التداخل بين إنسولين عادي (بشري) وساكساغليبتين وميتفورمين

Diabetic ketoacidosis should be treated with insulin.

• Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues: Consider a lower dosage of insulin or insulin secretagogue when used in combination with saxagliptin and metformin hydrochloride extended-release tablets.

Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues Saxagliptin When saxagliptin was used in combination with insulin or an insulin secretagogue, the incidence of confirmed hypoglycemia was increased over that of placebo used in combination with insulin or an insulin secretagogue [ see Adverse Reactions (6.1) ].

Therefore, a lower dosage of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with saxagliptin and metformin hydrochloride extended-release tablets.

Metformin HCl Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol.

For patients with type 2 diabetes mellitus, oral antidiabetic treatment dosage modifications may be needed.

For patients with type 2 diabetes mellitus, dosage modifications of concomitant oral antidiabetic treatment may be needed [see Drug Interactions ( 7 )] .

Risk Factors and Mitigation Strategies for Hypoglycemia The risk of hypoglycemia after use of AFREZZA is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal [See Clinical Pharmacology ( 12.3 )] .

Dosage Modifications for Drug Interactions Dosage modification may be needed when: AFREZZA is used concomitantly with certain drugs that increase and/or decrease the glucose lowering effect [see Drug Interactions ( 7 )].

Clinically Significant Drug Interactions with AFREZZA Antidiabetic agents, Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Receptor Blocking Agents, Disopyramide, Fibrates, Fluoxetine, Monoamine Oxidase Inhibitors, Pentoxifylline, Pramlintide, Salicylates, Somatostatin Analogs (e.g., octreotide), and Sulfonamide Antibiotics Prevention or Management Monitor…