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Author: Admin | 2025-04-28
IMPRINT: SG 105 SHAPE: round COLOR: white All Imprints metformin hydrochloride 1000 mg - s g 1 07 round white metformin hydrochloride 1000 mg oral tablet - s g 1 07 round white metformin hydrochloride tablet - s g 1 07 oval white metformin hydrochloride 500 mg oral tablet - sg 105 round white metformin hydrochloride 850 mg - sg 106 round white metformin hydrochloride 500 mg - sg 105 round white Boxed Warning Warning: Lactic Acidosis Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [ see Warnings and Precautions (5.1)]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certaindrugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having aradiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heartfailure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groupsare provided [ see Dosage and Administration (2.3), Contraindications (4), Warnings and Precautions (5.1)]. If metformin-associated lactic acidosis is suspected, immediately discontinue metformin and institutegeneral supportive measures in a hospital setting. Prompt hemodialysis is recommended [ see Warnings and Precautions (5.1)]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.( 5.1) Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. ( 5.1) If lactic acidosis is suspected, discontinue Metformin Hydrochloride Tablets and institute generalsupportive measures in a hospital setting. Prompt hemodialysis is recommended. ( 5.1) FDA Adverse Reactions Go PRO for all pill images Warning: Lactic Acidosis Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [ see Warnings and Precautions (5.1)]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certaindrugs (e.g. carbonic anhydrase inhibitors such
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