Catania Plus/Catania Max Special Precautions

Lactic Acidosis: There have been post-marketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by non-specific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis.
Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue Dapagliflozin and Metformin HCl (As Extended Release) Tablets if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.
Volume Depletion: Before initiating Dapagliflozin and Metformin HCl (As Extended Release) Tablets, assess and correct volume status in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy.
Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider a lower dosage of insulin or an insulin secretagogue to reduce the risk of hypoglycemia when used concomitantly with Dapagliflozin and Metformin HCl (As Extended Release) Tablets.
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
Vitamin B₁₂ Deficiency: Metformin may lower vitamin B₁₂ levels. Measure hematological parameters annually.
Genital Mycotic Infections: Monitor and treat if indicated.
Renal Impairment: Individuals with an eGFR of less than 45 mL/min/1.73 m² are not advised to initiate Dapagliflozin and Metformin HCl (As Extended Release) Tablets, and individuals receiving dialysis, end-stage renal disease, or severe renal impairment (eGFR <30 mL/min/1.73 m²) are contraindicated.
Dapagliflozin: In the DAPA-CKD trial, 4304 adult patients with chronic kidney disease (eGFR 25 to 75 mL/min/1.73 m²) were assessed for dapagliflozin 10 mg. In the DAPA-HF trial, 1926 adult patients with an eGFR of 30 to 60 mL/min/1.73 m² were also assessed for dapagliflozin 10 mg. Across all eGFR subgroups, dapagliflozin's safety profile matched the established safety profile.
Adult patients with moderate renal impairment (eGFR of 45 to less than 60 mL/min/1.73 m² and an eGFR of 30 to less than 60 mL/min/1.73 m²) were included in two glycemic control trials that assessed dapagliflozin 10 mg. When taking dapagliflozin 10 mg, patients with diabetes and renal impairment are more likely to have hypotension and may be more vulnerable to acute kidney injury due to volume depletion. Thirteen patients who received dapagliflozin suffered bone fractures in the trial of adult patients with an eGFR of 30 to less than 60 mL/min/1.73 m², but none of the patients who received a placebo did. When eGFR is less than 45 mL/min/1.73 m², dapagliflozin 10 mg should not be used for glycemic control in patients without known CV disease or CV risk factors.
Metformin HCl: Metformin is largely eliminated by the kidney, and the more severe the renal impairment, the higher the chance of metformin buildup and lactic acidosis. When a patient's estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73 m², Dapagliflozin and Metformin HCl (As Extended Release) Tablets is contraindicated.
Hepatic Impairment: Some incidences of lactic acidosis have been linked to the use of metformin in patients with hepatic impairment. It is not advised to use Dapagliflozin and Metformin HCl (As Extended Release) Tablets in people who have liver impairment.
Use in Children: Pediatric patients ten years of age and older have demonstrated the safety and efficacy of Dapagliflozin and Metformin HCl (As Extended Release) Tablets as a supplement to diet and exercise to enhance glycemic control in type 2 diabetes mellitus.
Pediatric pharmacokinetic studies, trials in adults with type 2 diabetes mellitus, and a 26-week placebo-controlled trial of dapagliflozin with a 26-week extension in 157 pediatric patients aged 10 to 17 years are all in favor of using Dapagliflozin and Metformin HCl (As Extended Release) Tablets for this indication. Dapagliflozin's safety profile in pediatric patients with type 2 diabetes mellitus was comparable to that of adults in the placebo-controlled trial.
In children under the age of ten, the safety and efficacy of Dapagliflozin and Metformin HCl (As Extended Release) Tablets for glycemic control in individuals with type 2 diabetes mellitus have not been proven.
It has not been demonstrated that Dapagliflozin and Metformin HCl (As Extended Release) Tablets is safe or effective in lowering the risk of; hospitalization for heart failure in those with several cardiovascular risk factors or existing cardiovascular disease (CVD) and type 2 diabetes mellitus.
Heart failure hospitalization and cardiovascular death in individuals with heart failure (NYHA class II-IV) who have a lower ejection fraction.
Patients with chronic renal disease at risk of progression may experience persistent declines in their estimated glomerular filtration rate, end-stage kidney disease, cardiovascular mortality, and heart failure hospitalization.
Use in the Elderly: Dapagliflozin and Metformin HCl (As Extended Release) Tablets: Age-based Dapagliflozin and Metformin HCl (As Extended Release) Tablets dosage changes are not advised. Elderly patients should have their renal function evaluated more frequently.
Dapagliflozin: In 21 double-blind, controlled clinical trials, 1424 (24%) of the 5936 patients treated with dapagliflozin were 65 years of age or older, and 207 (3.5%) were 75 years of age or older. These trials evaluated the effectiveness of dapagliflozin in enhancing glycemic control. Efficacy was comparable for patients under 65 and those 65 and older after adjusting for degree of renal function (eGFR). A greater percentage of individuals treated with dapagliflozin for glycemic control who were aged 65 and older experienced hypotension as an adverse response.
Safety and efficacy for patients 65 years of age and younger and those over 65 in the general population and patients with type 2 diabetes mellitus were comparable in the DAPA-HF and DAPA-CKD trials. Of the 4744 patients with heart failure with reduced ejection fraction (HFrEF) in the DAPA-HF trial, 2714 (57%) were over 65. 1211 (57%) of the 2139 individuals with HFrEF and type 2 diabetes mellitus were over 65. Of the 4304 patients with chronic renal disease in the DAPACKD trial, 1818 (42%) were over 65. 1399 (48%) of the 2906 patients with type 2 diabetes mellitus and chronic renal disease were over 65.
Metformin HCl: There were not enough elderly people in controlled clinical studies of metformin to ascertain whether their responses differed from those of younger patients. Due to the increased likelihood of lactic acidosis, concurrent disease or other medication therapy, and reduced hepatic, renal, or cardiac function, senior patients should generally have their dosages chosen carefully, starting at the low end of the dose range. In older individuals, evaluate renal function more often.