximately the human oral dose based on body surface area40 mgof17-68fold), from the first7days to35day continuous dosing28days, recovery period14days. The results showed an increase in the number of dead animals in the highest dose group. In addition, 140 mg/kg/day (approximately the human oral dose based on body surface area40 mg of34fold) and higher doses, a reduction in body weight and weight gain, reduction in femur weight and length, and an effect on overall growth were seen in animals.
Similar results were seen with esomeprazole strontium at equimolar doses in the above trials.
[Pharmacokinetics]
1. Absorption
Omeprazole and omeprazole magnesium are not acid-resistant and are therefore administered orally as enteric-coated pellets in capsules or tablets. Omeprazole is rapidly absorbed, with peak blood concentrations observed approximately 1-2hours after administration. Omeprazole is absorbed in the small intestine and is usually completely absorbed within 3-6hours. Simultaneous ingestion of food has no effect on its bioavailability. The systemic availability (bioavailability) of a single oral dose of omeprazole is approximately 40%. Bioavailability increased to approximately 60% after once-daily repeat dosing.
2. Distribution
The apparent volume of distribution in healthy subjects is approximately 0.3 l/kgbody weight. Omeprazole plasma protein binding rate 97%.
3. Biotransformation
Omeprazole is entirely composed of cytochromeP450P450 /span>system (CYP) for metabolism. The major part of its metabolism depends on the polymorphic expression of CYP2C19, which is responsible for the formation of the major metabolite hydroxy omeprazole in plasma. The remainder depends on another specific isoformCYP3A4, which is responsible for the production of omeprazole sulfone. Due to the high affinity of omeprazole with CYP2C19, its association with CYP2C19with other substrates with the potential for competitive inhibition and drug interactions. However, due to the low affinity for CYP3A4, omeprazole does not potentially inhibit other “font-family:Times New Roman”>CYP3A4substrate metabolism. In addition, omeprazole has no inhibitory effect on the major CYPenzyme.
Approximately3%of the Caucasian population and15%-20%of the Asian population lack functional span>CYP2C19enzyme and are referred to as slow metabolizers. In such individuals, the metabolism of omeprazole is likely to be catalyzed primarily by CYP3A4. The mean 20 mgdose of omeprazole after once-daily repeated dosing in slow metabolizersAUC than those with functionalCYP2C19enzyme (fast metabolizer) than subjects with functional5-10fold. The mean peak blood levels were also as high as3toto5fold. The above results have no impact on the dose selection of omeprazole.
4. Excretion
The plasma elimination half-life of omeprazole after single and once-daily repeated dosing is usually shorter than1hour. Omeprazole was completely eliminated from plasma at different doses with no tendency to accumulate during once-daily dosing. Almost80% of the oral dose of omeprazole was excreted as metabolites in the urine, with the remainder excreted from the feces after secretion by bile.
5. Linear/Nonlinear
Omeprazole’sAUCincreased with repeated dosing. This increase is dose-dependent, with a non-linear relationship in dose-AUC after repeated dosing. The above time and dose dependence is likely due to the effect of omeprazole and/ or its sulfone metabolite (e.g., sulfone) onCYP2C19enzyme inhibition resulting in reduced first pass elimination and systemic clearance. No metabolite was found to have any effect on gastric acid secretion.
[Storage]
Store in a dry place under shade and seal.
[Packaging]
Orally administered solid medication in high-density polyethylene bottles. Each bottle14 capsules, each box1bottle.
[Expiration date] 24months
[Executive Standard]
[Approval number]State Drug Certificate[Approval number]State Drug CertificateH10950086
[Manufacturer]
Company name: Changzhou Siyapharm Pharmaceutical Co.
Manufacturing Address: Zhongwu Avenue, Changzhou City, Jiangsu Province 567No.
Postal Code:213018
Phone Number:800-8284141
(0519)) span style=”font-family:Times New Roman”>88804418
Fax Number: (0519)88825678
Web
at www. czsiyao-pharm.com