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- 2. Drug overview: Generic name:ertugliflozin/Metformin Brand name: segluromet Dose:2.5mg/500mg,2.5mg/1000mg 7.5mg/500mg,7.5mg/1000mg Dosage Forms: Tablet Approval date: December 19, 2017
- 3. DESCRIPTION OF SEGRULOMET: seglurometcontains a combination of ertugliflozin and Metformin helps control blood sugar levels. Ertugliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin works by helping your liver release lower amounts of sugar into your blood. Segluromet is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus
- 5. Mechanism of Action Ertugliflozin:Selective sodium-glucose transporter-2 (SGLT2) inhibitor; 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 Metformin: Decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; improves glucose tolerance by lowering both basal and postprandial plasma glucose
- 6. Absorption Ertugliflozin Peak plasma time:1 hr (fasting); 2 hr (high-fat, high-caloric meal) Peak plasma concentration, steady-state: 81.3 ng/ml (5 mg qDay); 268 ng/ml (15 mg qDay) AUC, steady-state: 398 ng∙hr/ml (5 mg qDay); 1,193 ng∙hr/ml(15 mg qDay) Steady-state reached after 4-6 days Bioavailability, 15-mg dose: ~100% Metformin Steady-state reached after 24-48 hr Bioavailability, 500-mg dose: 50-60% Food decreases extent of and slightly delays absorption
- 7. Distribution Ertugliflozin Vd: 85.5 L Proteinbinding: 93.6% Blood-to-plasma concentration ratio of ertugliflozin: 0.66 Metformin Vd: 654 L Protein binding: Negligible
- 8. Metabolism Ertugliflozin Major metabolic pathwayfor ertugliflozin is UGT1A9 and UGT2B7-mediated O-glucorunide conjugation (pharmacologically inactive at clinically relevant concentrations) CYP-mediated (oxidative) metabolism of ertugliflozin is minimal (12%) Metformin Does not undergo hepatic nor biliary metabolism
- 9. Excretion Ertugliflozin Half-life: 16.6 hr Clearance:11.2 L/hr Excretion: unchanged ertugliflozin: Feces (33.8%); urine (1.5%) Metformin Half-life: 17.6 hr (blood); 6.2 hr (plasma) Excretion: ~90% urine (unchanged)
- 10. Ertugliflozin .Urinary tract infections(4-4.1%) .Headache (2.9-3.5%) .Vaginal pruritus (2.4-2.8%) .Increased urination (2.4-2.7%) .Nasopharyngitis (2-2.5%) .Back pain (1.7-2.5%) .Renal adverse effects (1.3-2.5%) .Weight decreased (1.2-2.4%) .Thirst (1.4-2.7%)
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- 12. CONTRA-INDICATION: It is contraindicatedin pregnant women and lactating women's
- 13. patient counselling points: limitcarbohydrate servings .Restrict protein in the presence of renal dysfunction .Lose weight. Limit sodium. Hypertension increases the risk for heart attack and stroke as well as nephropathy in people with diabetes. Limiting sodium can help decrease blood pressure. .Limit alcohol consumption. .Limit saturated fats and dietary cholesterol. .During this step the pharmacist explain about the his/her medications
- 14. Monitoring your bloodsugar Depending on your treatment plan, you may need to check and record your blood sugar level every now and then or, if you're on insulin, multiple times a day. Ask your doctor how often he or she wants you to check your blood sugar.