Saxagliptin

Saxagliptin is a medicine used to treat type 2 diabetes mellitus. It is used together with a healthy diet and regular exercise to control blood sugar levels. This helps to prevent serious complications of diabetes like kidney damage and blindness. You should take it regularly at the same time each day to get the most benefit, and you should not stop unless your doctor recommends. This medicine is helping you to control your blood sugar levels and prevent serious complications in the future. It is important to stay on the diet and exercise program recommended by your doctor while taking this medicine. Your lifestyle plays a big part in controlling diabetes. The most common side effect of taking this medicine is headache. This is usually minor and improves with time. Low blood sugar level (hypoglycemia) is a possible side effect if you are also taking other diabetes medicines like insulin or sulphonylurea, so you need to know how to recognize and deal with it. It may also cause upper respiratory tract infections like sore throat, cough and cold. Contact your doctor if the side effects worry you or if they do not go away. Before taking this medicine, let your doctor know if you have ever had liver or kidney disease, heart or pancreas problems, or if you drink a lot of alcohol. Pregnant or breastfeeding women should also consult their doctor before taking it. Some other medicines you are taking may interfere with this medicine's working. So, make sure your doctor knows about all the other medicines you are using. Limit your alcohol intake while taking this medicine because it can increase your risk of developing low blood sugar levels. You may need regular tests such as kidney function and blood glucose levels to check that the medicine is working properly. Saxagliptin is an antidiabetic medication. It works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces the fasting and postmeal sugar levels.

• Type 2 diabetes mellitus

Dipeptidyl peptidase IV (DPP-4) inhibition that results in increased incretin hormones and enhanced glycemic control.

Adult Dose: Oral Type 2 diabetes mellitus Adult: 2.5 or 5 mg once daily. Combination therapy: May need to reduce dosage of sulfonylurea or other insulin secretagogues when administered in combination Coadministration with strong CYP450 3A4/5 inhibitors: Not to exceed 2.5 mg PO qDay Elderly: No dosage adjustment. Hepatic Impairment No dosage adjustment. Child Dose: <18 years: Safety and efficacy not established Renal Dose: Renal impairment CrCl >50 mL/min: No dose adjustment required CrCl <50 mL/min: Not to exceed 2.5 mg PO qDay ESRD requiring hemodialysis: Not to exceed 2.5 mg PO qDay administered postdialysis ESRD requiring peritoneal dialysis: Not studied

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Saxagliptin may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Saxagliptin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common: • Headache • Nasopharyngitis (inflammation of the throat and nasal passages) • Urinary tract infection • Hypoglycaemia (low blood sugar level) in combination with insulin or sulphonylurea • Upper respiratory tract infection

[CAUTION] Your ability to drive may be affected if your blood sugar is too low or too high. Do not drive if these symptoms occur. Saxagliptin should be taken at the same time every day since this helps you remember to take it. Be careful while driving or operating machinery until you know how Saxagliptin affects you. It may cause hypoglycemia (low blood sugar level) when used with other antidiabetic medicines, alcohol or if you delay or miss a meal. Always carry some sugary food or fruit juice with you in case you experience hypoglycemia symptoms such as cold sweats, cool pale skin, tremor and anxiety. Inform your doctor if you notice joint pains or develop symptoms such as stomach pain, nausea and/or vomiting.

Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)

Strong CYP3A4/5 inhibitors (eg ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir & telithromycin).

[UNSAFE] It is unsafe to consume alcohol with Saxagliptin.

[SAFE IF PRESCRIBED] Saxagliptin is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.

[SAFE IF PRESCRIBED] Saxagliptin is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

[CAUTION] Saxagliptin should be used with caution in patients with kidney disease. Dose adjustment of Saxagliptin may be needed. Please consult your doctor. Regular monitoring of kidney function tests is recommended for dose adjustment. [CAUTION] Saxagliptin should be used with caution in patients with severe liver disease. Dose adjustment of Saxagliptin may be needed. Please consult your doctor. No dose adjustment is recommended for patients with mild to moderate liver disease.

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