Metgogamma 850 - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Metgogamma 850 inhibits gluconeogenesis in the liver, reduces absorption of glucose from the intestine, enhances peripheral utilization of glucose, and also increases the sensitivity of tissues to insulin.In this case, it has no effect on the secretion of insulin by beta cells of the pancreas. Reduces the level of triglycerides and low density lipoproteins in the blood. Stabilizes or reduces body weight. Has a fibrinolytic effect due to inhibition of the inhibitor of tissue-type plasminogen activator.

Pharmacokinetics:After oral administration metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is -50-60%. The maximum concentration in the blood plasma is reached after 2 hours after ingestion. Virtually does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys. It is allocated in an invariable kind by kidneys. The elimination half-life is 1.5-4.5 hours. In cases of kidney dysfunction, cumulation of the drug is possible.

Indications:Diabetes mellitus type 2, without a tendency to ketoacidosis (especially in patients with obesity) with ineffectiveness of diet therapy.

Contraindications:

Hypersensitivity to the drug;
diabetic ketoacidosis, diabetic precoma, coma;
severe renal dysfunction;
cardiac and respiratory failure, acute phase of myocardial infarction, acute disturbance of cerebral circulation, dehydration, chronic alcoholism and other conditions that may contribute to the development of lactic acidosis;
lactic acidosis and indication of it in an anamnesis; pregnancy and the period of breastfeeding;
serious surgery and trauma, when insulin therapy is indicated;
impaired liver function, acute alcohol poisoning;
application for at least 2 days before and within 2 days after carrying out radioisotope or radiographic studies with the introduction of iodine-containing contrast medium;
adherence to a hypocaloric diet (less than 1000 calories / day).

It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Dosing and Administration:

The dose of Metofamma® 850 is adjusted individually, taking into account the level of glucose in the blood. The initial dose is, as a rule, 850 mg (1 tablet) per day, there may be a further gradual increase in dose, depending on the effect of therapy.The maintenance dose of the drug is 850-1700 mg (1-2 tablets) per day. The maximum daily dose is 2550 mg (3 tablets). A daily dose of more than 850 mg, it is recommended to take in 2 divided doses (morning and evening). In elderly patients, the recommended daily dose should not exceed 850 mg. Tablets Metfogamma 850 should be taken with food, wholly, with a small amount of liquid (a glass of water). The course of treatment with the drug is long.

Due to the increased risk of lactic acidosis, the dose of the drug should be reduced in case of severe metabolic disorders.

Side effects:

From the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea, lack of appetite, "metallic" taste in the mouth. In these cases, it is usually not necessary to stop treatment, and the symptoms go away without changing the dose of the drug. The frequency and severity of GI side effects may decrease with a gradual increase in the dose of metformin. In rare cases - abnormal abnormalities of liver samples or hepatitis, transient after drug withdrawal.

Allergic reactions: skin rash.

From the endocrine system: hypoglycemia (mainly when used in inadequate doses).

From the side of metabolism: in rare cases - lactic acidosis (requires discontinuation of treatment), with prolonged treatment - hypovitaminosis B12 (impaired absorption).

On the part of the hematopoiesis system: in some cases - megaloblastic anemia.

Overdose:In case of an overdose of Methofogma® 850, lactoacidosis can develop with a fatal outcome. The cause of the development of lactic acidosis may also be cumulation of the drug due to impaired renal function. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, lower body temperature, abdominal pain, muscle pain, there may be more rapid breathing, dizziness, impaired consciousness and coma development. In case of signs of lactic acidosis, treatment with Metgammam® 850 should be stopped immediately, the patient should immediately be hospitalized and, after determining the concentration of lactate, confirm the diagnosis. The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment.With combined therapy with Metgammam® 850 with sulfonylureas, hypoglycemia may develop.

Interaction:

When used simultaneously with derivatives of sulfonylurea, acarbose, insulin, non-steroidal anti-inflammatory agents, monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide, B-blockers, hypoglycemic effect of metformin may be enhanced. When used simultaneously with glucocorticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormones, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, a decrease in the hypoglycemic effect of metformin is possible.

Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.Metformin can weaken the effect of indirect anticoagulants (coumarin derivatives). With the simultaneous use of alcohol may develop lactic acidosis.

Nifedipine increases absorption, Cmax, slows down excretion.

Incompatible with ethanol (lactoacidosis).

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, vancomycin), secreted in the tubules, compete for the canalpacial transport systems and, with prolonged therapy, can increase Cmax by 60%.

Special instructions:During the treatment it is necessary to monitor the kidney function. At least 2 times a year, and also with the appearance of myalgia, a determination of the lactate content in the plasma should be carried out. It is possible to use Metgammam® 850 in combination with sulfonylureas or insulin. In this case, a very careful monitoring of blood glucose levels is necessary.

Effect on the ability to drive transp. cf. and fur:

When using the drug in monotherapy does not affect the ability to drive vehicles and work with mechanisms.

When metformin is combined with other hypoglycemic agents (derivatives of sulfonylureas, insulin, etc.), it is possible to develop hypoglycemic conditions in which the ability to drive and engage in other potentially hazardous activities deteriorates,require increased attention and rapid psychomotor reactions.

Form release / dosage:Film coated tablets 850 mg.

Packaging:

10 tablets per blister, made of polyvinylchloride film and aluminum foil.

By 3, 6, 12 blisters together with the instructions for use are placed in a cardboard box.

20 tablets per blister, made of polyvinyl chloride film and aluminum foil.

For 6 blisters together with the instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013816 / 01

Date of registration:07.12.2007 / 12.03.2013

Expiration Date:Unlimited

The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany

Manufacturer: & nbsp

ARTESAN PHARMA, GmbH & Co. KG. KG Germany

DRAGENOPHARM APOTHEKER PUSCHL, GmbH & Co. KG. KG Germany

Representation: & nbspVEVWAG PHARMA GmbH & Co. KG VEVWAG PHARMA GmbH & Co. KG Germany

Information update date: & nbsp11.05.2018

Illustrated instructions

Instructions

Metfogamma® 850 (Metfogamma® 850)