Diabetalong, sustained release pills 30mg 60pcs

Composition

of 1 tab. gliclazide 30 mg

Auxiliary substances:

hypromellose (Metocel K-100 LV CR Premium),

colloidal silicon dioxide (aerosil),

calcium stearate,

talc,

lactose monohydrate (lactose 80).

Pharmacological action

 Oral hypoglycemic drug, a second-generation sulfonylurea derivative.

It stimulates the secretion of insulin by the pancreas, reduces the level of glucose in the blood, enhances the insulin-secretory effect of glucose and increases the sensitivity of peripheral tissues to insulin. After 2 years of treatment, most patients do not develop addiction to the drug (increased levels of postprandial insulin and C-peptide secretion remain).

Reduces the time interval from the moment of food intake to the beginning of insulin secretion. Restores the early peak of insulin secretion in response to glucose intake (unlike other sulfonylurea derivatives, which have an effect mainly during the second stage of secretion). It also enhances the second phase of insulin secretion. Reduces peak hyperglycemia after meals (reduces postprandial hyperglycemia).

Gliclazide increases the sensitivity of peripheral tissues to insulin (i. e., it has a pronounced extrapancreatic effect). In muscle tissue, the effect of insulin on glucose uptake, due to improved tissue sensitivity to insulin, is significantly increased (up to + 35%), since gliclazide stimulates the activity of muscle glycogen synthetase.

Reduces the formation of glucose in the liver, normalizing fasting glucose levels.

In addition to its effect on carbohydrate metabolism, gliclazide improves microcirculation. The drug reduces the risk of small vessel thrombosis by influencing two mechanisms that may be involved in the development of complications in diabetes mellitus: partial inhibition of platelet aggregation and adhesion and a decrease in the concentration of platelet activation factors (beta-thromboglobulin, thromboxane B2), as well as restoration of fibrinolytic activity of the vascular endothelium and increased activity of the tissue plasminogen activator.

Gliclazide has antioxidant properties: it reduces the level of lipid peroxides in plasma, increases the activity of erythrocyte superoxide dismutase.

Due to the peculiarities of the dosage form, daily use of a single dose of Diabetalong ® tablets 30 mg provides an effective therapeutic concentration of gliclazide in blood plasma for 24 hours

. Pharmacokinetics

 Suction

After oral use, gliclazide is completely absorbed from the gastrointestinal tract. Food intake does not affect absorption. The concentration of the Active ingredient in the blood plasma gradually gradually increases, reaches a maximum and reaches a plateau 6-12 hours after taking the drug. Individual variability is relatively low. The relationship between the dose taken and the concentration of the drug in the blood plasma is a linear relationship with time.

Distribution and metabolism

Binding to plasma proteins is approximately 95%.

It is metabolized in the liver and is mainly excreted by the kidneys. Active metabolites are absent in plasma.

Deduction

Excretion by the kidneys is mainly in the form of metabolites, less than 1% of the drug is excreted unchanged.

T1 / 2 is approximately 16 hours (12 to 20 hours).

Pharmacokinetics in special clinical cases

No clinically significant changes in pharmacokinetic parameters are observed in the elderly.

Indications

Type 2 diabetes mellitus in combination with diet therapy with insufficient effectiveness of diet and exercise.

Contraindications

• diabetes mellitus type 1;
• diabetic ketoacidosis, diabetic precoma, diabetic coma;
• severe renal and/or hepatic failure;
• age to 18 years;
• use of miconazole;
• pregnancy;
• the period of breast-feeding (lactation);
• congenital lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• hypersensitivity to gliclazide or any of the excipients of the drug, other sulfonylureas, sulfonamides.

It is not recommended to use the drug simultaneously in combination with phenylbutazone or danazol.

With caution: elderly age, irregular and/or unbalanced diet, severe diseases of the cardiovascular system (including CHD, atherosclerosis), hypothyroidism, adrenal or pituitary insufficiency, hypopituitarism, renal and/or liver failure, long-term therapy with corticosteroids, alcoholism, glucose-6-phosphate dehydrogenase deficiency.

Side effects

 From the digestive tract: very rarely — dyspeptic phenomena (nausea, vomiting, abdominal pain), extremely rarely-jaundice.

From the cardiovascular system and blood: reversible cytopenia, eosinophilia, anemia.

From the skin: rarely – allergic skin reactions, photosensitization.

From the side of metabolism: hypoglycemia.

From the nervous system and sensory organs: weakness, headache, dizziness, changes in taste sensations.

Interaction

Gliclazide enhances the effect of anticoagulants (warfarin), it may be necessary to adjust the dose of the anticoagulant.

Miconazole (with systemic use and when using a gel on the oral mucosa) increases the hypoglycemic effect of the drug (hypoglycemia may develop up to a coma).

Phenylbutazone (systemic use) increases the hypoglycemic effect of the drug (displaces it from binding to plasma proteins and / or slows down its excretion from the body), blood glucose monitoring and dose adjustment of gliclazide are necessary, both during phenylbutazone use and after its withdrawal.

Ethanol and ethanol-containing drugs increase hypoglycemia by inhibiting compensatory reactions, and may contribute to the development of hypoglycemic coma.

When taken concomitantly with other hypoglycemic drugs (insulin, acarbose, biguanides), beta-blockers, fluconazole, ACE inhibitors (captopril, enalapril), histamine H2-receptor blockers (cimetidine), MAO inhibitors, sulfonamides and NSAIDs, there is an increased hypoglycemic effect and the risk of hypoglycemia.

When taken concomitantly with danazol, a diabetogenic effect is noted. It is necessary to monitor blood glucose levels and adjust the dose of gliclazide, both during taking danazol and after its withdrawal.

Chlorpromazine in high doses (more than 100 mg/day) increases the level of glucose in the blood, reducing the secretion of insulin. It is necessary to monitor blood glucose and adjust the dose of gliclazide, both during the use of chlorpromazine and after its withdrawal.

CORTICOSTEROIDS (systemic, intra-articular, external, rectal use) increase blood glucose levels with the possible development of ketoacidosis (reduced tolerance to carbohydrates). It is necessary to monitor blood glucose and adjust the dose of gliclazide both during the use of corticosteroids and after their withdrawal.

Ritodrin, salbutamol, terbutaline (intravenous use) increase the blood glucose level. It is recommended to monitor blood glucose and, if necessary, transfer the patient to insulin therapy.

How to take, course of use and dosage

The drug is intended only for the treatment of adults.

Diabetalong ® modified release tablets 30 mg are taken orally 1 time / day during breakfast.

For patients who have not previously received treatment (including those over 65 years of age), the initial dose is 30 mg. Then the dose is selected individually until the required therapeutic effect is achieved.

The dose selection should be carried out in accordance with the blood glucose level after the start of treatment. Each subsequent dose change may be made after at least a two-week period.

The daily dose of the drug can vary from 30 mg (1 tab. ) to 90-120 mg (3-4 tab. ). The daily dose should not exceed 120 mg (4 tablets).

Diabetalong® can replace gliclazide tablets with a normal release (80 mg) in doses from 1 to 4 tablets/day.

If you miss one or more doses of the drug, you should not take a higher dose at the next reception (the next day).

When replacing another hypoglycemic drug with Diabetalong 30 mg tablets, no transition period is required. You must first complete the daily dose of another drug and only start taking this drug the next day.

If the patient has previously received therapy with sulfonylureas with a longer half-life, then careful monitoring (monitoring of blood glucose levels) for 1-2 weeks is necessary to avoid hypoglycemia as a consequence of the residual effects of previous therapy.

Diabetalong® can be used in combination with biguanides, alpha-glucosidase inhibitors or insulin.

In patients with mild to moderate renal insufficiency, the drug is prescribed in the same doses as in patients with normal renal function. Diabetalong® is contraindicated in patients with severe renal insufficiency.

In patients at risk of developing hypoglycemia (insufficient or unbalanced nutrition; severe or poorly compensated endocrine disorders – pituitary and adrenal insufficiency, hypothyroidism; withdrawal of CORTICOSTEROIDS after prolonged use and/or high doses; severe cardiovascular diseases (severe CHD, severe carotid artery atherosclerosis, advanced atherosclerosis/), it is recommended to use a minimum dose (30 mg 1 time/ day) of Diabetalong®.

Overdose

Symptoms: hypoglycemia, impaired consciousness, hypoglycemic coma.

Treatment: if the patient is conscious, take sugar inside.

It is possible to develop severe hypoglycemic conditions, accompanied by coma, convulsions or other neurological disorders. If such symptoms occur, it is necessary to provide emergency medical care and immediate hospitalization.

If hypoglycemic coma is suspected or diagnosed,50 ml of 40% dextrose (glucose) solution is quickly administered intravenously to the patient. Then, a 5% dextrose (glucose) solution is administered intravenously to maintain the required blood glucose level.

After regaining consciousness, it is necessary to give the patient food rich in easily digestible carbohydrates (in order to avoid the repeated development of hypoglycemia). Careful monitoring of blood glucose levels and monitoring of the patient should be carried out for at least 48 consecutive hours. After this period of time, depending on the patient’s condition, the attending physician decides whether further monitoring is necessary.

Dialysis is ineffective due to the pronounced binding of gliclazide to plasma proteins.

Special instructions

Treatment is carried out only in combination with a low-calorie diet with a low carbohydrate content.

It is necessary to regularly monitor the blood glucose level on an empty stomach and after meals, especially in the first days of treatment with the drug.

Diabetalong® can only be prescribed to patients who receive a regular diet that necessarily includes breakfast and provides a sufficient intake of carbohydrates.

When prescribing the drug, it should be borne in mind that hypoglycemia may develop due to taking sulfonylurea derivatives, and in some cases – in a severe and prolonged form, requiring hospitalization and glucose use for several days. Hypoglycemia is more likely to occur with a low-calorie diet, after prolonged or vigorous exercise, after drinking alcohol, or while taking several hypoglycemic medications at the same time.

To avoid the development of hypoglycemia, careful and individual selection of doses is necessary, as well as providing the patient with complete information about the proposed treatment.

In case of physical and emotional stress, when changing the diet, it is necessary to adjust the dose of Diabetalong®.

Especially sensitive to the effects of hypoglycemic drugs are elderly people, patients who do not receive a balanced diet, with a general weakened state, patients with pituitary-adrenal insufficiency.

Beta-blockers, clonidine, reserpine, and guanethidine may mask the clinical manifestations of hypoglycemia.

Patients should be warned about the increased risk of hypoglycemia in cases of taking ethanol, NSAIDs, and fasting.

If you take ethanol (alcohol), you may also develop a disulfiram-like syndrome (abdominal pain, nausea, vomiting, headache).

Major surgical interventions and injuries, extensive burns, and infectious diseases with febrile syndrome may require discontinuation of oral hypoglycemic medications and the appointment of insulin therapy.

It is possible to develop secondary drug resistance (it is necessary to distinguish it from the primary one, in which the drug does not give the expected clinical effect even at the first appointment).

During Diabetalong® therapy, the patient should refrain from using alcohol and / or ethanol-containing drugs and foods.

During treatment with Diabetalong®, the patient should regularly determine the levels of glucose and glycosylated hemoglobin in the blood, glucose in the urine.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Diabetalong pills.

Storage conditions

The drug should be stored in a dry place, protected from light, inaccessible to children at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Gliclazide

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes