Glucobay pills 50 mg 30 pcs
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Active ingredients
Acarbose
Release form
Pills
Composition
1 tablet contains: Acarbose 50 mg Supplementary substances: anhydrous colloidal silicon dioxide - 250 mcg, magnesium stearate - 500 mcg, corn starch - 54.25 mg, microcrystalline cellulose - 30 mg.
Pharmacological effect
Hypoglycemic drug. Acarbose is a microbial pseudotetrasaccharide. The mechanism of action of acarbose is based on the inhibition of the intestinal enzyme alpha-glucosidase, which breaks down di-, oligo- and polysaccharides. As a result of the suppression of enzyme activity, a dose-dependent prolongation of the time of absorption of carbohydrates and, consequently, of glucose, which is formed during the breakdown of carbohydrates, occurs. Thus, acarbose slows the flow of glucose into the bloodstream and reduces the concentration of glucose in the blood after a meal. By regulating the absorption of glucose from the intestine, the drug reduces its daily fluctuations in the blood plasma and leads to a decrease in its average level. In case of an increase in the concentration of glycated hemoglobin, acarbose reduces its level. In a prospective, randomized, placebo-controlled, double-blind study (duration of treatment is 3-5 years, on average, 3.3 years), in which 1429 patients with confirmed impaired glucose tolerance participated, the relative risk of developing type 2 diabetes mellitus in the Gl group Koba has decreased by 25% .u these patients also noted a significant reduction in the incidence of cardiovascular events by 49%, and myocardial infarction (MI) - by 91%. These results were confirmed by a meta-analysis of 7 placebo-controlled acarbose studies in the treatment of type 2 diabetes mellitus (a total of 2180 patients, of whom 1248 received acarbose and 932 were placebo). In patients receiving acarbose, and in which type 2 diabetes developed for the first time, the risk of developing MI decreased by 68%.
Pharmacokinetics
Absorption, distribution and metabolism Absorption of acarbose from the gastrointestinal tract is negligible. After ingestion of Glukobai, 2 peaks of Cmax of acarbose in the blood plasma are observed inside - after 1-2 hours and after 14-24 hours. The appearance of the second peak is due to the absorption of metabolites from the intestine. The oral bioavailability is 1-2%. Excretion of T1 / 2 acarbose in the distribution phase - 4 hours, in the elimination phase - 10 hours.The drug is excreted in the form of metabolites by the kidneys (35%) and through the intestines (51%).
Indications
- treatment of type 2 diabetes mellitus in combination with diet therapy.
Contraindications
- chronic gastrointestinal diseases with severe disorders of digestion and absorption - conditions that may be accompanied by flatulence (Remheld syndrome, large hernia of any size, impaired intestinal patency, peptic ulcer) - severe renal failure (with CC <25 ml / min); - pregnancy; - lactation (breastfeeding); - children and adolescents under 18 years of age; - hypersensitivity to acarbose or any of the components of the drug.
Precautionary measures
With caution, use the drug for fever, infectious diseases, injuries, surgical interventions. Since an asymptomatic increase in the activity of hepatic transaminases is possible when taking the drug, it is recommended to monitor the level of these enzymes during the first 6-12 months of therapy (usually, if the drug is canceled, these indicators normalize).
Use during pregnancy and lactation
Glucobay should not be used during pregnancy, because there is no reliable information on the use of the drug in pregnant women. Glucobay is not recommended for use during lactation. If necessary, the appointment of the drug during lactation breastfeeding should be discontinued.
Dosage and administration
Inside the Glukobai tablet should be taken whole, not chewed, with a small amount of water, immediately before a meal or chewed with the first portion of food. The optimal dose of the drug is selected individually for each patient. The initial dose is 1 tab. on 50 mg or 1/2 tab. 100 mg 3 times / day. The average daily dose of Glukoby is 300 mg (2 pills of 50 mg or 1 tablet of 100 mg 3 times / day). In case of insufficient effectiveness of treatment after 4-8 weeks of therapy, the dose may be increased to 200 mg 3 times / day. The maximum daily dose is 600 mg. In elderly patients over the age of 65, changing the dose or dosing regimen is not required. In patients with impaired liver function, changing the dosing regimen is also not required.
Side effects
On the part of the digestive system: often - flatulence, diarrhea, epigastric pain; sometimes nausea; rarely - an increase in liver enzymes (3 times), disappearing after discontinuation of the drug, bowel obstruction, jaundice and / or hepatitis and related liver damage.In Japan, isolated cases of fulminant hepatitis with a fatal outcome were noted, however, the relationship between these cases and the use of acarbose is not clear. Allergic reactions: rarely - skin rash, hyperemia, exanthema, urticaria.
Overdose
Symptoms: in the case of taking Glukobai together with products and / or drinks containing carbohydrates (oligo-, di- and polysaccharides), exceeding the recommended daily dose may lead to the development of symptoms of overdose in the form of flatulence and diarrhea. When taking Glukobai in excess doses, regardless of the meal, the development of adverse events from the gastrointestinal tract is not expected. Treatment: food and drinks containing carbohydrates should be excluded from the diet for 4-6 hours.
Interaction with other drugs
Kolestiramine, gastrointestinal adsorbents and preparations containing digestive enzymes can affect the efficacy of Glucobay, therefore, their combined use should be avoided. In rare cases, Glukobay can change the bioavailability of digoxin, which may require dose adjustment of digoxin.
special instructions
When using Glukobai, strict adherence to the diet is mandatory. A patient with diabetes should be warned about the impossibility of self-withdrawal of the drug, since this may be accompanied by an increase in blood glucose levels. Failure to follow the recommended diet may increase side effects from the gastrointestinal tract. If, despite strict adherence to the diet, the symptoms intensify, then the dose of the drug can be reduced (for a short or long term). Glucobay does not cause hypoglycemia when prescribed to patients only in combination with a diet. When Glucobaya joins insulin therapy or oral hypoglycemic agents, hypoglycemia may develop due to a decrease in the need for antidiabetic therapy (in rare cases up to coma, which may require correction of prescribed doses). It should be noted that the occurrence of Glucous acute hypoglycemia during its use, glucose should be used to stop it. In an outpatient card for a patient with diabetes mellitus, A note on the use of the drug Glucobay was made. The effect on the ability to drive vehicles and control mechanisms Glucobay does not affect the ability of patients to engage in potentially hazardous activities that require increased attention.