Overdose : מינון יתר

9 OVERDOSAGE
Dapagliflozin

In the event of an overdose, contact the Poison Control Center. The removal of dapagliflozin by hemodialysis has not been studied.
Metformin hydrochloride

Overdose of metformin hydrochloride has occurred, including ingestion of amounts >50 grams.. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1)]. 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.

10 DESCRIPTION
XIGDUO XR tablets contain: dapagliflozin , a SGLT2 inhibitor,        and metformin hydrochloride , a biguanide.
Dapagliflozin

Dapagliflozin    is    described   chemically   as    D-glucitol,    1,5-anhydro-1-C-[4-chloro-3-[(4- ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6•C3H8O2•H2O and the formula weight is 502.98. The structural formula is: Metformin hydrochloride

Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white to off- white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63.
Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, 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:



XIGDUO XR

XIGDUO XR is available for oral administration as tablets containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin hydrochloride which is equivalent to 389.9 mg metformin base (XIGDUO XR 5 mg/500 mg), the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (XIGDUO XR 5 mg/1000 mg), the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin hydrochloride which is equivalent to 389.9 mg metformin base (XIGDUO XR 10 mg/500 mg), or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (XIGDUO XR 10 mg/1000 mg).
Each film-coated tablet of XIGDUO XR contains the following inactive ingredients: microcrystalline cellulose PH302, lactose anhydrous, crospovidone, silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, and hypromellose 2208. The 5 mg/500 mg and 10 mg/500 mg strength tablets of XIGDUO XR also contain microcrystalline cellulose PH102 and hypromellose 2910.
The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the XIGDUO XR 5 mg/500 mg tablets contains FD&C Yellow No. 6/Sunset Yellow FCF aluminum lake. The film coating for the XIGDUO XR 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg tablets contains iron oxides.