Overdose : מינון יתר

12 OVERDOSAGE
In the event of an overdose with TRAJENTA DUO consider contacting poison control center or medical toxicologist for additional overdosage management recommendations.

Overdose of metformin HCl has occurred, including ingestion of amounts greater than 50 grams.
Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (8.1)]. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

Removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely.


13 DESCRIPTION
TRAJENTA DUO tablets for oral use contain: linagliptin and metformin HCl.

Linagliptin
Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.
The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2- butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 
The molecular formula is C25H28N8O2 and the molecular weight is 472.54 g/mol. The structural formula is:

O
N                   N
N
N
N
O       N   N
NH2


Boehringer Ingelheim Israel                                                                           15 Trajenta duo                                                                         Prescribing Information File coated tablets 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1,000mg                                  September 2023 Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL).

Metformin HCl
Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide.
Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63 g/mol. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is: 


TRAJENTA DUO
TRAJENTA DUO is available for oral administration as tablets containing: • 2.5 mg linagliptin and 500 mg metformin HCl (TRAJENTA DUO 2.5 mg/500 mg) • 2.5 mg linagliptin and 850 mg metformin HCl (TRAJENTA DUO 2.5 mg/850 mg) • 2.5 mg linagliptin and 1,000 mg metformin HCl (TRAJENTA DUO 2.5 mg/1000 mg) Each film-coated tablet of TRAJENTA DUO contains the following inactive ingredients: copovidone, maize starch, arginine, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide, talc, propylene glycol, Iron oxide, red (2.5 mg/850 mg; 2.5 mg/1000 mg) and/or Iron oxide, yellow (2.5 mg/500 mg; 2.5 mg/850 mg).