Xigduo Xr
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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
XIGDUO XR (dapagliflozin and metformin HCl extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate [see Clinical Studies (14)].
XIGDUO XR is not recommended for patients with type 1 diabeties mellitus or diabetic ketoacidosis.
History
There is currently no drug history available for this drug.
Other Information
XIGDUO XR (dapagliflozin and metformin HCl extended-release) tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride.
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 (XIGDUO XR 5 mg/500 mg), the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin hydrochloride (XIGDUO XR 5 mg/1000 mg), the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin hydrochloride (XIGDUO XR 10 mg/500 mg), or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin hydrochloride (XIGDUO XR 10 mg/1000 mg).
Each film-coated tablet of XIGDUO XR contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, crospovidone, silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, and hypromellose 2208. The 5 mg/500 mg and 5 mg/1000 mg strength tablets of XIGDUO XR also contain 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 and the film coating for the XIGDUO XR 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg tablets contains iron oxides.
Sources
Xigduo Xr Manufacturers
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Astrazeneca Pharmaceuticals Lp
![Xigduo Xr (Dapagliflozin And Metformin Hydrochloride) Tablet, Film Coated, Extended Release [Astrazeneca Pharmaceuticals Lp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Xigduo Xr | Astrazeneca Pharmaceuticals Lp
2.1 Recommended Dosing • Healthcare providers should individualize the starting dose of XIGDUO XR based on the patient’s current treatment [see Dosage Forms and Strengths (3)]. • XIGDUO XR should be taken once daily in the morning with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin. • XIGDUO XR tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of XIGDUO XR will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet. • Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 10 mg dapagliflozin and 2000 mg metformin HCl. • Patients taking an evening dose of metformin XR should skip their last dose before starting XIGDUO XR. • In patients with volume depletion, correcting this condition prior to initiation of XIGDUO XR is recommended [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Patient Counseling Information (17)]. 2.2 Patients with Renal ImpairmentNo dosage adjustment for XIGDUO XR is indicated in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
Assessment of renal function is recommended prior to initiation of XIGDUO XR therapy and periodically thereafter.
XIGDUO XR should not be used in patients with moderate to severe renal impairment (defined as eGFR <60 mL/min/1.73 m2 or CrCl <60 mL/min, or end-stage renal disease [ESRD]) [see Contraindications (4), Warnings and Precautions (5.3), Adverse Reactions (6.1), and Use in Specific Populations (8.6)].
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