Onglyza 5mg Astrazeneca tablets support diet, blood sugar control (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Saxagliptin

Ingredient

Composition information	Content
Saxagliptin	5mg

Uses

Indications

Onglyza 5 mg drug are indicated in the following cases:

Unit or coordinated therapy

Onglyza is indicated for treatment for diet and exercise to help control blood glucose in patients with adult age with diabetes Type 2 with many different clinical diseases.

Shelf limit

Do not use for patients with type 1 diabetes or keto - acidic acidic because the drug is 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.

Pharmacokic

In patients with type 2 diabetes, using Onglyza will inhibit DPP - 4 enzyme activity in 24 hours. After using oral glucose solution or after meals, the inhibition of DPP - 4 will increase 2-3 times the concentration of GLP - 1 hormone and GIP has the activity in the blood, reduces glucagon levels and increases glucose dependence from beta cells of the pancreatic 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 high -fat foods that increase the Saxagliptin's TMAX 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 (such as 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 CYP3A4/5 inhibitors and touch will change the kinetics of saxagliptin and its active metabolites.

Elimination

Saxagliptin is eliminated through both kidney and liver. After taking a single dose of 14C - Saxagliptin 50 mg, the intact saxagliptin, the active metabolic form and the sum of radioactive active compounds are excreted in the urine with a rate of 24%, 36%, and 75%used.

Average renal clearance of saxagliptin (about 230 ml/minute) is higher than the average filtration rate through the glomerular (about 120 ml/minute), showing active excretory mechanisms. About 22% of the radioactive substance is present in the stool, proving that there is a part of the Saxagliptin excreted through one and/or partly not absorbed through the gastrointestinal tract.

After taking a single -dose of 5 mg ongic monouns on healthy objects, the average selling time (T2) of saxagliptin and its active metabolites in plasma is 2.5 hours and 3 1 hour, respectively.

Before taking Onglyza 5mg Astrazeneca tablets support diet, blood sugar control (2 blisters x 14 tablets)

How to use

Onglyza pills are used orally, during or outside meals. Do not break or cut Onglyza pill.

Dosage

The recommended dose of OngLyza is 2.5 mg or 5 mg oral 1 time/day.

Patients with renal failure

No need to adjust the ongile dose for patients with mild renal impairment (Creatinine clearance [CrCl]> 50 ml/minute).

Use Onglyza at 2.5 mg doses/day for patients with average renal failure or severe renal failure and even the end of the end of the stage of hemolysis (Creatinine clearance [CrCl]

Because the dose of Onglyza needs to be limited to 2.5 mg/day based on kidney function, so it is necessary to assess the kidney function before starting treatment with Onglyza and then need to monitor the periodic kidney function. Kidney function can be estimated from the serum creatinine level using the Cockcroft - Gault or MDRD formula (Modification of Diet in Renal Dise: Adjust the diet for patients with renal impairment).

Use at the same time with strong CYP3A4/5 inhibitors

OngLyza's dose is 2.5 mg once a day when used at the same time with strong Cytochrom P450 3A4/5 (CYP3A4/5) such as ketoconazol, Atazanavir, Clarithromycin, indinavir, iTraconazole, NefazODon, Nelfinavir, Ritonavir, Sentonavir, and Sentonava telithromycin.

Use at the same time with insulin secretion stimulants (such as sulfonylurea) or with insulin.

When using Onglyza at the same time with insulin stimulants (such as sulfonylurea) or with insulin, low doses of insulin or insulin stimulants need to minimize the risk of hypoglycemia in blood. [See note and careful carefully when used].

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose? heart.

In case of overdose, appropriate supportive treatments are required based on the patient's clinical condition. Saxagliptin and its active metabolites can be excluded through hemolysis (23% dose in 4 hours).

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Onglyza 5 mg , you may experience unwanted effects (ADR).

runny nose, sore throat, headache, pain, abdominal pain, nausea, vomiting, diarrhea , flatulence.

Some side effects may be serious:

rash, floating urticaria , swelling of the face, lips, tongue or throat, shortness of breath or swallow, hoarseness.

Hypersensitivity reactions such as anaphylaxis, angioedema or flaking skin condition.

acute pancreatitis .

Instructions on how to handle ADR

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.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Onglyza 5mg

Hypersensitivity to active ingredients or any excipients.

History of serious hypersensitivity reaction with Onglyza such as anaphylactic reaction, angioedema or flaking skin condition.

Precautions when using

pancreatitis

Acute pancreatitis in patients using Onglyza was recorded after the drug circulated on the market. After starting to use, patients should be carefully monitored with signs and symptoms of pancreatitis. If there is a suspected pancreatitis, OngLyza should be stopped immediately and take appropriate control measures. It is unclear whether the patient has a history of pancreatitis when using Onglyzacó increases the risk of pancreatitis.

Use with medications that cause glucose in the blood

When using Onglyza in combination with sulfonylurea or with insulin, are drugs that cause blood glucose, frequency of blood glucose that is diagnosed higher when using placebo in combination with sulfonylurea or with insulin. [See unwanted effect. Therefore, low doses of insulin stimulants should be used to minimize the risk of lowering glucose in the blood when used in combination with Onglyza. [View Dosage and usage]

Hypersensitivity reactions have been reported on serious hypersensitivity reactions in patients using Onglyza after the drug circulates on the market. These reactions include anaphylactic reaction, vascular coverage, and flaky skin provinces. These reactions occurred within the first 3 months of treatment with Onglyza, some cases occurred after the first dose.

If suspected of severe hypersensitivity reaction, Onglyza stops, assessing the hidden causes of the event, and the heart of the replacement treatment for diabetes. [See unwanted effect. Use carefully for patients with a history of angioedema with other Dipeptidy Peptidase - 4 (DPP4) inhibitors because they still know if these patients may be covered with vascular vessels.

Effects on large blood vessels

No clinical studies have given evidence of the effect of reducing the risk on large blood vessels for Onglyza or any other diabetes treatment.

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

Classification of drugs for 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 necessary.

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 excreted drugs in breast milk, be cautious when using Onglyza at nursing women.

Drug interaction

No report.

Storage

Store at temperatures below 30 ° C.

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