Maninil, pills 1.75mg, 120pcs

Composition

Active ingredients:

glibenclamide 1.75 mg.

Auxiliary substances:

lactose monohydrate – 68.99967 mg,

potato starch-26 mg,

hymetellose-11 mg,

colloidal silicon dioxide-2 mg,

magnesium stearate-0.25 mg,

crimson dye (Ponceau 4R) (E 124) – 0.00033 mg

Pharmacological action

Pharmacodynamics

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

It stimulates insulin secretion by binding to specific receptors of the pancreatic beta-cell membrane, reduces the threshold of glucose irritation of pancreatic beta-cells, increases sensitivity to insulin and the degree of its binding to target cells, increases the release of insulin, enhances the effect of insulin on glucose uptake by muscles and liver, thereby reducing the concentration of glucose in the blood. It acts in the second stage of insulin secretion. 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, specially ground form of glibenclamide, which allows the drug to be absorbed faster from the gastrointestinal tract. Due to the earlier achievement of the Cmax of glibenclamide in plasma, the hypoglycemic effect almost corresponds to the time of an increase in the concentration of glucose in the blood after a meal, which makes the effect of the drug milder and more physiological. The duration of hypoglycemic action is 20-24 hours.

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

Suction

After oral use of Maninil 1.75 and Maninil 3.5, rapid and almost complete absorption from the gastrointestinal tract is observed. Complete release of the microionized Active ingredient occurs within 5 minutes.

After oral use of Maninil 5, absorption from the gastrointestinal tract is 48-84%. Tmax – 1-2 h. Absolute bioavailability-49-59%.

Distribution

Binding to plasma proteins is more than 98% for Maninil 1.75 and Maninil 3.5,95% for Maninil 5.

Metabolism and elimination

It is 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 Manil 1.75 and Manil 3.5 is 1.5-3.5 hours, for Manil 5 – 3-16 hours.

Indications

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

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

If pregnancy occurs, the drug should be discontinued.

Contraindications

• Hypersensitivity to glyburide and/or components included in the composition of product;
• hypersensitivity to other sulfonylureas, sulfonamides, diuretic (diuretic) media containing the molecule sulfonamide group, and the probenecid, as it may cross-reactions;
• diabetes mellitus, type 1;
• diabetic ketoacidosis, diabetic precoma and coma;
• condition after resection of the pancreas;
• severe hepatic impairment;
• renal failure severe (CC less than 30 ml/min);
• decompensation of carbohydrate metabolism in infectious diseases, burns, injuries or after major surgical operations, when shown holding insulin;
• leukopenia;
• intestinal obstruction, paresis of the stomach;
• hereditary lactose intolerance, lactase deficiency or malabsorption syndrome glucose and lactose;
• deficiency of glucose-6-phosphate dehydrogenase;
• pregnancy and lactation (breastfeeding);
• childhood and adolescence to 18 years (effectiveness 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) due to the risk of hypoglycemia.

Side effects

Determining the frequency of side effects:

• often ( > 1/100, > < 1/10);
• infrequently ( > 1/1000, > < 1/100);
• rarely ( > 1/10 000, >< 1/1000);
• very rare (

From the side of metabolism: often-hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, moist skin, impaired coordination of movements, tremor, general anxiety, fear, headache, transient neurological disorders, including visual and speech disorders, the appearance of paresis or paralysis, or altered perception of sensations); weight gain.

From the digestive system: infrequently – nausea, heaviness in the stomach, belching, vomiting, abdominal pain, diarrhea, metallic taste in the mouth.

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

From the immune system: infrequently-pruritus, urticaria, purpura, petechiae, increased photosensitization; very rarely-generalized allergic reactions accompanied by skin rash, arthralgia, fever, proteinuria and jaundice; allergic vasculitis; anaphylactic shock.

From the hematopoietic system: rarely-thrombocytopenia; very rarely: leukopenia, erythropenia, agranulocytosis; in isolated cases-pancytopenia, hemolytic anemia.

Other: very rare – visual 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, heat sensation of the face and upper body, tachycardia, dizziness, headache), cross-allergy to probenecid, sulfonylurea derivatives, sulfonamides, diuretics (diuretics) products containing a sulfonamide group in the molecule.

Interaction

The hypoglycemic effect of Maninil® may be enhanced when taken concomitantly with ACE inhibitors, anabolic agents and male sex hormones, other oral hypoglycemic agents (for example, acarbose, biguanides) and insulin, azapropazone, NSAIDs, beta-blockers, quinolone derivatives, chloramphenicol, clofibrate and its analogues, coumarin derivatives, disopyramide, phenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO inhibitors, PASC, pentoxifylline (in high dose with parenteral use), perhexylin, pyrazolone derivatives, phosphamides (for example, cyclophosphamide, ifosfamide, trophosfamide), probenecid, salicylates, sulfonamides, tetracyclines and tritoqualin.

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

The hypoglycemic effect of Maninil® may decrease with the simultaneous use of barbiturates, isoniazid, diazoxide, corticosteroids, glucagon, nicotinates (in high doses), phenytoin, phenothiazines, rifampicin, thiazide diuretics, acetazolamide, oral contraceptives and estrogens, thyroid hormone preparations, sympathomimetic agents, slow calcium channel blockers, lithium salts.

H2-receptor antagonists may, on the one hand, weaken and, on the other, enhance the hypoglycemic effect of Maninil®.

Pentamidine in isolated cases can cause a strong decrease or increase in the concentration of glucose in the blood.

When used concomitantly with Maninil®, the effect of coumarin derivatives may increase or decrease.

Along with increasing the hypoglycemic effect, beta-blockers, clonidine, guanethidine, and reserpine, as well as drugs with a central mechanism of action, can reduce the perception of harbingers of symptoms of hypoglycemia.

How to take, course of use and dosage

The dose of the drug depends on the age, the severity of diabetes mellitus, the concentration of glucose in the blood on an empty stomach and 2 hours after a meal.

The initial dose of Manilil ® 1.75 is 1-2 tablets (1.75-3.5 mg) 1 time / day. If there is 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. Dose increases should be made at intervals of several days to 1 week, until the required therapeutic dose is reached, which should not exceed the maximum. The maximum daily dose of Manilil 1.75 is 6 tablets (10.5 mg).

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

Switching from other hypoglycemic drugs to Manil 1.75 should be started under the supervision of a doctor with 1-2 tablets of Manil 1.75 per day (1.75-3.5 mg), gradually increasing the dose to the required therapeutic one.

The initial dose of Manilil ® 3,5 is 1/2-1 tablet (1.75-3 mg) 1 time / day. If there is 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. Dose increases should be made at intervals of several days to 1 week, until the required therapeutic dose is reached, which should not exceed the maximum.The maximum daily dose of Manilil ® 3,5 is 3 tablets (10.5 mg).

Switching from other hypoglycemic drugs to Manil ® 3,5 should be started under the supervision of a doctor with 1/2-1 tablet of Manil® 3,5 per day (1.75-3.5 mg), gradually increasing the dose to the required therapeutic one.

The initial dose of Maninil ® 5 is 1/2-1 tablet (2.5-5 mg) 1 time / day. If there is 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. Dose increases should be made at intervals of 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 medications to Maninil ® 5 should be started under the supervision of a doctor with 1/2-1 tablet of Maninil® 5 per day (2.5-5 mg), gradually increasing the dose to the required therapeutic one.

In elderly patients, debilitated patients, patients with reduced nutrition, in patients with severe renal or hepatic impairment, 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 with a small amount of liquid. Daily doses of the drug, 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 intake.

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

Overdose

Symptoms: hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, moist skin, impaired coordination of movements, tremor, general anxiety, fear, headache, transient neurological disorders (for example, visual and speech disorders, manifestations of paresis or paralysis, or altered perception of sensations). With the progression of hypoglycemia, the patient may lose self-control and consciousness, and develop hypoglycemic coma.

Treatment: for mild hypoglycemia, the patient should take a lump of sugar, food or drinks with a high sugar content (jam, honey, a glass of sweet tea). In case of loss of consciousness, it is necessary to introduce intravenous glucose-40-80 ml of 40% dextrose (glucose) solution, followed by an infusion of 5-10% dextrose solution. Then you can additionally enter 1 mg of glucagon intravenously, intramuscularly or subcutaneously. If the patient does not regain consciousness, this measure can be repeated; further intensive care may be required.

Special instructions

During treatment with Maninil®, it is necessary to strictly follow the doctor’s recommendations on diet and self-monitoring of blood glucose concentration.

Prolonged abstinence from food, insufficient carbohydrate intake, intense physical activity, diarrhea, or vomiting pose a risk of developing hypoglycemia.

Concomitant use of medications that have an effect on the central nervous system, reduce blood pressure (including beta-blockers), as well as peripheral neuropathy can mask the symptoms of hypoglycemia.

In elderly patients, the risk of hypoglycemia is slightly higher, so a more careful selection of the dose of the drug and regular monitoring of the concentration of glucose in the blood on an empty stomach and after meals, especially at the beginning of treatment, is necessary.

Alcohol can provoke the development of hypoglycemia, as well as the development of a disulfiram-like reaction (nausea, vomiting, abdominal pain, a feeling of heat on the face and upper body, tachycardia, dizziness, headache), so you should refrain from taking alcohol during treatment with Maninil®.

Major surgical procedures and injuries, extensive burns, and infectious diseases with febrile syndrome may require discontinuation of oral hypoglycemic medications and insulin use.

Prolonged exposure to the sun is not recommended during treatment.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

During treatment, patients should exercise caution when driving vehicles and other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Glibenclamide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes