Sindjardi (emagliflosin, metformin hydrochloride) coated tablets 12.5 mg/1000 mg. №60

$135.00

Manufacturer: Germany, Greece, France

Treatment of type 2 diabetes in adults as an adjunct to diet and exercise: if insufficient use of the maximum tolerated dose of metformin alone is sufficient; if the use of metformin in combination with other medicines for diabetes does not provide sufficient glycemic control; if patients are already receiving treatment with the combination of emagliflosin and metformin as separate drugs. Concerning the results of a study of combinations, effects on glycemic control, and cardiovascular disease.

Category:

Description

Sindjardi (emagliflosin, metformin hydrochloride) coated tablets 12.5 mg/1000 mg. №60

Composition

active substance: empagliflozin, metformin hydrochloride;

1 tablet contains 5 mg empagliflozin and 1000 mg metformin hydrochloride or 12.5 mg empagliflozin and 1000 mg metformin hydrochloride;

Excipients:

  • tablets 5 mg/1000 mg: corn starch, copovedon, colloidal anhydrous silicon dioxide, magnesium stearate, Opadry® Yellow film coat 02B220012;
    the composition of the film shell Opadry® Yellow 02B220012: hypromelose 2910, macrogol 400, titanium dioxide (E 171), iron oxide yellow (E 172), talc;
  • tablets 12.5 mg/1000 mg: corn starch, copovedon, colloidal anhydrous silicon dioxide, magnesium stearate, Opadry® Purple 02B200006 film coat;
    Opadry® Purple 02B200006 film shell composition: hypromelose 2910, macrogol 400, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172), talc.

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

  • tablets 5 mg/1000 mg: oval, biconvex film-coated tablets, brownish yellow, debossed with the Boehringer Ingelheim symbol and “S5” on one side and engraved with “1000” on the other side;
  • 12.5 mg/1000 mg tablets: oval, biconvex, film-coated tablets, purplish brown, debossed with the Boehringer Ingelheim symbol and “S12” on one side and “1000” engraved on the other side.

Pharmacological group

Medicines used in diabetes. Combination of oral hypoglycemic drugs.
Code ATX A10B D20.

Pharmacological properties

This is a combined hypoglycemic (sugar-lowering) drug. It lowers the level of glycated hemoglobin, blood glucose (after meals and on an empty stomach), increases glucose tolerance. Reduces the production of glucose in the liver, increases tissue insulin sensitivity (increases the absorption of glucose and its metabolism). It does not affect the production of insulin by the pancreas. In addition, it normalizes fat metabolism.

Indications

Sindjardi is prescribed for type II diabetes mellitus (especially in the case of concomitant obesity) when diet therapy is ineffective.

Contraindications

Sindjardi is contraindicated:

  • with hypersensitivity (intolerance to the components);
  • with kidney pathology or renal failure;
  • with a pronounced violation of the functional state of the liver;
  • in conditions accompanied by hypoxia (lack of oxygen), incl. heart and respiratory failure, in the acute phase of myocardial infarction, acute cerebrovascular accident, anemia);
  • with dehydration (dehydration);
  • with infectious diseases;
  • with extensive operations and injuries;
  • with chronic alcoholism or acute alcohol intoxication;
  • with acute / chronic metabolic acidosis, including diabetic ketoacidosis, lactic acidosis;
  • if you follow a low-calorie diet (less than 1000 kcal / day);
  • when conducting research using radioactive isotopes of iodine;
  • during pregnancy;
  • children;
  • when breastfeeding.

Sindjardi is prescribed with caution to children, the elderly (over 65 years old), people doing hard physical work (there is a risk of developing lactic acidosis).

Application during pregnancy and lactation

It is not recommended to take Sindjardi during pregnancy. In the case of planning a pregnancy or an identified pregnancy, treatment should be stopped immediately and switched to insulin therapy.
Breastfeeding should be discontinued during treatment.

Method of administration and dosage

Sindjardi is administered orally (by mouth) during or after meals.
The initial dose is one tablet 2 times a day.
After 10-15 days, the dose is adjusted according to the results of the glycemic profile.
The maximum recommended dose is 3000 mg of metformin per day.

Overdose

Symptoms: the development of lactic acidosis (dryness of the tongue, mucous membranes, skin, muscle pain, chest pain, dyspeptic symptoms, rapid breathing, apathy, insomnia / drowsiness, cardiovascular failure, vomiting, abdominal pain, neurological disorders, noisy breathing, development of collapse, oligoanuria / anuria, DIC).
Treatment: symptomatic therapy, hemodialysis.

Side effects:

  • Digestive disorders: lack of appetite, nausea, diarrhea / constipation, abdominal pain, vomiting.
  • Metabolic disorders: lactic acidosis, B12 hypovitaminosis, megaloblastic anemia, hypoglycemia.
  • Neurological disorders: taste disturbance.
  • Hepatobiliary disorders: liver dysfunction, hepatitis.
  • Changes in the skin, subcutaneous tissue: erythema, itching, urticaria, edema.