For medical use
active substance: voglibose;
1 tablet contains voglibose 0.2 mg or 0.3 mg;
excipients: lactose monohydrate, maize starch, povidone K30, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.
Pharmaceutical form: Tablets.
Main physicochemical properties:
Voxid®, tablets 0.2 mg: white round flat tablets with bevelled edges, embossed with "K" on one side and a score line on the other side.
Voxid®, tablets 0.3 mg: white round flat tablets with bevelled edges, embossed with "K" on one side.
Hypoglycemic agents, excluding insulins. Code АТС A10B F03.
Pharmacodynamics. Voglibose – is an oral hypoglycemic agent, a competitive inhibitor of intestinal alpha-glucosidases (hydrolase enzymes), which are involved in the cleavage of di-, oligo- and polysaccharides. The inhibition of alpha-glucosidase activity reduces the cleavage of complex carbohydrates and glucose absorption, resulting in a reduction in postprandial blood glucose level (postprandial hyperglycemia).
Voglibose does not affect the activity of β-glucosidase.
Pharmacokinetics. Voglibose is slowly and poorly absorbed and rapidly excreted in feces. As of today, no metabolites of the substance have been identified in the human blood and urine. The animal studies have shown that voglibose penetrates through the placenta and into breast milk.
- Treatment of type 2 diabetes mellitus, if a diet and/or physical exercises can not adequately maintain the blood glucose level; as monotherapy or in combination with other oral hypoglycemic agents or with insulin.
- Treatment of type 1 diabetes mellitus, as part of combined therapy in conjunction with insulin.
- Prevention of type 2 diabetes mellitus in patients with impaired glucose tolerance.
- Hypersensitivity to the active substance or to any other component of the drug.
- Diabetic ketoacidosis, diabetic pre-coma, diabetic coma.
- Severe infections.
- Major surgeries and traumas.
- Pathological conditions and bowel diseases, which may deteriorate under the conditions of enhanced gas production (inflammatory bowel diseases, erosive and ulcerative changes in the intestine, partial or complete intestinal obstruction, etc.).
- Severe pathological conditions and bowel diseases, accompanied by impaired digestion and absorption.
Voxid® should be used with caution in such cases:
- concomitant use of other hypoglycemic agents (the possibility of hypoglycemia) (see. section "Adverse reactions")
- laparotomy or ileus in past medical history (the possibility of the patient's condition deterioration due to excessive gas formation in the intestine);
- chronic bowel diseases, accompanied by indigestion and malabsorption (the possibility of the patient's condition deterioration due to voglibose mechanism of action);
- Roemheld's syndrome (the possibility of the patient's condition deterioration due to excessive gas formation in the intestine);
- hernia, stenosis or ulceration of the large intestine (the possibility of the patient's condition deterioration due to excessive gas formation in the intestine);
- severe hepatic dysfunction (the possibility of significant fluctuations in patient’s blood glucose levels because of metabolic disorders);
- hepatic cirrhosis (the possibility of further impairment of consciousness due to hyperammonemia);
- severe renal impairment (the possibility of significant fluctuations in patient’s blood glucose levels because of metabolic disorders).
Voxid® administration should be limited to patients with diabetes mellitus or impaired glucose tolerance.
In patients with diabetes mellitus, who keeps a diet and/or physical exercises, voglibose should be prescribed only when the post-prandial blood glucose levels are 11.1 mmol/L or more in 2 hours after meal.
In patients with diabetes mellitus who are recommended to keep a diet, physical exercises, oral hypoglycemic agents or insulin, voglibose should be prescribed only when the fasting blood glucose level is 7.77 mmol/L or more.
Patient’s condition and blood glucose level should be closely monitored while administering Voxid®. In addition, an important role in achieving the therapeutic effect plays a continuous administration of this drug.
If after 2-3 months of voglibose continuous administration (as mono-or combined therapy of diabetes mellitus) the hypoglycemic effect is unsatisfactory (post-prandial blood glucose levels are 11.1 mmol/L or more in 2 hours after meal), then a treatment should be appropriately adjusted.
If in case of voglibose administration (as mono- or combined therapy of diabetes mellitus) the hypoglycemic effect is satisfactory (postprandial blood glucose levels are 8.88 mmol/L or less in 2 hours after a meal), then discontinue the drug administration and monitor the further disease progression.
Drug interactions and other kinds of interactions
Combinations requiring precautions for use.
- Antidiabetic drugs: sulfonamide and sulfonylurea derivatives, biguanides, insulin drugs, and agents that improve insulin resistance (the risk of hypoglycemia).
- Drugs that increase the hypoglycemic effect of antidiabetic drugs (β-blockers, salicylic acid drugs, monoamine oxidase inhibitors, fibrate derivatives for the treatment of hyperlipidemia, warfarin, etc.).
- Drugs that reduce the hypoglycemic effect of antidiabetic drugs (adrenalin, adrenal hormones, thyroid hormones, etc.).
Consult a doctor if you were tested for some sugar intolerance, before taking this drug, as it contains lactose.
Administration during pregnancy and lactation.
Voxid®, tablets, can be administered to pregnant women or to women with presumable pregnancy only if the expected therapeutic benefit exceeds any potential risk. Safety usage of this drug for pregnant women is not identified.
It is preferable to avoid using voglibose by breast feeding women. In case of necessity of drug administration it should be decided to terminate breastfeeding.
Effects on ability to drive and operate machinery.
The drug therapy may cause adverse effects which can affect the ability to drive and operate other mechanisms.
The drug Voxid® is administered orally, directly before each meal time, followed with a sufficient amount of water.
Usually, the initial dose of the drug Voxid® for adults compiles 0.2 mg 3 times a day. If the therapeutic effect is insufficient, the drug dosage can be increased to 0.3 mg 3 times a day, provided that the disease course is closely observed.
For elderly patients the initial dose of the drug Voxid® is0.1 mg 3 times a day. If the therapeutic effect is insufficient, the drug dosage can be increased to 0.2–0.3 mg 3 times a day provided that the disease course is closely observed.
There is no data on using voglibose in children, therefore, it is not recommended in this age category of patients.
In case of overdose, a patient should consult a doctor.
Metabolic disorder: hypoglycemia.
Gastro-intestinaltract: feeling of abdominal distention, meteorism, diarrhea, iliac passion.
Hepatobiliary system: fulminant hepatitis, severely impaired liver function, level increase of liver transaminase (AST, ALAT), jaundice.
Storeat a temperature NMT 25°С in the original package.
Keep it out of reach of children.
10 tablets in a blister. 3 or 10 blisters in a carton pack.
Conditions of supply.
«Kusum Pharm» LTD.
54, Skryabina Str., Sumy 40020, Ukraine.