Instructions for Voxid tablets 0.3 mg blister No. 30
Composition
active ingredient: vogliboz;
1 tablet contains voglibose 0.2 mg or 0.3 mg;
Excipients: lactose monohydrate, corn starch, povidone K30, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties:
VoxidÒ, tablets 0.2 mg: white round flat tablets with beveled edges, embossed with “K” on one side and a break line on the other.
VoxidÒ, tablets 0.3 mg: white round flat tablets with beveled edges and embossed “K” on one side.
Pharmacotherapeutic group
Hypoglycemic drugs, except insulins. ATX code A10B F03.
Pharmacological properties
Pharmacodynamics
Voglibose is an oral hypoglycemic agent, a competitive inhibitor of intestinal alpha-glucosidases (hydrolase enzymes), which are involved in the breakdown of di-, oligo- and polysaccharides. Inhibition of α-glucosidases leads to a slowdown in the breakdown of complex carbohydrates and glucose absorption, resulting in a decrease in postprandial blood glucose levels (postprandial hyperglycemia).
Voglibose does not affect β-glucosidase activity.
Pharmacokinetics
Voglibose is slowly and poorly absorbed and rapidly excreted in the feces. To date, no metabolites of this substance have been identified in human blood or urine. Animal studies have shown that voglibose crosses the placenta and enters breast milk.
Indication
- Treatment of type 2 diabetes mellitus when blood glucose levels cannot be adequately controlled by diet and/or exercise alone; as monotherapy or in combination therapy with other oral hypoglycemic agents or with insulin.
- Treatment of type 1 diabetes mellitus, as part of combination therapy in combination with insulin.
- Prevention of type 2 diabetes in patients with established impaired glucose tolerance.
Contraindication
- Hypersensitivity to the active substance or to any other component of the drug.
- Diabetic ketoacidosis, diabetic precoma, diabetic coma.
- Severe infectious diseases.
- Serious surgeries and injuries.
- Pathological conditions and diseases of the intestine that may worsen under conditions of increased gas formation (inflammatory bowel diseases, erosive-ulcerative changes in the intestine, complete or partial intestinal obstruction, etc.).
- Severe pathological conditions and intestinal diseases accompanied by digestive and absorption disorders.
Special safety precautions
VoxidÒ is used with caution in the following situations:
- simultaneous use of other hypoglycemic agents (possibility of hypoglycemia) (see section "Adverse reactions");
- history of laparotomy or intestinal obstruction (possibility of worsening of the patient's condition due to excessive gas formation in the intestines);
- chronic intestinal diseases accompanied by impaired digestion and absorption (possibility of worsening of the patient's condition due to the mechanism of action of voglibose);
- Rechmeld's syndrome (possibility of worsening of the patient's condition due to excessive gas formation in the intestines);
- hernia, stenosis or ulcer of the large intestine (possibility of worsening of the patient's condition due to excessive gas formation in the intestine);
- severe liver dysfunction (possibility of significant fluctuations in the patient's blood glucose level due to metabolic disorders);
- cirrhosis of the liver (possibility of further impairment of consciousness due to hyperammonemia);
- severe renal dysfunction (possibility of significant fluctuations in the patient's blood glucose level due to metabolic disorders).
The use of Voxid should be restricted to patients who have been definitively diagnosed with diabetes mellitus or impaired glucose tolerance.
For patients with diabetes mellitus for whom diet and/or exercise are indicated, voglibose should be prescribed only when the postprandial blood glucose level within 2 hours after a meal is 11.1 mmol/L or more.
For patients with diabetes mellitus who are on diet, exercise, oral hypoglycemic agents, or insulin, voglibose should only be administered when fasting blood glucose levels are 7.77 mmol/L or greater.
While taking VoxidÒ, it is necessary to carefully monitor the patient's condition and constantly monitor the blood glucose level. In addition, continuous administration of this drug plays an important role in achieving the therapeutic effect.
If after 2-3 months of continuous administration of voglibose (as mono- or combination therapy for diabetes mellitus) the hypoglycemic effect is unsatisfactory (postprandial blood glucose level within 2 hours after a meal is 11.1 mmol/l or more), then treatment should be adjusted accordingly.
If the hypoglycemic effect of voglibose (as mono- or combination therapy for diabetes mellitus) is satisfactory (postprandial blood glucose level within 2 hours after a meal is 8.88 mmol/l or lower), the drug should be discontinued and the further course of the disease should be monitored.
Interaction with other medicinal products and other types of interactions
- Antidiabetic agents: sulfonamide and sulfonylurea derivatives, biguanide derivatives, insulin preparations and agents that improve insulin resistance (risk of hypoglycemia).
- Drugs that enhance the hypoglycemic effect of antidiabetic drugs (β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate derivatives for the treatment of hyperlipidemia, warfarin, etc.).
- Drugs that reduce the hypoglycemic effect of antidiabetic drugs (adrenaline, adrenal cortex hormone, thyroid hormone, etc.).
Application features
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, as this medicine contains lactose.
Use during pregnancy or breastfeeding
VoxidÒ tablets should be administered to pregnant women and women of childbearing potential only if the expected therapeutic benefit outweighs any potential risk. The safety of this drug in pregnant women has not been established.
It is preferable to avoid the use of voglibose in breastfeeding women. However, if use is necessary, breastfeeding should be discontinued.
The ability to influence the reaction speed when driving or working with other mechanisms
When using the drug, adverse reactions may occur that may affect the ability to drive or operate other mechanisms.
Method of administration and doses
The drug VoxidÒ is taken orally, immediately before each meal, with water.
The usual starting dose of VoxidÒ for adults is 0.2 mg 3 times a day. If the therapeutic effect is insufficient, the dose can be increased to 0.3 mg 3 times a day, subject to careful monitoring of the course of the disease.
For elderly patients, the initial dose of VoxidÒ is 0.1 mg 3 times a day. If the therapeutic effect is insufficient, the dose of the drug can be increased to 0.2–0.3 mg 3 times a day, subject to careful monitoring of the course of the disease.
Children
There are no data on the use of voglibose in children, so the drug should not be prescribed to this age group of patients.
Overdose
In case of overdose, the patient should consult a doctor.
Adverse reactions
Metabolic disorders: hypoglycemia.
Gastrointestinal: feeling of bloating, flatulence, diarrhea, intestinal obstruction.
On the part of the hepatobiliary system: fulminant hepatitis, severe liver dysfunction, increased levels of hepatic transaminases (AST, ALT), jaundice.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister. 3 or 10 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
"KUSUM FARM" LLC.
Location of the manufacturer and its business address
Ukraine, 40020, Sumy, Skryabina St., 54.
