VIPIDIA PILLS 25MG

Composition

1 pill 25 mg contains
Active substance: alogliptin benzoate - 34 mg (in terms of alogliptin -25 mg).
Excipients: 
Core: mannitol 79.7 mg, microcrystalline cellulose 22.5 mg, hyprolosis 4.5 mg, croscarmellose sodium 7.5 mg, Magnesium stearate 1.8 mg.
Film shell: hypromellose 2910 5.34 mg, titanium dioxide 0.6 mg, iron dye red oxide 0.06 mg, macrogol-8000 trace amounts, gray ink F1 trace amounts

Indications

Type 2 diabetes mellitus to improve glycemic control with the ineffectiveness of diet therapy and physical activity:
in adults, as monotherapy, in combination with other oral hypoglycemic agents, or with insulin.

Contraindications

• hypersensitivity to alogliptin or to any excipient, or serious hypersensitivity reactions to any DPP-4 inhibitor in the history, including Anaphylactic reactions, anaphylactic shock and angioedema;
• type 1 diabetes;
• diabetic ketoacidosis;
• chronic heart failure (functional class III-IV according to the functional classification of chronic heart failure of the New York Heart Association);
• severe liver failure (more than 9 points on the Child-Pugh scale) due to the lack of clinical data on the use;
• severe renal failure;
• pregnancy, breastfeeding period - due to the lack of clinical data on the application;
• Children up to 18 years old due to the lack of clinical data on the application.

Carefully
Acute pancreatitis in the anamnesis (see. Special instructions).
Patients with a renal failure of moderate severity (see. Special instructions).
In combination with a sulfonylurea derivative or insulin (see Special Instructions).
Acceptance of a three-component combination of Vipidium with Metformin and thiazolidinedione (see Special Instructions).

Side effects

Nervous system disorders:
Often: headache.
Violations of the gastrointestinal tract:
Often: pain in the epigastric region, gastroesophageal reflux disease.
Frequency is not installed: acute pancreatitis.
Disorders of the liver and biliary tract:
Frequency is not installed: abnormal liver function, including liver failure.
Violations of the skin and subcutaneous tissues:
Often: itching, rash.
Frequency is not installed: exfoliative skin diseases, including Stevens-Johnson syndrome, angioedema, urticaria.
Infectious or parasitic diseases
Often: upper respiratory tract infections, nasopharyngitis.
Immune system disorders
Frequency not established: hypersensitivity reactions, including anaphylactic reaction.

Interaction

Effect of other drugs on alogliptin
Aogliptin is mainly excreted from the body unchanged by the kidneys, and is slightly metabolized by the cytochrome (CYP) P450 enzyme system.
In studies on interaction with other drugs, the pharmacokinetics alogliptina no clinically significant effect of the following drugs: gemfibrozil (an inhibitor of CYP2C8 / 9), Fluconazole (an inhibitor of CYP2C9), Ketoconazole (an inhibitor of CYP3A4), cyclosporin (an inhibitor of P-glycoprotein), α- inhibitor glycosidase, Digoxin, metformin, cimetidine, pioglitazone or Atorvastatin. Effect of alogliptin on other drugs In vitro studies have shown that alogliptin does not inhibit and does not induce the CYP 450 isoform at the concentrations achieved when taking alogliptin at the recommended dose of 25 mg. Interactions with isoforms of CYP 450 are not expected and have not been identified.
In vitro studies have shown that alogliptin is neither a substrate, nor an inhibitor of OAT1, OATZ and OCT2. In addition, data from clinical studies do not indicate interaction with p-glycoprotein inhibitors or substrates.
In clinical studies on interaction with other drugs alogliptin no clinically significant effect on the pharmacokinetics of the following drugs: caffeine, (R) - and (S) -varfarina, pioglitazone, glibenclamide, tolbutamide, dextromethorphan, atorvastatin, midazolam, oral contraceptives (norethindrone and ethinyl estradiol), digoxin, fexofenadine, metformin or cimetidine.Based on these data, alogliptin does not inhibit cytochrome CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein and OCT2 isoenzymes.
Aogliptin had no effect on the prothrombin index or the International Normalized Attitude (MHO) in healthy volunteers while taking it with Warfarin. Reception of alogliptin in combination with metformin, or pioglitazone (thiazolidinedione), or α-glycosidase inhibitor, or glibenclamide (sulfonylurea derivative) showed no clinically significant pharmacokinetic interactions.

The drug is taken orally.
The recommended dose of Vipidia is 25 mg once daily as monotherapy or in addition to metformin, thiazolidinedione, sulfonylurea derivatives or insulin, or as a three-component combination with metformin, thiazolidinedione or insulin. The drug Vipidia can be taken regardless of the meal. pills should be swallowed whole, not liquid, squeezed water.
If a patient misses taking Vipidia, he should take the missed dose as soon as possible. Do not take a double dose of Vipidia on the same day.
When prescribing the drug Vipidiya in addition to metformin or thiazolidinedione, the dose of the latest drugs should be left unchanged.
When combining the drug Vipidiya with a sulfonylurea derivative or insulin, the dose of the latter should be reduced to reduce the risk of hypoglycemia.In connection with the risk of hypoglycemia, caution should be exercised when prescribing a three-component combination of the drug Vipidium with metformin and thiazolidinedione. In the case of hypoglycemia, it is possible to consider reducing the dose of metformin or thiazolidinedione. The efficacy and safety of alogliptin when taken in triple combination with metformin and a sulfonylurea derivative have not been studied.
Patients with renal failure 
Patients with mild renal insufficiency (creatinine clearance from> 50 to <80 ml / min) do not require dose adjustment for Vipidia. In patients with moderately severe renal failure (creatinine clearance from> 30 to <50 ml / min), the dose of Vipidia is 12.5 mg once a day.
Aogliptin should not be used in patients with severe renal insufficiency and in patients with end-stage renal failure who need hemodialysis (creatinine clearance from patients with renal insufficiency are encouraged to assess renal function before starting treatment with Vipidia and periodically during treatment.
Patients with liver failure 
No adjustment of the dose of Vipidium is required in patients with mild to moderate hepatic insufficiency (from 5 to 9 points on the Child-Pugh scale). The drug has not been studied in patients with severe liver failure (more than 9 points on the Child-Pugh scale), so it should not be used in this group of patients.
Patients over 65 
No dose adjustment of the drug Vipidia is required in patients over 65 years of age. Nevertheless, it is necessary to carefully select the dose of alogliptin in connection with the potential for reducing renal function in this group of patients.

Overdosage

The maximum dose of alogliptin in clinical studies was 800 mg / day in healthy volunteers and 400 mg / day in patients with type 2 diabetes for 14 days. This is 32 and 16 times, respectively, higher than the recommended daily dose of 25 mg alogliptin. There were no serious adverse events when taking the drug in these doses.
In case of overdose, gastric lavage and symptomatic treatment may be recommended.
Aogliptin is poorly dialyzed. In clinical studies, only 7% of the dose was removed from the body during the 3-hour dialysis session. Data on the effectiveness of peritoneal dialysis alogliptin not.

Use during pregnancy

No studies have been conducted on the use of alogliptin in pregnant women. Animal studies have not shown direct or indirect negative effects of alogliptin on the reproductive system. However, as a precaution, the use of the drug Vipidia during pregnancy is contraindicated.
There is no data on the penetration of alogliptin into breast milk in humans. Animal studies have shown that alogliptin penetrates into breast milk, so the risk of side effects in infants cannot be excluded. In this regard, the use of the drug during breastfeeding is contraindicated.

Special instructions

Use with other hypoglycemic drugs.
In order to reduce the risk of hypoglycemia, a reduction in the dose of sulfonylurea, insulin, or a combination of pioglitazone (thiazolidinedione) with metformin is recommended while taking it with Vipidia (see Dosage and Administration).
Unstudied combinations 
The efficacy and safety of using Vipidium in combination with inhibitors of sodium-dependent glucose 2 glucose cotransporters or analogues of the glucagon-like peptide and in triple combination with metformin and sulfonylurea derivatives have not been studied.
Renal failure 
Since patients with moderate renal failure require dose adjustment of the drug Vipidia, it is recommended to assess the renal function before and periodically during treatment (see Dosage and Administration).
Vipidia should not be used in patients with severe renal insufficiency, as well as in patients with end-stage chronic renal failure requiring hemodialysis (see Dosage and Administration).
Acute pancreatitis 
The use of DPP-4 inhibitors is associated with the potential risk of developing acute pancreatitis. In a generalized analysis of 13 clinical studies of the use of alogliptin at a dose of 25 mg / day, 12.5 mg / day, the comparator drug and placebo, the incidence of acute pancreatitis was 3, 1, 1 or 0 cases per 1000 patient-years in each group, respectively.Patients should be informed about the characteristic symptoms of acute pancreatitis: persistent severe pain in the abdomen, which may radiate to the back. If you suspect the development of acute pancreatitis, Vipidia is discontinued; when confirming acute pancreatitis, the drug is not resumed. There is no evidence that there is an increased risk of developing pancreatitis while taking the drug Vipidia in patients with a history of pancreatitis. Therefore, patients with a history of pancreatitis should be careful.
Liver failure 
Post-marketing reports of impaired liver function, including liver failure, were received when taking alogliptin. Their relationship with the use of the drug has not been established. However, patients should be carefully examined for possible abnormalities in liver function. If there are abnormalities in liver function and the alternative etiology of their occurrence has not been established, the possibility of discontinuing treatment with the drug should be considered.

Influence on ability to drive vehicles and mechanisms
Vipidia does not have or has a negligible effect on the ability to drive vehicles and mechanisms. Nevertheless, it is necessary to take into account the risk of hypoglycemia when using the drug in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin or combination therapy with pioglitazone and metformin) and care must be taken when driving vehicles and mechanisms.

Storage conditions

Store at a temperature not higher than 25 ° С.a