Linzess (linaclotide) 处方药使用说明2014

阿司匹林（Aspirin）使用说明书阿司匹林（Aspirin）使用说明书1. 概述阿司匹林，全名乙酰水杨酸（Acetylsalicylic acid），是一种常用的非处方药，用于缓解轻度至中度的疼痛和发热，并具有抗炎症的作用。

本说明书将提供关于阿司匹林的使用方法、剂量、适应症和不良反应等重要信息，请在使用前仔细阅读。

2. 使用方法- 此药适用于口服服用，并应随餐或饮水一起服用，以减轻对胃黏膜的刺激。

- 如无特殊需求或医嘱，成人每次可口服325-650毫克，每4-6小时重复服用一次，但每日总剂量不得超过4000毫克。

- 儿童和青少年应遵循年龄和体重相适应的剂量，且不得超过医生指导的推荐剂量。

- 健康成年人应在医生或药剂师指导下服用阿司匹林的最长时间不应超过7天。

3. 适应症阿司匹林主要用于以下症状的缓解：- 头痛、牙痛、关节痛、肌肉痛等轻度至中度疼痛；- 发热；- 感冒、流感和其他病毒性感染导致的疼痛与发热。

4. 注意事项- 请勿超过推荐剂量使用阿司匹林，以免引起中毒或加重不良反应。

- 孕妇、哺乳期妇女、儿童和青少年在使用阿司匹林前应咨询医生的建议。

- 阿司匹林可能与某些药物发生相互作用，包括但不限于抗凝剂、降糖药和非甾体消炎药，请在使用前咨询医生或药剂师关于药物相互作用的信息。

- 如出现过敏反应（如皮疹、呼吸急促、严重头痛等），应立即停止使用并就医。

5. 不良反应阿司匹林的常见不良反应包括但不限于以下情况：- 胃肠道不适，如胃灼热感、恶心、呕吐和消化不良；- 过敏反应，如荨麻疹、皮疹、哮喘和过敏性休克；- 出血倾向，如鼻出血、牙龈出血和皮下出血等。

6. 储存方法- 阿司匹林应存放在干燥、清洁、阴凉的地方，避免阳光直射。

- 儿童不易触及的地方储存。

7. 急救措施如出现严重不良反应或过量服药，应立即就医或拨打当地急救电话。

本说明书并不能包含所有有关阿司匹林的信息，若有疑问或需进一步了解，请咨询医生或药剂师的建议。

____________________________________________________________________________________________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to useACTONEL safely and effectively. See full prescribing information forACTONEL. ACTONEL ® (risedronate sodium) tabletsInitial U.S. Approval: 1998----------------------------RECENT MAJOR CHANGES--------------------------Warnings and Precautions (5.3) 7/2009 ----------------------------INDICATIONS AND USAGE---------------------------ACTONEL is a bisphosphonate indicated for: •Treatment and prevention of postmenopausal osteoporosis (1.1), •Treatment to increase bone mass in men with osteoporosis (1.2), •Treatment and prevention of glucocorticoid-induced osteoporosis (1.3), •Treatment of Paget’s disease (1.4). ----------------------DOSAGE AND ADMINISTRATION-----------------------Must be taken with plain water (6 to 8 oz) at least 30 minutes before the firstfood or drink of the day; do not lie down for 30 minutes (2) Treatment of Osteoporosis in Postmenopausal Women: 5 mg daily, 35 mg once a week, 75 mg taken on two consecutive days each month, or 150 mg once a month (2.1) Prevention of Osteoporosis in Postmenopausal Women: 5 mg daily, or 35 mg once a week (2.2)Men with Osteoporosis: 35 mg once a week (2.3)Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: 5 mg daily(2.4)Paget’s Disease: 30 mg daily for 2 months (2.5)---------------------DOSAGE FORMS AND STRENGTHS----------------------Tablets: 5, 30, 35, 75, and 150 mg (3) -------------------------------CONTRAINDICATIONS------------------------------• Inability to stand or sit upright for at least 30 minutes (4, 5.1) • Hypocalcemia (4, 5.2)• Known hypersensitivity to any component of this product (4, 6.2) -----------------------WARNINGS AND PRECAUTIONS------------------------• Upper gastrointestinal irritation may occur. Dosing instructions should be followed. Discontinue use if new or worsening symptoms occur (5.1). • Hypocalcemia may worsen and must be corrected prior to use (5.2). • Osteonecrosis of the jaw has been reported rarely (5.3). • Severe bone, joint, or muscle pain may occur. Consider discontinuing use if severe symptoms develop (5.4, 6.2). • Before initiating treatment in patients with glucocorticoid-induced osteoporosis, sex steroid hormonal status of both men and women should be ascertained and appropriate replacement considered (5.6). • Bisphosphonates may interfere with bone-imaging agents (5.7). ------------------------------ADVERSE REACTIONS-------------------------------Most common adverse reactions reported in >10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia (6.1). Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Procter & Gamble Pharmaceuticals, Inc. at 1-800-836-0658 or FDA at 1-800-FDA­1088 or /medwatch.------------------------------DRUG INTERACTIONS-------------------------------Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL (7.1). -----------------------USE IN SPECIFIC POPULATIONS------------------------ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) (5.5, 8.6, 12.3). ACTONEL is not indicated for use in pediatric patients (8.4).See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 07/2009 FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE 1.1 Postmenopausal Osteoporosis 1.2 Osteoporosis in Men 1.3 Glucocorticoid-Induced Osteoporosis 1.4 Paget’s Disease 2DOSAGE AND ADMINISTRATION 2.1 Treatment of Postmenopausal Osteoporosis [see Indications and Usage (1.1)]2.2 Prevention of Postmenopausal Osteoporosis [see Indications and Usage (1.1)] 2.3Treatment to Increase Bone Mass in Men with Osteoporosis [see Indications and Usage (1.2)] 2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis [see Indications and Usage (1.3)] 2.5 Treatment of Paget’s Disease [see Indications and Usage (1.4)] 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Upper Gastrointestinal Adverse Reactions 5.2 Mineral Metabolism 5.3 Jaw Osteonecrosis 5.4 Musculoskeletal Pain 5.5 Renal Impairment 5.6 Glucocorticoid-Induced Osteoporosis 5.7 Laboratory Test Interactions 6ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Calcium Supplements/Antacids 7.2 Hormone Replacement Therapy 7.3 Aspirin/Nonsteroidal Anti-Inflammatory Drugs 7.4 H 2 Blockers and Proton Pump Inhibitors (PPIs) 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Treatment of Osteoporosis in Postmenopausal Women 14.2 Prevention of Osteoporosis in Postmenopausal Women 14.3 Men with Osteoporosis 14.4 Glucocorticoid-Induced Osteoporosis 14.5 Treatment of Paget’s Disease 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 FDA-Approved Patient Labeling *Sections or subsections omitted from the full prescribing information are not listed.FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEOsteoporosis1.1 PostmenopausalACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].1.2 Osteoporosis in MenACTONEL is indicated for treatment to increase bone mass in men with osteoporosis.Osteoporosis1.3 Glucocorticoid-InducedACTONEL is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of ≥ 7.5 mg prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.Disease1.4 Paget’sACTONEL is indicated for treatment of Paget’s disease of bone in men and women.2 DOSAGE AND ADMINISTRATIONACTONEL should be taken at least 30 minutes before the first food or drink of the day other than water.To facilitate delivery to the stomach, ACTONEL should be swallowed while the patient is in an upright position and with a full glass of plain water (6 to 8 oz). Patients should not lie down for 30 minutes after taking the medication [see Warnings and Precautions (5.1)].Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Calcium supplements and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of ACTONEL and should be taken at a different time of the day. ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min). No dosage adjustment is necessary in patients with a creatinine clearance ≥30 mL/min or in the elderly.2.1 Treatment of Postmenopausal Osteoporosis [see Indications and Usage (1.1)]The recommended regimen is:•one 5 mg tablet orally, taken dailyor•one 35 mg tablet orally, taken once a weekor•one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each monthor•one 150 mg tablet orally, taken once a month2.2 Prevention of Postmenopausal Osteoporosis [see Indications and Usage (1.1)]The recommended regimen is:•one 5 mg tablet orally, taken dailyor•one 35 mg tablet orally, taken once a weekor•alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be consideredor•alternatively, one 150 mg tablet orally, taken once a month may be considered2.3 Treatment to Increase Bone Mass in Men with Osteoporosis [see Indications andUsage (1.2)]The recommended regimen is:•one 35 mg tablet orally, taken once a week2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis [see Indicationsand Usage (1.3)]The recommended regimen is:•one 5 mg tablet orally, taken daily2.5 Treatment of Paget’s Disease [see Indications and Usage (1.4)]The recommended treatment regimen is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than 1 course of retreatment.3 DOSAGE FORMS AND STRENGTHS• 5 mg film-coated, oval, yellow tablet with RSN on 1 face and 5 mg on the other.•30 mg film-coated, oval, white tablet with RSN on 1 face and 30 mg on the other.•35 mg film-coated, oval, orange tablet with RSN on 1 face and 35 mg on the other.•75 mg film-coated, oval, pink tablet with RSN on 1 face and 75 mg on the other.•150 mg film-coated, oval, blue tablet with RSN on 1 face and 150 mg on the other.4 CONTRAINDICATIONS•Inability to stand or sit upright for at least 30 minutes [see Dosage andAdministration (2), Warnings and Precautions (5.1)]•Hypocalcemia [see Warnings and Precautions (5.2)]•Known hypersensitivity to any component of this product [see Adverse Reactions(6.2)]5 WARNINGS AND PRECAUTIONS5.1 Upper Gastrointestinal Adverse ReactionsBisphosphonates, including ACTONEL, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcers. ACTONEL should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur. [see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17.1)].Metabolism5.2 MineralHypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting ACTONEL therapy. Adequate intake of calcium and vitamin D is important in all patients, especially in patients with Paget’s disease in whom bone turnover is significantly elevated [see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17.1)].Osteonecrosis5.3 JawOsteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including ACTONEL. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures).For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment. [see Adverse Reactions (6.2)]5.4 MusculoskeletalPainIn postmarketing experience, there have been reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates [see Adverse Reactions (6.2)]. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping medication. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Consider discontinuing use if severe symptoms develop.5.5 Renal ImpairmentACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).Osteoporosis5.6 Glucocorticoid-InducedBefore initiating ACTONEL treatment for the treatment and prevention of glucocorticoid-induced osteoporosis, the sex steroid hormonal status of both men and women should be ascertained and appropriate replacement considered.5.7 Laboratory Test InteractionsBisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ACTONEL have not been performed.REACTIONS6 ADVERSE6.1 Clinical Studies 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 practice.Treatment of Postmenopausal OsteoporosisDaily DosingThe safety of ACTONEL 5 mg once daily in the treatment of postmenopausal osteoporosis was assessed in four randomized, double-blind, placebo-controlled multinational trials of 3232 women aged 38 to 85 years with postmenopausal osteoporosis. The duration of the trials was up to three years, with 1619 patients exposed to placebo and 1613 patients exposed to ACTONEL 5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non­steroidal anti-inflammatory drugs, proton pump inhibitors, and H2 antagonists were included in these clinical trials. All women received 1000 mg of elemental calcium plus vitamin D supplementation up to 500 IU per day if their 25-hydroxyvitamin D3 level was below normal at baseline.The incidence of all-cause mortality was 2.0% in the placebo group and 1.7% in the ACTONEL 5 mg daily group. The incidence of serious adverse events was 24.6% in the placebo group and 27.2% in the ACTONEL 5 mg group. The percentage of patients who withdrew from the study due to adverse events was 15.6% in the placebo group and 14.8% in the ACTONEL5 mg group. Table 1 lists adverse events from the Phase 3 postmenopausal osteoporosis trials reported in ≥5% of patients. Adverse events are shown without attribution of causality.Table 1Adverse Events Occurring at a Frequency ≥5% in Either Treatment Group Combined Phase 3 Postmenopausal Osteoporosis Treatment TrialsBody System PlaceboN = 16195 mg ACTONELN = 1613% %Body as a WholeInfection 29.931.1 Back Pain 26.1 28.0Accidental Injury 16.8 16.9Pain 14.014.1 Abdominal Pain 9.9 12.2Flu Syndrome 11.6 10.5Headache 10.89.9 Asthenia 4.55.4 Neck Pain 4.7 5.4Chest Pain 5.1 5.0Allergic ReactionCardiovascular System5.9 3.8Hypertension Digestive System 9.810.5Constipation 12.612.9 Diarrhea 10.010.8 Dyspepsia 10.610.8Nausea Metabolic & Nutritional Disorders 11.210.5Peripheral EdemaMusculoskeletal System8.8 7.7Arthralgia 22.123.7 Arthritis 10.19.6 Traumatic Bone Fracture 12.3 9.3Joint Disorder 5.3 7.0Myalgia 6.26.7 Bone PainNervous System4.85.3Dizziness 5.77.1 Depression 6.16.8Insomnia Respiratory System 4.65.0Bronchitis 10.410.0 Sinusitis 9.18.7 Rhinitis 5.16.2 Pharyngitis 5.06.0 Increased CoughSkin and Appendages6.3 5.9Rash Special Senses 7.17.9Cataract Urogenital System 5.76.5Urinary Tract Infection 10.4 11.1Gastrointestinal Adverse Events: The incidence of adverse events in the placebo and ACTONEL 5 mg daily groups were: abdominal pain (9.9% vs. 12.2%), diarrhea (10.0% vs. 10.8%), dyspepsia (10.6% vs. 10.8%), and gastritis (2.3% vs. 2.7%). Duodenitis and glossitis have been reported uncommonly in the ACTONEL 5 mg daily group (0.1% to 1%). In patients with active upper gastrointestinal disease at baseline, the incidence of upper gastrointestinal adverse events was similar between the placebo and ACTONEL 5 mg daily groups.Musculoskeletal Adverse Events: The incidence of adverse events in the placebo and ACTONEL 5 mg daily groups were: back pain (26.1% vs. 28.0%), arthralgia (22.1% vs. 23.7%), myalgia (6.2% vs. 6.7%), and bone pain (4.8% vs. 5.3%).Laboratory Test Findings: Throughout the Phase 3 studies, transient decreases from baseline in serum calcium (<1%) and serum phosphate (<3%) and compensatory increases in serum PTH levels (<30%) were observed within 6 months in patients in osteoporosis clinical trials treated with ACTONEL 5 mg once daily. There were no significant differences in serum calcium, phosphate, or PTH levels between placebo and ACTONEL 5 mg once daily at 3 years. Serum calcium levels below 8 mg/dL were observed in 18 patients, 9 (0.5%) in each treatment arm (placebo and ACTONEL 5 mg once daily). Serum phosphorus levels below 2 mg/dL were observed in 14 patients, 3 (0.2%) treated with placebo and 11 (0.6%) treated with ACTONEL5 mg once daily. There have been rare reports (<0.1%) of abnormal liver function tests.Endoscopic Findings: In the ACTONEL clinical trials, endoscopic evaluation was encouraged in any patient with moderate-to-severe gastrointestinal complaints, while maintaining the blind. Endoscopies were performed on equal numbers of patients between the placebo and treated groups [75 (14.5%) placebo; 75 (11.9%) ACTONEL]. Clinically important findings (perforations, ulcers, or bleeding) among this symptomatic population were similar between groups (51% placebo; 39% ACTONEL).Once-a-Week DosingThe safety of ACTONEL 35 mg once-a-week in the treatment of postmenopausal osteoporosis was assessed in a 1-year, double-blind, multicenter study comparing ACTONEL5 mg daily and ACTONEL 35 mg once-a-week in postmenopausal women aged 50 to 95 years. The duration of the trials was one year, with 480 patients exposed to ACTONEL 5 mg daily and 485 exposed to ACTONEL 35 mg once-a-week. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H2 antagonists were included in these clinical trials. All women received 1000 mg of elemental calcium plus vitamin D supplementation up to 500 IU per day if their25-hydroxyvitamin D3 level was below normal at baseline.The incidence of all-cause mortality was 0.4% in the ACTONEL 5 mg daily group and 1.0% in the ACTONEL 35 mg once-a-week group. The incidence of serious adverse events was 7.1% in the ACTONEL 5 mg daily group and 8.2% in the ACTONEL 35 mg once-a-week group. The percentage of patients who withdrew from the study due to adverse events was 11.9% in the ACTONEL 5 mg daily group and 11.5% in the ACTONEL 35 mg once-a-week group. The overall safety and tolerability profiles of the two dosing regimens were similar.Gastrointestinal Adverse Events: The incidence of gastrointestinal adverse events was similar between the ACTONEL 5 mg daily group and the ACTONEL 35 mg once-a-week group: dyspepsia (6.9% vs. 7.6%), diarrhea (6.3% vs. 4.9%), and abdominal pain (7.3% vs. 7.6%).Musculoskeletal Adverse Events: Arthralgia was reported in 11.5% of patients in the ACTONEL 5 mg daily group and 14.2% of patients in the ACTONEL 35 mg once-a-week group. Myalgia was reported by 4.6% of patients in the ACTONEL 5 mg daily group and 6.2% of patients in the ACTONEL 35 mg once-a-week group.Laboratory Test Findings: The mean percent changes from baseline at 12 months were similar between the ACTONEL 5 mg daily and ACTONEL 35 mg once-a-week groups, respectively, for serum calcium (0.4% vs. 0.7%), phosphate (-3.8% vs. -2.6%) and PTH (6.4% vs. 4.2%).Monthly DosingTwo Consecutive Days per MonthThe safety of ACTONEL 75 mg administered on two consecutive days per month for the treatment of postmenopausal osteoporosis was assessed in a double-blind, multicenter study in postmenopausal women aged 50 to 86 years. The duration of the trial was two years; 613 patients were exposed to ACTONEL 5 mg daily and 616 were exposed to ACTONEL 75 mg two consecutive days per month. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H2 antagonists were included in this clinical trial. All women received 1000 mg of elemental calcium plus 400 to 800 IU of vitamin D supplementation per day.The incidence of all-cause mortality was 1.0% for the ACTONEL 5 mg daily group and 0.5% for the ACTONEL 75 mg two consecutive days per month group. The incidence of serious adverse events was 10.8% in the ACTONEL 5 mg daily group and 14.4% in the ACTONEL75 mg two consecutive days per month group. The percentage of patients who withdrew from treatment due to adverse events was 14.2% in the ACTONEL 5 mg daily group and 13.0% in the ACTONEL 75 mg two consecutive days per month group. The overall safety and tolerability profiles of the two dosing regimens were similar.Acute Phase Reactions: Symptoms consistent with acute phase reaction have been reported with bisphosphonate use. The overall incidence of acute phase reaction was 3.6% of patients on ACTONEL 5 mg daily and 7.6% of patients on ACTONEL 75 mg two consecutive days per month. These incidence rates are based on reporting of any of 33 acute phase reaction-like symptoms within 5 days of the first dose. Fever or influenza-like illness with onset within the same period were reported by 0.0% of patients on ACTONEL 5 mg daily and 0.6% of patients on ACTONEL 75 mg two consecutive days per month.Gastrointestinal Adverse Events: The ACTONEL 75 mg two consecutive days per month group resulted in a higher incidence of discontinuation due to vomiting (1.0% vs. 0.2%) and diarrhea (1.0% vs. 0.3%) compared to the ACTONEL 5 mg daily group. Most of these events occurred within a few days of dosing.Ocular Adverse Events: None of the patients treated with ACTONEL 75 mg two consecutive days per month reported ocular inflammation such as uveitis, scleritis, or iritis;1 patient treated with ACTONEL 5 mg daily reported uveitis.Laboratory Test Findings: When ACTONEL 5 mg daily and ACTONEL 75 mg two consecutive days per month were compared in postmenopausal women with osteoporosis, the mean percent changes from baseline at 24 months were 0.2% and 0.8% for serum calcium, -1.9% and -1.3% for phosphate, and -10.4% and -17.2% for PTH, respectively. Compared to the ACTONEL 5 mg daily group, ACTONEL 75 mg two consecutive days per month resulted in a slightly higher incidence of hypocalcemia at the end of the first month of treatment (4.5% vs. 3.0%). Thereafter, the incidence of hypocalcemia with these regimens was similar at approximately 2%.Once-a-MonthThe safety of ACTONEL 150 mg administered once a month for the treatment of postmenopausal osteoporosis was assessed in a double-blind, multicenter study in postmenopausal women aged 50 to 88 years. The duration of the trial was one year, with642 patients exposed to ACTONEL 5 mg daily and 650 exposed to ACTONEL 150 mg once-a­month. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H2 antagonists were included in this clinical trial. All women received 1000 mg of elemental calcium plus up to 1000 IU of vitamin D supplementation per day.The incidence of all-cause mortality was 0.5% for the ACTONEL 5 mg daily group and 0.0% for the ACTONEL 150 mg once-a-month group. The incidence of serious adverse events was 4.2% in the ACTONEL 5 mg daily group and 6.2% in the ACTONEL 150 mg once-a-month group. The percentage of patients who withdrew from treatment due to adverse events was 9.5% in the ACTONEL 5 mg daily group and 8.6% in the ACTONEL 150 mg once-a-month group. The overall safety and tolerability profiles of the two dosing regimens were similar.Acute Phase Reactions: Symptoms consistent with acute phase reaction have been reported with bisphosphonate use. The overall incidence of acute phase reaction was 1.1% in the ACTONEL 5 mg daily group and 5.2% in the ACTONEL 150 mg once-a-month group. These incidence rates are based on reporting of any of 33 acute phase reaction-like symptoms within3 days of the first dose and for a duration of 7 days or less. Fever or influenza-like illness with onset within the same period were reported by 0.2% of patients on ACTONEL 5 mg daily and 1.4% of patients on ACTONEL 150 mg once-a-month.Gastrointestinal Adverse Events: A greater percentage of patients experienced diarrhea with ACTONEL 150 mg once-a-month compared to 5 mg daily (8.2% vs. 4.7%, respectively). The ACTONEL 150 mg once-a-month group resulted in a higher incidence of discontinuation due to abdominal pain upper (2.5% vs. 1.4%) and diarrhea (0.8% vs. 0.0%) compared to the ACTONEL 5 mg daily regimen. All of these events occurred within a few days of the first dose. The incidence of vomiting that led to discontinuation was the same in both groups (0.3% vs.0.3%).Ocular Adverse Events: None of the patients treated with ACTONEL 150 mg once-a­month reported ocular inflammation such as uveitis, scleritis, or iritis; 2 patients treated with ACTONEL 5 mg daily reported iritis.Laboratory Test Findings: When ACTONEL 5 mg daily and ACTONEL 150 mg once-a-month were compared in postmenopausal women with osteoporosis, the mean percent changes from baseline at 12 months were 0.1% and 0.3% for serum calcium, -2.3% and -2.3% for phosphate, and 8.3% and 4.8% for PTH, respectively. Compared to the ACTONEL 5 mg daily regimen, ACTONEL 150 mg once-a-month resulted in a slightly higher incidence of hypocalcemia at the end of the first month of treatment (0.2% vs. 2.2%). Thereafter, the incidence of hypocalcemia with these regimens was similar at approximately 2%.Prevention of Postmenopausal OsteoporosisDaily DosingThe safety of ACTONEL 5 mg daily in the prevention of postmenopausal osteoporosis was assessed in two randomized, double-blind, placebo-controlled trials. In one study of postmenopausal women aged 37 to 82 years without osteoporosis, the use of estrogen replacement therapy in both placebo- and ACTONEL-treated patients was included. The duration of the trial was one year, with 259 exposed to placebo and 261 patients exposed to ACTONEL 5 mg. The second study included postmenopausal women aged 44 to 63 years without osteoporosis. The duration of the trial was one year, with 125 exposed to placebo and 129 patients exposed to ACTONEL 5 mg. All women received 1000 mg of elemental calcium per day.In the trial with estrogen replacement therapy, the incidence of all-cause mortality was 1.5% for the placebo group and 0.4% for the ACTONEL 5 mg group. The incidence of serious adverse events was 8.9% in the placebo group and 5.4% in the ACTONEL 5 mg group. The percentage of patients who withdrew from treatment due to adverse events was 18.9% in the placebo group and 10.3% in the ACTONEL 5 mg group. Constipation was reported by 1.9% of the placebo group and 6.5% of ACTONEL 5 mg group.In the second trial, the incidence of all-cause mortality was 0.0% for both groups. The incidence of serious adverse events was 17.6% in the placebo group and 9.3% in the ACTONEL5 mg group. The percentage of patients who withdrew from treatment due to adverse events was6.4% in the placebo group and 5.4% in the ACTONEL 5 mg group. Nausea was reported by 6.4% of patients in the placebo group and 13.2% of patients in the ACTONEL 5 mg group. Once-a-Week DosingThere were no deaths in a 1-year, double-blind, placebo-controlled study of ACTONEL 35 mg once a week for prevention of bone loss in 278 postmenopausal women without osteoporosis. More treated subjects on ACTONEL reported arthralgia (placebo 7.8%; ACTONEL 13.9%), myalgia (placebo 2.1%; ACTONEL 5.1%), and nausea (placebo 4.3%; ACTONEL 7.3%) than subjects on placebo.。

复方谷氨酰胺肠溶胶囊治疗肠易激综合征的疗效及对胃肠激素的影响覃树芬;刘俊;邓翔宇【摘要】目的分析复方谷氨酰胺肠溶胶囊治疗肠易激综合征的疗效及对患者胃肠激素的影响.方法 72例肠易激综合征患者随机分为观察组和对照组.对照组患者给予肠易激综合征常规治疗,观察组患者在常规治疗基础上使用复方谷氨酰胺肠溶胶囊治疗.结果观察组患者治疗总有效率为94.45％,显著高于对照组的77.78％ (P ＜0.05).观察组患者排便异常、腹胀、腹痛、胃肠不适、焦虑、抑郁及头痛改善率显著高于对照组(P＜0.05).观察组患者VIP及SS水平显著低于对照组患者(P＜0.01).结论复方谷氨酰胺肠溶胶囊能有效改善肠易激综合征患者症状,增强胃肠免疫力,调节胃肠激素分泌.【期刊名称】《实用临床医药杂志》【年(卷),期】2016(020)005【总页数】3页(P73-75)【关键词】肠易激综合征;复方谷氨酰胺肠溶胶囊;血浆血管活性肽;生长抑素【作者】覃树芬;刘俊;邓翔宇【作者单位】广西医科大学第四附属医院/柳州市工人医院消化内科1病区,广西柳州,545005;广西医科大学第四附属医院/柳州市工人医院消化内科1病区,广西柳州,545005;广西医科大学第四附属医院/柳州市工人医院消化内科1病区,广西柳州,545005【正文语种】中文【中图分类】R574.4肠易激综合征(IBS)是由精神压力、饮食习惯等因素引起的胃肠道结构和生化功能异常的肠道功能紊乱性疾病[1]。

近年来，调查研究[2]发现因工作压力、饮食习惯不规律等原因引起的肠易激综合征发病率逐年增加，并且由于肠道功能紊乱，患者易出现情绪焦躁不安，严重影响患者日常生活及工作质量。

有研究[3]报道，复方谷氨酰胺肠溶胶囊治疗肠易激综合征疗效显著，但其相关机制仍少见报道。

本研究采用复方谷氨酰胺肠溶胶囊治疗肠易激综合征，观察其对患者胃肠激素的影响，现报告如下。

1.1 一般资料选择2012年8月—2014年9月在本院就诊的肠易激综合征患者72例作为研究对象，年龄20～47岁。

核准日期：修订日期：利那洛肽胶囊说明书通用名称：利那洛肽胶囊商品名称：令泽舒®（Linzess®）英文名称：Linaclotide Capsules汉语拼音：Linaluotai Jiaonang【成份】本品活性成份为利那洛肽。

化学名称：L-半胱氨酰-L-半胱氨酰-L-谷氨酰-L-酪氨酰-L-半胱氨酰-L-半胱氨酰-L-门冬酰胺酰-L-脯氨酰-L-丙氨酰-L-半胱氨酰-L-苏氨酰-甘氨酰-L-半胱氨酰-L-酪氨酸环(1-6),(2-10),(5-13)-三(二硫键)化学结构式：分子式：C59H79N15O21S6分子量：1526.8【性状】本品囊体为白色或类白色，囊帽为橙色，囊帽上印有灰色“290”字样，内容物为白色或类白色微丸。

【适应症】治疗成人便秘型肠易激综合征(IBS-C)。

【规格】290μg【用法用量】成人推荐每日1粒(含290μg利那洛肽)，至少首餐前30分钟服用。

医生应定期评估患者是否需要继续治疗。

利那洛肽的疗效经过了为期最长6个月的双盲、安慰剂对照研究验证。

治疗4周后如果症状未改善，应重新检查患者，并重新评估继续治疗的风险。

【不良反应】安全性特性总结在对照临床试验中有1,166例IBS-C患者口服了利那洛肽治疗。

其中892例患者接受的是推荐剂量290μg，每日一次。

临床研发计划中的总暴露量超过1,500患者-年。

与利那洛肽治疗相关的最常见不良反应是腹泻，大多为轻度至中度，大约在20%的患者中发生。

在罕见的严重病例中，其可能会导致脱水、低钾血症、低血碳酸氢盐水平、头晕和体位性低血压。

其他常见不良反应(>1%)包括腹痛、腹胀和肠胃胀气。

不良反应总结推荐剂量下(290μg，每日一次)，在对照临床试验中观察到下列不良反应。

发生频率定义为：十分常见(≥1/10)、常见(≥1/100至<1/10)、偶见(≥1/1,000至<1/100)、罕见(≥1/10,000至<1/1,000)、十分罕见(<1/10,000)和未知(根据现有数据无法评估发生频率)。

利那洛肽胶囊药品名称：【通用名称】利那洛肽胶囊【商品名称】令泽舒 Linzess【英文名称】Linaclotide Capsules【汉语拼音】Li Na Luo Tai Jiao Nang警示语：成份：本品活性成份为利那洛肽。

化学名称：L-半胱氨酰-L-半胱氨酰-L-谷氨酰-L-酪氨酰-L-半胱氨酰-L-半胱氨酰-L-门冬酰胺酰-L-脯氨酰-L-丙氨酰-L-半胱氨酰-L-苏氨酰-甘氨酰-L-半胱氨酰- L-酪氨酸环(1-6),(2-10),(5-13)-三(二硫键)化学结构：分子式：C59H79N15O21S6分子量：1526.8。

性状：本品囊体为白色或类白色，囊帽为橙色，囊帽上印有灰色“290”字样，内容物为白色或类白色微丸。

作用类别：鸟苷酸环化酶激动剂适应症：用于治疗成人便秘型肠易激综合征（IBS-C）的处方药。

规格：290μg用法用量：成人推荐每日1粒(含290μg利那洛肽)，至少首餐前30分钟服用。

医生应定期评估患者是否需要继续治疗。

利那洛肽的疗效经过了为期最长6个月的双盲、安慰剂对照研究验证。

治疗4周后如果症状未改善，应重新检查患者，并重新评估继续治疗的风险。

不良反应：安全性特性总结在对照临床试验中有1166例IBS-C患者口服了利那洛肽治疗。

其中892例患者接受的是推荐剂量290μg,每日一次。

临床研发计划中的总暴露量超过1500患者年。

与利那洛肽治疗相关的最常见不良反应是腹泻,大多为轻度至中度,大约在20％的患者中发生。

在罕见的严重病例中,其可能会导致脱水、低钾血症、低血碳酸氢盐水平、头晕和体位性低血压。

其他常见不良反应(>1％)包括腹痛、腹胀和肠胃胀气。

不良反应总结推荐剂量下(290ug,每日一次),在对照临床试验中观察到下列不良反应。

发生频率定义为:十分常见（≥1/10)、常见（≥1/100至＜1/10）、偶见（≥1/1000至小于1/100）、罕见（≥1/10000至1/1000），十分罕见（＜1/10000）和未知（根据现有数据无法评估发生频率）。

（点击查看放大图）通用名称：谷维素片英文名称：Oryzanol Tablets汉语拼音：Guweisu Pian成份：本品每片含谷维素10毫克。

辅料为：淀粉、糊精、滑石粉、聚山梨酯80、硬脂酸镁、羧甲淀粉钠。

性状：本品为白色或类白色片。

作用类别：本品为镇静助眠类非处方药药品。

适应症：神经官能症、经前期紧张综合征、更年期综合征的镇静助眠。

规格：10毫克用法用量：口服。

一次1～3片，一日3次。

不良反应：服后偶有胃部不适、恶心、呕吐、口干、疲乏、皮疹、乳房肿胀、油脂分泌过多、脱发、体重增加等不良反应。

停药后均可消失。

禁忌：尚不明确。

注意事项：1.如使用7天症状未缓解，请向医师或药师咨询。

2.胃及十二指肠溃疡患者慎用。

3.如服用过量，请及时向医务人员求助。

4.对本品过敏者禁用，过敏体质者慎用。

5.本品性状发生改变时禁止使用。

6.请将本品放在儿童不能接触的地方。

7.儿童必须在成人监护下使用。

8.如正在使用其他药品，使用本品前请咨询医师或药师。

药物相互作用：如与其他药物同时使用可能会发生药物相互作用，详情请咨询医师或药师。

药理作用：本品具有调节植物神经功能失调及内分泌平衡障碍的作用。

贮藏：密闭保存。

包装：口服固体药用高密度聚乙烯瓶每瓶100片有效期：24个月执行标准：部颁标准化学药品及制剂第一册WS1-48(B)-89批准文号：国药准字H44020707申明：请仔细阅读说明书并按说明书使用或在药师指导下购买和使用。

IRESSA易瑞沙(吉非替尼片)【用法用量】1.本品的推荐剂量为250mg(1片)，一日1次，口服，空腹或与食物同服。

2.如果有吞咽困难，可将片剂分散于半杯饮用水中（非碳酸饮料）。

不得使用其他液体。

将片剂丢入水中，无需压碎，搅拌至完全分散（约需10分钟），即刻饮下药液。

以半杯水冲洗杯子，饮下。

也可通过鼻-胃管给予该药液。

3.无需因下述情况不同调整给药剂量:年龄、体重、性别、种族、肾功能、因肝转移而引起的中至重度肝功能损害。

4.剂量调整:当患者出现不能耐受的腹泻或皮肤不良反应时，可通过短期暂停治疗(最多14天)解决，随后恢复每天250mg的剂量 (见不良反应)。

5.儿童中使用。

目前尚无本品用于儿童或青少年患者安全性与疗效的资料，故不推荐使用。

【注意事项】1.饮食宜清淡。

2.不宜在服药期间同时服用滋补性中成药。

3.有高血压、心脏病、肝病、糖尿病、肾病等慢性病严重者、孕妇或在那个在接受其它治疗的患者，均应在医师指导下服用。

4.服药三天后症状未改善，或出现吐泻明显，并有其它严重症状时应去医院就诊。

5.按照用法用量服用，小儿、年老体虚者应在医师指导下服用。

6.长期服用应向医师咨询。

7.对本品过敏者禁用，过敏体质者慎用。

8.本品性状发生改变时禁止使用。

9.儿童必须在成人监护下使用。

10.请将本品放在儿童不能接触的地方。

11.如正在使用其他药品，使用本品前请咨询医师或药师。

【不良反应】最常见(发生率20％以上)的药物为腹泻、皮疹、瘙痒、皮肤干燥和痤疮，一般见于服药后的第1个月内，通常是可逆性的。

大约8％的患者出现严重的药物(CTC标准3或4级)。

因停止治疗的患者仅有1％。

【禁忌】已知对该活性物质或该产品任一赋形剂有严重超敏反应者。

【适应症】适用于治疗既往接受过化学治疗的局部晚期或转移性非小细胞肺癌（NSCLC）。

【药物相互作用】对人肝微粒体进行的体外试验证实，吉非替尼主要通过肝细胞色素P-450系统的CYP3A4代谢。

阿司匹林咀嚼片【用法用量】口服:1.成人一次1片，若发热或疼痛不缓解可间隔4-6小时重复用药1次，24小时不超过4片。

2.儿童6-8岁1/2片，9-14岁2/3片，14岁以上1片。

咀嚼后咽下。

【注意事项】1．本品为对症治疗药，用于解热连续使用不超过3天，用于止痛不超过5天，症状未缓解请咨询医师或药师。

2．不能同时服用其他含有解热镇痛药的药品（如某些复方抗感冒药）。

3．年老体弱患者应在医师指导下使用。

4．服用本品期间不得饮酒或含有酒精的饮料。

5．痛风、肝肾功能减退、心功能不全、鼻出血、月经过多以及有溶血性贫血史的患者慎用。

6．发热伴脱水的患儿慎用。

7．如服用过量或出现严重不良反应，应立即就医。

8．对本品过敏者禁用，过敏体质者慎用。

9．本品性状发生改变时禁止使用。

10．请将本品放在儿童不能接触的地方。

11．儿童必须在成人监护下使用。

12．如正在使用其他药品，使用本品前请咨询医师或药师。

【不良反应】1．较常见的有恶心、呕吐、上腹部不适或疼痛等胃肠道反应。

2．较少见或罕见的有（1）胃肠道出血或溃疡，表现为血性或柏油样便，胃部剧痛或呕吐血性或咖啡样物，多见于大剂量服药患者。

（2）支气管痉挛性过敏反应，表现为呼吸困难或哮喘。

（3）皮肤过敏反应，表现为皮疹、荨麻疹、皮肤瘙痒等。

（4）血尿、眩晕和肝脏损害。

【禁忌】1．孕妇、哺乳期妇女禁用。

2．哮喘、鼻息肉综合征、对阿司匹林和其他解热镇痛药过敏者禁用。

3．血友病或血小板减少症、溃疡病活动期患者禁用。

【适应症】用于缓解轻度或中度疼痛，如头痛、牙痛。

用于缓解感冒引起的发热、咽喉痛。

【药物相互作用】1．本品不宜与抗凝血药（如双香豆素、肝素）及溶栓药（链激酶）同用。

2．抗酸药如碳酸氢钠等可增加本品自尿中的排泄，使血药浓度下降，不宜同用。

3．本品与糖皮质激素（如地塞米松等）同用，可增加胃肠道不良反应。

4．本品可加强口服降糖药及甲氨蝶呤的作用，不应同用。

5．如与其他药物同时使用可能会发生，详情请咨询医师或药师。

诺康律【适用症】: 雌激素缺乏综合征，包括萎缩性阴道炎，预防妇女骨矿物质丢失而增加的骨折危险。

【注意事项】: 有子宫的妇女出现原因不明的阴道流血或曾用非对抗雌激素治疗过，应注意检查是否有子宫内膜过度刺激／恶变情况。

定期检查肝功能。

患有静脉血栓栓塞性疾病或以前有因使用雌激素出现血栓栓塞的妇女，接受抗高血压治疗，或有癫痫、偏头痛、糖尿病、气喘或心衰的妇女慎用。

治疗期间原有的子宫肌瘤可能增大，子宫内膜异位症可能加剧。

用药期间如有异常或不规律的阴道流血或其后发生，则有必要作活检以排除恶性子宫肿瘤的可能性。

诺康律没有避孕作用。

如发现静脉血栓栓塞疾病，黄疸，偏头痛突然发作，突发视力障碍，血压显著升高或妊娠，应立刻停药。

【成分】: 片剂白色雌二醇 2 mg,醋酸炔诺酮1 mg.片剂红色雌二醇 1mg.片剂蓝色三相片，雌二醇2 mg【用法与用量】: 每日1片。

有月经的妇女，在月经第5天开始服用第1片（由蓝片开始）。

其他妇女可以在任一天开始用药。

【禁忌】: 已知或疑有乳癌（或病史），雌激素依赖性肿瘤，如子宫内膜癌以及代谢性卟啉症患者。

【不良反应】: 乳房胀痛，不规律的阴道流血，包括有些周期无经的现象发生，偶见恶心和水肿。

皮肤反应，头痛，胆石病，气喘，脱发，偏头痛和静脉血栓罕见。

乳腺癌，子宫内膜癌，血栓栓塞性疾病的肝功能变化也曾有报道。

【药物相互作用】: 与诱导肝酶的药物如巴比妥，苯妥英，利福平，酰胺咪嗪可发生相互作用。

【规格】: 片剂蓝色12片。

片剂白色 10片。

片剂红色6片。

【注意事项】大家在用药的时候，药物说明书里面有三种标识，一般要注意一下：1.第一种就是禁用，就是绝对禁止使用。

2.第二种就是慎用，就是药物可以使用，但是要密切关注患者口服药以后的情况，一旦有不良反应发生，需要马上停止使用。

3.第三种就是忌用，就是说明药物在此类人群中有明确的不良反应，应该是由医生根据病情给出用药建议。

如果一定需要这种药物，就可以联合其他的能减轻不良反应的药物一起服用。