Glicana 100 Tablet

Glicana 100 Tablet is used for: Type 2 diabetes mellitus

Oral Tablet As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease, To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria Adults >18 years: Recommended Dose: 100 mg PO once daily taken before the first meal of the day May increase the dose to 300 mg once daily in patients tolerating 100 mg/day who have an eGFR >60 mL/min/1.73 m² and require additional glycemic control.

The safety and effectiveness of Canagliflozin in pediatric patients under 18 years of age have not been established.

Renal impairment eGFR >60 mL/min/1.73 m2: No dosage adjustment necessary eGFR 30 to <60 mL/min/1.73 m2: 100 mg daily eGFR <30 mL/min/1.73 m2 with albuminuria >300 mg/day: 100 mg daily to reduce risk of end-stage kidney disease, doubling of serum creatinine, CV death, and hospitalization for heart failure eGFR <30 mL/min/1.73 m2: Initiation not recommended On dialysis: Contraindicated

Take orally with or without food

History of a serious hypersensitivity reaction and hypersensitivity to canagliflozin. Severe renal impairment (eGFR <30 mL/min/1.73 m2), end stage renal disease or patients on dialysis. Diabetic Ketoacidosis, Type-1 Diabetes.

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 Canagliflozin if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting Lower Limb Amputation: Consider factors that may increase the risk of amputation before initiating Canagliflozin. Monitor patients for infection or ulcers of lower limb and discontinue if these occur Volume Depletion: May result in acute kidney injury. Before initiating Canagliflozin, assess and correct volume status in patients with renal impairment, elderly patients, or patients on loop 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 dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with Canagliflozin 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 Genital mycotic infections: Monitor and treat if indicated Hypersensitivity reactions: Discontinue Canagliflozin and monitor until signs and symptoms resolve Bone fracture: Consider factors that contribute to fracture risk before initiating Canagliflozin MONITORING PARAMETERS Determine renal function before treatment and at least annually thereafter and before initiation of concomitant drugs that reduce renal function and periodically thereafter. Monitor for infection, new pain or tenderness, and sores or ulcers involving the lower limbs. Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery). Consider ketone monitoring in patients at risk for ketoacidosis.

Pregnancy Based on juvenile animal data showing adverse renal effects, this drug is not recommended during second and third trimesters of pregnancy. Limited data on pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy In juvenile animal studies, adverse renal pelvic and tubule dilatations that were not reversible were observed in rats when canagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at an exposure 0.5 times the 300 mg clinical dose, based on AUC Clinical considerations Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications Poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity Lactation No information regarding distribution in human milk or effects on the breastfed infant or milk production Present in milk of lactating rats Since human kidney maturation occurs in utero and during the first 2 yr of life when lactational exposure may occur, there may be risk to the developing human kidney Inform women not to breastfeed while taking canagliflozin

UGT Enzyme Inducers (Rifampin, phenytoin, phenobarbital, ritonavir) UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of Canagliflozin. Insulin or Insulin Secretagogues The risk of hypoglycemia is increased when Canagliflozin is used concomitantly with insulin secretagogues (e.g., sulfonylurea) or insulin Digoxin Canagliflozin increases digoxin exposure Lithium Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.

Side effects of Canagliflozin : >10% Female genital mycotic infections (10.4-11.4%) 1-10% Increased urination (4.6-5.3%),Male genital mycotic infections (3.7-4.2%),Vulvovaginal pruritus (1.6-3%),Thirst (2.3-2.8%),Constipation (1.8-2.3%),Nausea (2.2-2.3%),Abdominal pain (1.7-1.8%) Volume depletion Overall population (2.3-3.4%),Age >75 yr (4.9-8.7%),eGFR <60/mL/min/1.73 m³ (4.7-8.1%),Use of loop diuretic (3.2-8.8%)

Sodium-glucose co-transporter 2 SGLT-2 inhibition lowers the renal glucose threshold (ie, the plasma glucose concentration which exceed the maximum glucose reabsorption capacity of the kidney); lowering the renal glucose threshold results in increased urinary glucose excretion.

Glicana 100 100mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Canagliflozin. Glicana 100 is availble in Bangladesh. Farmaco BD drug index information on Glicana 100 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.