SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(十八)
ARDY XR is contraindicated in moderate to severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.1)].
8.7 Hepatic Impairment
SYNJARDY XR should generally be avoided in patients with clinical or laboratory evidence of hepatic disease [see WARNINGS AND PRECAUTIONS (5.1)].
Empagliflozin
Empagliflozin may be used in patients with hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].
Metformin hydrochloride
Use of metformin hydrochloride in patients with hepatic impairment has been associated with some cases of lactic acidosis. SYNJARDY XR is not recommended in patients with hepatic impairment [see WARNINGS AND PRECAUTIONS (5.1)].
CLOSE
10 OVERDOSAGE
In the event of an overdose with SYNJARDY XR, 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 empagliflozin by hemodialysis has not been studied. 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 SYNJARDY XR overdosage is suspected.
Metformin hydrochloride
Overdose of metformin hydrochloride 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 (5.1)].
11 DESCRIPTION
SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) tablets, for oral use, contain two antihyperglycemic drugs used in the management of type 2 diabetes: empagliflozin and metformin hydrochloride.
Empagliflozin
Empagliflozin is an orally-active inhibitor of the sodium-glucose co-transporter 2 (SGLT2).
The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S).
Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:
Empagliflozin Structure
Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene.
Metformin hydrochloride
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin 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 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:
Metformin Hydrochloride Structure
Each film-coated tablet of SYNJARDY XR consists of an extended-releas |
