SAXAGLIPTIN-METFORMIN ER (Generic for KOMBIGLYZE XR)

Saxagliptin 2.5mg, Metformin Hydrochloride 1,000mg, Oral tablet, extended release

Grapefruit juice

· Severity: Mild

· Notes for Consumers: Saxagliptin and grapefruit juice may be taken together. Tell your healthcare professional about any unusual symptom that occurs.

· Notes for Professionals: Saxagliptin plasma concentrations are expected to increase in the presence of moderate CYP 3A4/5 inhibitors such as grapefruit juice, but saxagliptin dose adjustment is not advised.

Saxagliptin 2.5mg, Metformin Hydrochloride 1,000mg, Oral tablet, extended release

Tobacco

· Severity: Moderate

· Notes for Consumers: If you use tobacco or are trying to quit tobacco use, monitor your blood sugar more frequently. Nicotine, a component of tobacco, can increase blood sugar. Also, if you are trying to quit tobacco use, as your body adjusts, your blood sugar levels may change; the actions of Antidiabetic Agents (medicines used to treat diabetes) may be increased and this could lead to low blood sugar. Know the symptoms of low or high blood sugar and talk with your health care provider if they occur. Monitor your blood sugar regularly.

· Notes for Professionals: Tobacco smoking is known to aggravate insulin resistance. The cessation of tobacco smoking may result in a decrease in blood glucose. Blood glucose concentrations should be monitored more closely whenever a change in either smoking status occurs; dosage adjustments in antidiabetic agents may be needed.

Saxagliptin 2.5mg, Metformin Hydrochloride 1,000mg, Oral tablet, extended release

Alcohol

· Severity: Moderate

· Notes for Consumers: Avoid or limit the use of alcohol with metformin, due to an increased risk for side effects. Avoid excessive use of alcohol in any form. Alcoholic beverages can increase the risk of low blood sugar, or can cause increased blood sugar due to the calories in these beverages. Limit alcohol containing medicines and beverages if you are a patient with diabetes. If you use a blood sugar monitoring device, check your blood sugar regularly. Learn the signs and symptoms of high or low blood sugar, and know how you should treat these if they occur. Contact your health care provider immediately if you experience extreme weakness, increasing drowsiness, or difficulty breathing (heavy breathing, shortness of breath) which are symptoms of the more serious side effects of Metformin.

· Notes for Professionals: Patients taking metformin should be advised to limit their use of ethanol (alcohol). Blood lactate concentrations and the lactate to pyruvate ratio are increased during excessive (acute or chronic) intake of alcohol with metformin. Elevated lactic acid concentrations are associated with increased morbidity rates as the risk for lactic acidosis is increased. In patients with diabetes, alcohol intake can also cause hypoglycemia or worsen glycemic control as it provides a source of additional calories. Many non-prescription drug products may be formulated with alcohol; have patients scrutinize product labels prior to consumption.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>