Forsiga

Forsiga is a hypoglycemic drug used in the treatment of type 2 diabetes mellitus.

The main active ingredient, Dapagliflozin, helps to accelerate the excretion of glucose from the body by the kidneys, reducing the threshold of reverse reabsorption (absorption) of glucose in the renal tubules.

The beginning of the drug is observed after the first dose of Forsigi, the increase in glucose elimination persists for the next 24 hours and continues throughout the course of treatment. The amount of glucose output by the kidneys depends on the glomerular filtration rate (GFR) and the blood sugar level.

One of the advantages of the drug is that Forsiga reduces the level of sugar action even if the patient has damage to the pancreas, leading to the death of part of the β-cells or the development of insensitivity to insulin.

Clinical and pharmacological group

Oral hypoglycemic drug.

Terms of sale from pharmacies

Can buyby prescription.

Price

How much does Forsyge cost in pharmacies? The average price is at the level of2 600 rubles.

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Composition and form of release

The drug is available in the form of tablets having a dosage of 10 or 5 mg and packaged in blisters in an amount of 10, as well as 14 pieces.

Each tablet contains Dapaglyflozin, which is the main active ingredient.

The following substances are classified as auxiliary substances:

microcrystalline cellulose;
lactose anhydrous;
silica;
crospovidone;
magnesium stearate.

Shell composition:

polyvinyl alcohol partially hydrolyzed (Opadry II yellow);
titanium dioxide;
macrogol;
talc;
dye of iron oxide yellow.

Pharmacological effect

The effect of the drug Forsiga is based on the ability of the kidneys to collect glucose in the blood and excrete it in the urine. Blood in our body is constantly contaminated with metabolic products and toxic substances. The role of the kidneys is to filter out these substances and get rid of them. For this, the blood passes through the renal glomeruli many times a day. At the first stage, only the protein components of the blood do not pass through the filter, the rest of the liquid enters the glomeruli. This is the so-called primary urine, formed during the day tens of liters.

To become secondary and get into the bladder, the filtered fluid should become more concentrated. This is achieved in the second stage, when all useful substances - sodium, potassium, blood elements - are absorbed into the blood in a dissolved form. Glucose organism also considers it necessary, because it is the source of energy for the muscles and the brain. Return it to the blood of special protein-transporter SGLT2. They form a kind of tunnel in the tubule of the nephron through which sugar flows into the blood. In a healthy person, glucose is returned completely, in a patient with diabetes mellitus begins to partially enter the urine, when its level exceeds the renal threshold of 9-10 mmol / l.

The drug Forsiga was discovered through the search for pharmaceutical companies substances that can close these tunnels and block glucose in the urine. Research began in the last century, and, finally, in 2011, Bristol-Myers Squibb and AstraZeneca an application was filed for the registration of a principally new drug for the treatment of diabetes mellitus.

The active substance of Vorsigi is dapagliflozin, it is an inhibitor of the proteins SGLT2. This means that he is able to suppress their work. Absorption of glucose from the primary urine decreases, it begins to be excreted by the kidneys in increased amounts. As a consequence, the blood glucose level, the main enemy of blood vessels and the main cause of all complications of diabetes mellitus. A distinctive feature of dapagliflozin is its high selectivity, it has almost no effect on glucose transporters to tissues and does not interfere with its absorption in the intestine.

At a standard dosage of the drug, about 80 g of glucose are released into the urine per day, regardless of the amount of insulin produced by the pancreas, or obtained as injections. Does not affect the effectiveness of Forsigi and the presence of insulin resistance. Moreover, a decrease in glucose concentration makes it easier to pass the remaining sugar through the cell membranes.

Indications for use

According to the instructions, the drug should be used:

at type 2 diabetes mellitus as an auxiliary medicine or as a monotherapy;
complex with "Metformin", insulin injections, sulfonylurea derivatives;
with unsatisfactory glycemic profile during treatment with other drugs.

Can I lose weight with Forsiga?

In the instructions to the medicine, the manufacturer indicates a reduction in weight that is observed during therapy. This is most noticeable in patients who suffer not only from diabetes but also from obesity.

Due to diuretic properties, the agent reduces the amount of fluid in the body. The ability of the components of the drug to remove part of the glucose also contributes to the loss of extra pounds. The main conditions for achieving the effect of using the drug are insufficient nutrition and introduction of dietary restrictions according to the recommended diet.

Healthy people should not use these pills to lose weight. This is due to the excessive burden on the kidneys, as well as the lack of experience with the use of Forsigi.

Contraindications

Absolute:

type 1 diabetes mellitus;
diabetic ketoacidosis;
children and adolescents under 18 years of age (safety and efficacy not studied); patients taking "loop" diuretics, or with reduced BCC, for example, due to acute diseases (such as gastrointestinal diseases);
elderly patients aged 75 years and older (for initiation of therapy);
renal failure of moderate to severe severity (GFR <60 mL / min / 1.73 m2) or terminal stage of renal failure;
hereditary lactose intolerance, lactase deficiency and glucose-galactose intolerance;
pregnancy;
the period of breastfeeding;
increased individual sensitivity to any component of the drug.

With caution: hepatic impairment of severe degree, urinary tract infection, risk of reduction BCC, elderly patients, chronic heart failure, increased hematocrit.

Intended use for pregnancy and lactation

Forsiga is not prescribed for treatment of pregnant women. This is due to the fact that the clinical effect of the drug on the fetus and the course of pregnancy has not been studied and the safety of Dapagliflozin has not been proven.

Forsig tablets are contraindicated for ingestion by nursing mothers, since the active ingredient of the drug can be excreted in breast milk and enter the body of the child, causing severe hypoglycemia. If it is necessary to treat the preparation with a lactating mother, the question of the completion of lactation should be resolved.

Dosage and route of administration

As indicated in the instructions for use, the drug Forsiga is taken orally, regardless of food intake.

Monotherapy: the recommended dose is 10 mg 1 time / day.
Combination therapy: the recommended dose of the drug Forsig is 10 mg 1 time / day in combination with metformin, sulfonylurea derivatives (including in combination with metformin), thiazolidinediones, inhibitors of DPP-4 (including in combination with metformin), insulin preparations (including in combination with one or two hypoglycemic drugs for oral administration).

In order to reduce the risk of hypoglycemia in the joint appointment of the drug Forsig with insulin preparations or drugs that increase the secretion of insulin (eg, a sulfonylurea derivative), a dose reduction of insulin preparations or insulin secretagogues may be required.

Start combined therapy with metformin: the recommended dose of the drug Forsiga is 10 mg 1 time / day, a dose of metformin - 500 mg 1 time / day. In case of inadequate glycemic control, the dose of metformin should be increased.

When violations of liver function of mild or moderate severitythere is no need to adjust the dose of the drug. Patients with severe liver dysfunction are recommended an initial dose of 5 mg. With good tolerability, the dose can be increased to 10 mg.

The effectiveness of dapagliflozin depends on the function of the kidneys. In patients with impaired renal function of moderate severity, the effectiveness of treatment is reduced, and in patients with severe disorders - most likely, there is no. The drug Forsiga contraindicatedpatients with moderate and severe renal insufficiency (CC <60 mL / min or GFR <60 mL / min / 1.73 m2)or withterminal stage of renal failure. With violations of the function of the kidneys of an easy degree, dose adjustment is not required.

In elderly patients, dose adjustment is not required. However, when choosing a dose, it should be borne in mind that in this category of patients, kidney dysfunction and the risk of a reduction in BCC are more likely. Since the clinical experience of using the drug in patients aged 75 years and older is limited, it is contraindicated to start therapy with dapagliflozin in this age group.

The safety and effectiveness of dapagliflozin in patients under the age of 18 years has not been studied.

Adverse Reactions

During therapy with Forsiga, patients may develop side effects:

from the skin and appendages of the skin - increased sweating;
from the side of the nervous system - drowsiness, dizziness, tremors of limbs, lethargy;
from the side of the cardiovascular system - dyspnea, heart palpitations, lower blood pressure indicators;
infectious diseases - candidiasis of the vagina, balanitis and balanoposthitis, vulvovaginitis, colpitis, itching of the external genital organs;
a metabolic disorder - a rapid decrease in blood glucose levels, increased thirst, a decrease in the volume of circulating blood;
on the part of the digestive system - nausea, severe hunger, constipation, bloating, rumbling in the intestine;
laboratory indicators - increasing cholesterol and lipid levels, increasing hematocrit, increasing the concentration of creatinine in the blood, increasing the level of urea.

Overdose

According to the instructions, Forsiga is a safe drug, with a single dose of up to 500 mg in healthy volunteers, it is tolerated well. In case of an overdose, the incidence of adverse events, including arterial hypotension or dehydration, is similar to the frequency in the placebo group, while clinically significant, dose-dependent changes in laboratory parameters were not detected.

In cases of overdose, supportive therapy should be conducted taking into account the patient's condition. Dapagliflozin removal by hemodialysis has not been studied.

special instructions

The main factors predisposing to the development of ketoacidosis include a decrease in the dose of insulin, a low functional activity of β-cells due to impaired pancreatic function gland, reduced calorie intake of food or increased need for insulin due to infections, illnesses, alcohol abuse or surgery. This drug should be given with caution.

With the excretion of glucose by the kidneys, there may be an increased risk of urinary tract infections, connection with what in the treatment of urosepsis or pyelonephritis need to consider the possibility of a temporary withdrawal Forsiga.

When post-marketing use was reported for serious infections of the urinary tract, including the development of urosepsis and pyelonephritis, which required hospitalization of patients taking Forsig and other SGLT2 inhibitors. Since the therapy with SGLT2 inhibitors increases the likelihood of urinary tract infections, the condition of patients should be monitored for the development of such infections. Confirmation of the diagnosis requires immediate treatment.

Efficacy of Forsigi depends on renal function: in patients with moderate renal insufficiency, it is reduced, and in case of severe disease, probably is absent.

Control of the functional state of the kidneys is recommended to be carried out as follows: before the start of reception Forsiga, later - at least once a year; before the reception concomitant medications that can affect renal function, subsequently - periodically; in patients with renal impairment, close to the average degree severity - at least 2-4 times a year, with a decrease in the creatinine clearance <60 ml / min, or estimated GFR <60 ml / min / 1.73 m2, the drug is canceled.

In cases of severe liver dysfunction, dapagliflozin exposure is increased.

At a very high concentration of glucose in the blood, the diuretic effect can be more pronounced.

Patients for whom a decrease in blood pressure caused by dapagliflozin can be a risk, for example, with a history of cardiovascular disease, arterial hypotension, as well as during antihypertensive therapy and in elderly patients, care should be taken during therapy.

During the reception of Forsiga, it is recommended to carry out a thorough control of the volume of circulating blood and the concentration of electrolytes (in particular, physical examination, laboratory tests, including hematocrit, measurement of blood pressure) against the background of concomitant conditions that may cause a decrease in this indicator. When it decreases, a temporary cessation of therapy is indicated before correction of this condition.

If during the therapy there are such symptoms as abdominal pain, nausea, dyspnea, malaise, vomiting, it is necessary to check the patient for ketoacidosis (even in cases of blood glucose concentration up to 14 mmol / l). If suspected of developing this disorder, consideration should be given to the possibility of abolishing / discontinuing the use of Forsigi and immediately to conduct a survey.

The experience of using Forsigi in patients with chronic cardiac insufficiency of I-II functional class according to the NYHA classification is limited, During clinical trials, the drug was not used in patients with chronic cardiac insufficiency III-IV.

Due to the mechanism of action of Forsigi during therapy, the results of urine analysis for glucose will be positive.

It is not recommended to assess the glycemic control by the determination of , -anhydroglucitol, since measurement of , -anhydroglucitol is an unreliable method for taking SGLT2 inhibitors of patients. For the purpose of assessing glycemic control, alternative methods should be used.

Compatibility with other drugs

Possible interactions:

Thiazide and loop diuretics: increased their diuretic effect and increased probability of arterial hypotension and dehydration;
insulin and drugs that increase the secretion of insulin: the development of hypoglycemia; The combination requires caution and, possibly, correction of the doses of these drugs.

For more information on the relationship, contact your doctor.

Reviews

We offer you to read reviews of people who used Forsyg:

Oksana. I've been professionally engaged in gymnastics all my life. At the age of 24 she got married, gave birth, with great sport had to say goodbye. If, as an athlete, she kept herself in her arms, then she started her "ordinary" life, did not restrain herself any more. She began to lean on a very high-calorie food. She began to gain weight, but he did not interfere much until there was a constant feeling of weakness, intense thirst and dizziness. On the advice of her husband passed the analysis for sugar, as a result of diabetes type 2. To reduce the figures, the doctor prescribed Forsig. I've been taking him for about a year now. I feel much better.
Liuba. Diabetes itself is not sick, but this disease affected my family. A year ago, he was diagnosed with my mother. A woman of 46 years old, never complained about anything and there is such a shock! On the advice of the endocrinologist, my mother started drinking Forsiga. We also had to work on food, excluding all harmful food. Judging by the indicators, sugar in the blood fell, but my mother began to complain that she feels pain while urinating. When we switch to other tablets, then this is not. Who knows, maybe this is how Forsiga influences the body

Analogues

The analogues of the drug Forsig are:

Gluconorm;
Formethine;
Glinov;
Glirolal;
Dianorm;
Diaperid.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

Keep the package with the drug in a place inaccessible to children, away from moisture and direct sunlight. The optimum storage temperature of the preparation is 20-25 degrees, the shelf life is 2 years from the date of manufacture. At the end of the expiration date, tablets should not be taken orally.