Vipidia, 25 mg 28 pcs

Type 2 diabetes

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

Active ingredient

Alogliptin

Composition

1 tablet 25 mg contains

Active ingredients:

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

Auxiliary substances:

Kernel:

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 F1 ink trace amounts

How to take, the 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 may be taken regardless of meals. Tablets should be swallowed whole, without chewing, with water.

If a patient misses a dose of Vipidia, he should take the missed dose as soon as possible. Double doses of Vipidia should not be taken on the same day.

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

If Vipidya is combined with a sulfonylurea derivative 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. In case of hypoglycemia, a dose reduction 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 impairment

. In patients with mild renal insufficiency (creatinine clearance from >50 to <80 ml/min) correction of Vipidia dose is not required. In patients with moderate renal insufficiency (creatinine clearance from >30 to <50 ml/min) the dose of this medicine Vipidia is 12.5 mg once daily.

Alogliptin should not be used in patients with severe renal insufficiency and patients with end-stage renal failure requiring hemodialysis (creatinine clearance from >30 to <50 ml/min). patients with renal insufficiency should have renal function assessed before starting treatment with Vipidia and periodically during treatment.

Patients with hepatic impairment

There is no need to adjust the dose of Vipidia in patients with mild to moderate hepatic impairment (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), therefore, it should not be used in this group of patients.

Patients over 65 years of age

The dose of Vipidia in patients over 65 years of age does not need to be adjusted. However, the dose of alogliptin should be adjusted particularly carefully due to the potential for decreased renal function in this group of patients.

Interaction

The effect of other drugs on alogliptin

Alogliptin is mainly excreted unchanged by the kidneys, and to a small extent is metabolized by the cytochrome enzyme system (CYP) P450.

In studies on interactions with other drugs the following drugs had no clinically significant effect on the pharmacokinetics of alogliptin: gemfibrozil (CYP2C8/9 inhibitor), fluconazole (CYP2C9 inhibitor), ketoconazole (CYP3A4 inhibitor), cyclosporine (p-glycoprotein inhibitor), α-glycosidase inhibitor, digoxin, metformin, cimetidine, pioglitazone or atorvastatin. Effect of alogliptin on other drugs In in vitro studies it has been shown that alogliptin neither inhibits nor induces CYP 450 isoforms at concentrations achieved when taking alogliptin at the recommended dose of 25 mg. Interactions with CYP 450 isoforms are not expected and have not been identified.

In in vitro studies have shown that alogliptin is neither a substrate nor an inhibitor of OAT1, OATZ and OST2. In addition, data from clinical studies indicate no interaction with p-glycoprotein inhibitors or substrates.

In clinical studies on interactions with other drugs, alogliptin had no 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 ethinylestradiol), digoxin, fexofenadine, metformin or cimetidine. Based on these data, alogliptin does not inhibit the cytochrome system isoenzymes CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein and OST2.

Alogliptin had no effect on the prothrombin index or the International Normalized Ratio (MHO) in healthy volunteers when taken concomitantly with warfarin. Administration of alogliptin in combination with metformin, or pioglitazone (thiazolidinedione), or α-glycosidase inhibitor, or glibenclamide (sulfonylurea derivative) showed no clinically significant pharmacokinetic interactions.

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Special Instructions

Application with other hypoglycemic drugs

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

Unstudied combinations

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

Renal Impairment

To the extent that patients with moderate renal insufficiency require dose adjustment of Vipidia, it is recommended that renal function be assessed before and periodically during treatment (see Dosage and administration).
The drug 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 a potential risk of acute pancreatitis. In a pooled analysis of 13 clinical trials using alogliptin at 25 mg/day, 12.5 mg/day, the comparison drug, and placebo, the incidence of acute pancreatitis was 3, 1, 1, or 0 cases per 1,000 patient-years in each group, respectively. Patients should be informed about the characteristic symptoms of acute pancreatitis: persistent severe abdominal pain, which may irradiate to the back. If acute pancreatitis is suspected, administration of Vipidia should be stopped; if acute pancreatitis is confirmed, the drug should not be resumed. There are no data on whether there is an increased risk of pancreatitis during taking Vipidia in patients with a history of pancreatitis. Therefore, caution should be exercised in patients with a history of pancreatitis.

Hepatic impairment

Postmarketing reports of hepatic dysfunction, including hepatic impairment, have been received when taking alogliptin. Their association with the use of the drug has not been established. However, patients should be carefully evaluated for possible liver function abnormalities. If liver function abnormalities are found and no alternative etiology has been established, discontinuation of treatment with the drug should be considered.

Influence on driving and operating ability

The drug Vipidia has no or negligible effect on driving and operating ability. Nevertheless, it is necessary to take into account the risk of hypoglycemia when using the drug in combination with other hypoglycemic agents (sulfonylureas, insulin or combined therapy with pioglitazone and metformin) and to be careful when driving vehicles and using mechanisms.

Contraindications

• high sensitivity to alogliptin or any excipient, or a history of serious hypersensitivity reactions to any DPP-4 inhibitor, including anaphylactic reactions, anaphylactic shock and angioedema;
• sugar type 1 diabetes;
• diabetic ketoacidosis;
• chronic heart failure (New York Heart Association functional class III-IV in the functional classification of chronic heart failure);
• severe hepatic impairment (greater than 9 points on the Child-Pugh scale) due to lack of clinical evidence of use;
• severe renal impairment;
• children under 18 years of age – due to lack of clinical data for use.

Cautions
Acute pancreatitis in history (see Special Instructions).
In patients with moderate renal insufficiency (see Particular Guidelines).
In combination with sulfonylurea derivative or insulin (see Special Precautions).
Taking a three-component combination of the drug Vipidia with metformin and thiazolidinedione (see Special Guidelines).

Side effects

Nervous system disorders:

Often: headache.

Gastrointestinal tract disorders:
Often: pain in the epigastric region, gastroesophageal reflux disease.
Frequency not determined: acute pancreatitis.

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

Skin and subcutaneous tissue disorders:
Often: itching, rash.
Frequency not established: exfoliative skin disorders, 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.

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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 for 14 days. This is 32 and 16 times the recommended daily dose of 25 mg of alogliptin, respectively. 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 studies, only 7% of the dose was removed from the body during a 3-hour dialysis session. There is no data on the effectiveness of peritoneal dialysis of alogliptin.

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