Maninil tablets 3.5mg, No. 120

Diabetes mellitus type 2 (non-insulin dependent) with ineffective diet therapy, weight loss with obesity and sufficient physical activity.

Inside, morning and evening, before meals, without chewing. The dose is set individually, depending on the severity of the disease.

ManinilЃ 1.75

The initial dose is 1/2 tab., The average is 2 tab. per day, maximum - 3, in exceptional cases - 4 tab. per day. If it is necessary to take higher doses of the drug (up to 14 mg / day), they switch to Maninil 3.5 mg.

ManinilЃ 3.5

The initial dose is 1 / 2-1 table. The average dose is 1 table. per day, maximum - 3, in exceptional cases - 4 tab. per day. Daily doses up to 2 tablets. usually taken once (in the morning), higher ones are divided into 2 doses (in the morning and in the evening).

ManinilЃ 5

The initial dose is 1/2 tab., The average is 2 tab. per day, maximum - 3-4 table. per day.

Three dosage forms allow for 20 possible dosing regimens.

ManinilЃ 1.75

in glass bottles, 120 pcs.; in a cardboard box 1 bottle or in a blister 10 or 20 pcs.; in a pack of cardboard 3 blisters.

ManinilЃ 3.5

in glass bottles, 120 pcs.; in a cardboard box 1 bottle or in a blister 10 or 20 pcs.; in a pack of cardboard 3 blisters.

ManinilЃ 5

in glass bottles, 120 pcs.; in a cardboard box 1 bottle or in a blister 20 pcs.; in a cardboard box 1, 2, 3, 4 or 6 blisters.

• Hypersensitivity (including to sulfa drugs and other sulfonylurea derivatives), type 1 diabetes mellitus (insulin-dependent),

• metabolic decompensation (ketoacidosis, precoma, coma),

• condition after resection of the pancreas,

• severe liver and kidney disease,

• some acute conditions (for example, decompensation of carbohydrate metabolism in infectious diseases, burns, trauma or after major surgical operations, when insulin therapy is indicated),

• leukopenia,

• intestinal obstruction,

• paresis of the stomach,

• conditions accompanied by impaired absorption of food and the development of hypoglycemia,

• pregnancy and breastfeeding period.

pharmachologic effect

Oral hypoglycemic drug from the group of II generation sulfonylurea derivatives. Stimulates insulin secretion by binding to specific receptors of the pancreatic ?-cell membrane, reduces the threshold of glucose irritation of pancreatic ?-cells, increases insulin sensitivity and the degree of its binding to target cells, increases insulin release, enhances the effect of insulin on glucose uptake by muscles and the liver, thereby reducing the concentration of glucose in the blood. Acts in the second stage of insulin secretion. Inhibits lipolysis in adipose tissue. It has a hypolipidemic effect, reduces the thrombogenic properties of blood. ManinilЃ 1.5 and ManinilЃ 3.5 in micronized form is a high-tech, specially milled form of glibenclamide,allowing the drug to be absorbed faster from the gastrointestinal tract. Due to the earlier achievement of Cmax of glibenclamide in plasma, the hypoglycemic effect practically corresponds in time to the rise in blood glucose concentration after a meal, which makes the effect of the drug softer and more physiological. The duration of the hypoglycemic action is 20-24 hours. The hypoglycemic effect of ManinilЃ 5 develops after 2 hours and lasts 12 hours.

Pharmacokinetics

Suction

After oral administration of Maninil 1.75 and Maninil 3.5, rapid and almost complete absorption from the gastrointestinal tract is observed. The complete release of the microionized active substance occurs within 5 minutes. After oral administration of Maninil 5, absorption from the gastrointestinal tract is 48-84%. Tmax - 1-2 hours. Absolute bioavailability - 49-59%.

Distribution

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

Metabolism and excretion

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 Maninil 1.75 and Maninil 3.5 is 1.5-3.5 hours, for Maninil 5 - 3-16 hours.

Side effect

Determination of the frequency of side effects: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rarely (<1 / 10,000), including individual messages. From the side of metabolism: often - hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, skin moisture, impaired coordination of movements, tremor, general anxiety, fear, headache, transient neurological disorders, including visual disturbances and speech, the appearance of paresis or paralysis or altered perception of sensations); increase in body weight; From the digestive system: infrequently - nausea, 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. From 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; very rare: leukopenia, erythropenia, agranulocytosis; in isolated cases - pancytopenia, hemolytic anemia. Others: very rarely - visual impairment and accommodation disorders, increased diuresis, transient proteinuria, hyponatremia, disulfiram-like reaction when drinking alcohol (the most common signs of the effect: nausea, vomiting, abdominal pain, feeling of heat of the skin of the face and upper body, tachycardia, dizziness , headache),cross-allergy to probenecid, sulfonylurea derivatives, sulfonamides, diuretics (diuretics) containing a sulfonamide group in the molecule.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and during breastfeeding. When pregnancy occurs, the drug should be discontinued.

Application for violations of liver function

The drug is contraindicated in severe hepatic impairment. In patients with severely impaired liver function, the initial and maintenance dose of ManinilЃ should be reduced due to the risk of hypoglycemia.

Application for impaired renal function

The drug is contraindicated in severe renal failure (CC less than 30 ml / min). In patients with severely impaired renal function, the initial and maintenance dose of ManinilЃ should be reduced due to the risk of hypoglycemia.

Application in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

In elderly patients, the initial and maintenance dose of ManinilЃ should be reduced due to the risk of hypoglycemia.

special instructions

During treatment with ManinilЃ, it is necessary to strictly follow the doctor's recommendations on diet and self-control of blood glucose concentration. Prolonged abstinence from food, inadequate carbohydrate supply, intense physical activity, diarrhea or vomiting pose a risk of hypoglycemia. Simultaneous administration of drugs that have an effect on the central nervous system, lowering blood pressure (including beta-blockers), as well as peripheral neuropathy can mask the symptoms of hypoglycemia. In elderly patients, the risk of developing hypoglycemia is slightly higher, therefore, 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 a meal, 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 of the skin of the face and upper body, tachycardia, dizziness, headache), so you should refrain from drinking alcohol during treatment with ManinilЃ. Major surgical interventions and trauma, extensive burns, infectious diseases with a febrile syndrome may require the withdrawal of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.sensation of heat of the skin of the face and upper body, tachycardia, dizziness, headache), therefore, you should refrain from drinking alcohol during treatment with ManinilЃ. Major surgical interventions and trauma, extensive burns, infectious diseases with a febrile syndrome may require the withdrawal of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.sensation of heat of the skin of the face and upper body, tachycardia, dizziness, headache), therefore, you should refrain from drinking alcohol during treatment with ManinilЃ. Major surgical interventions and trauma, extensive burns, infectious diseases with a febrile syndrome may require the withdrawal of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.therefore, you should refrain from taking alcohol during treatment with ManinilЃ. Major surgical interventions and trauma, extensive burns, infectious diseases with a febrile syndrome may require the withdrawal of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.therefore, you should refrain from taking alcohol during treatment with ManinilЃ. Major surgical interventions and trauma, extensive burns, infectious diseases with a febrile syndrome may require the withdrawal of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.infectious diseases with febrile syndrome may require discontinuation of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.infectious diseases with febrile syndrome may require discontinuation of oral hypoglycemic drugs and the appointment of insulin. Prolonged exposure to the sun is not recommended during treatment. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.Influence on the ability to drive vehicles and control mechanisms During the period of treatment, patients should be careful when driving vehicles and other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: hypoglycemia (feeling of hunger, pyrexia, tachycardia, drowsiness, weakness, skin moisture, impaired coordination of movements, tremors, 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, the development of hypoglycemic coma. Treatment: in case of mild hypoglycemia, the patient should take inside a piece of sugar, food or drinks with a high sugar content (jam, honey, a glass of sweet tea). loss of consciousness must be injected intravenously glucose - 40-80 ml of 40% dextrose (glucose) solution, then 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, then this measure can be repeated; further intensive care may be required.

Drug interactions

Enhancing the hypoglycemic effect of ManinilЃ is possible when taken simultaneously with ACE inhibitors, anabolic agents and male sex hormones, other oral hypoglycemic agents (for example, acarbose, biguanides) and insulin, azapropazone, NSAIDs, beta-blockers, chloramphenicolone derivatives its analogs, coumarin derivatives, disopyramide, fenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO inhibitors, PASK, pentoxifylline (in a high dose for parenteral administration), perhexilidine, pyrazolone derivatives, phosphlophosphates (for example ), probenecid, salicylates, sulfonamides, tetracyclines and tritoqualin. Urine acidifying agents (ammonium chloride,calcium chloride) enhance the effect of ManinilЃ by reducing the degree of its dissociation and increasing its reabsorption. The hypoglycemic effect of ManinilЃ may decrease with the simultaneous use of barbiturates, isoniazid, diazoxide, corticosteroids, glucagon, nicotinates (in high doses), phenytoin, phenothiazines, rifampicin, thiazide diuretics, acetazolamide, oral contraceptives, thyroid hormones and hormones , blockers of slow calcium channels, lithium salts. Antagonists of H2 receptors can, on the one hand, weaken and, on the other hand, enhance the hypoglycemic effect of ManinilЃ. Pentamidine in isolated cases can cause a strong decrease or increase in the concentration of glucose in the blood.With simultaneous use with the drug ManinilЃ, the effect of coumarin derivatives may increase or decrease. Along with an increase in the hypoglycemic effect of beta-blockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can weaken the sensation of harbingers of hypoglycemic symptoms.