Glibenclamide | Maninil 5 tablets 5 mg, 120 pcs.

Latin name

MANINILВ®

Release form

Tablets.

Packing

120 pcs

Pharmacological action

Pharmacodynamics

Oral hypoglycemic drug from the group of sulfonylurea derivatives of the second generation.

Stimulates insulin secretion by binding to specific membrane receptors of the pancreatic cell, reduces the threshold for glucose pancreas , increases the sensitivity to insulin and its binding to target cells, increases the release of insulin, enhances the effect of insulin on glucose uptake muscle and liver, thereby reducing the concentration of glucose in the blood. Acts in the second stage of insulin secretion. It inhibits lipolysis in adipose tissue. It has a hypolipidemic effect, reduces the thrombogenic properties of blood.

Maninil® 1.5 and Maninil® 3.5 in micronized form is a high-tech, especially ground form of glibenclamide, which allows the drug to be absorbed from the digestive tract faster. In connection with the earlier achievement of Cmax of glibenclamide in plasma, the hypoglycemic effect almost corresponds to the time increase in the concentration of glucose in the blood after eating, which makes the effect of the drug softer and physiological. The duration of the hypoglycemic effect is 20-24 hours.

The hypoglycemic effect of Maninil® 5 develops after 2 hours and lasts 12 hours.

Pharmacokinetics

Absorption

After oral administration of Maninyl 1.75 and Maninil 3.5, a rapid and almost complete absorption from the gastrointestinal tract is observed. Full release of the microionized active substance occurs within 5 minutes.

After ingestion of Maninil 5, absorption from the gastrointestinal tract is 48-84%. Tmax - 1-2 hours. Absolute bioavailability - 49-59%.

Distribution of

Plasma protein binding is more than 98% for Maninil 1.75 and Maninil 3.5, 95% for Maninil 5.

Metabolism and excretion

Almost completely metabolized in the liver to form two inactive metabolites, one of which is excreted by the kidneys and the other with bile.

T1 / 2 for Maninil 1.75 and Maninil 3.5 is 1.5-3.5 hours, for Maninil 5-3-16 hours

Indications

Type 2 diabetes mellitus - as monotherapy or as part of combination therapy with other oral hypoglycemic drugs, except for sulfonylureas and clayides.

Contraindications

Hypersensitivity to glibenclamide and / or components of the

preparation hypersensitivity to other sulfonylurea derivatives, sulfonamides, diuretics (diuretics) containing a sulfonamide group in the molecule and probenecid, since cross reactions may occur

type 1 diabetes severe (CC less than 30 ml / min)

decompensation of carbohydrate metabolism in infectious diseases, burns, injuries or after major surgery when insulin is indicated inoculation

leukopenia

intestinal obstruction, gastric paresis

hereditary lactose intolerance, lactase deficiency or glucose and lactose malabsorption syndrome

glucose-6-phosphate dehydrogenase deficiency

pregnancy and lactation (breastfeeding)

children and adolescents under 18 years of age (efficacy and safety have not been studied).

With caution, the drug should be prescribed: for diseases of the thyroid gland (with impaired function), febrile syndrome, hypofunction of the anterior pituitary or adrenal cortex, chronic alcoholism, acute alcohol intoxication, in elderly patients (over 70 years old) due to the risk of hypoglycemia .

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and during breastfeeding.

When pregnancy occurs, the drug should be discontinued.

Composition

1 tablet contains:

Active substances:

glibenclamide 5 mg.

Excipients:

lactose monohydrate - 90 mg,

potato starch - 48.697 mg,

magnesium stearate - 1.5 mg,

talc - 2.25 mg,

gelatin - 2.55 mg,

dye crimson (Pon) (E124) - 0.003 mg.

Dosage and administration

The dose depends on the age, severity of diabetes mellitus, fasting blood glucose concentration and 2 hours after a meal.

The initial dose of Maninil 1.75 is 1-2 tablets (1.75-3.5 mg) 1 time / day. With insufficient effectiveness, under the supervision of a doctor, the dose of the drug is gradually increased until the daily dose necessary to stabilize carbohydrate metabolism is reached. Increasing the dose should be done at intervals from several days to 1 week, until the required therapeutic dose is reached, which should not exceed the maximum. The maximum daily dose of Maninil 1.75 is 6 tablets (10.5 mg).

If the daily dose of glibenclamide exceeds 3 tablets of the drug Maninil® 1.75, it is recommended to use the drug Maninil 3.5.

Switching from other hypoglycemic drugs to Maninil 1.75 should be started under medical supervision with 1-2 tablets of Maninil 1.75 per day (1.75-3.5 mg), gradually increasing the dose to the necessary therapeutic level.

The initial dose of Maninil® 3.5 is 1 / 2-1 tablets (1.75-3 mg) 1 time / day. With insufficient effectiveness under the supervision of a doctor, the dose of the drug is gradually increased until the daily dose is reached, necessary to stabilize carbohydrate metabolism. Increasing the dose should be done at intervals from several days to 1 week, until the required therapeutic dose is reached, which should not exceed the maximum. The maximum daily dose of Maninil® 3.5 is 3 tablets (10.5 mg).

Switching from other hypoglycemic drugs to Maninil® 3.5 should begin under medical supervision with 1 / 2-1 tablets of Maninil® 3.5 per day (1.75-3.5 mg), gradually increasing the dose to the necessary therapeutic level.

The initial dose of Maninil® 5 is 1 / 2-1 tablets (2.5-5 mg) 1 time / day. With insufficient effectiveness, under the supervision of a doctor, the dose of the drug is gradually increased until the daily dose necessary to stabilize carbohydrate metabolism is reached. Increasing the dose should be done at intervals from several days to 1 week, until the required therapeutic dose is reached, which should not exceed the maximum. The maximum daily dose of Maninil® 5 is 3 tablets (15 mg).

Switching from other hypoglycemic drugs to Maninil® 5 should begin under the supervision of a doctor with 1 / 2-1 tablets of Maninil® 5 per day (2.5-5 mg), gradually increasing the dose to the necessary therapeutic level.

In elderly patients, debilitated patients, patients with reduced nutrition, in patients with severe impaired renal or hepatic function, the initial and maintenance dose of Maninil® should be reduced due to the risk of hypoglycemia.

Maninil® should be taken before meals, without chewing and drinking a small amount of liquid. Daily doses of up to 2 tablets should usually be taken 1 time / day - in the morning, immediately before breakfast. Higher doses are divided into morning and evening doses.

If you skip one dose of the drug, the next tablet should be taken at the usual time, while it is not allowed to take a higher dose.

Side effects

Determination of the frequency of side effects:

often (> 1/100, <1/10)

infrequently (> 1/1000, <1/100)

rare (> 1/10 000, <1/1000)

is very rare (<1/10 000), including individual messages.

From the side of metabolism: often - hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, moisture in the skin, impaired coordination of movements, tremor, general anxiety, a sense of fear, headache, transient neurological disorders, including disorders vision and speech, the appearance of paresis or paralysis or altered perceptions of sensations) increase in body weight.

From the digestive system: infrequently - nausea, a feeling of heaviness in the stomach, belching, vomiting, abdominal pains, diarrhea, metallic taste in the mouth.

From the liver and biliary tract: very rarely - a temporary increase in the activity of liver enzymes, intrahepatic cholestasis, hepatitis.

On the part of the immune system: infrequently - itching, urticaria, purpura, petechiae, increased photosensitivity very rarely - generalized allergic reactions, accompanied by skin rash, arthralgia, fever, proteinuria and jaundice allergic vasculitis anaphylactic shock.

From the hemopoietic system: rarely - thrombocytopenia is very rare: leukopenia, erythropenia, agranulocytosis in isolated cases - pancytopenia, hemolytic anemia.

Other: very rare - impaired vision and accommodation disorders, increased diuresis, transient proteinuria, hyponatremia, disulfiram-like reaction when taking alcohol (the most common signs of the effect: nausea, vomiting, abdominal pain, sensation of heat of the face and upper body, tachycardia, dizziness, headache), cross-allergy to probenecid, sulfonylureas, sulfonamides, diuretics (diuretics) agents containing a sulfonamide group in the molecule.

Drug Interaction

Alcohol consumption during treatment with Stopdiar may cause disulfiram-like reactions.

In the course of treatment with the drug, it is impossible to take other oral medicines at the same time due to the strong absorption properties of the drug.

Since Stopdiar is virtually non-absorbable and does not enter the systemic circulation, drug interaction with drugs for systemic use is unlikely and is still unknown. pproduct4677 dfrew7 dfrew7 Drug Interaction srdlk Enhanced hypoglycemic action of Maninil® is possible with simultaneous administration with ACE inhibitors, anabolic agents, such as, for example, , chloramphenicol, clofibrate and its analogs, coumarin derivatives, disopyramide, fenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO inhibitors, PASK, pentoxifylline (in high doses with parenteral administration), perhexilin, pyrazolone derivatives, phosphamides (eg, cyclophosphamide, ifosfamide, trophosacetamide, trophosaclamide, trophosacetamide)

Urine acidifying agents (ammonium chloride, calcium chloride) enhance the action of Maninil® by reducing its dissociation and increasing its reabsorption. srdl sr srlpic glycemic action of Maninil® drug may decrease with simultaneous use of barbiturates, isoniazid, diazoxide, GCS, glucagon, nicotinates (in high doses), phenytoin, phenothiazines, rifampicin, thiazidine agents, slow calcium channel blockers, lithium salts.

H2 receptor antagonists may weaken on one side and enhance the hypoglycemic action of Maninil® on the other.

Pentamidine may cause a severe decrease or increase in blood glucose concentration in isolated cases.

When used with Maninil®, the action of coumarin derivatives can be enhanced or weakened.

Along with increased hypoglycemic action, beta-blockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can attenuate the anticipation of the symptoms of hypoglycemia. pproduct469657 dfrew65 drug interaction srdlk Enhancement of hypoglycemic action of Maninil® is possible with simultaneous administration with ACE inhibitors, anabolic agents, such as, for example, , chloramphenicol, clofibrate and its analogs, coumarin derivatives, disopyramide, fenfluramine, antifungal medicines (mykonazole, fluconazole), fluoxetine, MAO inhibitors, PASC, pentoxifillin (in high doses with parenteral administration), perhexilin, pyrazolone derivatives, phosphamidates, cyclophosphamide, tritokvalin.

Urine acidifying agents (ammonium chloride, calcium chloride) enhance the action of Maninil® by reducing its dissociation and increasing its reabsorption.

The hypoglycemic action of Maninil® may be reduced when co-administered with barbiturates, isoniazid, diazoxide, GCS, glucagon, nicotinate (in high doses), phenytoin, phenothiazines, rifampicin, thiazide contraceptiveamide drugs of thyroid hormones, sympathomimetic agents, slow calcium channel blockers, lithium salts.

H2 receptor antagonists may weaken on one side and enhance the hypoglycemic action of Maninil® on the other.

Pentamidine may cause a severe decrease or increase in blood glucose concentration in isolated cases.

When used with Maninil®, the action of coumarin derivatives can be enhanced or weakened.

Along with increased hypoglycemic action, beta-blockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can attenuate the anticipation of the symptoms of hypoglycemia. pproduct469655 dfrew65 drug interaction srdlk Enhancement of hypoglycemic action of Maninil® is possible with simultaneous administration with ACE inhibitors, anabolic agents, such as, for example, , chloramphenicol, clofibrate and its analogs, coumarin derivatives, disopyramide, fenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO inhibitors, PASK, pentoxifylline (in high doses with parenteral administration), perhexilin, pyrazolone derivatives, phosphamides (eg, cyclophosphamide, ifosfamide, trophosacetamide, trophosaclamide, trophosacetamide)

Urine acidifying agents (ammonium chloride, calcium chloride) enhance the action of Maninil® by reducing its dissociation and increasing its reabsorption. srdl sr srlpic glycemic action of Maninil® drug may decrease with simultaneous use of barbiturates, isoniazid, diazoxide, GCS, glucagon, nicotinates (in high doses), phenytoin, phenothiazines, rifampicin, thiazidine agents, slow calcium channel blockers, lithium salts.

H2 receptor antagonists may weaken on one side and enhance the hypoglycemic action of Maninil® on the other.

Pentamidine may cause a severe decrease or increase in blood glucose concentration in isolated cases.

When used with Maninil®, the action of coumarin derivatives can be enhanced or weakened.

Along with increased hypoglycemic action, beta-blockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can attenuate the anticipation of the symptoms of hypoglycemia.

Overdose

Symptoms: hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, dampness of the skin, impaired movement coordination, tremor, general anxiety, feeling of fear, headache, transient neurological disorders, transient disorders paresis or paralysis or altered perceptions of sensations.) With the progression of hypoglycemia, patients may lose self-control and consciousness, develop hypoglycemic coma. no patient should take a piece of sugar, food or drinks with a high sugar content (jam, honey, a glass of sweet tea) .In case of unconsciousness, it is necessary to enter in / into glucose - 40-80 ml of 40% dextrose (glucose) solution, followed by infusion 5 -10% dextrose solution. You can then additionally inject 1 mg of glucagon in / in, in / m or p / k. If the patient does not regain consciousness, this measure can be repeated further, intensive care may be required.

Storage conditions

Store in a dark place at a temperature not exceeding 25 РC.

The Expiration of

is 3 years.

Deystvuyuschee substances

Hlybenklamyd

Terms of delivery from

pharmacies Prescription

dosage form

dosage form

tablets

Berlin-Schemes / Menarines, Germany