Voglibose Tablets

This product is an oral hypoglycemic drug. Its mechanism of hypoglycemic effect is to inhibit the activity of a-glucosidase in the small intestinal wall cells, delay the degradation of ingested carbohydrates, and thus reduce postprandial blood sugar levels.

Voglibose, chemical name: ()-1L-[1(hydroxy), 2,4,5/3]-5-[2-hydroxy-1-(hydroxymethyl)ethyl]amino-1-C-(hydroxymethyl)-1,2,3,4-cyclohexanetetraol. Molecular weight: C10H21NO7

This product is white or slightly yellow tablets.

Improve postprandial hyperglycemia in diabetics. This product is suitable for patients who have not seen significant effects from diet therapy or exercise therapy, or who have not seen significant effects from oral hypoglycemic drugs or insulin preparations in addition to diet therapy or exercise therapy.

Usually, adults take 0.2 mg once, 3 times a day, orally before meals, and eat immediately after taking the medicine. If the therapeutic effect is not obvious, the dosage can be increased to 0.3 mg each time after sufficient observation.

According to foreign literature, 154 cases (16.0%) out of 965 patients who took 0.6 mg or 0.9 mg per day, and 316 cases (11.1%) out of 2,855 patients in the post-marketing use results survey (as of August 1997) had side effects including abnormal clinical test values. The following side effects can be seen in the above survey or spontaneous reports. 1. Serious side effects 1) Hypoglycemia may occur when used in combination with other diabetes drugs (less than 0.1-5%). In addition, there are reports that hypoglycemia may occasionally occur without other diabetes drugs (less than 0.1%). This product can delay the digestion and absorption of disaccharides. If hypoglycemia symptoms occur, sucrose should not be given, but glucose should be given for appropriate treatment. 2) Abdominal distension and increased intestinal gas (less than 0.1-5%) may occur. Due to the increase in intestinal gas, intestinal obstruction-like symptoms may occasionally occur (less than 0.1%). The patient should be fully observed and appropriate treatment such as discontinuation of the drug should be taken if symptoms occur. 3) Severe liver dysfunction accompanied by jaundice, increased GOT, and GPT may occasionally occur (less than 0.1%). In addition, there have been reports of fulminant hepatitis (less than 0.1%) with similar drugs (acarbose), so full observation should be made, and appropriate measures such as discontinuation of administration should be taken when abnormalities occur. 4) When administering to patients with severe liver cirrhosis, due to the worsening of hyperammonemia and impaired consciousness (frequency unknown) triggered by constipation, etc., bowel movements should be fully observed, and appropriate measures such as immediate discontinuation of administration should be taken when abnormalities are found. 2. Other side effects 1) Digestive system: diarrhea, soft stools, abdominal borborygmi, abdominal pain, constipation, loss of appetite, nausea, vomiting, heartburn (incidence rate is less than 0.1-5%), stomatitis, thirst, abnormal taste (less than 0.1%), 2) Allergic symptoms Note 1): rash, itching (incidence rate is less than 0.1%), 3) Liver: increased GOT, GPT, LDH, g-GTP, ALP (incidence rate is less than 0.1-5%), 4) Psychoneural system: headache, dizziness, staggering, drowsiness (incidence rate is less than 0.1%), 5) Others: paralysis, facial edema, blurry eyes, fever, fatigue, weakness, hyperkalemia, increased serum amylase, decreased high-density lipoprotein, sweating, hair loss (incidence rate is less than 0.1-5%), Note 1) If these conditions occur, the drug should be discontinued.

The following patients are prohibited from using the drug: 1. Patients with severe ketosis, diabetic coma or pre-coma. [Since high blood sugar must be quickly adjusted with infusion and insulin, this product is not suitable for them. 2. Patients with severe infection, patients before and after surgery, or patients with severe trauma. [Since it is necessary to adjust blood sugar by injecting insulin, this product is not suitable for them. 3. Patients with a history of allergy to the ingredients of this product.

Precautions for children: The safety of the drug for children has not been established. Precautions for pregnancy and lactation: Pregnant women, parturients and lactating women should use the drug with caution, because the safety of the drug during pregnancy has not been established. Pregnant women or women who may become pregnant can only use the drug when it is determined that the benefits of treatment outweigh the risks. Although lactating women should avoid using the drug as much as possible, breastfeeding should be avoided when the drug must be used. Precautions for the elderly: The elderly usually have decreased physiological functions, so they should start with a small dose and pay attention to the occurrence of blood sugar levels and digestive system symptoms. At the same time, the drug should be used with caution.

Precautions for combined use 1. When using diabetes drugs (such as sulfonamides and sulfonylureas, biguanides, insulin preparations, insulin sensitizers) together: When using insulin and sulfonylureas together, there have been reports of hypoglycemia. Therefore, when using the above drugs together, the possibility of hypoglycemia should be considered and the drug should be administered cautiously from a low dose. 2. When using diabetes drugs together with drugs that enhance or reduce their hypoglycemic effects: 1) Drugs that enhance the hypoglycemic effect of diabetes drugs (β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate-type hyperlipidemia treatment agents, warfarin, etc.) 2) Drugs that reduce the hypoglycemic effect of diabetes drugs (epinephrine, adrenocortical hormones, thyroid hormones, etc.) The above drugs should not be used together with this product

seal.

0.3mg

24 months

Tianjin Takeda Pharmaceuticals Co., Ltd.

• Founded in:

  1994-03-08

• Address:

  No. 11 Xinghua Road, Xiqing District, Tianjin

• Tax NO.:

  91120111600580619K

• Registered Funds:

  $154.84 million

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