Forsiga

Forsiga is a hypoglycemic drug used in the complex therapy of type 2 diabetes.

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

The onset of the effect of the drug is observed already after the first dose of Forsigi, the increased glucose excretion persists for the next 24 hours and lasts for the entire course of treatment. The amount of glucose excreted by the kidneys depends on the glomerular filtration rate (GFR) and blood sugar level.

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

Clinico-pharmacological group

Oral hypoglycemic drug.

Terms of sale from pharmacies

You can buy by prescription.

Price

How much does Forsig in pharmacies? The average price is 2,600 rubles.

Composition and release form

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.

The composition of each tablet includes Dapagliflozin, which is the main active ingredient.

Auxiliary substances include the following elements:

  • microcrystalline cellulose;
  • anhydrous lactose;
  • 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 action of the drug Forsig is based on the ability of the kidneys to collect glucose in the blood and remove it as part of urine. The blood in our body is constantly polluted by metabolic products and toxic substances. The role of the kidneys is to filter out these substances and get rid of them. To do this, the blood passes through the glomerulus 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, it is formed during the day tens of liters.

To become secondary and enter the bladder, the filtered fluid must become more concentrated. This is achieved at the second stage, when all useful substances are absorbed back into the blood in a dissolved form - sodium, potassium, blood elements. The body also considers glucose necessary, because it is the source of energy for the muscles and the brain. Special SGLT2 transporter proteins return it to the blood. They form a kind of tunnel in the tubule of the nephron, through which sugar passes into the blood. In a healthy person, glucose returns completely, in a patient with diabetes mellitus, it begins to partially fall into the urine when its level exceeds the renal threshold of 9-10 mmol / l.

Forsig's drug was discovered through a search by pharmaceutical companies for substances capable of closing these tunnels and blocking urine glucose. Research began in the last century, and finally, in 2011, the companies Bristol-Myers Squibb and AstraZeneca filed an application for registration of a fundamentally new tool for the treatment of diabetes.

The active ingredient Forsigi is dapagliflozin, it is an inhibitor of SGLT2 proteins. 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 result, the blood glucose level drops, the main enemy of the vessels and the main cause of all the complications of diabetes. A distinctive feature of dapagliflozin is its high selectivity, it has almost no effect on glucose transporters to the tissues and does not interfere with its absorption in the intestine.

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

Indications for use

According to the instructions, the drug should be used:

  • with type 2 diabetes mellitus as an adjunct drug or as monotherapy;
  • complex with Metformin, insulin injections, sulfonylurea derivatives;
  • with poor glycemic profile during treatment with other drugs.

Can I lose weight with Forsigoy?

In the instructions for the drug manufacturer indicates a weight loss, which is observed during therapy. This is most noticeable in patients suffering from not only diabetes, but also obesity.

Due to the diuretic properties of the tool 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 the use of the drug are insufficient nutrition and the introduction of restrictions in the diet according to the recommended diet.

Healthy people should not use these pills for weight loss. This is due to the excessive load on the kidneys, as well as insufficient experience with the use of Forsigi.

Contraindications

Absolute:

  • type 1 diabetes;
  • 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 (to start therapy);
  • moderate to severe renal failure (GFR <60 ml / min / 1.73 m2) or end-stage renal disease;
  • hereditary lactose intolerance, lactase deficiency and glucose-galactose intolerance;
  • pregnancy;
  • breastfeeding period;
  • increased individual sensitivity to any component of the drug.

With caution: severe liver failure, urinary tract infection, risk of reducing BCC, elderly patients, chronic heart failure, increased hematocrit.

Appointment during pregnancy and lactation

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

Forsigg tablets are contraindicated for ingestion by nursing mothers, since the active active ingredient of the drug can be excreted in breast milk and into the baby’s body, causing him severe hypoglycemia. If necessary, therapy with a nursing mother should solve the issue with the completion of lactation.

Dosage and method of use

As indicated in the instructions for use of the drug Forsiga taken by mouth, regardless of the meal.

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

In order to reduce the risk of hypoglycemia when co-prescribing Forsigg with insulin preparations or drugs that increase insulin secretion (for example, with a sulfonylurea derivative), it may be necessary to reduce the dose of insulin preparations or drugs that increase insulin secretion.

  • Starting combination therapy with metformin: the recommended dose of Forsig is 10 mg 1 time / day, the dose of metformin is 500 mg 1 time / day. In case of inadequate glycemic control, the dose of metformin should be increased.

When liver dysfunction mild or moderate severity There is no need to adjust the dose of the drug. For patients with severely impaired liver function, an initial dose of 5 mg is recommended. With good tolerance, 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 severely impaired disorders, it is most likely absent. The drug Forsiga contraindicated in patients with moderate to severe renal failure (CC <60 ml / min or GFR <60 ml / min / 1.73 m2) or with end-stage renal disease. When violations of the kidney mild dose adjustment is not required.

Elderly patients dose adjustment is not required. However, when choosing a dose, it should be borne in mind that this category of patients is more likely to have impaired renal function and the risk of reducing BCC. Since the clinical experience of the drug in patients aged 75 years and older is limited, it is contraindicated to begin 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 Forsig, patients may develop side effects:

  • on the part of the skin and skin appendages - increased sweating;
  • on the part of the nervous system - drowsiness, dizziness, tremor of the limbs, lethargy;
  • on the part of the cardiovascular system - shortness of breath, rapid heartbeat, a decrease in blood pressure;
  • infectious diseases - candidiasis of the vagina, balanitis and balanoposthitis, vulvovaginitis, colpitis, itching of the external genital organs;
  • Metabolic disorders - a rapid decrease in blood glucose, increased thirst, a decrease in circulating blood volume;
  • on the part of the digestive system - nausea, severe hunger, constipation, abdominal distension, rumbling in the intestine;
  • laboratory indicators - increased cholesterol and lipids, increased hematocrit, increased concentration of creatinine in the blood, increased levels of urea.

Overdose

According to the instructions, Forsig is a safe drug, when taken in doses up to 500 mg by healthy volunteers, it is well tolerated. In overdose, the incidence of adverse events, including hypotension or dehydration, is similar to the frequency in the placebo group, with no clinically significant, dose-dependent changes in laboratory parameters.

In cases of overdose, supportive therapy should be conducted according to the patient’s condition. Dapagliflozin excretion by hemodialysis has not been studied.

Special instructions

The main factors predisposing to the development of ketoacidosis include insulin dose reduction, low β-cell functional activity due to dysfunction of the pancreas, reduced caloric intake of food or increased insulin requirements due to infections, illness, alcohol abuse or surgery. This group of patients should be prescribed the drug with caution.

When glucose is eliminated by the kidneys, there may be an increased risk of urinary tract infections, and therefore the treatment of urosepsis or pyelonephritis should consider the possibility of temporary cancellation of Forsigi.

In post-registration use, serious urinary tract infections were reported, including the development of urosepsis and pyelonephritis, which required hospitalization of patients taking Forsigu and other SGLT2 inhibitors. Since therapy with SGLT2 inhibitors increases the likelihood of urinary tract infections, the condition of patients should be monitored for the development of such infections. When confirming the diagnosis, immediate treatment is required.

The effectiveness of Forsigi depends on the renal function: in patients with moderately severe renal insufficiency, it is reduced, and in severe disease it is probably absent.

Monitoring of the functional state of the kidneys is recommended to be carried out as follows: before the start of Forsigi, then later - at least 1 time per year; until the start of concomitant medications that may affect renal function, then periodically; in patients with renal impairment close to moderate severity - at least 2-4 times a year, with a decrease in creatinine clearance <60 ml / min, or estimated GFR <60 ml / min / 1.73 m2, the drug is canceled.

In severe liver function, exposure to dapagliflozin is increased.

With a very high concentration of glucose in the blood diuretic effect may be more pronounced.

Patients for whom a decrease in blood pressure caused by dapagliflozin may be a risk, for example, with an aggravated history of cardiovascular diseases, arterial hypotension, as well as during antihypertensive therapy and in elderly patients, caution should be exercised during the period of therapy.

While taking Forsigi, it is recommended to carefully monitor the circulating blood volume and electrolyte concentration (in particular, physical examination, laboratory tests, including hematocrit, blood pressure measurement) against the background of associated conditions that may cause a decrease in this indicator. When it is reduced before the correction of this condition, a temporary cessation of therapy is indicated.

If symptoms such as abdominal pain, nausea, shortness of breath, malaise, vomiting appear in the period of therapy, the patient should be checked for ketoacidosis (even in cases of glucose concentrations up to 14 mmol / l). If you suspect the development of this violation should consider the possibility of cancellation / short-term cessation of the use of Forchiga and immediately conduct an examination.

The experience of using Forsigi in patients with chronic heart failure I-II functional class according to the NYHA classification is limited, during clinical studies the drug was not used in patients with chronic heart failure class III-IV.

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

Evaluation of glycemic control using the determination of 1,5-anhydroglucitol is not recommended, as measuring 1,5-anhydroglucitol is an unreliable method for patients receiving SGLT2 inhibitors. To assess glycemic control, alternative methods should be used.

Compatibility with other drugs

Possible interactions:

  • thiazide and loop diuretics: increasing their diuretic effect and increasing the likelihood of arterial hypotension and dehydration;
  • insulin and drugs that increase insulin secretion: the development of hypoglycemia; the combination requires caution and, possibly, dose adjustment for these drugs.

For more information about the interaction check with your doctor.

Reviews

We offer you to read the reviews of people who used Forsig:

  1. Oksana. All my life I have been professionally engaged in gymnastics. At the age of 24 she got married, gave birth, had to say goodbye to a lot of sports.If, being an athlete, she kept herself in her hands, then starting a “normal” life, she no longer held herself back. Began to lean on very high-calorie food. She began to gain excess weight, but he did not interfere much until a constant feeling of weakness, great thirst and dizziness appeared. On the advice of her husband, she tested for sugar, and as a result, she was diagnosed with type 2 diabetes. To reduce the performance, the doctor prescribed Vorsigu. I accept it for about a year. I feel much better.
  2. Lyuba I do not get sick with diabetes myself, but this disease has 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 an endocrinologist, Mom started drinking Forsig. Over nutrition, too, had to work, eliminated all junk food. Judging by the indicators, blood sugar fell, but my mother began to complain that she feels pain during urination. When we go to other pills, then this is not. Who knows, maybe this is how Forsiga affects the body

Analogs

Analogues of the drug Forsig are:

  • Gluconorm;
  • Formetin;
  • Clay;
  • Glioral;
  • Dianorm-m;
  • Diaperid.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

Keep packaging with the drug should be out of the reach of children, away from sources of moisture and direct sunlight. The optimal storage temperature of the drug is 20-25 degrees, the shelf life is 2 years from the date of manufacture. At the end of the shelf life of the tablet can not be taken orally.

Watch the video: Jalan Santai FORSIGA (April 2020).

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