Onglyza 2.5mg Astrazeneca tablets for blood sugar control (2 blisters x 14 tablets)

Do not use Onglyza® for patients with type 1 diabetes or keto-acid infection due to diabetes because drugs are not effective on these objects.

Onglyza® has not been studied in patients with a history of pancreatitis. It is unclear whether the patient has a history of pancreatitis when using Onglyza®, which increases the risk of pancreatitis or not.

Pharmacokological

concentration of invoretin hormones such as GLP-1 (Glucagon-Like Peptide-1) and GIP (Glucoseedependent insulinotropic polypeptide) are increased to release from the small intestine into the blood intestine when responded to food.

These hormones cause insulin release from the beta cells of the pancreatic gland in a way that depends on the level of glucose, but will be inactivated by the DPP4 enzyme for a few minutes.

GLP-1 also reduces the amount of glucagon secreted from the alpha cell of the pancreas, reducing the synthesis of glucose in the liver.

In patients with type 2 diabetes, the concentration of GLP-1 decreases but the response of insulin with GLP-1 has not changed.

Saxagliptin is a DPP4 competitive inhibitor, which reduces the inactiveness of hormones, the position increases the concentration of these hormones in the blood and reduces glucose concentration at hunger and after meals in a way that depends on the amount of glucose in type 2 diabetes patients.

In patients with type 2 diabetes, using Onglyza® will inhibit the enzyme activity DPP-4 for 24 hours.

After using oral glucose test or after meals, the inhibition of DPP-4 will increase 2-3 times the concentration of GLP-1 and GLP hormone concentration in blood, reducing glucagon levels and increasing glucose deposit release from Beta cells of the pancreat gland.

Insulin levels and a reduction in glucagon concentration are associated with reducing glucose concentration at hunger and reducing glucose after taking glucose or after meals.

pharmacokinetic

absorption

Average time to achieve maximum plasma concentrations (TMAX) after use 5 mg 1 time/day is 2 hours for saxagliptin and 4 hours for active metabolites.

Use at the same time with saxagliptin's increased fat foods about 20 minutes compared to hunger.

Saxagliptin's AUC increased by about 27% when used with food compared to hunger.

Onglyza® can be used during or outside meals.

Distribution

In vitro research shows that the cohesion of saxagliptin and its active metabolites with non -significant human serum protein. Therefore, changes in blood protein content in different conditions (for example, kidney failure or liver failure) will not affect the distribution of saxagliptin.

Metabolism

Metabolism of saxagliptin mainly occurs through the cytochrom P450 3A4/5 (CYP3A4/5). The activity of Saxagliptin also has the effect of inhibiting DPP-4 and is active in % compared to saxagliptin. Therefore, strong inhibitors and induction CYP3A4/5 will change the pharmacokinetics of saxagliptin and its active metabolites.

Elimination

Saxagliptin is excreted through both lines: kidney and liver.

After taking a single dose of TC-Saxagliptin 50 mg, the intact saxagliptin, the active metabolic form and tones of radioactive active compounds are excreted in the urine with a rate of 24%, 30% and 75% of the dose of use.

The average renal clearance of saxagliptin (-230 ml/min) is higher than the average filtration rate through the glomerular (-120 ml/min), showing the active excretory mechanisms.

About 22% of the radioactive substance is present in the feces, proving that there is a part of the Saxagliptin excreted through one and/or a part that is not absorbed through the gastrointestinal tract.

After taking a single dose of Onglyza® 5 mg on healthy objects, the average emissions time (t1/2) of saxagliptin and its active metabolites in plasma are 25 hours and 3.1 hours respectively.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Precautions when using

pancreatitis

Acute pancreatitis in patients using Onglyza® was recorded after the drug circulated on the market. After starting to use Onglyza®, patients should be carefully monitored with signs and symptoms of pancreatitis.

If there is a suspected pancreatic inflammation, you should stop using Onglyza® immediately and take appropriate control measures. It is unclear whether the patient has a history of pancreatitis when using Onglyza®, which increases the risk of pancreatic inflammation.

Use with medications that cause glucose in the blood

When using Onglyza® in combination with sulfonylurea or with insulin are medications that cause glucose in the blood, the frequency of blood glucose hypoglycemia is diagnosed higher when using a placebo in combination with sulfonylurea or with insulin.

Therefore, the dose of cross -stimulating drugs should be used to minimize the risk of lowering glucose in the blood when used in combination with Onglyza®.

Hypersensitivity reaction

These reactions include anaphylactic reaction, angioedema and flaking skin condition. These reactions occur within the first 3 months of treatment with Onglyza®, some cases occurred after the first dose.

If suspected of severe hypersensitivity reactions, OngLyza® is suspected, assessing the hidden causes of the event and finding an alternative treatment for diabetes.

Use cautiously for patients with a history of angioedema with other dipeptidyl peptidase-4 inhibitors (DPP4) because they still know if these patients may have angioed with onglyza®.

Effects on large blood vessels

There has been no clinical research that has provided evidence of the effect of reducing flag risks on large blood vessels for Onglyza® or any other diabetes medicine.

Use in children

Not determined the safety and effectiveness of OngLyza® in children.

Used in the elderly

Despite the unpretved clinical experience of the response between the elderly patients and the young patient, it is not possible to rule out the ability to be more sensitive to drugs in some elderly patients.

Saxagliptin and its active metabolites are partially eliminated through the kidneys. Because elderly patients often have the ability to impaired kidney function, caution should be careful when choosing the dose for the elderly based on kidney function.

The ability to drive and operate machinery

There has been no research on the impact of the drug on the ability to drive and operate machinery. However, when driving or operating the machine, it should be noted that dizziness has been recorded when treated with saxagliptin.

Pregnancy

Pregnant women - Group b.

There are not enough control studies on the use of saxagliptin in pregnant women. Because animal reproductive studies cannot always be used to predict the response occurs in humans, it is not advisable to use Onglyza® and other diabetes medications during pregnancy unless really needed.

saxagliptin passes through the placenta and fetus at the dose on the mother mouse is pregnant.

Breastfeeding period

Saxagliptin is excreted in milk in breastfeeding mice at a ratio of about 1: 1 compared to plasma concentrations. It has not yet been determined whether saxagliptin is excreted in breast milk in humans or not. Due to a lot of excretion in breast milk, be careful when using Onglyza® in breastfeeding women.

Medicine interaction

Strong supplies inhibitors CYP3A4/5

Ketoconazole increases the concentration and time of contact with saxagliptin. The increase in the concentration of saxagliptin in plasma also occurs when using strongly strong inhibitors CYP3A4/5 (for example: Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nefazodon, Nelfinavir, Ritonavir, Saquinavir and Telithromycin).