Date of approval.
Date of revision.
Omeprazole Enteric Dissolve Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Omeprazole Enteric-coated Tablets
English name: Omeprazole Enteric-coated Tablets
Hanyu Pinyin: Aomeilazuo Changrongpian
Ingredients
The main ingredient of this product is omeprazole.
Chemical Name: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]-thiocarbonyl]-1H-benzimidazole
Chemical structure formula.
Molecular formula: C17H19N3O3S
Molecular weight: 345.42
Properties
This product is an enteric coated tablet, which appears white or off-white after removing the coating.
Indications
It is suitable for gastric ulcer, duodenal ulcer, gastroesophageal reflux disease and Zhuo-El’s syndrome (gastrinoma).
Specification
10mg
Dosage and Administration
Take orally, do not chew.
1. Gastric ulcer, duodenal ulcer: 20mg once, 1~2 times a day. Swallow once a day in the morning or once in the morning and once in the evening. The course of treatment for gastric ulcer is usually 4-8 weeks, and for duodenal ulcer is usually 2-4 weeks. For patients with milder symptoms, 10mg is available or as prescribed by the doctor.
2. Gastroesophageal reflux disease: 20mg once, 1 to 2 times a day. Swallow once a day in the morning or once in the morning and once in the evening. The course of treatment should be as prescribed by the doctor. After the symptoms are controlled, 10mg can be used or as prescribed by the doctor.
3.Zhuo-Ai syndrome (gastrinoma): 60mg once a day, once a day, later the total daily dose can be adjusted to 20mg-120mg according to the condition. if the total daily dose needs to exceed 80mg, it should be divided into two doses.
Hepatic impairment
For severe hepatic impairment, the daily dosage should be 10mg-20mg.
Renal impairment
No dosage adjustment is required for patients with renal impairment.
Adverse reactions]
The most common adverse reactions (occurring in 1-10% of patients) are headache, abdominal pain, constipation, diarrhea, gastric distention and nausea/vomiting. Gastric mucosal cell hyperplasia and atrophic gastritis may occur in some long-term treatment cases.
The following adverse reactions have been identified or suspected during clinical trials and post-marketing use of omeprazole. No dose-related reactions were identified. The adverse reactions listed below are classified according to frequency of occurrence and human organ system (SOC). Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), occasional (≥ 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 Reactions Blood and Lymphatic System Disorders Rare Leukopenia, Thrombocytopenia Very Rare Granulocyte Deficiency, Pancytopenia Immune System Disorders Rare Hypersensitivity Reactions (e.g., fever), Angioedema, and Tachyphylaxis/Shock Metabolic and Nutritional Disorders Rare Hyponatremia Unknown Frequency Hypomagnesemia, Severe Hypomagnesemia May Lead to Hypocalcemia, Hypomagnesemia May also be associated with hypokalemia Psychiatric disorders Occasional insomnia Rare agitation, confusion, depression Very rare aggression, hallucinations Various neurological disorders Common headache Occasional dizziness, sensory abnormalities, drowsiness Rare taste abnormalities Ocular disorders Rare blurred vision Ear and vagal disorders Occasional vertigo Respiratory, thoracic and mediastinal disorders Rare bronchospasm Gastrointestinal disorders Common abdominal pain, constipation, diarrhea, gastrointestinal flatulence, nausea/vomiting
Gastric fundic gland polyps (benign) rare dry mouth, oral mucositis, gastrointestinal candidiasis unknown frequency microscopic colitis hepatobiliary system disorders occasional elevated liver enzymes rare hepatitis with or without jaundice very rare liver failure, encephalopathy in patients with previous history of liver disease skin and subcutaneous tissue disorders occasional dermatitis, pruritus, rash, urticaria rare alopecia, photosensitivity very rare erythema multiforme, Stevens-Johnson Johnson syndrome, toxic epidermolysis bullosa (TEN) unknown frequency subacute cutaneous lupus erythematosus various musculoskeletal and connective tissue disorders occasional hip, wrist, or spine fractures rare arthralgia, myalgia very rare myasthenia gravis renal and urinary disorders rare interstitial nephritis genital and breast disorders very rare male breast development systemic disorders and various reactions at the site of drug administration occasional discomfort, Peripheral edema rare Increased sweating
Contraindications
Known hypersensitivity to omeprazole, other benzimidazoles, or any other component of this product is contraindicated. Hypersensitivity reactions may include tachyphylaxis, anaphylaxis, angioedema, bronchospasm, interstitial nephritis, and urticaria. 2.
2. As with other proton pump inhibitors, omeprazole should not be combined with nelfinavir and rilpivirine.
【Caution】.
1. Malignant tumor of the stomach
When gastric ulcer is suspected or confirmed and alarm symptoms (such as significant weight loss, recurrent vomiting, dysphagia, vomiting of blood or black stool) occur, malignancy should be ruled out first.
Consider additional follow-up and diagnostic testing in adult patients who experience poor remission or recurrence of early symptoms after completion of PPI therapy. In elderly patients, endoscopy needs to be considered.
The presence of gastric malignancy cannot still be ruled out in adult patients who have achieved symptomatic remission with this product.
2. Acute interstitial nephritis
Acute interstitial nephritis has been observed in patients taking PPIs (including this product). Acute interstitial nephritis may occur at any time point during PPI therapy 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 that PPI therapy (such as this product) may increase the risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. If diarrhea does not improve, this diagnosis should be considered.
4. Cyanocobalamin (vitamin B-12) deficiency
Long-term (e.g., more than 3 years) daily treatment with an antacid may result in cyanocobalamin (vitamin B-12) malabsorption due to a decrease or deficiency of gastric acid. Rare reports of cyanocobalamin deficiency with 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 use of 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. The combined use of drugs that inhibit CYP2C19 activity (e.g., omeprazole) can impair the metabolism of clopidogrel into its active metabolite. Coadministration of clopidogrel and 80 mg omeprazole decreases the pharmacologic activity of clopidogrel, even when the two are administered 12 hours apart. Therefore, other antiplatelet therapy should be considered when using this product.
6. Combination of St. John’s wort or rifampin
Drugs that induce CYP2C19 or CYP3A4 (e.g., St. John’s wort or rifampin) can significantly reduce omeprazole blood levels (see [Drug Interactions]). This product should be avoided in combination with St. John’s Wort or rifampin.
7. Combined use of methotrexate
The literature suggests that the combined use of PPIs and methotrexate (primarily at high doses) may increase serum concentrations of methotrexate and/or its metabolites, prolong the duration of high serum concentrations, and may lead to methotrexate toxicity. Temporary discontinuation of PPIs may be considered in some patients on high doses of methotrexate.
8. Combination of atazanavir
The combination 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, adding 100 mg ritonavir, and the omeprazole dose should not exceed 20 mg.
9. Hypomagnesemia
Rare cases of asymptomatic and symptomatic hypomagnesemia have been reported in patients treated with PPI for at least 3 months (the vast majority after 1 year of treatment). Serious adverse events include hand and foot twitching, cardiac arrhythmias, and seizures. For most patients, correction of hypomagnesemia requires magnesium supplementation and discontinuation of the PPI.
Periodic monitoring of magnesium concentrations needs to be considered in anticipation of prolonged PPI therapy or in the presence of comorbid medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics).
10. Fractures
Several published observational studies suggest that treatment with proton pump inhibitors (PPIs) may put people at increased risk for fractures of the hip, wrist, or spine due to osteoporosis. For patients treated with high doses (defined as multiple daily doses) and long-term PPI therapy (1 year or more), there is an increased risk of fracture. Patients should be treated with the lowest dose and shortest course of PPI therapy 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
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including this product, with CLE being more common than SLE. Such events are both new onset and worsening of existing autoimmune disease. The most common type of CLE is subacute CLE (SCLE), which often occurs within weeks to years after continuous drug therapy and develops in a population ranging from infants to elderly patients. In general, histological findings are observed without organ involvement.
The severity of PPI-associated SLE is usually less severe than that of non-drug-induced SLE. episodes of SLE usually occur within days to years after initiation of treatment, and the onset population is predominantly young to elderly patients. Most patients present with only a rash, but arthralgia and hemocytopenia have been reported.
PPI analogs should be avoided for longer than clinically necessary, and if signs or symptoms consistent with CLE or SLE are observed in patients receiving this product, the drug should be discontinued and the patient referred to the appropriate specialist for evaluation. within 4 to 12 weeks of discontinuation of the PPI monotherapy, symptoms improve in most patients. Elevated serologic findings may take longer to resolve compared to the clinical presentation.
12. Interaction with diagnostic tests for neuroendocrine tumors
Serum chromogranin A (CgA) levels may be elevated secondary to a drug-induced decrease in gastric acid, and elevated CgA levels may lead to false-positive diagnostic tests for neuroendocrine tumors. Healthcare professionals should suspend omeprazole use for at least 14 days prior to evaluating blood CgA levels and consider retesting this indicator if the initial test CgA level is elevated. Because normal reference values may vary between laboratories, if a series of tests (e.g., monitoring) is required, they should be performed in the same laboratory.
13. This product contains lactose. Patients with rare genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this product.
14. Patients taking this product for a long period of time, especially those who have been using it for more than 1 year, should be monitored regularly.
15. Treatment with proton pump inhibitors may result in a slightly increased risk of gastrointestinal infections (e.g., Salmonella and Campylobacter).
16. This product is an enteric tablet. Take care not to chew it when taking it to avoid premature release of the drug in the stomach and compromise its efficacy.
17. Effects on driving and mechanical handling ability: 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.
Pregnant women and nursing mothers
Pregnancy: There are no adequate and well-controlled controlled studies of this product implemented in pregnant women. The available epidemiologic data fail to demonstrate that the use of omeprazole 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, this product 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 maternal underlying disease on the breastfed infant should be weighed while considering the development and health of the infant and child by breastfeeding, and this product should be used only if the benefits outweigh the potential risks.
Pediatric Use]
No domestic trials have been conducted and no reliable references are available.
Geriatric use
No dose adjustment is required for elderly patients.
Drug Interactions】 1.
1. Effect of omeprazole on the pharmacokinetics of other active substances
(1) pH-dependent absorption of active substances.
During omeprazole treatment, a decrease in gastric acid may facilitate or inhibit the absorption of active substances that show gastric pH-dependent absorption.
Nelfinavir, atazanavir.
The blood levels of nelfinavir and atazanavir are reduced when used in combination with omeprazole.
Combined use of omeprazole and nelfinavir is prohibited. Co-administration of omeprazole (40 mg once daily) reduces the mean exposure to nelfinavir by approximately 40% and the mean exposure to the pharmacologically active metabolite M8 by approximately 75-90%. Interactions may also include inhibition of CYP2C19.
Combined use of omeprazole and atazanavir is not recommended. In healthy volunteers, the combination of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg resulted in a 75% reduction in atazanavir exposure. An increase in the atazanavir dose to 400 mg did not compensate for the effect of omeprazole on atazanavir exposure. In healthy volunteers, the combination of omeprazole (20 mg once daily) and atazanavir 400 mg/ritonavir 100 mg reduced atazanavir exposure by approximately 30% compared with atazanavir 300 mg/ritonavir 100 mg (once daily).
Digoxin.
Concomitant administration of omeprazole (20 mg once daily) with digoxin in healthy subjects resulted in a 10% increase in digoxin bioavailability. Digoxin toxicity was rarely reported. However, caution should be exercised when high doses of omeprazole are given to elderly patients. If the combination is necessary, therapeutic drug monitoring of digoxin should be intensified.
Clopidogrel.
Results from studies in healthy subjects showed that the pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and omeprazole (80 mg daily orally) resulted in a mean 46% decrease in exposure to the active metabolite of clopidogrel and led to a mean decrease in maximal inhibition of platelet aggregation (ADP induction) of 16%.
Inconsistent data have been reported from both observational and clinical studies regarding the clinical significance of omeprazole and clopidogrel PK/PD interactions in major cardiovascular events. 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 substance metabolized by CYP2C19.
Omeprazole is a moderately potent inhibitor of CYP2C19, which is the main metabolizing enzyme of omeprazole. Therefore, the combination of active substances also metabolized by CYP2C19 decreases their metabolism, which in turn increases the systemic exposure of these substances. Such drugs include R-warfarin and other vitamin K antagonists, cilostazol, diazepam, and phenytoin.
Cilostazol.
In a crossover study, healthy subjects receiving a 40 mg dose of omeprazole increased the Cmax and AUC of cilostazol by 18% and 26%, respectively, and one of the active metabolites by 29% and 69%, respectively.
Phenytoin.
Monitoring of phenytoin blood levels is recommended during the first two weeks after initiation of omeprazole therapy, and if phenytoin dose adjustments are made, they should be monitored and further adjusted after completion of omeprazole therapy.
(3) Unknown mechanism
Saquinavir.
The combination of omeprazole and saquinavir/ritonavir results in an approximately 70% increase in saquinavir blood concentrations associated with good tolerability in HIV-infected patients.
Tacrolimus.
The combination of omeprazole can result in elevated blood concentrations of tacrolimus. Monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be intensified and 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. Effects of other active substances on omeprazole pharmacokinetics
(1) CYP2C19 and/or CYP3A4 inhibitors.
Because omeprazole is metabolized by CYP2C19 and CYP3A4, active agents known to inhibit CYP2C19 or CYP3A4 (e.g., clarithromycin and voriconazole) may reduce the rate of omeprazole metabolism, 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 treatment is required.
(2) CYP2C19 and/or CYP3A4 inducers.
Active drugs known to induce CYP2C19 and/or CYP3A4 (e.g., rifampin and St. John’s wort) can increase the rate of omeprazole metabolism, which in turn can lead to a decrease in omeprazole blood levels.
[Drug overdose].
Information on the effects of omeprazole drug overdose in humans is limited. Doses of up to 560 mg have been reported in the literature, and occasionally single oral doses of up to 2400 mg (which is 120 times the recommended clinical dosage) have 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 case reports of serious clinical outcome were received. Clearance (primary pharmacokinetics) remained constant with increasing dose. There is no known specific antidote for omeprazole overdose. Because omeprazole is extensively bound to plasma proteins in vivo, an overdose of omeprazole is not readily cleared by dialysis. In case of drug overdose, symptomatic and supportive treatment should be given.
Pharmacology and Toxicology]
Pharmacological effects
Omeprazole is a benzimidazole compound that blocks the final step of gastric acid secretion by specifically inhibiting the H+-K+ ATPase system of gastric lining cells. The effect is dose-dependent and inhibits both basal gastric acid secretion and gastric acid secretion in the stimulated state.
Microbiology
Omeprazole in diphasic combination with clarithromycin or triple combination of omeprazole, clarithromycin and amoxicillin is effective against most strains of H. pylori in in vitro tests as well as in clinical practice.
Toxicological studies
Genotoxicity.
Negative results in the omeprazole Ames test, mouse lymphoma cell test and rat liver DNA damage test, positive results in the in vitro human lymphocyte chromosome aberration test, 1 of 2 mouse micronucleus tests and in vivo mouse bone marrow cell chromosome test.
Reproductive toxicity.
No significant abnormalities in fertility or reproductive behavior were observed in rats given orally 138 mg/kg/day of omeprazole (approximately 34 times the human oral dose of 40 mg based on body surface area).
No potential teratogenic effects of omeprazole were found in pregnant rats given orally 138 mg/kg/day (approximately 34 times the human oral dose of 40 mg based on body surface area) and pregnant rabbits given orally 69 mg/kg/day (approximately 34 times the human oral dose of 40 mg based on body surface area).
In rabbits given omeprazole 6.9-69.1 mg/kg/day (approximately 3.4-34 times the human oral dose of 40 mg based on body surface area), dose-dependent increases in embryonic mortality, fetal resorption and abortion rates were seen.
Dose-dependent embryo/fetus toxicity and postnatal developmental toxicity were seen in offspring of parental rats given omeprazole at 13.8-138.0 mg/kg/day (approximately 3.4-34 times the human oral dose of 40 mg on a body surface area basis).
Carcinogenicity.
In two 2-year carcinogenicity tests in rats, omeprazole doses of 1.7, 3.4, 13.8, 44.0, and 140.8 mg/kg/day (approximately 0.4-34 times the human oral dose of 40 mg based on body surface area) resulted in dose-dependent gastrointestinal chromophobic (ECL) cell carcinoids in both males and females; 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, whereas ECL cell hyperplasia was seen in both female and male administered groups.
In another trial, female rats were given omeprazole 13.8 mg/kg/day (approximately 3.4 times the human oral dose of 40 mg based on body surface area) for 1 year, after which the drug was discontinued for 1 year, and no carcinoid tumors were seen to develop. However, drug-related ECL cell hyperplasia occurred in rats at 1 year of administration (94% in the dosed group and 10% in the control group), and the difference between the dosed and control groups narrowed by the second year, although the incidence of ECL cell hyperplasia was still higher in the dosed group (46%/26%). gastric adenocarcinoma developed in one rat (2%) and was not seen in either male or female rats at 2 years of dosing. Historically, no similar tumors have been documented in rats of this species, and since only one case occurred, its significance is difficult to judge. In a 52-week toxicity test in SD rats, omeprazole doses of 0.4, 2, and 16 mg/kg/day (approximately 0.1-3.9 times the human oral dose of 40 mg based on body surface area) resulted in a small number of brain astrocytomas in males, but not in females. In a 2-year carcinogenicity test in SD rats at a maximum dose of 140.8 mg/kg/day (approximately 34 times the human oral dose of 40 mg based on body surface area), astrocytomas were not seen in males or females.
No increase in tumor incidence was seen in the 78-week oncogenicity test in omeprazole mice, but the results of this test were inconclusive. p53 (+/-) transgenic mice had negative results in the 26-week oncogenicity test.
Juvenile animal test.
Juvenile rats were given esomeprazole magnesium at doses of 70-280 mg/kg/day (approximately 17-68 times the human oral dose of 40 mg based on body surface area) for 28 consecutive days from postnatal day 7 to day 35, with a recovery period of 14 days. The results showed an increase in the number of dead animals in the highest dose group. In addition, at 140 mg/kg/day (approximately 34 times the human oral dose of 40 mg based on body surface area) and higher doses, a decrease in body weight and weight gain, a reduction in femur weight and length, and an effect on overall growth were seen.
Similar results were seen with esomeprazole strontium at equimolar doses in the above tests.
Pharmacokinetics
1. Plasma drug concentration
Maximum plasma concentrations of omeprazole 10mg and 20mg were achieved in healthy adults after single oral doses on an empty stomach for about 2 hours. The plasma elimination half-life of omeprazole is usually about 1~2 hours. In healthy adults given 20 mg omeprazole once daily before breakfast for 7 consecutive days, the Cmax and area under the blood concentration curve (AUC) increased approximately 1.4-fold on day 7 compared to day 1.
In addition, 20 mg omeprazole given once daily after breakfast for 14 consecutive days to patients with gastric ulcer (5 patients) and duodenal ulcer (4 patients) showed a significant increase in AUC on day 7 compared to day 1, but no increase in Cmax or AUC was observed on day 14 compared to day 7.
2. Time to onset of action
In patients with gastric ulcer, 20 mg of omeprazole was given orally once daily after breakfast and inhibition of gastric acid secretion was observed 2 to 6 hours after administration.
3. Metabolism
Data from foreign populations show that when omeprazole is administered orally to healthy adults, the major metabolites in plasma are omeprazole sulfone and hydroxy omeprazole, and almost none of these metabolites show gastric acid secretion inhibition. In addition, the results of in vitro tests on human liver microsomes showed that hydroxy and sulfone metabolites were mainly associated with CYP2C19 and CYP3A4, and the metabolic clearance of hydroxy metabolites was four times higher than that of sulfone metabolites. genetic polymorphisms exist in CYP2C19, and carriers of CYP2C19 loss-of-function alleles (PM) account for 13-20% of the Mongolian population (including Japanese) and Caucasian ethnic groups accounted for 3-4%. In PM, the slow metabolism of omeprazole is identical to other proton pump inhibition.
4. Excretion
Data from foreign populations show that when 14C-labeled omeprazole is given, approximately 80% is excreted in the urine and approximately 20% in the feces.
5. Interaction
Data from foreign populations indicate that omeprazole is metabolized in the liver primarily via cytochrome P450 2C19 (CYP2C19) and part of 3A4 (CYP3A4).
In combination with clarithromycin, the Cmax and AUC of omeprazole increased approximately 2-fold. On the other hand, co-administration with amoxicillin hydrate did not affect the plasma kinetics of omeprazole. Diazepam, warfarin (R-warfarin), and phenytoin are also metabolized by CYP2C19. When combined with this product, the clearance of diazepam and phenytoin decreased by 27% and 15%, respectively, and the blood concentration of warfarin increased by 12%.
6. Protein binding rate
96%~98% (ultrafiltration method).
7. Hemodialysis
In chronic dialysis patients, omeprazole 20 mg was given orally once daily and blood concentration was tested. This product cannot be removed by hemodialysis and dialysis has no effect on the pharmacokinetics of this product.
8. Bioequivalence
Omeprazole 20mg tablets x 1 tablet and 10mg tablets x 2 tablets are biologically equivalent.
Storage】Store in a cool and dry place under shade and seal.
Package】Double aluminum packaging. 14 tablets/plate, 28 tablets/box, 56 tablets/box; 18 tablets/plate, 36 tablets/box, 54 tablets/box.
Effective period】18 months
【Execution standard
Approval Number】State Drug Administration H20044871
【Manufacturer】.
Listing license holder: Shandong New Era Pharmaceutical Co.
Registered Address: No. 1, North Outer Ring Road, Feixian, Shandong
Manufacturer: Shandong New Era Pharmaceutical Co.
Production Address: No. 1, North Outer Ring Road, Feixian, Shandong
Postal code: 273400
Telephone number: 0539-8336336 (Sales Department) 5030608 (Quality Assurance Department)
Fax number: 0539-5030900
Web address: www.LUNAN.com.cn