Vipidia, pills 25mg 28pcs

Composition

1 tablet of 25 mg contains

Active ingredient:

alogliptin benzoate-34 mg (in terms of alogliptin -25 mg).

Excipients:

Core:

mannitol 79.7 mg,

microcrystalline cellulose 22.5 mg,

hyprolose 4.5 mg,

croscarmellose sodium 7.5 mg,

magnesium stearate 1.8 mg.

Film coating:

Hypromellose 2910 5.34 mg,

titanium dioxide 0.6 mg,

iron oxide red dye 0.06 mg,

macrogol-8000 trace amounts, gray ink F1 trace amounts

Indications

Type 2 diabetes mellitus to improve glycemic control when diet therapy and exercise are ineffective:  in adults, as monotherapy, in combination with other oral hypoglycemic agents or with insulin.

Contraindications

• hypersensitivity to alogliptin or to any auxiliary substance, or severe hypersensitivity reaction to any DPP-4 inhibitor in history, including anaphylactic reaction, anaphylactic shock and angioedema;
• diabetes mellitus, type 1;
• diabetic ketoacidosis;
• chronic heart failure (functional class III-IV functional classification of chronic heart failure new York heart Association);
• severe liver failure (more than 9 points on a scale child-Pugh) due to the lack of clinical data on use;
• severe renal failure;
• pregnancy, breastfeeding, in the absence of clinical data for use;
• children up to age 18 years – due to the lack of clinical data on the application.

With cautionA history of acute pancreatitis (see special instructions). In patients with moderate renal insufficiency (see Special instructions). In combination with a sulfonylurea derivative or insulin (see Special instructions). Taking a three-component combination of Vipidia with metformin and thiazolidinedione (see Special instructions).

Side effects

Nervous system disorders:

Common: headache.

Disorders of the gastrointestinal tract:  Common: epigastric pain, gastroesophageal reflux disease. Frequency not established: acute pancreatitis.

Liver and biliary tract disorders:  Frequency not established: impaired liver function, including liver failure.

Skin and subcutaneous tissue disorders:  Often: itching, rash. Frequency not established: exfoliative skin diseases, including Stevens-Johnson syndrome, angioedema, urticaria.

Infectious or parasitic diseases are common: upper respiratory tract infections, nasopharyngitis.

Immune system disorders Frequency not established: hypersensitivity reactions, including anaphylactic reaction.

Interaction

Effect of other medications on alogliptin

Alogliptin is mainly excreted unchanged by the kidneys, and is only slightly metabolized by the cytochrome P450 enzyme system.

In drug interaction studies, the following drugs did not have a clinically significant effect on the pharmacokinetics of alogliptin: gemfibrozil (a CYP2C8/9 inhibitor), fluconazole (a CYP2C9 inhibitor), ketoconazole (a CYP3A4 inhibitor), cyclosporine (a p-glycoprotein inhibitor), a-glycosidase inhibitor, digoxin, metformin, cimetidine, pioglitazone, or atorvastatin. Effect of alogliptin on other medicinal products In vitro studies have shown that alogliptin does not inhibit or induce CYP 450 isoforms at concentrations achieved with alogliptin at the recommended dose of 25 mg. Interactions with CYP 450 isoforms are not expected and have not been detected.

In vitro studies have shown that alogliptin is neither a substrate nor an inhibitor of OAT 1, OATP and OST 2. In addition, data from clinical studies do not indicate interaction with inhibitors or substrates of p-glycoprotein.

In clinical drug interaction studies, alogliptin did not have a clinically significant effect on the pharmacokinetics of the following drugs: caffeine, (R)- and (S)-warfarin, 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 isoenzymes CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein and OST 2.

Alogliptin had no effect on the prothrombin index or International Normalized Ratio (MHO) in healthy volunteers when co-administered with warfarin. Taking alogliptin in combination with metformin, pioglitazone (thiazolidinedione), an alpha-glycosidase inhibitor, or glibenclamide (a sulfonylurea derivative) did not show clinically significant pharmacokinetic interactions.

How to take, course of use and dosage

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 food intake. Tablets should be swallowed whole, without chewing, washed down with water.

If the patient missed taking Vipidia, they should take the missed dose as soon as possible. It is unacceptable to take a double dose of Vipidia on the same day.

When prescribing Vipidia in addition to metformin or thiazolidinedione, the dose of the latter drugs should be left unchanged.

When combining the drug Vipidia with a derivative of sulfonylureas or insulin, the dose of the latter should be reduced to reduce the risk of hypoglycemia. Due to the risk of hypoglycemia, caution should be exercised when prescribing a three-component combination of Vipidia with metformin and thiazolidinedione. If hypoglycemia develops, a reduction in the dose of metformin or thiazolidinedione may be considered. The efficacy and safety of alogliptin when taken in triple combination with metformin and a sulfonylurea derivative have not been studied.

Patients with renal insufficiency

Patients with mild renal insufficiency (creatinine clearance > 50 to > In patients with moderate renal insufficiency (creatinine clearance > 30 to >

Alogliptin should not be used in patients with severe renal insufficiency and patients with end-stage renal insufficiency requiring hemodialysis (creatinine clearance from Patients with renal insufficiency, it is recommended to evaluate renal function before starting treatment with Vipidia and periodically during treatment.

Patients with hepatic insufficiency

No dose adjustment of Vipidia 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 hepatic insufficiency (more than 9 points on the Child-Pugh scale), so it should not be used in this group of patients.

Patients over 65 years of age

No dose adjustment of Vipidia is required in patients over 65 years of age. However, the dose of alogliptin should be carefully selected due to the potential for reduced renal function in this group of patients.

Overdose

The maximum dose of alogliptin in clinical trials was 800 mg / day in healthy volunteers and 400 mg / day in patients with type 2 diabetes mellitus for 14 days. This is 32 and 16 times higher, respectively, than the recommended daily dose of 25 mg of alogliptin. There were no serious adverse events when taking the drug at these doses.

In case of overdose, gastric lavage and symptomatic treatment may be recommended.

Alogliptin is poorly dialyzed. In clinical trials, only 7% of the dose was removed from the body during a 3-hour dialysis session. There are no data on the effectiveness of alogliptin peritoneal dialysis.

Special instructions

Use with other hypoglycemic drugs

In order to reduce the risk of hypoglycemia, it is recommended to reduce the dose of sulfonylurea derivatives, insulin or a combination of pioglitazone (thiazolidinedione) with metformin when used simultaneously with Vipidia (see Dosage and use).

Unexplored combinations

The efficacy and safety of Vipidia in combination with sodium-dependent glucose cotransporter 2 inhibitors or glucagon-like peptide analogues and in triple combination with metformin and sulfonylurea derivatives have not been studied.

 Renal insufficiency

Since patients with moderate renal insufficiency need to adjust the dose of Vipidia, it is recommended to evaluate renal function before and periodically during treatment (see Dosage and use). 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 use).

Acute pancreatitis

The use of DPP-4 inhibitors is associated with a potential risk of acute pancreatitis. In a generalized analysis of 13 clinical trials using alogliptin at a dose of 25 mg / day,12.5 mg / day, the reference 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 abdominal pain that may radiate to the back. If acute pancreatitis is suspected, the drug Vipidia is discontinued; if acute pancreatitis is confirmed, the drug is not resumed. There is no data on whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking Vipidia. Therefore, caution should be exercised in patients with a history of pancreatitis.

Liver failure

There have been post-marketing reports of impaired liver function, including liver failure, when taking alogliptin. Their association with the use of the drug was not established. However, patients should be carefully evaluated for possible abnormalities in liver function. If abnormalities in liver function are detected and an alternative etiology of their occurrence is not established, discontinuation of treatment with the drug should be considered.

Influence on the ability to drive vehicles and mechanisms

The drug Vipidia has no or negligible effect on the ability to drive vehicles and mechanisms. However, the risk of hypoglycaemia should be considered when using the drug in combination with other hypoglycaemic drugs (sulfonylureas, insulin or combination therapy with pioglitazone and metformin) and caution should be exercised when driving vehicles and mechanisms.

Storage conditions

Store at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Alogliptin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes