Gliklazid-MV

General characteristics. Structure:

Active ingredient: 30 mg or 60 mg of gliclazide.

Excipients: silicon dioxide colloid anhydrous, hydroxypropyl-methyl cellulose, sodium of a stearil fumarates, talc, lactose monohydrate.

Allows to avoid the long giperinsulinemiya which is the key moment in a diabetes mellitus pathogeny 2 types.

Indications to use:

Non-insulin-dependent diabetes (II type). Drug is intended for reception in combination with a diet and an exercise stress when observance of a diet and an exercise stress are insufficient for maintenance of normal level of glucose in blood.

Route of administration and doses:

For intake. Drug is intended only for treatment of adults.

The daily dose of MB Gliclazide can vary from 30 mg to 120 mg. It is recommended to accept during a breakfast once a day, to swallow of tablets entirely, without chewing.

At the admission of administration of drug it is impossible to increase a dose next day. As well as concerning other hypoglycemic medicines, the dose of this drug in each case needs to be selected individually, depending on metabolic reaction of the patient.

The initial recommended dose - 30 mg (1 tablet of Gliklazd MB a dosage of 30 mg or the 12th tablets a dosage of 60 mg).

In case of effective control of level of glucose in blood, this dose it is possible to use as a maintenance therapy.

If adequate control of level of glucose is not received, it is possible to increase a dose step by step to 60 mg, 90 mg or 120 mg a day. The interval between consecutive increases in a dose of drug has to make not less than 1 month, except for cases when after two weeks of therapy glucose level in blood does not decrease. In such cases the dose can be increased in two weeks after an initiation of treatment.

The maximum recommended daily dose makes 120 mg.

One tablet with the modified release MB Gliclazide of 60 mg is equivalent to two tablets with the modified release MB Gliclazide of 30 mg. The tablet MB Gliclazide of 60 mg easily shares with the modified release that allows to adapt a drug dosing.

Use in a combination with other antidiabetic drugs MB Gliclazide can be applied in combination with biguanidina, inhibitors of alpha glucosidase or insulin. To patients at whom glucose level in blood is not enough controlled by MB Gliclazide reception under fixed medical supervision therapy by insulin can be appointed.

Elderly people. The doses of drug recommended to elderly people are identical to that concerning adults up to 65 years.

Renal failure. The recommended drug doses at a renal failure of weak and moderate degree of manifestation are identical to that for persons with normal renal function. To patients with the increased risk of development of a hypoglycemia: at insufficient or improper feeding; at the heavy or poorly compensated endocrine frustration (a hypopituitarism, a hypothyroidism, insufficiency of adrenocorticotropic hormone); after cancellation of the previous long and/or high-dosage corticosteroid therapy; at serious vascular diseases (a severe form of a coronary disease of heart, heavy disturbance of passability of a carotid artery, diffusion vascular frustration).

It is recommended to appoint administration of drug from the minimum daily initial dose of 30 mg.

Features of use:

At reception of derivatives of sulphonylurea    including gliclazide,  the hypoglycemia can razviyovatsya, and in certain cases - in the severe and long form demanding hospitalization and intravenous administration of solution of glucose  within several days.

 In order to avoid development of a hypoglycemia  careful individual selection of doses, and also providing the complete information to the patient about the offered treatment is necessary.   The patients of advanced age, persons  who are not receiving the balanced food, the patients with the general weakened state and also suffering adrenal or pituitary недостаточно­стью are especially sensitive to effect of hypoglycemic drugs.

  It is sometimes difficult to distinguish development of a hypoglycemia in   the elderly people and patients receiving therapy by beta adrenoblockers. At purpose of MB Gliclazide patients of advanced age need to carry out tshchayotelny control of level of glucose of blood. Purpose of drug has to be gradual and during the first days of therapy it is necessary to control blood glucose level on an empty stomach and after food.

Drug can be appointed only by that patient  whose food is regular and vklyuyochat a breakfast.

 It is very important to support sufficient intake of carbohydrates  as the risk of development of a hypoglycemia increases at irregular food or consumption of the food poor in carbohydrates. The hypoglycemia  develops at a low-calorie diet, after long or vigorous physical exercises, after  alcohol intake or at reception of several hypoglycemic drugs at the same time more often.

The heavy renal or liver failure can exert impact on  a gliclazide raspreyodeleniye in an organism. The liver failure  can also promote decrease in intensity of a gluconeogenesis. The specified effects increase risk of development of hypoglycemic states.

Insufficient control of level of glucose of blood. Control of level of glucose of blood at the patients receiving therapy by hypoglycemic means can  be weakened in the following cases:  temperature increase, travyoma, infectious diseases or surgical interventions.   Under these circumstances there can be a need to stop therapy by drug and to appoint an insulin therapy.

Some patients have an efficiency of any peroral hypoglycemic prepayorat,   including gliclazide, tends to decrease after the long period of treatment. This effect can be caused by either progressing of a disease or decrease in the answer to drug.

This phenomenon is known as secondary medicinal resistance which needs to be distinguished from primary, at which medicine already at the first appointment does not give the expected effect.  Before diagnosing  secondary insufficiency of medicinal therapy for the patient, it is necessary to estimate adequacy of selection of a dose and a soyoblyudeniye to patients of the ordered diet.

Laboratory tests. It is regularly necessary to determine the level of glucose and glikozilirovanny hemoglobin in blood.

Renal and liver failure. At patients with a liver and/or heavy renal failure  pharmacokinetic and/or pharmakodinamichesky properties of gliclazide can change. The condition of a hypoglycemia developing at such patients can be  rather long, in such cases immediate performing the corresponding therapy is necessary.

Information for patients. It is necessary to inform the patient and members of his family on the risk of development of a hypoglycemia, its symptoms and conditions promoting its development. It is also necessary to explain what is primary and secondary medicinal resistance. The patient needs to be informed on potential risk and advantages of the offered treatment, to tell about other types of therapy. The patient needs to explain importance and the sequence of observance of a diet, a neyoobkhodimost of regular physical exercises and control of level of glucose in blood.

Usually   administration of drug in a combination with phenylbutazone and danazoly is not recommended. It is also necessary that the patient gave the following information if:  surgery is necessary, it was traumatized, temperature rose, there are infektsionyony diseases, there is an intention to bring the child.

Patients have to  be informed on symptoms of a hypoglycemia and observe an ostorozhyonost  during  driving or performance of the work demanding the high speed of physical and mental reactions.

Side effects:

Hypoglycemia. Treatment  by MB Gliclazide can lead to approach of a hypoglycemia in cases of nereyogulyarny meal and especially in cases of the admission of its receptions. Possible symptoms of a hypoglycemia:  the headache, acute sense of hunger, nausea, vomiting, bystry fatigue,  sleep disorders, excitement, aggression, weak concentration  of attention,  decline in the ability to estimate a situation and the slowed-down reakyotion, a depression, opacification of consciousness, a visual disturbance and the speech, aphasia, a shiver, paresis, decrease in sensitivity, dizziness, feeling of helplessness, loss само­контроля,  delirium, spasms, shallow breathing, bradycardia, a sonliyovost  and  a loss of consciousness which can come to the end with a coma or lead to a lethal outcome.  Besides,  emergence of such signs of an adrenergic kontrregulyayotion  as sweating, sticky skin, uneasiness, tachycardia, the raised arterial davyoleniye, a cardiopalmus, stenocardia and cardiac arrhythmia is possible. Usually these symptoms disappear after reception of carbohydrates (sugar). At the same time, iskusstyovenny sweeteners have no such effect. At heavy and long attacks of a hypoglycemia even if she manages to be ustrayonit temporarily sugar reception, it is necessary to provide urgently medical care or, at a neobkhoyodimost, even to hospitalize the patient.

Other undesirable effects: disturbances from gastrointestinal system (nausea, diarrhea, heavy feeling in a stomach, a lock, abdominal pains, vomiting nausea). These symptoms meet less often at purpose of MB Gliclazide during a breakfast.

Seldom noted by-effects. Allergic reactions: itch, urticaria, makulopapulezny rash;

 from hemopoietic and lymphatic system: hematologic changes. It can be anemia, a leukopenia, thrombocytopenia, a granulocytopenia. Usually these simyoptoma disappear after the termination of administration of drug;

disturbances  from a liver and a gall bladder: increase in activity of "hepatic" enzymes ( aminotransferase aspartate, alanine of aminotransferase, alkaline phosphatase), hepatitis (separate cases). When developing cholestatic jaundice it is necessary to stop treatment. Usually these symptoms disappear after the termination of reception of a preparayot;

disturbances from ophthalmology: passing vision disorders.

Interaction with other medicines:

1) The drugs strengthening effect of MB Gliclazide (increase in risk of development of a gipogyolikemiya):

Contraindicated combinations. Miconazolum (at its system introduction or drawing on mucous an oral cavity in the form of  gel): strengthens hypoglycemic effect of MB Gliclazide (possibly development of a hypoglycemia up to coma).

Not recommended combinations. Phenylbutazone (system introduction) strengthens hypoglycemic effect of derivatives of sulphonylurea (forces out them from communication with proteins of plasma and/or slows down their removal from an organism). It is more preferable to use other antiinflammatory drug.

Alcohol: strengthens a hypoglycemia, inhibiting compensatory reactions, can sposobyostvovat to development of a hypoglycemic coma. It is necessary to refuse  alcohol intake and reception of medicines which part alcohol is.

The combinations demanding special precautions. Simultaneous use of the following drugs can aggravate hypoglycemic effect of drug and lead in certain cases to approach of a hypoglycemia: other antidiabetic means (insulin, acarbose, guanyl guanidines), beta-blockers, флуконазол, inhibitors angiotensin - reformative enzyme (kartoprit, enalapril), antagonists of a receptor of H2, irreversible inhibitors monoamine of an oxidase (MAOI), sulfonamides and non-steroidal anti-inflammatory drugs.

2) The drugs weakening effect of MB Gliclazide.

Not recommended combinations. Danazol: diabetogenic effect of a danazol. If it is impossible to refuse use of a danazol, explain to the patient importance кон­троля concentration of glucose in blood and urine. Sometimes it is required to modify a dose of anti-diabetic means for therapy time danazoly and after it. There can be a need  of dose adjustment of antidiabetic drug for time and after completion of reception of a danazol.

The combinations demanding special precautions. Chlorpromazinum: in high doses ( more than 100 mg a day) blood glucose level increases, reducing insulin secretion.

Glucocorticosteroids (system and topical administration: intra joint, skin and rectal administration) and тетракозактрин increase   blood glucose level with possible development of ketoacidosis (decrease in tolerance to carbohydrates glucocorticosteroids).

Progestogens: diabetogenic effect of high doses of progestogens.

R-2-adrenostimulyatory - Ritodrinum, salbutamol, тербуталин (system use): increase in level of glucose.

Pay special attention to importance of self-checking of level of glucose in blood. If it is necessary, transfer the patient to therapy with insulin.  If necessary to use above-mentioned combinations it is necessary to pay special attention to control of level of glucose in blood. There can be a need for additional dose adjustment of MB Gliclazide both in the period of a combination therapy, and after cancellation of additional drug.

Combinations which should be considered. Reception of anticoagulating drugs (warfarin): reception of derivative drugs of sulphonylurea  can lead to strengthening of anticoagulating effect of similar drugs. Anticoagulant dose adjustment can be required.

Contraindications:

The real drug should not be used in the following cases:

- persons with an allergy to gliclazide or on any other of the ingredients which are a part of drug on any similar drug (derivative sulphonylurea) or on sulfonamides;

- persons with insulin-dependent diabetes (diabetes of the I type);

- in case of a diabetic coma or a prekoma or at diabetes with ketoacidosis;

- persons with a heavy abnormal liver function or kidneys;

- the persons undergoing treatment by Miconazolum (see. "Interaction with other medicines") (phenylbutazone, даназол);

- lactation period;

- pregnancy;

- children up to 18 years.

Purpose of drugs of sulphonylurea to patients with deficit of glucose-6-fosfatadegidrogenazy (G6PD), can lead to hemolitic anemia. As gliclazide belongs to a class of drugs of sulphonylurea, it is necessary to be careful at its appointment to patients with deficit of G6PD and to consider the alternative possibilities of treatment by drugs of other classes.

Overdose:

The overdose of derivatives of sulphonylurea, including  MB Gliclazide, can при­ lead to development of a hypoglycemia up to a hypoglycemic coma.  In case of a hypoglycemia it is necessary  to eat immediately a little sugar (4-6 pieces). Umeyorenny  symptoms of a hypoglycemia without disturbance of consciousness or neurologic simptoyom  adjust reception of carbohydrates, selection of a dose and/or change of a diet. Tshchayotelny  observation of a condition of the patient has to continue     until is confidence that nothing threatens health of the patient.

 Development of the serious hypoglycemic conditions which are followed by a coma, spasms or other neurologic disturbances is possible. At emergence of such symptoms rendering emergency medical service and immediate hospitalization is necessary.

At suspicion or diagnosis of a hypoglycemic coma, to the patient intravenously struyno enter 50 ml of 40% of solution of a dextrose (glucose). Then intravenously kapelno 5% solution of a dextrose (glucose) for maintenance of necessary level of glucose of blood  about 1 g/l.      It is necessary to make careful control of level of a glycemia and observation of the patient at least within 48 next hours. After this span  depending on a condition of the patient the attending physician resolves an issue of need of further observation.

At patients with  liver diseases the plasma clearance of gliclazide can be longer. Carrying out dialysis for such patients  is not effective, in view of the expressed linkng of gliclazide with proteins of plasma.

Storage conditions:

To store in the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in blister strip packagings. On 3 or 6 blister strip packagings in a cardboard pack together with the application instruction.