【藥品庫存】 藥品安全警訊 (藥品回收)：本品經食藥署公告回收，停用期間請以本院同成分單方 Repaglinide 1mg 及 Uformin 500mg 替代，不便之處，請多包涵。更新日期：2020/10/15。

糖尿病 (Metformin / 其他) Type 2 diabetes mellitus

The combination regimen of 2 antidiabetic agents, repaglinide and metformin hydrochloride, offers different mechanisms of action to improve glycemic control among patients with type 2 diabetes mellitus. Repaglinide, a prandial glucose regulator, increases insulin release. Metformin, an insulin sensitizer, decreases intestinal absorption of glucose, decreases hepatic glucose output, and increases peripheral glucose uptake and utilization?.

Absorption:
Bioavailability: Repaglinide 56% ;Metformin 50% to 60%
Distribution:
Vd:Repaglinide 31 L ;Metformin 654 +/- 358 L
Metabolism:
Repaglinide, Hepatic: via P450 3A4 and 2C8 enzymes;Metformin hydrochloride, does not undergo hepatic or biliary metabolism
Excretion:
Renal: Repaglinide 8%; Metformin 90%
Repaglinide, Dialyzable: no (hemodialysis);Metformin , Dialyzable: yes (hemodialysis), up to 170 mL/min Elimination Half Life:
Repaglinide, adults: approximately 1 hr ;Metformin, adults: 6.2 hrs

Severe renal impairment (eGFR below 30 mL/min/1.73 m(2))
Metabolic acidosis, acute or chronic, including diabetic ketoacidosis
Concomitant therapy with gemfibrozil
Hypersensitivity to metformin hydrochloride, repaglinide, or any other component of the product

C(FDA)

Infant risk cannot be ruled out.(MDX)

Common:
Endocrine metabolic: Hypoglycemia (33% ), Serum vitamin B12 low (7% )
Gastrointestinal: Diarrhea (19% ), Disorder of gastrointestinal tract (33% ), Nausea (15% )
Neurologic: Headache (22% )
Respiratory: Upper respiratory infection (11% )
Serious:
Cardiovascular: Cardiac dysrhythmia (1% or less ), Cardiovascular event risk, Myocardial infarction (1% or less ), Myocardial ischemia
Dermatologic: Stevens-Johnson syndrome
Endocrine metabolic: Lactic acidosis
Hematologic: Hemolytic anemia

General Dosage Information:
titrate dose for optimal glycemic control; MAX, 10 mg repaglinide and 2500 mg metformin hydrochloride daily, or 2 tablets (2 mg repaglinide/500 mg metformin hydrochloride) (equivalent of 4 mg repaglinide/1000 mg metformin hydrochloride) per meal
Type 2 diabetes mellitus:
(Inadequate control with metformin hydrochloride monotherapy) Initial, 1 tab (repaglinide 1 mg/metformin 500 mg) orally twice daily within 15 minutes prior to a meal
Iodinated contrast imaging procedure: Discontinue metformin at the time of or before procedure in patients with a history of liver disease, alcoholism, or heart failure, or with planned intraarterial administration of iodinated contrast; evaluate estimated GFR 48 hours after the imaging procedure and restart metformin if renal function is stable

General Dosage Information:
safety and efficacy not established in pediatric patients

Renal impairment (estimated GFR less than 30 mL/min/1.73 m(2)): Use is contraindicated
Renal impairment (estimated GFR between 30 to 45 mL/min/1.73 m(2)): Use is not recommended
Renal impairment (estimated GFR falls less than 45 mL/min/1.73 m(2) after initiation): Assess benefits and risks of continuing treatment
Renal impairment (estimated GFR falls below 30 mL/min/1.73 m(2) after initiation): Discontinue treatment
Renal impairment (patients undergoing iodinated contrast imaging procedure, estimated GFR between 30 to 60 mL/min/1.73 m(2)): Discontinue at time of or before procedure; evaluate estimated GFR 48 hours after imaging procedure; restart if renal function stable

Hepatic impairment: Use is not recommended