Maninil 5 pills 5 mg 120 pcs
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Active ingredients
Glibenclamide
Release form
Pills
Composition
1 tablet contains: Glybenclamide 5 mg Auxiliary substances: lactose monohydrate - 90 mg, potato starch - 48.697 mg, magnesium stearate - 1.5 mg, talc - 2.25 mg, gelatin - 2.55 mg, dye crimson (Ponso 4R) (E124) - 0.003 mg .
Pharmacological effect
Oral hypoglycemic drug from the group of sulfonylurea derivatives of the II generation. It stimulates insulin secretion by binding to the specific receptors of the β-cell membrane of the pancreas, reduces the threshold of irritation of the β-cells of the pancreas by glucose, increases the sensitivity to insulin and the degree of its binding to target cells by the pancreas, increases its sensitivity to insulin, and the degree of its binding to target cells by pancreatic glands, increases its sensitivity to insulin, and the degree of its binding to target cells by pancreatic glands. release of insulin 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 blood thrombogenic properties. Maninil 1.5 and Maninil 3.5 in micronized form is a high-tech, specially crushed form of glibenclamide, allowing the drug to be absorbed faster from the gastrointestinal tract. In connection with the earlier achievement of plasma Glibenclamide Cmax, the hypoglycemic effect practically corresponds in time to the rise in glucose concentration in the blood 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 in 2 hours and lasts 12 hours.
Pharmacokinetics
Absorption After ingestion of Maninil 1.75 and Maninil 3.5 there is a rapid and almost complete absorption from the gastrointestinal tract. The total release of the micro-ionized active substance occurs within 5 minutes. After ingestion of Maninil 5, absorption from the gastrointestinal tract is 48-84%. Тmax - 1-2 hours. Absolute bioavailability - 49-59%. DistributionPlasma protein binding is more than 98% for Maninil 1.75 and Manila 3.5, 95% for Maninil 5. Metabolism and elimination 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 h, 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, except for sulfonylurea derivatives and glinides.
Contraindications
- hypersensitivity to glibenclamide and / or components that make up the drug; - hypersensitivity to other sulfonylurea derivatives, sulfonamides, diuretic (diuretic) drugs containing a sulfonamide group in the molecule, and to the probenecid, since cross-reactions can occur; - diabetes mellitus type 1; - diabetic ketoacidosis, diabetic precoma and coma; - condition after resection of the pancreas; - severe hepatic failure; - severe renal failure (CC 30 ml / min); - decompensation of carbohydrate metabolism in infectious diseases, burns, injuries or after major surgeries when insulin therapy is indicated; - leukopenia; - intestinal obstruction, paresis of the stomach; lactose; - deficiency of glucose-6-phosphate dehydrogenase; - pregnancy; - lactation period (breastfeeding); - children and adolescents under 18 years of age (efficacy and safety have not been studied).
Precautionary measures
The drug should be prescribed with caution 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) because of the risk of hypoglycemia.
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and during breastfeeding. When a pregnancy occurs, the drug should be stopped.
Dosage and administration
The concentration of glucose in the blood on an empty stomach and 2 hours after a meal. The initial dose of the drug Maninil 5 is 1 / 2-1 tab. (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 for stabilization of 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 tab.(15 mg). The transition from other hypoglycemic drugs on Maninil 5 should be started under the supervision of a doctor with a 1 / 2-1 tab. drug Maninil 5 per day (2.5-5 mg), gradually increasing the dose to the required therapeutic dose. In elderly patients, debilitated patients, patients with reduced nutrition, in patients with severely impaired renal function or liver, the initial and maintenance dose of Manilil should be reduced. for the risk of hypoglycemia. Manilin should be taken before meals, without chewing and washing down with a small amount of liquid. Daily doses of the drug, up to 2 tab., Usually should be taken 1 time / day - in the morning, just before breakfast. Higher doses are divided into morning and evening intake. When skipping a single dose of the drug, the next pill should be taken at the usual time, and you should not take a higher dose.
Side effects
On the part of metabolism: often - hypoglycemia (hunger, hyperthermia, tachycardia, drowsiness, weakness, moisture of the skin, 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 perceptions of sensations); increase in body weight; On the part of the digestive system: rarely - nausea, feeling of heaviness in the stomach, belching, vomiting, abdominal pain, diarrhea, metallic taste in the mouth. , hepatitis. From the immune system: rarely - itching, 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 rare cases - pancytopenia, hemolytic anemia. Others: very rarely - 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 torso, tachycardia, dizziness, headache), cross-allergy to probenecid, sulfonylurea derivatives, sulfonamides, diuretic (diuretic) products containing a sulfonamide group in the molecule.
Overdose
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 (eg, visual and speech disorders, manifestations of paresis or paralysis or altered perceptions of sensations). With the progression of hypoglycemia, patients may lose self-control and consciousness, the development of hypoglycemic coma. Treatment: if mild hypoglycemia occurs, the patient should be ingested a sugar cube, food or drinks with a high sugar content (jam, honey, a glass of sweet tea). If you lose consciousness, you need to enter into / into glucose - 40-80 ml of 40% dextrose (glucose) solution, then infusion of 5-10% dextrose Then you can additionally enter 1 mg of glucagon in / in, in / m or n / k. If the patient does not regain consciousness, then this measure can be repeated, then may require intensive therapy.
Interaction with other drugs
Strengthening the hypoglycemic effect of the drug Maninil is possible 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-adrenergic blockers, quinolone, and quinolone, in the same way as in quinolone, i'm, I, I, I, I,… analogues, coumarin derivatives, disopyramide, fenfluramine, antifungal drugs (miconazole, fluconazole), fluoxetine, MAO inhibitors, PAS K, pentoxifylline (in high dosage when administered parenterally), perhexylin, derivatives of pyrazolones, phosphamides (for example, cyclophosphamide, ifosfamide, trofosfamidom), probenecid, salicylates, sulfonamides, tetracyclines, and tritoqualine. drug Maninil by reducing the degree of its dissociation and increasing its reabsorption. The hypoglycemic effect of the drug Maninil may decrease with the simultaneous use of barbiturates, isoniazid, diazoxide, GCS, glucagon, nicotinates (in high doses), phenytoin, phenothiazines, rifampicin, thiazide diuretics,acetazolamide, oral contraceptives and estrogens, thyroid hormone drugs, sympathomimetic drugs, slow calcium channel blockers, lithium salts. H2 receptor antagonists can weaken on the one hand, and on the other, Manilil can strengthen the hypoglycemic effect of Maninil. or an increase in the concentration of glucose in the blood. When used simultaneously with Maninil, the effect of coumarin derivatives may increase or decrease. Along with By enhancing the hypoglycemic effect, beta-blockers, clonidine, guanethidine, and reserpine, as well as drugs with a central mechanism of action, can weaken the feeling of precursors of symptoms of hypoglycemia.
special instructions
During treatment with Maninil, it is imperative to strictly follow the doctor’s recommendations regarding dietary and self-monitoring of glucose concentration in the blood. on the central nervous system, reducing blood pressure (including beta-blockers), as well as peripheral neuropathy can mask the symptoms of hypoglycemia. In elderly patients age, the risk of hypoglycemia is somewhat higher, therefore, a more careful selection of the drug dose and regular monitoring of fasting blood glucose concentrations and after eating is necessary, especially at the beginning of treatment. Alcohol can provoke the development of hypoglycemia, as well as the development of a disulfiram-like reaction (nausea, vomiting, pain in stomach, sensation of heat of the skin of the face and upper torso, tachycardia, dizziness, headache), so you should refrain from taking alcohol during treatment with Maninil. Big surgeon Interventions and injuries, extensive burns, infectious diseases with febrile syndrome may require discontinuation of oral hypoglycemic drugs and insulin. Long-term exposure to the sun is not recommended during treatment. Effect on ability to drive motor vehicles and control mechanisms During the period of treatment, patients should be careful when driving and other potentially hazardous activities that require increased attention and speed torrential reactions.