伏格列波糖片说明书
伏格列波糖片剂药品说明书(英文)
Revised: October 2009 (12th version) Standard Commodity Classification No. of Japan873969- Improving agent for postprandial hyperglycemia –<Japanese Pharmacopoeia, Voglibose tablets>BASEN®Tablets 0.2BASEN®Tablets 0.3Prescription drugCaution - Use only pursuant to the prescription of a physician etc.CONTRAINDICATIONS (BASEN® Tablets are contra-indicated in the following patients.)(1) Patients with severe ketosis, or in a state of diabeticcoma or pre-coma [Since it becomes essential to quickly rectify hyperglycemia with administration of intrave-nous fluid or insulin, the use of BASEN® Tablets is not suitable.](2) Patients with severe infections, before or after operation,or with serious trauma [It is desirable to control plasma glucose with the injection of insulin. Therefore, ad-ministration of this drug is not appropriate.](3) Patients with a history of hypersensitivity to any of theingredients of this drugDESCRIPTION351 352Upper Lower Side Upper Lower Side7.1 8.12.63.1 Inactive ingredients:Corn Starch, Hydroxypropylcellulose, Magnesium Stearate, Lactose INDICATIONS○I mprovement of postprandial hyperglycemia in diabetes mel-litus (However, BASEN® Tablets should be used only when sufficient effect has not been obtained in patients already un-dergoing dietary treatment and/or exercise therapy, or when sufficient effect has not been obtained in patients who have been using oral hypoglycemic drugs or insulin preparations, in addition to dietary treatment and/or exercise therapy.)○P revention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for BASEN® Tablets 0.2) (However, BASEN® Tablets should be used only when im-paired glucose tolerance has not been improved in patients al-ready undergoing appropriate dietary treatment and/or exercise therapy.)< Precautions >Prevention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for BASEN® Tablets 0.2) Administration of BASEN® Tablets should be limited to those who is judged as impaired glucose tolerance (fasting plasma glucose is <126mg/dL and two-hour plasma glucose levels is 140 to 199mg/dL in 75 grams oral glucose tolerance test) and has not improved by dietary treatment and/or exercise therapy, which are the basics for the prevention of onset of diabetes mellitus, for three to six months and has any of followings; hypertension, dyslipidemia (hypertriglyceridemia, low HDL cholesterolemia etc.), obesity (Body Mass Index: BMI ≥25kg/m2) or a family history of diabetes mellitus in first-degree or second-degree relatives.DOSAGE AND ADMINISTRATION○I mprovement of postprandial hyperglycemia in diabetes mellitusStorageStore at room temperature.Expiration dateDo not use after the expiration date in-dicated on the package. (Use as soon as possible after unsealing, even before the expiration date.)Tablets 0.2 Tablets 0.3 Approval No.(6AM)1120(6AM)1121 Date of listing in the NHI reimbursement price August 1994August 1994 Date of initial marketing in Japan September 1994September 1994 Date of latest reexamination September 2004September 2004 Date of latest approval of indications October 2009 -Usually, for adults, BASEN® Tablets are orally administered in a single dose of 0.2 mg as voglibose, three times a day, just before each meal. If the effect is not sufficient enough, the single dose may be increased up to 0.3 mg, under close obser-vation of the course of disease.○P revention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for BASEN® Tablets 0.2)Usually, for adults, BASEN® Tablets are orally administered in a single dose of 0.2 mg as voglibose, three times a day, just before each meal.< Precautions >Prevention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for BASEN® Tablets 0.2)During administration of BASEN® Tablets, the examination of glycemic control should be made at appropriate intervals and careful attention should always be paid to the necessity for continuous administration of this drug. (See 2. Important Pre-cautions)PRECAUTIONS1. Careful Administration (BASEN® Tablets should beadministered with care in the following patients.)(1) Patients who are receiving other antidiabetic drugs[Hypoglycemia may occur.] (See 4. (1) Clinically sig-nificant adverse reactions.)(2) Patients with a history of laparotomy or ileus [Intes-tinal obstruction-like symptoms are liable to developdue to an increase in intestinal gas, etc.](3) Patients with chronic intestinal disease accompanied bya disturbance in digestion and absorption[The actions of this drug may aggravate the pathologiccondition.](4) Patients with Roemheld’s syndrome, severe hernia, orstenosis or ulceration of the large intestine, etc.[Symptoms may worsen due to an increase in intestinalgas, etc.](5) Patients with serious hepatic dysfunction [Because ofpossible changes in metabolic condition, the status ofplasma glucose control may greatly vary. In patientswith severe liver cirrhosis, hyperammonemia mayworsen, followed by disturbance of consciousness.](6) Patients with serious renal dysfunction [Because ofpossible changes in metabolic conditions, the status ofplasma glucose control may greatly vary.](7) Elderly patients (See 5. Use in the Elderly.)2. Important PrecautionsFor all indications(1) The administration of BASEN® Tablets should be lim-ited to the patients who have been definitely diagnosedas having diabetes mellitus or those who are with im-paired glucose tolerance. It should be noted that inaddition to these, there are such diseases as positiveurinary sugar that represent diabetes-like symptoms(renal glucosuria, senile abnormal glucose tolerance,abnormal thyroid function, pancreatic diseases such aschronic pancreatitis and drug-induced impaired glucose tolerance etc.).(2) The administration of BASEN® Tablets should be con-sidered only when sufficient effect has not been ob-tained in patients already undergoing dietary treatment and exercise therapy, which are the basics for diabetes treatment and/or the prevention of onset of diabetes mellitus.(3) In administration of BASEN® Tablets, hypoglycemicsymptoms and measures to be taken should be suffi-ciently explained to patients with diabetes mellitus or with impaired glucose tolerance (See 4. (1) Clinically significant adverse reactions.)Improvement of postprandial hyperglycemia in diabe-tes mellitus(1) For patients who are undergoing only the basic treat-ment for diabetes mellitus, namely, dietary treatment and /or exercise therapy, this drug should be given only when the two-hour postprandial plasma glucose is 200 mg/dL or more.(2) For patients who are using oral hypoglycemic drugs orinsulin preparations, in addition to dietary treatment and/or exercise therapy, a rough standard for admini-stration of this drug is to give it when the fasting plas-ma glucose is about 140 mg/dL or more.(3) During administration of BASEN® Tablets, the patientshould be closely observed with the monitoring of plasma glucose at regular intervals, and careful atten-tion should always be paid to the necessity for con-tinuous administration of this drug. If its effect on postprandial plasma glucose is not satisfactory even after the administration of this drug for 2 to 3 months(e.g. the reduction in the two-hour postprandial glucoselevel in venous plasma to 200 mg/dL or below can not be achieved), such consideration as the change to more possible appropriate treatment should be made.When sufficient control of the postprandial plasma glucose has been attained (the two-hour postprandial glucose level reduced to 160 mg/dL or below in venous plasma), and is judged to be satisfactorily maintained only with dietary treatment and/or exercise therapy, or with additional use of oral hypoglycemic drugs or in-sulin preparations, the administration of BASEN®Tablets should be discontinued and the patient should be observed.Prevention of onset of type 2 diabetes mellitus in im-paired glucose toleranceAfter starting of BASEN® Tablets administration, glu-cose metabolism assessment, such as fasting plasma glucose, casual plasma glucose or HbA1c, etc., and measurement of body weight should be conducted ap-proximately every 1 to 3 months and the patient should be observed with the monitoring of 75 grams oral glu-cose tolerance test approximately every 6 to 12 months, and careful attention should always be paid to the necessity for continuous administration of thisdrug. Since it has been reported that the risk of de-veloping diabetes mellitus increases in the patients with high level of plasma glucose (fasting plasma glucoseand two-hour plasma glucose levels in 75 grams oralglucose tolerance test) or with decreased insulin secre-tion in initial phase following glycemic load, patients should be observed closely. When a patient is diagnosed as type 2 diabetes melli-tus, such consideration as the change to appropriate treatment should be made. In case impaired glucose tolerance improved after starting of BASEN ®Tablets administration and it is considered that dietary treat-ment and/or exercise therapy alone would provide suf-ficient effects, the administration of BASEN ®Tablets should be discontinued and the patient should be ob-served with glucose metabolism assessment etc.3. Drug InteractionsPrecautions for coadministration (BASEN ®Tablets should be administered with care when coadministeredwith the following drugs.)Drugs Signs, Symptoms, Treatment, Mecha-nisms, etc. Antidiabetic drugs Derivatives of sulfonylamide and sul-fonylurea, biguanide derivatives, in-sulin preparations and improvingagents for insulin resistance It has been reported that hypoglycemiaoccurred in the concomitant use ofBASEN ® Tablets with insulin prepara-tions or sulfonylurea derivatives. There-fore, when this drug is used in combina-tion with any of the left-listed drugs, such careful caution as starting from a lowerdose should be exercised, taking into ac-count the possible development of hypo-glycemia.For the concomitant use of antidia-betic drugs and the drugs which en-hance or diminish the hypoglycemic action of antidiabetic drugs ◊ Drugs enhancing the hypoglyce-mic action of antidiabetic drugs: β- blockers, salicylic acid prepa-rations, monoamine oxidase in-hibitors, fibrate derivatives for treatment of hyperlipemia, war-farin, etc.◊ Drugs diminishing the hypoglyce-mic action of antidiabetic drugs:Adrenaline, adrenocortical hor-mone, thyroid hormone, etc. When BASEN ® Tablets are further ad-ministered concurrently, in addition to the concomitant use among any of the left -listed drugs, careful attention should bepaid to the drug interactions listed in thepackage inserts of these antidiabeticdrugs. Further cautious attention shouldalso be paid to the influence that might be additionally caused by the delaying action of this drug on the absorption of carbo-hydrates. 4. Adverse Reactions Improvement of postprandial hyperglycemia in diabe-tes mellitus Adverse reactions, including abnormalities in laboratory data, were observed in 154 (16.0%) of 965 patients given the daily doses of 0.6 mg or 0.9 mg of BASEN ® Tablets in the studies performed up to the time of approval, and in 460 (10.3%) of 4,446 patients in the postmarketing inves-tigation of the results of drug use (as of the end of reex-amination). Major adverse reactions were diarrhea(4.0%), increased flatus (4.0%) and abdominal distension(3.5%), etc.Prevention of onset of type 2 diabetes mellitus in im-paired glucose toleranceAdverse reactions, including abnormalities in laboratory data, were observed in 452 (47.5%) of 951 patients given the daily doses of 0.6 mg of BASEN ® Tablets in the stud-ies performed up to the time of approval. Major adverse reactions were flatulence (17.4%), abdominal distension (13.1%) and diarrhea (12.0%), etc.Adverse reactions listed below have been found in theabove-mentioned studies, investigations or spontaneousreports, etc. (1) Clinically significant adverse reactions1) When BASEN ® Tablets are used in combination with other antidiabetic drugs, hypoglycemia mayoccur (0.1% - < 5%). Furthermore, hypoglyce-mia has been reported to occur (< 0.1%) even when other antidiabetic drug was not concomi-tantly used with this drug. This drug delays the digestion and absorption of disaccharides. Therefore, if any hypoglycemic symptom is ob-served, appropriate measures, such as the admini-stration of glucose instead of sucrose, should betaken. 2) Abdominal swelling, increased flatus, etc., may occur, and intestinal obstruction-like symptomdue to an increase in intestinal gas, etc., may occur (<0.1%). Therefore, close observation should bemade, and if any of such symptoms occurs, appro-priate measures, such as discontinuation of BASEN ® Tablets, should be taken. 3) Fulminant hepatitis , serious hepatic dysfunctionwith increased AST (GOT), ALT (GPT), etc., orjaundice may occur (each < 0.1%). Therefore,close observation should be made, and if any ab-normality is found, the administration should be discontinued and appropriate measures should be taken. 4) When BASEN ® Tablets are administered to thepatients with serious liver cirrhosis , hyperam-monemia may worsen with the development of constipation, etc., followed by disturbance ofconsciousness (frequency unknown). Therefore, the condition of bowel movement, etc., shouldbe observed closely, and if any abnormality is ob-served, appropriate measures, such as immediatediscontinuation of this drug, should be taken.sea,vomiting, heart-burn or thirsttestinalis2) Hyper-sensitivityNote 1)Rash, pruri-tus or photo-sensitivity3) Hepatic IncreasedAST(GOT),ALT(GPT),LDH, γ- GTP orALP4) Psycho-neurologic DizzinessHeadache,light-headedness or sleepi-ness5) Hema-tologic AnemiaThrombocy-topeniaGranulo-cytopenia6) Others Numbness, ede-ma of face etc.,blurred vision,hot flushes, ma-laise, weakness,hyperkalemia,increased serumamylase, de-creased HDLcholesterol, dia-phoresis or alo-peciaNote 1) In such a case, administration of BASEN® Tablets should be discontinued.5. Use in the ElderlySince the elderly have a physiological hypofunction in general, the administration of BASEN® Tablets should be initiated at a lower dose (e.g. single dose of 0.1 mg).Furthermore, this drug should be carefully administered under close observation of the course of disease, such as careful attention to the plasma glucose level and the onset of gastrointestinal symptoms.6. Use during Pregnancy, Delivery or Lactation(1) BASEN® Tablets should be administered to pregnantwomen or women having possibilities of being preg-nant only if the expected therapeutic benefit is thoughtto outweigh any possible risk. [The safety of thisdrug in pregnant women has not been established.](2) It is desirable to avoid the administration of this drug tonursing mothers. However, if the administration isindispensable, nursing should be discontinued. [Ani-mal studies (rats) have revealed a suppressive action ofthis drug on body weight increase in newborns, pre-sumably due to suppression of milk production result-ing from inhibition of carbohydrate absorption inmother animals.1-2)]7. Pediatric UseThe safety of BASEN® Tablets in children has not been established (no clinical experience).8. Precautions concerning UseWhen dispensing the drug:The patient must be instructed to remove the tabletsfrom the press-through package (PTP) before they areingested. [It has been reported that, if the PTP sheet isswallowed, the sharp corners of the sheet may puncturethe esophageal mucosa, and this could result in seriouscomplications such as mediastinitis.] PHARMACOKINETICS(1) When BASEN® Tablets were repeatedly administered tohealthy male adults (6 subjects) in a single dose of 0.2 mg, three times a day, for 7 consecutive days, no voglibose was detected in plasma or urine.3)(For reference) In administration of this drug to healthymale adults (10 subjects) in a single dose of 2 mg, no vo-glibose was detected in plasma or urine.(2) In a study in which a single dose of 1 mg/kg of [14C] vo-glibose was administered to rats, the transfer of voglibose to fetus and mother's milk was observed, and the rates of excretion into urine and feces were about 5% and 98%, re-spectively.4)CLINICAL STUDIES5-21)1. Improvement of postprandial hyperglycemia in diabetes mellitusIn various clinical studies, including double-blind comparative controlled clinical trials, in which BASEN® Tablets were ad-ministered in daily doses of 0.6 mg or 0.9 mg to patients with non-insulin-dependent diabetes mellitus or insulin-dependent diabetes mellitus, the improvement rates by the type of diabe-tes mellitus in 877 patients, who were included in the analysis of the final global improvement rating in plasma glucose, were as shown in the table.Type of diabetesmellitusNumber ofpatientsImprovement orbettter evaluationSlight improvementor better evaluation Non-insulin-dependentdiabetes mellitus812 371 (45.7) 613 (75.5) Insulin-dependent dia-betes mellitus65 31 (47.7) 47 (72.3)Total 877 402 (45.8) 660 (75.3) Figures denote the number of patients, and figures in parentheses indicate the cumulative %.Improvement or better evaluation: "marked improvement" + "improvement" Slight improvement or better evaluation: "marked improvement" + "improvement" + "Slight improvement"The usefulness of BASEN® Tablets has been proved in dou-ble-blind controlled clinical trials in the above-cited patients with non-insulin-dependent diabetes mellitus.5-6) The useful-ness of this drug, including improvement of postprandial hy-perglycemia, has also been recognized not only in patients un-dergoing dietary treatment alone but also in patients using in-sulin preparations7-10) or oral hypoglycemic drugs.11-15) In ad-dition, in long-term administration study (for an average of 7 months), the lasting efficacy of this drug has been confirmed, and stable control of plasma glucose has been attained.16-20)The results of the clinical pharmacological tests have revealed that the typical adverse reactions pertaining to BASEN® Tab-lets, such as increased flatus, feeling of enlarged abdomen, di-arrhea or loose stools, etc, are considered to be attributable to decomposition and fermentation of unabsorbed carbohydrate resulting from pharmacological actions of this drug.2. Prevention of onset of type 2 diabetes mellitus in im-paired glucose toleranceIn the double-blind comparative trial (for an average of 336.7 ± 254.0 days), voglibose were administered in a single dose of 0.2 mg, three times a day to patients with impaired glucose tol-erance and any of followings; hypertension, hyperlipemia, obe-sity (Body Mass Index: BMI ≥25kg/m2) or a family history of diabetes mellitus in a first-degree or second-degree relative. As the result, the number of patients progressing to type 2 dia-betes mellitus was 50 of 897 patients in the voglibose group, and 106 of 881 patients in the placebo group at the end of the study.Hazard ratio of voglibose to placebo group (two-sided 95% CI) was 0.595 (0.4334–0.8177) (stratified log-rank test: p=0.0014).21)The cumulative progression rates to type 2 diabetes mellitus were as shown in the figure and the table.PHARMACOLOGY22-29)Voglibose inhibits the hydrolase (α-glucosidase) for disaccha-rides that catalyzes decomposition of disaccharides into mono-saccharides in the intestine, thereby delaying the digestion and absorption of carbohydrate, resulting in improvement of post-prandial hyperglycemia.1. Mechanism of action22)(1) Voglibose exhibits the inhibitory actions on porcinesmall intestine-derived maltase and sucrase, which areabout 20 and 30 times as strong as acarbose, respec-tively, while the inhibitory actions of voglibose on ratsmall intestine-derived maltase and sucrase are about270 and 190 times as strong as those of acarbose, re-spectively (in vitro). On the other hand, the inhibitoryactions of voglibose on porcine and rat pancreaticα-amylase are about 1/3,000 of those of acarbose, andvoglibose produces no inhibitory action onβ-glucosidase (in vitro).(2) The mode of inhibitory action of voglibose on the di-saccharide hydrolase for the complex of rat small intes-tine-derived sucrase and isomaltase is competitive an-tagonistic (in vitro).2. Suppressive action on increase in plasma glucose(1) When administered orally to normal rats, voglibosesuppresses the plasma glucose increase resulting fromthe loading of starch, maltose and sucrose. However,it is ineffective in suppressing the plasma glucose in-crease resulting from the loading of glucose, fructoseand lactose (in vivo).22)(2) When healthy adults were loaded with sucrose andtheir expired hydrogen gas was measured, suppressiveaction of voglibose on increase in plasma glucose atclinical doses was presumed to be attributable to slightinhibition of the absorption of carbohydrate based onits partial suppressing action on the decomposition ofdisaccharides, resulting in delayed absorption of car-bohydrate.23)PHYSICOCHEMISTRYStructural formula:Nonproprietary name:Voglibose [JAN]Chemical name:3,4-Dideoxy-4-[2-hydroxy-1-(hydroxymethyl)-ethyl amino]-2-C-(hydroxymethyl)-D-epi-inositol Molecular formula:C10H21NO7Molecular weight:267.28Melting point:163-168°CDescription:Voglibose occurs as white crystals or crystalline pow-der. It is very soluble in water, freely soluble in aceticacid (100), slightly soluble in methanol, very slightlysoluble in ethanol (99.5). It is soluble in 0.1mol/L hy-drochloride solution.CONDITIONS FOR APPROVALPrevention of onset of type 2 diabetes mellitus in im-paired glucose tolerancePost-marketing clinical trials (including follow-up inves-tigation after discontinuation of this drug) and special post-marketing investigation for long-term use should be conducted in a timely manner and their results should be submitted to regulatory agency. Furthermore, the neces-sary information should be provided to medical institu-tions promptly and thoroughly.PACKAGINGTablets 0.2:100 tablets (10 tablets × 10), 500 tablets (loose, 10 tablets × 50), 1,000 tablets (10 tablets × 100), 2,100 tablets (21 tablets × 100)Tablets 0.3:100 tablets (10 tablets × 10), 500 tablets (loose, 10 tablets × 50), 1,000 tablets (10 tablets × 100), 2,100 tablets (21 tablets × 100)SCOPE OF JAPANESE NATIONAL HEALTH INSURANCE COVERAGEIn administration of BASEN® Tablets for “Prevention of onset of type 2 diabetes mellitus in impaired glucose tol-erance (However, BASEN® Tablets should be used only when impaired glucose tolerance has not been improved in patients already undergoing appropriate dietary treat-ment and/or exercise therapy.)”, Japanese national health insurance coverage should be dealt as followings:1. Japanese national health insurance should onlycover for patients who are judged as impaired glucose tolerance (fasting plasma glucose is <126mg/dL and two-hour plasma glucose levels is 140 to 199mg/dL in75 grams oral glucose tolerance test) and has not im-proved by dietary treatment and/or exercise therapy, which are the basics for the prevention of onset of diabetes mellitus, for three to six months and has any of followings as the underlying condition; hyperten-sion, dyslipidemia (hypertriglyceridemia, low HDL cholesterolemia etc.).2. Basis for diagnosis of impaired glucose tolerance(date of diagnosis and the results), no improvement by dietary treatment and/or exercise therapy for three to six months and/or hypertension or dyslipidemia should be described in the space for notes of the cer-tificates of medical remuneration.REFERENCES1) Morseth, S.L. et al.: Jpn. Pharmacol. Ther., 19: 4325,1991.2) Morseth, S.L. et al.: ibid., 19: 4375, 1991.3) Hiraga, K.: Clinical Report, 26: 283, 1992.4) Maeshiba, Y. et al.: Jpn. Pharmacol. Ther., 19: 3639,1991.5) Goto, Y. et al.: J.Clin. Exp. Med., 160: 943, 1992.6) Kamiya, F. et al.: The Journal of Adult Diseases, 22:573, 1992.7) Ikeda, Y. et al.: Journal of New Remedies & Clinics,41: 20, 1992.8) Nakano, K. et al.: Medical Consultation & New Reme-dies, 28: 2315, 1991.9) Morishima, T. at al.: Jpn. J. Clin. Exp. Med., 69: 3997,1992.10) Kawamori, R. et al.: J. Jpn. Diabetes Society, 35: 633,1992.11) Shibata, A. et al.: Prog. Med., 12: 239, 1992.12) Taminato, A. et al.: Journal of New Remedies & Clin-ics, 41: 193, 1992.13) Nishizawa, Y. et al.: Jpn. J. Med. Pharm. Sci., 27: 123,1992.14) Matsuoka, H. et al.: Medical Consultation & NewRemedies, 29: 255, 1992.15) Kaku, K. et al.: Jpn. Pharmacol. Ther., 20: 887, 1992.16) Mimura, K. et al.: Jpn. J. Clin. Exp. Med., 69: 919,1992.17) Mimura, K. et al.: ibid., 69: 235, 1992.18) Nakamura, M. et al.: Journal of New Remedies &Clinics, 41: 2, 1992.19) Koizumi, J. et al.: Medical Consultation & New Reme-dies, 29: 241, 1992.20) Umeda, F. et al.: Jpn. J. Clin. Exp. Med., 69: 1309,1992.21) Kawamori, R. et al.: Lancet, 373: 1607, 2009.22) Odaka, H. et al.: Journal of Japanese Society of Nutri-tion and Food Science, 45: 27, 1992.23) Goto, Y. et al.: The Journal of Adult Diseases, 22: 451,1992.24) Ikeda, K. et al.: Jpn. Pharmacol. Ther., 19: 4105, 1991.25) Odaka, H. et al.: Journal of Nutritional Science andVitaminology, 38: 27, 1992.26) Ikeda, K. et al.: Jpn. Pharmacol. Ther., 19: 4451, 1991.27) Odaka, H. et al.: Journal of Japanese Society of Nutri-tion and Food Science, 45: 33, 1992.28) Takami, K. et al.: Jpn. Pharmacol. Ther., 19: 4457,1991.29) Odaka, H. et al.: ibid., 19: 4829, 1991.REQUEST FOR LITERATURE SHOULD BE MADE TO: Customer Relations, Pharmaceutical Information Services for Ethical Products DepartmentPharmaceutical Marketing DivisionTAKEDA PHARMACEUTICAL COMPANY LIMITED12-10, Nihonbashi 2-chome, Chuo-ku,Tokyo 103-8668, JapanOpen: 9:00-17:30 (except Saturday, Sunday, national holidays and nonbusiness days)Manufactured and Distributed by:TAKEDA PHARMACEUTICAL COMPANY LIMITED1-1, Doshomachi 4-chome, Chuo-ku,Osaka 540-8645, Japan。
伏格列波糖片的功能主治是
伏格列波糖片的功能主治是：一、背景介绍伏格列波糖片是一种口服降糖药物，通常用于治疗2型糖尿病。
它属于非胰岛素促泌剂，通过提高胰岛素的分泌来帮助降低血糖水平。
伏格列波糖片已经在全球范围内得到广泛应用，成为控制糖尿病的常用药物之一。
二、伏格列波糖片的功能主治 1. 改善血糖控制伏格列波糖片主要的功能是通过刺激胰岛素的分泌来调节血糖水平。
它能够增强胰腺β细胞对葡萄糖的敏感性，并促进胰岛素的合成与分泌。
这种作用有助于提高机体利用葡萄糖的能力，从而降低血糖水平。
2.适用于2型糖尿病的治疗伏格列波糖片针对2型糖尿病患者的治疗需求进行设计。
2型糖尿病是一种慢性代谢性疾病，主要特征是胰岛素抵抗和胰岛素分泌不足。
伏格列波糖片通过促进胰岛素的分泌，有助于改善胰岛素抵抗和维持正常的血糖水平。
3.提高胰岛素敏感性伏格列波糖片通过增加机体对胰岛素的敏感性，能够提高胰岛素的效果。
它通过作用于胰岛素受体，促进胰岛素进入细胞并发挥作用。
这有助于减少胰岛素的需求量，提高胰岛素的利用率。
4.保护胰岛细胞伏格列波糖片还具有保护胰岛细胞功能。
研究发现，它能够减少胰岛细胞的损伤，并改善胰岛细胞的功能。
这对于长期使用降糖药物的患者来说，可以减轻胰岛素分泌的压力，延缓糖尿病的进展。
5.调节血脂水平伏格列波糖片不仅可以降低血糖水平，还可以调节血脂水平。
它能够降低低密度脂蛋白胆固醇（LDL-C）和总胆固醇的含量，同时提高高密度脂蛋白胆固醇（HDL-C）的水平。
这对于糖尿病患者来说，有助于降低心血管疾病的风险。
6.延缓糖尿病并发症的进展伏格列波糖片的功能主治还包括延缓糖尿病并发症的进展。
糖尿病患者往往面临着心血管疾病、损伤神经系统、糖尿病肾病等并发症的风险。
伏格列波糖片通过降低血糖水平和调节血脂水平，可以减少并发症的发生。
三、伏格列波糖片的使用注意事项 1. 适用人群伏格列波糖片适用于2型糖尿病患者，尤其是胰岛素分泌不足的患者。
对于对伏格列波糖片或其中任何成分过敏的人以及妊娠、哺乳期妇女，使用前应咨询医生。
糖尿病常用药品说明书
糖尿病常用药品说明书药品名称：胰岛素注射液主要成分：本品主要成分是人胰岛素，系用重组 DNA 技术制备的结晶牛胰岛素冻干粉与稀硫酸溶液配制而成的。
适应症：本品用于治疗糖尿病，特别是Ⅰ型和Ⅱ型糖尿病，包括胰岛素依赖型和非胰岛素依赖型。
用法用量：本品仅供注射，不能口服。
具体用法用量请遵医嘱，根据血糖水平、饮食和运动状况进行调整。
不良反应：注射部位可能会出现疼痛、红肿、瘙痒等局部反应。
少数患者可能会出现低血糖症状，如心慌、出汗、饥饿感等。
禁忌：对胰岛素过敏的患者禁用。
注意事项：1.使用本品时，请务必遵守医生的指导，注意注射技巧。
2.注射后要定时监测血糖水平，避免发生低血糖。
3.请注意保存条件，避免高温和潮湿。
药品名称：二甲双胍片主要成分：本品主要成分是二甲双胍，化学名称为1,1-二甲基双胍。
适应症：本品用于治疗2型糖尿病，特别是肥胖的2型糖尿病患者。
用法用量：口服，每日2-3次，餐前半小时服用。
具体用法用量请遵医嘱。
不良反应：常见不良反应包括腹泻、恶心、呕吐等消化道症状。
少数患者可能会出现低血糖症状。
禁忌：对二甲双胍过敏的患者禁用。
注意事项：1.使用本品时，请务必遵守医生的指导。
2.请与饮食调整和运动相结合，以达到更好的治疗效果。
3.请注意监测血糖水平，避免发生低血糖。
药品名称：瑞格列奈片主要成分：本品主要成分是瑞格列奈，化学名称为(2S)-2-[(3-乙基-2,4-二氧噻吩-5-基)氧]丙酰胺。
适应症：本品用于治疗2型糖尿病，特别是餐后高血糖患者。
用法用量：口服，每日3次，餐前15-30分钟服用。
具体用法用量请遵医嘱。
不良反应：常见不良反应包括头痛、鼻塞、咳嗽等感冒症状。
少数患者可能会出现低血糖症状。
禁忌：对瑞格列奈过敏的患者禁用。
注意事项：1.使用本品时，请务必遵守医生的指导。
2.请与饮食调整和运动相结合，以达到更好的治疗效果。
3.请注意监测血糖水平，避免发生低血糖。
药品名称：磺脲类降糖片主要成分：本品主要成分是磺脲类降糖药，如格列本脲、格列齐特等。
伏格列波糖分散片的注意事项
伏格列波糖分散片的注意事项伏格列波糖分散片是一种用于治疗2型糖尿病的药物。
在使用伏格列波糖分散片时，我们需要注意以下几点：
首先，按照医生或药师的建议正确使用伏格列波糖分散片。
剂量和用法通常根据个体状况而定，因此不要自行调整剂量或更改用法。
如果有任何疑问或需要帮助，请咨询医生或药师。
其次，伏格列波糖分散片通常应该在饭前半小时内服用。
这样可以确保药物在进食之前起效，有助于控制血糖水平。
建议将药片倒入干燥的手掌中，然后直接送入口中。
切勿将药物湿润、咬碎或吞咽整片。
第三，使用伏格列波糖分散片期间，我们需要密切关注自己的血糖变化。
定期测量血糖，并将结果记录在血糖日记中，以便及时调整用药方案。
同时，要密切听从医生的建议，控制饮食，保持适度的体力活动，避免过度劳累和过食甜食。
第四，使用伏格列波糖分散片时，可能会出现一些副作用。
常见的副作用包括胃部不适、恶心、头痛等。
如果出现严重的不良反应或过敏症状，如呼吸困难、皮肤发红等，应立即停药并就医。
最后，伏格列波糖分散片不适用于孕妇、哺乳期妇女以及使用其它糖尿病治疗药物的患者。
此外，对于有肝脏或肾脏病的患者，需要
谨慎使用。
建议在使用伏格列波糖分散片之前告知医生自己的病史和目前的健康状况。
总之，伏格列波糖分散片是一种有效的糖尿病治疗药物，但在使用时需要注意上述事项。
正确使用它，结合健康的生活方式，有助于控制血糖水平，提高生活质量。
同时，我们也要时刻关注自己的身体变化，与医生保持良好的沟通，及时调整治疗方案，以达到良好的治疗效果。
伏格列波糖(江苏晨牌)
Ref: Satoh N, et al. Metabolism Clinical and Experimental 2006(55):786-793
家 能®
家能显著降低全天血糖及胰岛素水平
(mg/dL) 260 220 180 20
——全天血糖——
(mU/mL) 30
——全天血胰岛素——
140
100 60 0 10
家 能®
家能长期治疗降低血糖浓度
(mg/dl) 300 平均值 ±SE
——血糖浓度的变化——
250
餐后2小时浓度
200
** **
*
*
**
* *
空腹浓度
150
**
**
**
开始前 (29)
8 (29)
12~20 (27)
24~32 (28)
36~44 (23)
消化道症状（%）
腹部胀满
排气增加
阿卡波糖每日用量
统计例数
消化道症状（%） 腹部胀满 f: 1.GOTO et al. Lgakuno Ayumi 1992;160(12): 943-971 2. Goto, et al. Basic and Clinical report 1989 .23(10):3929
1.7×10-6
10-4
10-1
6.4×10-9
3.9×10-9
7.3×10-7 2.0×10-2 5.9×10-6
家能 阿卡波糖
麦芽糖
O O HOH2 H H C O OH HO OH OH HOH2C HO HO HO
家能（双糖水解酶抑制剂）
H H N H HO
口服降糖药α-葡萄糖苷酶抑制剂(AGI)比较总结
口服降糖药α-葡萄糖苷酶抑制剂（AGI）比较总结（阿卡波糖、伏格列波糖和米格列醇）一、AGI家族成员二、AGI作用机制比较三、AGI抑酶谱差异比较四、AGI药动学参数差异比较五、AGI用法用量区别比较六、AGI降糖差异比较七、患者用药注意事项八、AGI常见不良反应比较九、AGI特殊注意事项比较α-葡萄糖苷酶抑制剂（AGI）是一种临床常用的口服降糖药，但它到底是一种怎样作用的降糖药物，不同的AGI之间又有怎样的区别呢？今天我们一起来了解一下。
一、AGI家族成员常见的AGI包括阿卡波糖、伏格列波糖和米格列醇。
认识他们从化学结构开始：表1 阿卡波糖、伏格列波糖和米格列醇三药比较图1 三药结构比较二、AGI作用机制比较糖类是人体最主要的供能物质。
食物中的糖包括多糖（淀粉）、双糖（包括麦芽糖、蔗糖等）、单糖（包括葡萄糖、果糖以及半乳糖）。
除单糖可以直接由小肠上皮细胞吸收入血外，其余均需经α-葡萄糖苷酶水解转化成单糖才能利用，也就是说如果抑制了α-葡萄糖苷酶活性就可以减少糖的吸收。
α-葡萄糖苷酶抑制剂的结构类似这些寡糖，能在寡糖与α-葡萄糖苷酶的结合位点与后者结合，可逆性抑制或竞争性抑制α-葡萄糖苷酶，减少寡糖分解为单糖，从而延缓肠道对单糖，特别是葡萄糖的吸收，使餐后血糖峰值渐变低平、波动减小，糖化血红蛋白（HbA1c）明显降低。
如阿卡波糖，它是一种生物合成的假性四糖，其化学结构类似于四个葡萄糖结合成寡糖。
用药教育：阿卡波糖等和碳水化合物（糖）化学结构相似，它会冒充碳水化合物，与肠道上水解碳水化合物的酶——α-葡萄糖苷酶结合，使真正的碳水化合物无法被水解，从而降低餐后血糖。
阿卡波糖等应在用餐前即刻整片吞服或与前几口食物一起咀嚼服用。
如果饭后服用，α-葡萄糖苷酶已经与碳水化合物结合，或碳水化合物已被α-葡萄糖苷酶水解，阿卡波糖等将无法发挥降糖作用。
注意：α-葡萄糖苷酶是麦芽糖酶、异麦芽糖酶、α-临界糊精酶、蔗糖酶和乳糖酶等组成的一类酶的总称。
西药试卷试题及答案
西药试卷1. 螺内酯片治疗水肿性疾病的用法用量（） [单选题] *A.口服，每日40—120mg ，分1—2次B.口服，每日40—120mg，分2—4次(正确答案)C.口服，每日20—80mg，分1—2次D.口服，每日20—80mg，分2—4次2.属于孕激素拮抗剂的药物是（） [单选题] *A.己烯雌酚B.米非司酮(正确答案)C.炔雌醇D.黄体酮3.非那雄胺片的说明书中的常用用法用量（） [单选题] *A.口服，一次10mg，一日1次B.口服，一次5mg，一日1次(正确答案)C.口服，一次5mg，一日2次D.口服，一次10mg，一日2次4.同仁牛黄清心丸的常规用法用量（） [单选题] *A.口服，一次2—3丸，一日2次B.口服，一次2—3丸，一日3次C.口服，一次1—2丸，一日2次(正确答案)D.口服，一次1—2丸，一日3次5. 醋酸地塞米松片的用法用量（） [单选题] *A. 口服，一次0.75～3.00mg，一日2～4次(正确答案)B.口服，一次0.75～1.5mg，一日2～4次C. 口服，一次0.75～3.00mg，一日1～2次D.口服，一次0.75～1.5mg，一日1～2次6. 甲巯咪唑的不良反应不包括（） [单选题] *A.皮疹B.白细胞减少C.嗜睡(正确答案)D.味觉减退7. 格列吡嗪片的用法用量（） [单选题] *A.口服，一般5～10mg/日，早餐前30分钟服。
日剂量超过15mg，宜分3次餐前服用B.口服，一般5～10mg/日，早餐时30分钟服。
日剂量超过15mg，宜分2次餐前服用C.口服，一般2.5～20mg/日，早餐前30分钟服。
日剂量超过15mg，宜分3次餐前服用(正确答案)D.口服，一般2.5～20mg/日，早餐时30分钟服。
日剂量超过15mg，宜分2次餐前服用8. 盐酸二甲双胍片（格华止）的用法用量（） [单选题] *A. 0.5克，每日3次；或0.85克，每日2次；随餐服用。
伏格列波糖片(华怡平)的说明书
伏格列波糖片(华怡平)的说明书
治疗糖尿病是当今社会的一个热议话题，不少中老年朋友很容易患上糖尿病这种疾病，由于身体的衰老，各方面的机能都有所降低，因此很容易受到糖尿病的侵袭。
许多年轻人也患上了糖尿病，治疗迫在眉睫。
在此我们为您介绍一种叫做伏格列波糖片(华怡平)的药物，它是一种全新治疗糖尿病的药物，控糖效果显著。
【药品名称】
通用名称：伏格列波糖片
商品名称：伏格列波糖片(华怡平)
【适应症/功能主治】改善糖尿病餐后高血糖。
【规格型号】0.2mg*20s
【用法用量】通常成人1次1片，1日3次，餐前口服，服药后即刻进餐
【不良反应】详见说明书
【禁忌】详见说明书
【注意事项】详见说明书
【有效期】0 月
【批准文号】国药准字H20093758
【生产企业】苏州中化药品工业有限公司
【主要成份】伏格列波糖
看完上面对于伏格列波糖片(华怡平)的介绍，您是否对于这种药物有了一个比较清晰的了解了呢?治疗糖尿病我们千万不要病急乱投医，科学正规的治疗才是治愈该病的根本所在。
糖尿病虽然不像其他疾病那么可怕，但是对人体的危害却是实实在在的。
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伏格列波糖片说明书
通用名：伏格列波糖片
生产厂家: 苏州中化药品工业有限公司
批准文号：国药准字H20213758
药品规格：0.2mg*20片
药品价格：￥34.2元
【通用名称】伏格列波糖片
【商品名称】伏格列波糖片华怡平
【适应症/功能主治】改善糖尿病餐后高血糖。
【规格型号】0.2mg*20s
【用法用量】通常成人1次1片，1日3次，餐前口服，服药后即刻进餐
【不良反应】详见说明书
【禁忌】详见说明书
【注意事项】详见说明书
【有效期】24月
【批准文号】国药准字H20213758
【生产企业】苏州中化药品工业有限公司
伏格列波糖片华怡平的功效与作用伏格列波糖片华怡平改善糖尿病餐后高血糖。
伏格列波糖片是一个安全性较高的药物，常用于糖尿病的治疗。
伏格列波糖片在临床上的应用广泛，有显著的疗效，受到了广大患者的一致好评。
那么，伏格列波糖片能长期吃吗?
伏格列波糖片是可以长期吃的，但因人而异，需根据个人病情而定。
伏格列波糖片的服用方法是通常成人1次0.2mg1次1片，1日3次，餐前口服，服药后即刻进餐，疗效不明显时，经充分观察可以将每次用量增至0.3mg1次1.5片。
伏格列波糖片在临床上适用于改善糖尿病餐后高血糖。
伏格列波糖片适用于患者接受饮食疗法、运动疗法没有得到明显效果时，或者患者除饮食疗法、运动疗法外还用口服降血糖药物或胰岛素制剂而没有得到明显效果时。
伏格列波糖片能抑制各种α葡萄糖苷酶如麦芽糖酶、异麦芽糖酶、葡萄糖淀粉淀粉酶及蔗糖酶的活性，延缓糖分的消化与吸收，使淀粉分解成寡糖如麦芽糖双糖、麦芽三糖及糊精低聚糖，蔗糖分解成葡萄糖和果糖的速度减慢，造成肠道对葡萄糖的吸收减缓，从而缓解餐后高血糖。
综上所述，伏格列波糖片是可以长期吃的，但为了安全起见，应在医生或药师的指导下服用。
患者服用伏格列波糖片时，应按说明书要求服用。
感谢您的阅读，祝您生活愉快。