Maninil® [Glibenclamide]

Brand Berlin-Chemie / Menarini

In stock 1492 Items

Available since: 2019-09-19

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Clinical Pharmacology

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

Stimulates insulin secretion by binding to the specific receptors of the β-cell membrane of the pancreas, reduces the threshold of stimulation of glucose β-cells of the pancreas, increases insulin sensitivity and the degree of its binding to target cells, increases the release of insulin, enhances the effect of insulin on the absorption of glucose by the 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 blood thrombogenic properties.

Maninil 1.5 and Maninil 3.5 in micronized form is a high-tech, specially crushed form of glibenclamide, which allows the drug to be absorbed faster from the gastrointestinal tract. In connection with the earlier reaching 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 hypoglycemic action is 20-24 hours.

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

Pharmacokinetics

Suction

After oral administration Maninil 1.75 and Maninil 3.5 there is a rapid and almost complete absorption from the gastrointestinal tract. The complete release of the micro-ionized active substance occurs within 5 minutes.

After oral administration, Maninil 5, absorption from the gastrointestinal tract is 48-84%. T_max - 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

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.

T_1/2 for Maninil 1.75 and Maninil 3.5 is 1.5-3.5 hours, for Maninil 5 is 3-16 h.

Indications

Type 2 diabetes mellitus - as monotherapy or as part of combination therapy with other oral hypoglycemic drugs other than sulfonylurea derivatives and glinides.

Composition

1 tablet contains:

Active substances: glibenclamide 1.75 mg.

Excipients: lactose monohydrate - 68.99967 mg, potato starch - 26 mg, gimetellose - 11 mg, colloidal silicon dioxide - 2 mg, magnesium stearate - 0.25 mg, crimson dye (Ponso 4R) (E124) - 0.00033 mg.

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Dosage and Administration

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

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

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

Transition from other hypoglycemic drugs to Maninil 1,75 It should begin under the supervision of a doctor with 1-2 pills of the drug Maninil 1.75 per day (1.75-3.5 mg), gradually increasing the dose to the required therapeutic.

The initial dose of the drug Maninil 3,5 is 1 / 2-1 tablet (1.75-3 mg) 1 time / day. With insufficient effectiveness under the supervision of a physician, the dose of the drug is gradually increased until the daily dose necessary to stabilize carbohydrate metabolism is reached. The dose should be increased at intervals of several days to 1 week, up to the achievement of the required therapeutic dose, which should not exceed the maximum. The maximum daily dose of the drug Maninil 3.5 is 3 pills (10.5 mg).

Transition from other hypoglycemic drugs to Maninil 3,5 It should begin under the supervision of a doctor with 1 / 2-1 tablet of the drug Manin® 3.5 per day (1.75-3.5 mg), gradually increasing the dose to the required therapeutic.

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

Transition from other hypoglycemic drugs to Maninil 5 It should begin under the supervision of a doctor with 1 / 2-1 pills of the drug Maninil® 5 per day (2.5-5 mg), gradually increasing the dose to the required therapeutic.

In elderly patients, debilitated patients, in patients with reduced nutrition, in patients with severely impaired renal or liver 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 washing down with a small amount of liquid. Daily doses of the drug, up to 2 pills, usually should be taken 1 time / day - in the morning, just before breakfast. Higher doses are divided into morning and evening intake.

When you skip a single drug intake, the next pill should be taken at the usual time, and you should not take a higher dose.

Adverse reactions

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.

Metabolism: often - hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, moisture of the skin, loss of motor coordination, 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, feeling of heaviness in the stomach, belching, vomiting, abdominal pain, diarrhea, metallic taste in the mouth.

Liver and biliary tract: very rarely - a temporary increase in liver enzymes, intrahepatic cholestasis, hepatitis.

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

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

Other: very seldom - 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 skin of the face and upper body, tachycardia, dizziness, headache pain), cross-allergy to probenecid, sulfonylurea derivatives, sulfonamides, diuretic (diuretic) agents containing a sulfonamide group in a molecule.

Contraindications

Should be taken with precaution in 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) because of the risk of hypoglycemia.

Drug interactions

Strengthening the hypoglycemic effect of the drug Maninil® is possible with simultaneous use with ACE inhibitors, anabolic agents and male sex hormones, other oral hypoglycemic agents (for example, acarbose, biguanides) and insulin, azapropazone, NSAIDs, beta adrenoblockers, quinolone derivatives, and craps. its analogues, coumarin derivatives, disopyramide, fenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO, PA inhibitors SC, pentoxifylline (in high dose with parenteral administration), perhexylin, derivatives of pyrazolones, phosphamides (for example, cyclophosphamide, ifosfamide, trofosfamida), probenecid, salicylates, sulfonamides, tetracyclines and tritoqualine.

Acidifying means (ammonium chloride, calcium chloride) urine increases the effect of the drug Maninil® by reducing the degree of its dissociation and increasing its reabsorption.

The hypoglycemic effect of Maninil® may diminish with the simultaneous use of barbiturates, isoniazid, diazox-sycapes, and core ccccccccccccccccccccccccccccgappies, sycromacapixors, glucagon, glucagon, nicotinate, acycophagus, syphysicus, syphysicus, sycophagus , blockers of slow calcium channels, lithium salts.

H antagonists₂- on the one hand, receptors can 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.

With simultaneous use with the drug Maninil® may increase or weaken the effect of coumarin derivatives.

Along with the increased hypoglycemic effect, beta-blockers, clonidine, guanethidine and reserpine, as well as drugs with a central mechanism of action, can weaken the feeling of precursors to the symptoms of hypoglycemia.

Pregnancy and Lactation

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

When pregnancy occurs, the drug should be discontinued.

Special instructions

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

Prolonged abstinence from food intake, insufficient provision of the body with carbohydrates, intense physical exertion, diarrhea or vomiting constitute the risk of hypoglycemia.

Simultaneous medication that has an effect on the central nervous system, lowers blood pressure (including beta-blockers), as well as peripheral neuropathy can mask the symptoms of hypoglycemia.

In elderly patients, the risk of hypoglycemia is somewhat higher, therefore, a more careful selection of the dose of the drug and regular monitoring of fasting blood glucose concentrations 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, sensation of heat in the skin of the face and upper body, tachycardia, dizziness, headache), so you should refrain from taking alcohol during treatment with Manilin®.

Large surgical interventions and injuries, extensive burns, infectious diseases with a febrile syndrome may require discontinuation of oral hypoglycemic drugs and insulin administration.

During treatment, prolonged exposure to the sun is not recommended.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

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

Overdosage

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

Treatment: for mild hypoglycemia, the patient should ingest a piece of sugar, food or drinks with a high sugar content (jam, honey, a glass of sweet tea). With loss of consciousness, it is necessary to introduce intravenous glucose - 40-80 ml of 40% dextrose solution (glucose), then infusion of 5-10% dextrose solution. Then you can additionally enter 1 mg of glucagon in / in, in / m or s / c. If the patient does not regain consciousness, then this measure can be repeated; further may require intensive care.