Maninil

Maninil – peroral hypoglycemic drug.

Form of release and structure

Maninil is produced in the form of tablets: ploskotsilindrichesky, with risky and a facet on one of the parties; on 1,75 mg – light pink color, on 3,5 and 5 mg – pink color (on 120 pieces in colourless glass bottles, on 1 bottle in a cardboard pack).

Is a part of 1 tablet:

• Active agent: Glibenclamidum – 1,75, 3,5 or 5 mg (in the micronized form);
• Auxiliary components (on 1,75/3,5/5 mg respectively): monohydrate of lactose – 68,99967/63,9967 / 90 mg, potato starch – 26/27,75/48,697 mg, a gimetelloza – 11/11/0 mg, colloid silicon dioxide – 2/3,5/0 mg, magnesium stearate – 0,25/0,25/1,5 mg, talc – 0/0/2,25 mg, gelatin – 0/0/2,55 mg, crimson dye (Ponso 4R) (E124) – 0,00033/0,0033/0,003 mg.

Indications to use

Maninil appoint at a diabetes mellitus 2 types as monotherapy or along with other peroral hypoglycemic medicines, except for glinid and derivatives of sulphonylurea.

Contraindications

• Diabetes mellitus of type 1;
• Leukopenia;
• Diabetic coma and prekoma, diabetic ketoacidosis;
• State after removal of a pancreas;
• Heavy liver and renal failure (at clearance of creatinine it is less than 30 ml in a minute);
• Stomach paresis, intestinal impassability;
• Decompensation of carbohydrate metabolism at infectious diseases, injuries, burns or after carrying out big surgeries when an insulin therapy is shown;
• Deficit glyukozo-6-fosfatdegidrogenazy;
• Hereditary lactose intolerance, deficit of lactase or sprue of lactose and glucose;
• Age up to 18 years (efficiency and safety of use of Maninil for this age group of patients are not studied);
• Pregnancy and period of breastfeeding (lactation);
• Hypersensitivity to drug components, and also to other derivatives of sulphonylurea, streptocides, a probenetsid, diuretic (diuretic) means with contents in a molecule of sulphonamide group (because of a possibility of development of cross-reactions).

Maninil should be taken with caution the patient with an acute drunkenness, an alcoholism, a feverish syndrome, diseases of a thyroid gland (with dysfunction), hypofunction of bark of adrenal glands or a front share of a hypophysis, and also to patients of 70 years (because of danger of emergence of a hypoglycemia).

Route of administration and dosage

Maninil is accepted inside, without chewing and washing down with a small amount of liquid, it is more preferable – before meal. If the daily dose makes 1-2 tablets, it is accepted once in the morning, just before a breakfast. Higher doses should be accepted in 2 receptions (in the morning and in the evening).

At the accidental admission of one reception of Maninil, the following pill needs to be taken in usual time, without increasing a dose.

The scheme of administration of drug is defined by age, weight of disease, concentration of glucose in blood on an empty stomach and 2 hours later after meal.

In case of insufficient efficiency of the appointed initial dose, under medical control it gradually (from several days to 1 week) is increased before achievement sufficient for stabilization of carbohydrate metabolism (but not above maximum).

Upon transition from reception of other hypoglycemic medicines Maninil is appointed in a usual initial dose under medical control with gradual increase to optimum.

The daily dose (initial/maximum) makes:

• Maninil 1,75: 1,75-3,5/10,5 mg (if the daily dose is higher than 3 tablets, are recommended Maninil 3,5 use);
• Maninil 3,5: 1,75-3,5/10,5 mg;
• Maninil 5: 2,5-5/15 mg.

Because of danger of development of a hypoglycemia by the patient of advanced age, at heavy functional disturbances of a liver or kidneys, the weakened patients and patients with subnutrition need to lower initial and maintenance doses of Maninil.

Side effects

During use of Maninil development of disturbances from some systems of an organism is possible (> 1/100, 1/1000, 1/10 000, <1/1000 – редко, < 1/10 000, включая отдельные случаи – очень редко):

• Alimentary system: infrequently – feeling of weight in a stomach, nausea, abdominal pains, an eructation, vomiting, metal smack in a mouth, diarrhea;
• Immune system: infrequently – a purpura, an itch, a small tortoiseshell, the raised photosensitization, petechias; very seldom – the generalized allergic reactions which are followed by an arthralgia, skin rash, fever, jaundice and a proteinuria; acute anaphylaxis, allergic vasculitis;
• System of a hemopoiesis: seldom – thrombocytopenia; very seldom – an agranulocytosis, an erythropenia, a leukopenia; in isolated cases – hemolitic anemia, a pancytopenia;
• Liver and biliary tract: very seldom – an intra hepatic cholestasia, short-term increase in activity of liver enzymes, hepatitis;
• Metabolism: often – a hypoglycemia (in the form of feeling of hunger, a tremor, a hyperthermia, tachycardia, drowsiness, weakness, a headache, humidity of integuments, a lack of coordination of movements, the general concern, sensation of fear, passing neurologic disturbances, including alalias, emergence of paralyzes or paresis or the changed perception of feelings); increase in body weight;
• Others: very seldom – disorders of accommodation and a vision disorder, strengthening of a diuresis, a hyponatremia, a passing proteinuria, disulfiramopodobny reaction at alcohol intake (treat the most frequent signs of effect: vomiting, nausea, abdominal pains, tachycardia, feeling of heat of an upper part of a trunk and face skin, a headache, dizziness), a cross allergy on пробенецид, the streptocides derivative of sulphonylurea, the diuretic (diuretic) means containing sulphonamide group in a molecule.

Special instructions

During use of Maninil it is necessary to adhere strictly to instructions of the doctor concerning self-checking of concentration of glucose in blood and observance of a diet.

At long abstention of meal, insufficient providing an organism with carbohydrates, an intensive exercise stress, diarrhea or vomiting the risk of development of a hypoglycemia increases.

With the medicines having effect on the central nervous system, reducing arterial pressure including beta adrenoblockers, and also a peripheral neuropathy hypoglycemia signs can mask a concomitant use of Maninil.

At elderly patients the risk of emergence of a hypoglycemia is slightly higher in this connection they need more careful selection of a dose and regular control of concentration of glucose in blood on an empty stomach and after meal, in particular at the beginning of drug use.

Alcohol increases risk of development of a hypoglycemia and emergence of disulfiramopodobny reaction, for this reason it is recommended to refuse its inclusion in time of treatment.

Extensive burns, injuries and big surgical interventions, infectious diseases with a feverish syndrome can become the reason of cancellation of Maninil and purpose of insulin.

Long stay in the sun during therapy is not recommended.

During Maninil use by the patient it is necessary to be careful during control of vehicles and performance of other potentially dangerous works requiring special attention and bystry psychomotor reactions.

Medicinal interaction

At simultaneous use of Maninil with some medicines there can be following effects:

• Inhibitors of an angiotensin-converting enzyme, non-steroidal anti-inflammatory drugs, anabolic drugs and male sex hormones, insulin and other peroral hypoglycemic means (for example, guanyl guanidines, acarbose), азапропазон, the beta adrenoblockers derivative of a hinolon and coumarin, chloramphenicol, Clofibratum and its analogs, фенфлурамин, Disopyramidum, antifungal medicines (Miconazolum, флуконазол), fluoxetine, monoamine oxidase inhibitors, para-Aminosalitsilovaya acid, пентоксифиллин (in high a dose at parenteral administration), пергексилин, derivatives of pyrazyl ketones, phosphamides (for example, ифосфамид, cyclophosphamide, трофосфамид), salicylates, пробенецид, sulfonamides, тритоквалин and tetracyclines: strengthening of hypoglycemic effect of Maninil;
• Barbiturates, isoniazid, diazoxide, glucocorticosteroids, glucagon, nikotinata (in high doses), Phenytoinum, fenotiazina, rifampicin, thiazide diuretics, acetazoleamide, oral contraceptives and estrogen, drugs of hormones of a thyroid gland, sympathomimetic means, blockers of slow calcium channels, lithium salts: decrease in hypoglycemic effect of Maninil;
• Clonidine, beta adrenoblockers, Reserpinum and гуанетидин, and also drugs with the central mechanism of action: weakening of feeling of harbingers of signs of a hypoglycemia;
• Antagonists _{of H2 receptors}: strengthening or weakening of hypoglycemic effect of Maninil;
• Coumarin derivatives: strengthening or weakening of their action;
• The drugs acidifying urine (ammonium chloride, calcium chloride): strengthening of effect of Maninil;
• Pentamidine: strong increase or decrease in concentration of glucose in blood (in isolated cases).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature:

• Maninil 1,75 and 3,5 – to 30 °C;
• Maninil 5 – to 25 °C.

Period of validity – 3 years.