Universal reference book for medicines
Product name: AVANDAMET

Active substance: metformin, rosiglitazone

Type: Oral hypoglycemic drug

Manufacturer: GlaxoSmithKline Trading (Russia) manufactured by Glaxo Wellcome (Spain)
PREGNANCY AND LACTATION
Currently, there is insufficient data on the use of the drug in pregnant women. It reported on the ability of rosiglitazone to cross the placenta in humans and is found in fetal tissues. During pregnancy, women with diabetes are usually recommended to prescribe insulin. Pregnant women Avandamet can be given only if the expected benefit to the patient outweighs the potential risk to the fetus.
At present, there is insufficient data on the use Avandameta in lactating women. It is not known whether Avndamet into breast milk. Lactating women suffering from diabetes, insulin is usually recommended to assign. Avandamet lactating women can be given only if the expected benefit outweighs the potential risk to the child.
APPLICATION FOR FUNCTIONS OF THE LIVER

Metformin is excreted by the kidneys, so before treatment Avandametom continue at regular intervals is necessary to determine the concentration of creatinine in serum. Particular attention should be given to patients with an increased risk of kidney failure, such as elderly patients or patients whose condition may be accompanied by a reduction in renal function (dehydration, severe infection, or shock). Avandamet not be prescribed to patients with serum creatinine concentrations of more than 135 micromol / l for men or 110 pmol / L in women.
The drug is contraindicated in case of renal failure (creatinine content in serum more than 135 micromol / l for men and more than 100 micromol / l for women) and / or CC less than 70 ml / min.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Since the liver is one of the risk factors in the treatment of lactic acidosis metformin Avandamet not recommended for patients with impaired liver function.
APPLICATION FOR CHILDREN

The drug is intended for adults.
APPLICATION IN ELDERLY PATIENTS

In elderly patients the initial and maintenance dose should be adequately adjusted Avandameta, given the likely decline in renal function. Any dose correction should be performed depending on renal function, which should be constantly monitored.
SPECIAL INSTRUCTIONS

The combination metformin + rosiglitazone, including Avandamet, only effective while maintaining endogenous insulin production, and the drug should not be administered for the treatment of patients with type 1 diabetes.
Due to increasing insulin sensitivity treatment combination metformin + rosiglitazone premenopausal women with anovulation and insulin resistance (e.g., patients with polycystic ovarian syndrome) can lead to a resumption of ovulation. Such patients may become pregnant. Premenopausal women age received rosiglitazone during clinical studies. Hormonal imbalance observed in the experiment, but during the treatment of women with rosiglitazone there was no significant adverse reactions accompanied by menstrual irregularities. In case of violations of the menstrual cycle should critically assess the feasibility of continuing treatment Avandametom.
Because of cumulation of metformin in rare cases, a serious metabolic complication - lactic acidosis, especially in patients with diabetes mellitus with clinically significant renal dysfunction. Before treatment with metformin and therefore, the combination metformin + rosiglitazone necessary to assess the risk factors associated lactic acidosis, e.g., insufficiently controlled diabetes, ketosis, prolonged fasting, excessive drinking, abnormal liver function (including hepatic failure), and any diseases accompanied by tissue hypoxia. For suspected lactic acidosis should be abolished Avandamet and hospitalize the patient immediately.
There are limited data on rosiglitazone treatment of patients with severe renal insufficiency. Metformin is excreted by the kidneys, so before treatment Avandametom continue at regular intervals is necessary to determine the concentration of creatinine in serum. Particular attention should be given to patients with an increased risk of kidney failure, such as elderly patients or patients whose condition may be accompanied by a reduction in renal function (dehydration, severe infection, or shock). Avandamet not be prescribed to patients with serum creatinine concentrations of more than 135 micromol / l for men or 110 pmol / L in women.
In patients with impaired liver function mild (6 points or less on the scale of Child-Pugh) reduce the dose of rosiglitazone is not necessary. However, given that the liver is a risk factor for lactic acidosis associated with metformin, rosiglitazone plus metformin combination is not recommended for patients with impaired liver function.
Thiazolidinedione derivatives, including rosiglitazone, may induce or aggravate the chronic heart failure. After initiation of therapy and during rosiglitazone titration dose requires careful control of patient medical condition in respect of the following symptoms and signs of heart failure: a rapid and excessive weight gain, dyspnea, edema. With the development of heart failure symptoms should consider a dose reduction or withdrawal Avandameta and assign therapy in accordance with the current standards of treatment of heart failure. We do not recommend using a combination of rosiglitazone + metformin in patients with symptomatic heart failure. The drug is contraindicated in patients with heart failure I-IV NYHA functional class classification.
Patients with acute coronary syndrome (ACS) were not included in clinical studies. Since the development of acute coronary syndrome increases the risk of heart failure, rosiglitazone is not recommended in patients with ACS. Data on the ability of rosiglitazone to increase the risk of myocardial ischemia are insufficient. Retrospective analysis of mostly short-clinical studies with placebo, but not with the comparison drug, says the relationship between the intake of rosiglitazone and the risk of myocardial ischemia. These findings are not supported by long-term clinical studies with comparison drugs (metformin and / or sulfonylurea), and the relationship between the rosiglitazone and the risk of ischemia has not been established. An increased risk of ischemic myocardial damage was observed in patientsis in clinical studies on the basal nitrate therapy.
Also, no reliable data on the effect of oral hypoglycemic drugs, including group of thiazolidinediones on the state of the large vessels in patients with diabetes mellitus type 2.
There are rare reports of the development or worsening diabetic macular edema with decreased visual acuity. In the same patients often reported on the development of peripheral edema. In some cases, such violations were resolved after discontinuation of therapy. It should be borne in mind the possibility of this complication when the patient's complaints of decreased visual acuity.
Patients receiving Avandamet in a ternary combination with a sulphonylurea may be at risk for dose-related hypoglycaemia. You may need to decrease the dose at the same time taking the drug.
Metformin and hence Avandamet to cancel 48 hours before elective surgery with general anesthesia and resume the therapy is not earlier than 48 hours after surgery.
B / in the introduction of iodine-containing contrast agents in X-ray studies, can cause renal failure. With this in mind, Avandamet as the preparation containing metformin should be discontinued prior to contrast X-ray examination or during it, to resume only after receiving confirmation of normal renal function.
In a longitudinal study monotherapy of diabetes type 2 patients, not previously treated with oral hypoglycemic agents was an increase in the incidence of fractures in women rosiglitazone group (9.3%; 2.7 per 100 patient-years) compared to metformin groups (5.1%; 1.5 cases per 100 patient-years) and glyburide / glibenclamide (3.5%; 1.3 cases per 100 patient-years). The majority of registered messages in the rosiglitazone group concerned forearm fracture, the hand and foot. Possible increased risk of fractures should be considered in the appointment of rosiglitazone, especially women. Requires monitoring of bone health and maintenance of bone health in accordance with accepted standards of care.
When concomitant administration with inhibitors or inducers of CYP2C8 and while the use of cationic drugs outputted by renal glomerular secretion requires careful control of blood glucose and correction dose of rosiglitazone or metformin.
Use in paediatrics
There is currently no data on the use of the drug in children and adolescents under the age of 18 years , so the use of the drug is not recommended in this age group.
Impact on the ability to drive vehicles and manage mechanisms

Rosiglitazone and metformin did not affect the ability to drive vehicles and to operate machinery.
OVERDOSE

There is currently no data on overdose Avandameta. In clinical trials, volunteers tolerated single oral doses up to 20 mg of rosiglitazone.
Symptoms: an overdose of metformin (or concomitant risks of lactic acidosis) may lead to the development of lactic acidosis.
Treatment: Lactic acidosis is a medical condition and requires treatment in a hospital. It is recommended that maintenance therapy, monitoring the patient's clinical condition. For excretion of lactate and hemodialysis use of metformin, rosiglitazone but not removed by dialysis (due to high degree of protein binding).
DRUG INTERACTION

Special studies on the interaction Avandameta not conducted. The following data reflect the available information about the interactions of the individual active components Avandameta (rosiglitazone and metformin).
Rosiglitazone
Gemfibrozil (an inhibitor of CYP2C8) at a dose of 600 mg of 2 times / day increased the C ss rosiglitazone 2 times. Such an increase in the concentration of rosiglitazone associated with the risk of dose-related side effects, so the combined use with Avandameta CYP2C8 inhibitors may require a reduction in the dose of rosiglitazone.
Other inhibitors of CYP2C8 caused a slight increase in the systemic concentration of rosiglitazone.
rifampicin (Inductor CYP2C8) at a dose of 600 mg / day rosiglitazone reduced the concentration to 65%. Therefore, in patients who receive simultaneously rosiglitazone and inductors enzyme CYP2C8, necessary to carry out thorough control


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