泮托拉唑钠肠溶片说明书
药品名称
• 用法：一次2粒，一日3次，饭后 服用。
• 不良反应：个别患者服药2-3天后， 出现胃部不适感
复方谷氨酰胺肠溶胶囊
规格:0.2g/粒 • 作用：用于急、慢性肠道疾病和 肠道功能紊乱，促进创伤或术后 肠道功能的恢复。 • 用法：一日3次，一次2～3粒， 饭前口服。
天丹通络胶囊
规格:0.4g/粒 • 作用：活血通络，熄风化痰。用于 半身不遂、偏身麻木、口眼歪斜、 语言蹇塞；脑梗死急性期、恢复早 期
• 用法：一次5粒，一日3次。
• 禁 忌：脑出血患者急性期禁用。
优思弗
化学名： 熊去氧胆酸胶囊 规格：250mg/粒 • 作用：固醇性胆囊结石—必须是 X射线能穿透的结石，同时胆囊 收缩功能须正常。 2. 胆汁郁积性 肝病 3. 胆汁反流性胃炎。。
• 用法：按说明书服用。
• 不良反应：胃肠道紊乱、肝胆功 能紊乱。
缬克
化学名：缬沙坦胶囊 规格:40mg/粒
• 作用：原发性高血压
• 用法：每次1-2粒，每日一次。 • 不良反应：头痛、水肿、腹泻、偏 头痛，偶尔可导致转氨酶增加、白 细胞及血小板减少、高血钾等。
银杏酮酯分散片
规格:0.15g/片
• 作用：活血化瘀，通脉舒络。用 于血淤引起的胸痹、眩晕
• 用法：一次一片，一日三次
• 作用：支气管哮喘、喘息性支气 管炎、急性支气管炎、慢性阻塞 性肺部疾病。 • 用法：每日1-2次，每次1片，清 晨及睡前服用。。
• 不良反应：：口干、鼻塞、倦怠、 恶心、胃部不适、肌颤、头痛、 眩晕、耳鸣、皮疹、心律失常、 心悸、面部潮红等、罕见休克、 过敏性症状。
奇曼丁
化学名：盐酸曲马多缓释片 规格:100mg/片 • 作用：用于中度至重度疼痛。 • 用法：每日最高剂量通常不超 过400mg，两次服药的间隔不得 少于8小时 • 不良反应为：过敏反应、低血 压、心动过速、恶心、呕吐、 便秘、头昏、嗜睡、呼吸抑制 等。
注射用泮托拉唑钠
注射用泮托拉唑钠说明书【药品名称】通用名：注射用泮托拉唑钠曾用名：商品名：英文名：Pantoprazole Sodium for Injection汉语拼音：Zhusheyong pantuolazuona本品主要成分为泮托拉唑钠，其化学名称为：5-二氟甲氧基-2-[ (3, 4-二甲氧基-2-吡啶基 ) 甲基 ] 亚硫酰基-1H-苯骈咪唑钠盐一水合物。
其结构式为：分子式：C16H14F2N3NaO4S · H2O分子量：423.38【性状】本品为白色或类白色疏松块或粉末，专用溶媒为无色的澄明液体。
【药理毒理】本品为胃壁细胞质子泵抑制剂，在中性和弱酸性条件下相对稳定，在强酸性条件下迅速活化，其pH依赖的活化特性，使其对H+、K+-ATP酶的作用具有更好的选择性。
本品能特异性地抑制壁细胞顶端膜构成的分泌性微管和胞浆内的管状泡上的H+、K+-ATP酶，引起该酶不可逆性的抑制，从而有效地抑制胃酸的分泌。
由于H+、K+-ATP酶是壁细胞泌酸的最后一个过程，故本品抑酸能力强大。
它不仅能非竞争性抑制促胃液素、组胺、胆碱引起的胃酸分泌，而且能抑制不受胆碱或H2受体阻断剂影响的部分基础胃酸分泌。
本品与其它药物伍用时，具有药物间相互作用小的优点。
本品通过肝细胞内的细胞色素P450酶系的第I系统进行代谢，同时也可以通过第II系统进行代谢。
当与其它通过P450酶系代谢的药物伍用时，本品的代谢途径可以通过第II 酶系统进行，从而不易发生药物代谢酶系的竞争性作用，减少体内药物间的相互作用。
无致突变、致癌和致畸作用。
【药代动力学】本品具有较高的生物利用度，首次口服时即可以达到70%～80%，达峰时间1小时，有效抑酸达24小时。
静脉注射与口服给药的生物利用度比值为1.2。
口服40mg时的t max为2～4小时，C max约为2～3μg/ml，清除半衰期约为1.1小时。
约80%的口服或静注本品的代谢物经尿中排泄，肾功能不全不影响药代动力学，肝功能不全时可延缓清除。
泮托拉唑钠肠溶片治疗老年浅表性胃炎的临床效果观察
泮托拉唑钠肠溶片治疗老年浅表性胃炎的临床效果观察
胃炎是指胃黏膜的炎症性病变，常见症状包括上腹部不适、胃脘疼痛、恶心、呕吐等。
老年人常因胃黏膜萎缩、胃酸分泌功能下降等原因而易患胃炎。
本文旨在观察泮托拉唑钠
肠溶片治疗老年浅表性胃炎的临床效果。
方法：选取2019年6月至2020年6月在我院就诊的80例老年浅表性胃炎患者，将其随机分为治疗组和对照组，每组各40例。
治疗组患者口服泮托拉唑钠肠溶片，每次20mg，每日2次，持续8周；对照组患者口服每日40毫升人工胃液，持续8周。
治疗前、治疗4周和治疗8周，对两组患者进行胃镜检查和评估，记录患者主诉、体征、病理学改变等指标，以评价治疗效果。
结果：治疗4周时，治疗组患者的主诉、体征、胃镜检查结果明显改善，病理学改变
也有所减轻，与对照组相比差异有统计学意义（P<0.05）。
治疗8周时，治疗组患者主诉、体征、胃镜检查结果和病理学改变均比治疗4周时更显著改善，与对照组相比差异有更显
著统计学意义（P<0.01）。
结论：泮托拉唑钠肠溶片治疗老年浅表性胃炎具有显著疗效，在短时间内能改善患者
主诉、体征、胃镜检查结果和病理学改变，且在治疗8周时更具有效性。
该药物不仅能抑
制胃酸分泌，还能促进胃黏膜的修复，有望成为老年胃疾病的重要治疗药物。
泮托拉唑钠缓释片说明书(FDA)
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX.PROTONIX (pantoprazole sodium) delayed-release tablets PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000———————— RECENT MAJOR CHANGES ———————— Indications and Usage, Pediatric (1) 11/2009 Dosage and Administration, Pediatric (2) 11/2009 Contraindications (4) 11/2009 Warnings and Precautions, Bone Fracture (5.4) 0x/2010 ———————— INDICATIONS AND USAGE ———————— PROTONIX is a proton pump inhibitor indicated for the following: ∙Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)∙Maintenance of Healing of Erosive Esophagitis (1.2)∙Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)——————— DOSAGE AND ADMINISTRATION ——————Indication Dose FrequencyShort-Term Treatment of Erosive Esophagitis Associated With GERD (2.1)Adults 40 mg Once Daily for up to 8 wks Children (5 years and older)≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks≥ 40 kg 40 mgMaintenance of Healing of Erosive Esophagitis (2.1)Adults 40 mg Once DailyPathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)Adults 40 mg Twice DailySee full prescribing information for administration instructions—————— DOSAGE FORMS AND STRENGTHS —————— ∙Delayed-Release Tablets, 20 mg and 40 mg (3)∙For Delayed-Release Oral Suspension, 40 mg (3) ————————— CONTRAINDICATIONS ———————— Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)——————— WARNINGS AND PRECAUTIONS —————— ∙Symptomatic response does not preclude presence of gastric malignancy (5.1)∙Atrophic gastritis has been noted with long-term therapy (5.2)∙ Bone FractureLong-term and multiple daily dose PPI therapy may be associatedwith an increased risk for osteoporosis-related fractures of thehip, wrist or spine. (5)————————— ADVERSE REACTIONS ————————— The most frequently occurring adverse reactions are as follows: ∙For adult use (>2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6) ∙For pediatric use (>4%) are URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (6)To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or /medwatch————————— DRUG INTERACTIONS ————————— ∙Do not co-administer with atazanavir or nelfinavir (7.1)∙Concomitant warfarin use may require monitoring (7.2)∙May interfere with the absorption of drugs where gastric pH is important for bioavailability (7.3)∙May produce false-positive urine screen for THC (7.4)See 17 for PATIENT COUNSELING INFORMATION andFDA-approved patient labeling.Revised: 12/2009FULL PRESCRIBING INFORMATION: CONTENTS *1 INDICATIONS AND USAGE1.1 Short-Term Treatment of Erosive Esophagitis Associated WithGastroesophageal Reflux Disease (GERD)1.2 Maintenance of Healing of Erosive Esophagitis1.3 Pathological Hypersecretory Conditions Including Zollinger-EllisonSyndrome2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing Schedule2.2 Administration Instructions3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Concurrent Gastric Malignancy5.2 Atrophic Gastritis5.3 Cyanocobalamin (Vitamin B-12) Deficiency5.4 Bone Fracture5.5 Tumorigenicity5.6 Interference with Urine Screen for THC6 ADVERSE REACTIONS6.1 Clinical Trial Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Interference with Antiretroviral Therapy7.2 Coumarin Anticoagulants7.3 Drugs for Which Gastric pH Can Affect Bioavailability7.4 False Positive Urine Tests for THC* Sections or subsections omitted from the full prescribing information are not listed 8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Gender8.7 Patients with Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics12.4 Pharmacogenomics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal RefluxDisease (GERD)14.2 Long-Term Maintenance of Healing of Erosive Esophagitis14.3 Pathological Hypersecretory Conditions Including Zollinger-EllisonSyndrome16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATIONFULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEPROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.1.2 Maintenance of Healing of Erosive EsophagitisPROTONIX is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing SchedulePROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.Table 1: Recommended Dosing Schedule for PROTONIXIndication Dose FrequencyShort-Term Treatment of Erosive Esophagitis Associated With GERDAdults 40 mg Once daily for up to 8 weeks*Children (5 years and older)≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks≥ 40 kg 40 mgMaintenance of Healing of Erosive EsophagitisAdults 40 mg Once dailyPathological Hypersecretory Conditions Including Zollinger-Ellison SyndromeAdults 40 mg Twice daily*** For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.Table 2: Administration InstructionsFormulation Route Instructions*Delayed-Release TabletsFor Delayed-Release Oral Administered in 1 teaspoonful of applesauce or apple Oral Suspension juice approximately 30 minutes prior to a mealFor Delayed-Release Nasogastric See instructions belowOral Suspension tube* Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed.PROTONIX Delayed-Release TabletsPROTONIX Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIXDelayed-Release Tablets.PROTONIX For Delayed-Release Oral SuspensionPROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation. PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce∙Open packet.∙Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES.∙Take within 10 minutes of preparation.∙Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary.PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice∙Open packet.∙Empty granules into a small cup or teaspoon containing one teaspoon of apple juice.∙Stir for 5 seconds (granules will not dissolve) and swallow immediately.∙To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately.PROTONIX For Delayed-Release Oral Suspension - Nasogastric (NG) Tube or Gastrostomy Tube AdministrationFor patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed-Release Oral Suspension can be given as follows:∙Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger.∙Connect the catheter tip of the syringe to a 16 French (or larger) tube.∙Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing.∙Empty the contents of the packet into the barrel of the syringe.∙ Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the sameamount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe.3 DOSAGE FORMS AND STRENGTHSDelayed-Release Tablets:∙40 mg, yellow oval biconvex tablets imprinted with PROTONIX (brown ink) on one side∙20 mg, yellow oval biconvex tablets imprinted with P20 (brown ink) on one sideFor Delayed-Release Oral Suspension:40 mg, pale yellowish to dark brownish, enteric-coated granules in a unit dose packet4 CONTRAINDICATIONSPROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)] or any substituted benzimidazole.5 WARNINGS AND PRECAUTIONS5.1 Concurrent Gastric MalignancySymptomatic response to therapy with PROTONIX does not preclude the presence of gastric malignancy.5.2 Atrophic GastritisAtrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with PROTONIX, particularly in patients who were H. pylori positive.5.3 Cyanocobalamin (Vitamin B-12) DeficiencyGenerally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.5.4 Bone FractureSeveral published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].5.5 TumorigenicityDue to the chronic nature of GERD, there may be a potential for prolonged administration of PROTONIX. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown [see Nonclinical Toxicology (13.1)].5.6 Interference with Urine Screen for THCSee Drug Interactions (7.4).6 ADVERSE REACTIONSThe adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets are similar.6.1 Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.AdultsSafety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral PROTONIX (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another proton pump inhibitor, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 3.Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at aFrequency of > 2%PROTONIX Comparators Placebo(n=1473) (n=345) (n=82)% %% Headache 12.2 12.8 8.5 Diarrhea 8.8 9.6 4.9 Nausea 7.0 5.2 9.8 Abdominal pain 6.2 4.1 6.1 Vomiting 4.3 3.5 2.4 Flatulence 3.9 2.9 3.7 Dizziness 3.0 2.9 1.2 Arthralgia 2.8 1.4 1.2 Additional adverse reactions that were reported for PROTONIX in clinical trials with a frequency of ≤ 2% are listed below by body system:Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema Gastrointestinal: constipation, dry mouth, hepatitisHematologic: leukopenia, thrombocytopeniaMetabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevatedMusculoskeletal: myalgiaNervous: depression, vertigoSkin and Appendages: urticaria, rash, pruritusSpecial Senses: blurred visionPediatric PatientsSafety of PROTONIX in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials. Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to PROTONIX are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.For safety information in patients less than 1 year of age see Use in Specific Populations (8.4). Additional adverse reactions that were reported for PROTONIX in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system:Body as a Whole: allergic reaction, facial edemaGastrointestinal: constipation, flatulence, nauseaMetabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase)Musculoskeletal: arthralgia, myalgiaNervous: dizziness, vertigoSkin and Appendages: urticariaThe following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision.Zollinger-Ellison SyndromeIn clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking PROTONIX 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during postapproval use of PROTONIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.These adverse reactions are listed below by body system:Immune System Disorders: anaphylaxis (including anaphylactic shock)Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal), and angioedema (Quincke’s edema)Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis, bone fractureRenal and Urinary Disorders: interstitial nephritisHepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure Psychiatric Disorders: hallucination, confusion7 DRUG INTERACTIONS7.1 Interference with Antiretroviral TherapyConcomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended. Coadministration of atazanavir or nelfinavir with proton pump inhibitors is expected to substantially decrease atazanavir or nelfinavir plasma concentrations and may result in a loss of therapeutic effect and development of drug resistance.7.2 Coumarin AnticoagulantsThere have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including PROTONIX, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.7.3 Drugs for Which Gastric pH Can Affect BioavailabilityPantoprazole causes long-lasting inhibition of gastric acid secretion. Therefore, pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g., ketoconazole, ampicillin esters, and iron salts).7.4 False Positive Urine Tests for THCThere have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving proton pump inhibitors. An alternative confirmatory method should be considered to verify positive results.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyTeratogenic EffectsPregnancy Category BReproduction studies have been performed in rats at oral doses up to 88 times the recommended human dose and in rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology (13.2)]. 8.3 Nursing MothersPantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.8.4 Pediatric UseThe safety and effectiveness of PROTONIX for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available. Therefore, PROTONIX is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of PROTONIX for pediatric uses other than EE have not been established.1 year through 16 years of ageUse of PROTONIX in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of PROTONIX for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies (14.1), and Clinical Pharmacology (12.3)].Safety of PROTONIX in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel-treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 yearto 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of PROTONIX (approximating 0.6 mg/kg or 1.2 mg/kg). All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with a range of doses of PROTONIX once daily for 8 weeks. For safety findings see Adverse Reactions (6.1). Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of PROTONIX for symptomatic GERD in the pediatric population. The effectiveness of PROTONIX for treating symptomatic GERD in pediatric patients has not been established. Although the data from the clinical trials support use of PROTONIX for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration (2)].In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of 2.4 L/h. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. The estimated AUC for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean AUC value of 6.8 µg•hr/mL. Neonates to less than one year of agePROTONIX was not found to be effective in a multicenter, randomized, double-blind, placebo-controlled, treatment-withdrawal study of 129 pediatric patients 1 through 11 months of age. Patients were enrolled if they had symptomatic GERD based on medical history and had not responded to non-pharmacologic interventions for GERD for two weeks. Patients received PROTONIX daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive PROTONIX treatment or placebo for the subsequent four weeks in a double-blind manner. Efficacy was assessed by observing the time from randomization to study discontinuation due to symptom worsening during the four-week treatment-withdrawal phase. There was no statistically significant difference between PROTONIX and placebo in the rate of discontinuation.In this trial, the adverse reactions that were reported more commonly (difference of ≥ 4%) in the treated population compared to the placebo population were elevated CK, otitis media, rhinitis, and laryngitis.In a population pharmacokinetic analysis, the systemic exposure was higher in patients less than 1 year of age with GERD compared to adults who received a single 40 mg dose (geometric mean AUC was 103% higher in preterm infants and neonates receiving single dose of 2.5 mg of PROTONIX, and 23% higher in infants 1 through 11 months of age receiving a single dose of approximately 1.2 mg/kg). In these patients, the apparent clearance (CL/F) increased with age (median clearance: 0.6 L/hr, range: 0.03 to 3.2 L/hr).These doses resulted in pharmacodynamic effects on gastric but not esophageal pH. Following once daily dosing of 2.5 mg of PROTONIX in preterm infants and neonates, there was an increase in the mean gastric pH (from 4.3 at baseline to 5.2 at steady-state) and in the mean % time that gastric pH was > 4 (from 60% at baseline to 80% at steady-state). Following once daily dosing of approximately 1.2 mg/kg of PROTONIX in infants 1 through 11 months of age, there was an increase in the mean gastric pH (from 3.1 at baseline to 4.2 at steady-state) and in the mean % time that gastric pH was > 4 (from 32% at baseline to 60% at steady-state). However, no significant changes were observed in mean intraesophageal pH or % time that esophageal pH was < 4 in either age group.Because PROTONIX was not shown to be effective in the randomized, placebo-controlled study in this age group, the use of PROTONIX for treatment of symptomatic GERD in infants less than 1 year of age is not indicated.8.5 Geriatric UseIn short-term US clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with PROTONIX were similar to those found in patients under the age of 65. The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.8.6 GenderErosive esophagitis healing rates in the 221 women treated with PROTONIX Delayed-Release Tablets in US clinical trials were similar to those found in men. In the 122 women treatedlong-term with PROTONIX 40 mg or 20 mg, healing was maintained at a rate similar to that in men. The incidence rates of adverse reactions were also similar for men and women.8.7 Patients with Hepatic ImpairmentDoses higher than 40 mg/day have not been studied in patients with hepatic impairment [see Clinical Pharmacology (12.3)].10 OVERDOSAGEExperience in patients taking very high doses of PROTONIX (> 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of PROTONIX.Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.11 DESCRIPTIONThe active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.PROTONIX (pantoprazole sodium) is supplied as a for delayed-release oral suspension, available in one strength (40 mg), and as a delayed-release tablet, available in two strengths (20 mg and 40 mg).Each PROTONIX (pantoprazole sodium) Delayed-Release Tablet contains 45.1 mg or22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension, 40 mg, contains the active ingredient pantoprazole sodium sesquihydrate in the form of enteric-coated granules in unit dose packets. Each unit dose packet contains enteric-coated granules containing 45.1 mg pantoprazole sodium sesquihydrate (equivalent to 40 mg of pantoprazole) with the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.。
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来源快易捷医药网
【药品名称】
泮托拉唑钠肠溶片
【英文名】
Pantoprazole Sodium Enteric-Coated Tablets
【汉语拼音】
Pantuolazuona Changrongpian
【主要成分】
本品主要成份为泮托拉唑钠，其化学名称为5-二氟甲氧基-2-[[(3，4-二甲氧基-2-吡啶基)甲基]-亚磺酰基]-1H-苯并咪唑钠一水合物。
【化学结构式】
【分子式】
C16H14F2N3O4SNa·H2O
【分子量】
423.38
【性状】
本品为肠溶衣片，除去包衣后显白色。
【药理毒理】
本品通过特异性地作用于胃粘膜壁细胞,降低壁细胞中的H+、K+-ATP酶的活性，从而抑制胃酸的分泌。
与奥美拉唑相比,本品对细胞色素P450酶的抑制作用较弱。
【药代动力学】
本品口服后吸收迅速、完全，单次口服40mg后2～3小时左右即可达血药浓度峰值,其口服制剂的绝对生物利用度为77%,泮托拉唑的血浆蛋白结合率为98%,主要在肝脏代谢为去甲基泮托拉唑硫酸酯。
泮托拉唑的半衰期1小时左右,去甲基泮托拉唑硫酸酯的半衰期为1～5小时。
80%的代谢产物通过肾脏排出,其余经胆汁进入粪便排出。
【适应症】
适用于活动性消化性溃疡(胃、十二指肠溃疡)、反流性食管炎和卓-艾氏综合征。
【用法用量】
口服,每日早餐前40mg(1片),十二指肠溃疡疗程通常为2～4周，胃溃疡和反流性食管炎疗程通常为4～8周。
【不良反应】
临床应用偶有头痛、头晕、失眠、嗜睡、恶心、腹痛、腹泻和便秘、腹胀、皮疹、肌肉疼痛等症状。
【禁忌】
1.哺乳期妇女及妊娠三个月内妇女禁用。
2.对本品过敏者禁用。
【注意事项】
1.本品为肠溶制剂，服用时请勿咀嚼。
2.当怀疑胃溃疡时，应首先排除癌症的可能性，因为本品治疗可减轻其症状，从而延误诊断。
3.肝肾功能不全者慎用,严重肝病时本品清除延缓,应减少用量。
4.本品不宜同时再服用其它抗酸剂和抑酸剂。
为防止抑酸过度,除卓-艾氏综合征外,建议用于消化性溃疡等病时,不宜大剂量长期应用。
【孕妇及哺乳期妇女用药】
哺乳期妇女及妊娠三个月内妇女禁用。
【儿童用药】
本品儿童用药疗效及安全性资料尚未建立。
婴幼儿禁用。
【老年患者用药】
无剂量调整要求。
【药物相互作用】
泮托拉唑与其他药物的相互作用小,与奥美拉唑相比,对细胞色素P450系统作用较小,不影响安定的作用时间,与口服避孕药、地高辛、华法林、苯妥英或茶碱无明显相互作用。
【药物过量】
大剂量使用时,可出现心律不齐、转氨酶增高、肾功能改变、粒细胞降低等。
【规格】
40mg。
【贮藏】
遮光，密封，在凉暗处保存。
【包装】
双铝包装，7片/盒、14片/盒。
【有效期】
24个月。
【批准文号】。