"Boehringer Ingelheim and Eli Lilly have filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial for their SGLT2 inhibitor"...
In the event of an overdose with JENTADUETO, contact the Poison Control Center. Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient's clinical status. Removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely. However, metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful partly for removal of accumulated metformin from patients in whom JENTADUETO overdosage is suspected.
During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions. There is no experience with doses above 600 mg in humans.
Overdose of metformin has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
JENTADUETO is contraindicated in patients with:
- Renal impairment (e.g., serum creatinine ≥ 1.5 mg/dL for men, ≥ 1.4 mg/dL for women, or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see WARNINGS AND PRECAUTIONS]
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin [see WARNINGS AND PRECAUTIONS]
- A history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]
- Hypersensitivity to metformin
Last reviewed on RxList: 8/17/2015
Additional Jentadueto Information
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