| Generic Name |
Voglibose Tablets |
| Strength |
0.2mg |
| Packing |
3*10 Tablets/box |
| Origin |
China |
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Product name:
Voglibose Tablets
Character:
This product is white or yellowish.
Indications:
Improve diabetic postprandial hyperglycemia. (This product is suitable for patients receiving diet therapy, exercise therapy did not get significant effect, or patients in addition to diet therapy, exercise therapy also take oral hypoglycemic drugs or insulin preparations did not get significant effect.)
Adverse reactions:
According to foreign literature, 154 out of 965 patients (16.0 percent) who took 0.6mg or 0.9mg on the first day and 460 out of 4,446 patients (10.3 percent) who took the drug after marketing (as of September 2000) had adverse reactions, including abnormal values in clinical tests.
The following adverse reactions can be seen from the above investigations or spontaneous reports.
1. Serious adverse reactions
1) Sometimes hypoglycemia occurs when used with other diabetes drugs (the incidence is 0.1-5%). In addition, occasional hypoglycemia (less than 0.1%) was also reported without other diabetes medications. This product can delay the digestion and absorption of disaccharides, such as hypoglycemia symptoms should not be given sucrose should be given glucose for appropriate treatment.
2) Sometimes abdominal fullness, increased intestinal exhaust (incidence of 0.1-5%), etc., due to the increase in intestinal gas, occasionally appear intestinal obstruction-like symptoms (less than 0.1%), should be fully observed, symptoms should be stopped and other appropriate treatment.
3) Occasional fulminant hepatitis, severe liver dysfunction or jaundice with elevated AST(GOT), ALT(GPT), etc. (all less than 0.1%). Therefore, it should be fully observed, and appropriate treatment such as stopping drug administration should be carried out when abnormalities occur.
4) In cases of severe cirrhosis, due to the aggravation of hyperammonemia and disturbance of consciousness (frequency unknown) accompanied by constipation, the situation such as defecation should be fully observed, and appropriate treatment such as stopping the administration should be carried out immediately if abnormal conditions are found.
2. Other adverse reactions
1) Digestive system: diarrhea, soft stool, abdominal crying, abdominal pain, constipation, loss of appetite, nausea, vomiting, heartburn (the incidence is less than 0.1 ~ 5%), stomatitis, thirst, abnormal taste, intestinal wall cystic pneumatosis (less than 0.1%)
2) Allergy [sup] Note 1)[/sup] : rash, itching, light sensitivity (incidence less than 0.1%)
3) Liver: GOT, GPT, LDH, γ-GTP, ALP increased (incidence 0.1-5%)
4) Psychoneurotic system: headache, dizziness, stumbling, drowsiness (incidence is less than 0.1%)
5) Blood system: anemia (incidence below 0.1-5%), thrombocytopenia (below 0.1%)
6) Others: paralysis, facial puffiness, hazy eyes, fever, lethargy, fatigue, hyperkalemia, increased serum amylase, decreased high-density lipoprotein, sweating, hair removal (incidence 0.1-5%)
Note 1) Medication should be discontinued when these conditions occur
Pharmacology and toxicology:
Pharmacological action
This product is an oral hypoglycemic drug. This product inhibits the disaccharide hydrolase (α-glucosidase) that breaks down disaccharides into monosaccharides in the gut, thus delaying the digestion and absorption of sugars, thereby improving postprandial-high blood sugar. Exhaled hydrogen was measured after sucrose loading in healthy adults, and the results showed that this drug has an inhibitory effect on blood glucose increase under clinical use. In normal rats, this product inhibited the increase of blood glucose after starch, maltose and sucrose loading, but did not inhibit the increase of blood glucose after glucose, fructose and lactose loading. The mechanism of action in vitro showed that this product had strong inhibitory effect on maltase and sucrase obtained from the small intestine of pigs and rats. On the other hand, the inhibition of α-pancreatic amylase in pigs and rats was weak, and there was no inhibition of β-glucosidase. The disaccharide hydrolase of the sucrase-isomaltitoase complex in the rat small intestine was competitively inhibited.
Toxicological study
Rats were given [14C] voglibose 1mg/kg at a single dose, and the drug distribution was observed in the fetus and milk.
Storage:
Seal and store in a dry place at 25ºC.
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