Type 2 diabetes (non-insulin dependent), especially in obese people, in which the use of diet and exercise alone was ineffective.
Composition:
1 tabl contains 50 mg or 100 mg of acarbose.
Action:
An oral antidiabetic drug from the group of α-glucosidase inhibitors. The action of acarbose is associated with the inhibition of intestinal enzymes (α-glucosidases) involved in the digestion of carbohydrates: disaccharides, oligosaccharides and polysaccharides, which leads to a dose-dependent delay in the digestion of these carbohydrates. As a result, Glucose is more liberally released from carbohydrates and is more slowly absorbed into the blood. In this way, acarbose delays and reduces the postprandial increase in blood glucose. This action relieves pancreatic β cells and prevents the occurrence of reflex postprandial hyperinsulinaemia. The result of balancing the absorption of glucose from the intestines is a reduction in the daily fluctuation of blood glucose levels and a reduction in the average blood glucose values. Taking acarbose does not increase weight. During treatment with acarbose, there is a significant reduction in fasting glucose and a decrease in glycated hemoglobin (HbA1c). The effectiveness of a drug depends to a large extent on the time it is taken: the drug works most effectively if it was taken with the first bite of a meal; taking the drug about 30 minutes before a meal or 15 minutes after starting a meal significantly reduces its effectiveness. Changes in drug concentration in plasma have a two-phase course. The first peak occurs after 1.1 ± 0.3 hours and coincides with the peak of the active compound in the plasma; the second peak occurs after 20.7 ± 5.2 h and is the result of the absorption of bacterial degradation products from further parts of the intestine. T0,5 elimination is 3.7 ± 2.7 h for the distribution phase and 9.6 ± 4.4 h for the elimination phase. 1.7% of the administered dose is excreted in the urine and 51% are excreted in the faeces within 96 hours.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Chronic bowel diseases associated with pronounced digestive and absorption disorders. Conditions that may deteriorate as a result of increased intestinal gas accumulation (eg, Roemheld's syndrome, large hernia, intestinal obstruction, intestinal ulcer). Severe renal failure (creatinine clearance <25 ml / min). Pregnancy and breastfeeding.
Precautions:
In individual cases, asymptomatic elevation of liver enzymes may occur. These changes usually disappear after discontinuation of the medicinal product. The safety and efficacy of the product in children and adolescents under 18 years of age have not been established, therefore the use of acarbose in this age group is not recommended. Do not stop taking your product regularly without consulting your doctor because of the risk of increasing blood glucose. If hypoglycaemia occurs in patients taking acarbose in combination therapy with insulin, a sulphonylurea or Metformin, the patient should receive Glucose, not another sugar (sucrose).
Pregnancy and lactation:
Due to the lack of sufficient data from controlled clinical trials on the safety of the medicine, acarbose should not be given during pregnancy and breast-feeding. Pregnant women with diabetes are recommended to use insulin.
Side effects:
Very often: bloating. Common: diarrhea, gastrointestinal pain and abdominal distress. Uncommon: nausea, vomiting, indigestion; increase in liver enzymes. Rare: edema; jaundice. Not known: thrombocytopenia; allergic reactions (rash, erythema, efflorescence, urticaria); intestinal obstruction, intestinal hypertension, intestinal choriosa; hepatitis. An abnormal diet during treatment may exacerbate gastrointestinal side effects. If, despite the patient's compliance with the appropriate diet, there are still noxious side effects, the dose should be temporarily or permanently reduced.
Dosage:
Orally, individually.The following dosage is recommended: 50 mg once daily (dinner) for the first 3 days; 50 mg 2 times a day (lunch and dinner) for the Next 3 days; 50 mg 3 times a day (breakfast, lunch, dinner) for the next 7 days; then 3 times a day (50 mg breakfast, 50 mg lunch and 100 mg supper) for 3 days; 3 times a day (50 mg breakfast, 100 mg dinner and 100 mg supper) for the next 3 days; from 4-8 weeks 100 mg 3 times a day (breakfast, lunch and dinner). The average dose is 300 mg acarbose per day. In some cases, it may be necessary to further increase the dose to 200 mg 3 times a day. The dose may be increased after 4-8 weeks of use and in the event of insufficient patient response to the drug. In exceptional cases, the dose may be increased to 600 mg per day. The preparation should be taken immediately before a meal or with the first bites. The tablets should be swallowed whole with a small amount of liquid. No restrictions are envisaged regarding the length of treatment with the preparation.