Hlybenklamyd | Maninil tablets 3.5 mg, 120 pcs.

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SKU
BID469657
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Latin name

MANINILВ®
Latin name

MANINILВ®

Release form

Tablets.

Packing

120 pcs

Pharmacological action

Pharmacodynamics

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

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 Maninyl 1.75 and Maninil 3.5, 95% for Maninil 5.

Metabolism and excretion

Almost completely metabolized in the liver with the formation of 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, other than sulfonylureas and clayides.

Contraindications

Hypersensitivity to glibenclamide and / or the components of the

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

type 1 diabetes mellitus

diabetic ketoacidosis, diabetic precoma and coma

pancreatic pancreatic resection ml / min)

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

leukopenia

intestinal I have obstruction, paresis of the stomach

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 (in micronized form) 3.5 mg.

Excipients:

lactose monohydrate - 63.9967 mg,

potato starch - 27.75 mg,

hemetellose - 11 mg,

silicon dioxide colloidal - 3.5 mg,

magnesium stearate - 0.25 mg,

dye (Ponceau 4R) (E124) - 0.0033 mg.

Dosing 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 feeling of fear, headache, transient neurological disorders, including visual and speech disorders, the appearance of paresis or paralysis or altered perceptions of sensations) an increase in body weight.

From the digestive system: infrequently - nausea, a feeling of heaviness in the stomach, belching, vomiting, abdominal pain, 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 hematopoietic 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) containing a sulfonamide group in the molecule.

Overdose

Symptoms: hypoglycemia (feeling hungry, hyperthermia, tachycardia, drowsiness, weakness, dampness of the skin, impaired movement coordination, tremor, general anxiety, feeling of fear, headache, transient neurological disorders, transient disorders manifestations of paresis or paralysis or altered sensations). With the progression of hypoglycemia, patients may lose self-control and consciousness, develop hypoglycemic coma.

Treatment: With mild hypoglycemia, the 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 / in glucose - 40-80 ml of 40% solution of dextrose (glucose), then infusion of 5-10% solution of dextrose. 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.

Expiration

3 years.

Deystvuyuschee substances

Hlybenklamyd

dosage form

dosage form

tablets

Berlin-Chemie / Menarini, Germany

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