Hua Yi Ping Fu Ge Lie Bo Tang Pian / Voglibose tablets For Diabetes 0.2mg*30 Tablets*5 boxes

伏格列波糖片

Generic name: Voglibose tablets

Product name: Voglibose Tablets (Hua Yiping)

English name: Voglibose Tablets

Full Pinyin Code: FuGeLieBoTangPian(HuayiPing)

[Main Ingredients] The main ingredients of this product are: Voglibose.

【Ingredients】

Molecular weight: C10H21NO7

[Properties] This product is white or slightly yellow tablets.

[Indications/Functions and Indications] The indication is to improve postprandial hyperglycemia in diabetes. (This product is suitable for patients receiving diet therapy or exercise therapy without obvious effects, or when patients use oral hypoglycemic drugs or insulin preparations in addition to diet therapy or exercise therapy, but no obvious effects are obtained.)

【Specification Model】 0.2mg*30s

【Usage and Dosage】Usually adult 0.2mg (1 tablet per time), 3 times a day, orally before meals, and eat immediately after taking the medicine. When the effect is not obvious, the dosage can be increased to 0.3mg (1 1.5 tablets each time).

[Adverse reactions] According to foreign literature, among 965 cases taking 0.6 mg or 0.9 mg a day, 154 cases (16.0%), and 460 cases out of 4446 cases in the post-marketing use result survey (up to September 2000) (10.3%) There were adverse reactions including abnormal values ​​in clinical examinations. The following adverse reactions can be seen in the above investigations or spontaneous reports. 1. Serious adverse reactions 1) Hypoglycemia sometimes occurs when combined with other diabetes drugs (incidence rate is 0.1 to 5%). In addition, there are reports of occasional hypoglycemia (less than 0.1%) without using other diabetes drugs. This product can delay the digestion and absorption of disaccharides. If symptoms of hypoglycemia occur, sucrose should not be given but glucose should be given for proper treatment. 2) Occasionally, abdominal fullness, increased intestinal gas flow (incidence rate of 0.1 to 5%), etc., due to the increase of intestinal gas, occasional intestinal obstruction-like symptoms (less than 0.1%), should be fully observed, appear Symptoms should be treated appropriately such as drug withdrawal. 3) Occasionally fulminant hepatitis, severe liver dysfunction or jaundice accompanied by an increase in AST (GOT), ALT (GPT), etc. (all less than 0.1%). Therefore, it should be fully observed, and appropriate treatments such as stopping the administration should be performed when abnormalities occur. 4) In case of severe liver cirrhosis, due to the deterioration of hyperammonemia and disturbance of consciousness (unknown frequency) caused by constipation, etc., the conditions such as defecation should be fully observed. If abnormalities are found, the drug should be stopped immediately and appropriate treatment . 2. Other adverse reactions 1) Digestive system: diarrhea, soft stools, abdominal pain, abdominal pain, constipation, loss of appetite, nausea, vomiting, heartburn (incidence below 0.1% to 5%), stomatitis, thirst, abnormal taste, Intestinal wall cystoid pneumocystis (less than 0.1%) 2) Allergies [sup]Note 1)[/sup]: rash, itching, photosensitivity (incidence below 0.1%) 3) Liver: GOT, GPT, LDH , Γ-GTP, ALP increase (incidence rate is 0.1～5%) 4) Nervous system: headache, dizziness, staggering, drowsiness (incidence rate is less than 0.1%) 5) Blood system: anemia (incidence rate is 0.1～5 % Or less), thrombocytopenia (less than 0.1%) 6) Others: paralysis, facial swelling, hazy eyes, fever, fatigue, fatigue, hyperkalemia, increased serum amylase, decreased high-density lipoprotein, sweating , Hair loss (incidence rate is 0.1～5%) Note 1) When these conditions occur, the medication should be stopped

[Contraindications] The following patients are prohibited from medication 1. Patients with severe ketosis, diabetic coma or pre-coma. (Because infusion and insulin must be used to quickly adjust hyperglycemia, it is not suitable for taking this product.) 2. Patients with severe infections, patients before and after surgery or patients with severe trauma. (Because it is necessary to regulate blood sugar by injecting insulin, it is not suitable for taking this product.) 3. Patients who have a history of allergies to the ingredients of this product.

【Notes】 1. The following patients should take medication with caution 1) Patients who are taking other diabetes drugs (while taking this product may cause hypoglycemia.) 2) Patients with a history of abdominal surgery or intestinal obstruction (because taking this product may increase intestinal gas , Prone to intestinal obstruction-like symptoms.) 3) Patients with chronic intestinal diseases accompanied by digestion and absorption disorders (Because this product may cause adverse gastrointestinal reactions, it may make the condition worse.) 4) Lemme Patients with Roem-held syndrome, severe hernia, large bowel stenosis and ulcers. (Because taking this product may increase intestinal gas, it may worsen the condition.) 5) Patients with severe liver dysfunction (Due to changes in metabolic status, significant changes in blood glucose control may be induced. In addition, in severe liver cirrhosis In the case, hyperammonemia may worsen and accompanied by disturbance of consciousness.) 6) Patients with severe renal dysfunction (Due to changes in metabolic status, significant changes in blood glucose control may be induced.) 2. Important note 1) This product is only used for patients who have been clearly diagnosed with diabetes. It must be noted that in addition to diabetes, abnormal glucose tolerance and positive urine glucose can also cause diabetes-like symptoms (renal diabetes, senile glucose metabolism, thyroid Abnormal function, etc.). 2) For patients who only receive the basic treatment of diabetes, that is, diet therapy and exercise therapy, they are limited to a blood sugar level of 200 mg/dl (11.1 mmol/L) or more 2 hours after a meal. 3) In addition to diet therapy and exercise therapy, for patients who use oral hypoglycemic agents or insulin preparations, the index of taking this product is that the blood glucose level on fasting is above 140 mg/dl (7.8mmol/L). 4) During the period of taking this medicine, the blood glucose level must be monitored regularly and pay attention to observation, and pay full attention to the necessity of continuous medication. If the effect of controlling postprandial blood glucose is not satisfactory after taking the medicine for 2 to 3 months (the blood glucose level of intravenous plasma cannot be controlled below 200mg/dl (11.1mmol/L) 2 hours after the meal), another more suitable treatment must be considered method. In addition, postprandial blood glucose is adequately controlled (the blood glucose level drops below 160 mg/dl (8.9 mmol/L) 2 hours after a meal in intravenous plasma), diet therapy, exercise therapy, or combined oral hypoglycemic drugs or insulin preparations can adequately control blood glucose At times, stop taking this product and pay attention to observation. 5) When using this product, the symptoms of hypoglycemia and its treatment should be fully explained to the patient. 6) When the drug is delivered: the drug in the aluminum-plastic blister pack should be taken out of the aluminum-plastic blister sheet (it has been reported that due to accidental ingestion of the aluminum-plastic blister sheet, the hard acute angle pierced the esophageal mucosa, and then perforation occurred, and the mediastinum Serious complications such as inflammation). Please read the instructions carefully and follow the doctor's advice.

【Children's Medication】Unclear.

[Medication for elderly patients] Elderly people usually decline in physiological functions. They should start with a small dose (for example, 0.1 mg once), and observe the occurrence of blood sugar levels and digestive system symptoms. At the same time, they should be used with caution.

[Medication for pregnant women and breastfeeding women] Pregnant women, parturients and breastfeeding women should take the drug carefully, because the safety of medication during pregnancy has not been established, pregnant women or women who may become pregnant, only when it is judged that the therapeutic benefit is greater than the risk Only medicine can be used. Although breastfeeding women should be avoided as much as possible, breastfeeding should be stopped when they have to. 【Animal experiments (rats) have found that this product inhibits the weight gain of newborn rats, presumably because it inhibits the absorption of sugar from the mother animal and inhibits milk secretion. 】

[Drug interactions] Precautions for combined medication 1. When combined with diabetes drugs (such as sulfonamides and sulfonylurea drugs, biguanides, insulin preparations, insulin sensitizers): When combined with insulin and sulfonylurea drugs , Due to reports of hypoglycemia, when the above-listed drugs are used in combination, the possibility of hypoglycemia should be considered, and the administration should be carefully started from a low dose. 2. When diabetic drugs and drugs that enhance or reduce their hypoglycemic effect are used together: 1) Drugs that enhance the hypoglycemic effect of diabetes drugs (β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate) Hyperlipidemia treatment agent, warfarin, etc.). 2) Drugs that reduce the glucose-lowering effect of diabetes drugs (epinephrine, adrenaline corticosteroids, thyroid hormones, etc.) When the above-listed drugs are used in combination with this product, attention should be paid to the interactions recorded in the note item of concomitant use of diabetes drugs, and should also be adequate Pay attention to the effect of delayed sugar absorption of this product.

【Overdose】Unclear.

[Pharmacology and Toxicology] Pharmacological effects This product is an oral hypoglycemic agent. This product inhibits the disaccharide hydrolase (α-glucosidase) that breaks down disaccharides into monosaccharides in the intestines, thus delaying the digestion and absorption of sugars, thereby improving postprandial hyperglycemia. Exhaled hydrogen gas was measured after the healthy adults were given sucrose load. The results confirmed that the drug has an inhibitory effect on the increase of blood sugar under clinical dosage. When administered orally to normal rats, this product inhibits the increase in blood sugar after loading with starch, maltose and sucrose, but has no inhibitory effect on the increase in blood sugar after loading with glucose, fructose and lactose. In vitro studies on the mechanism of action have shown that this product has a strong inhibitory effect on maltase and sucrase obtained from the small intestine of pigs and rats; on the other hand, it has weak inhibitory effect on α-pancreatic amylase in pigs and rats. No inhibitory effect on β-glucosidase. The disaccharide hydrolase of the invertase-isomaltase complex in the rat small intestine is competitively inhibiting. Toxicological studies Rats were given a single dose of [[sup]14[/sup]C] voglibose 1 mg/kg, and the drug distribution was seen in the fetus and milk.

[Pharmacokinetics] According to foreign research data, in healthy adult males, once 0.2mg, 3 times a day, for 7 days, no voglibose was detected in plasma or urine. In healthy adult men, no voglibose was detected in plasma and urine when a single dose of 2 mg was taken.

【Storage】Sealed.

[Packing] 0.2mg*30s/box.

【Validity Period】 24 months

[Approval number] National Medicine Standard H20093758

[Manufacturer] Suzhou Sinochem Pharmaceutical Industry Co., Ltd.