11 DESCRIPTION Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. Its structural formula is: Metformin HCl is a white to off-white crystalline powder that 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 HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.
⚠️ Warnings
• Ertugliflozin can lead to severe or life-threatening ketoacidosis especially in patients at risk e.g. those with acute fever, pancreatic disorder or
alcohol abuse
. The level of ketones in the urine should regularly be monitored even if the blood sugar is normal.
• Patients should be monitored for the signs and symptoms of volume depletion or low blood pressure during ertugliflozin therapy.
• Abnormalities of kidney function tests like increased serum creatinine levels or decreased glomerular filtration rate may occur during ertugliflozin therapy. Patients should be monitored for kidney function before and after initiating ertugliflozin therapy.
• Ertugliflozin can increase the risk of developing urinary tract infections (UTI) such as urosepsis or
pyelonephritis
(kidney infection). Patients should be monitored for the signs and symptoms of UTI and should be treated appropriately.
• Patients should be monitored for the signs and symptoms of pain, tenderness, ulcers or sores of the lower limbs, and bone infections such as osteomyelitis. Ertugliflozin therapy should be discontinued in such cases to avoid the risk of limb amputation.
• Increase in genital fungal or bladder infections have been observed in patients on ertugliflozin therapy. It is necessary to monitor to detect early and treat with appropriately. Patients who are uncircumcised or who have a history of genital fungal or bladder infections could be at a particularly higher risk.
• Patients who have high cholesterol levels should be monitored for the rise in the level of low-density lipoproteins and treated accordingly.
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