sotagliflozin

Action and Spectrum

Actions and Spectrum: 

Actions: 

The actions of sotagliflozin involve inhibiting the SGLT2 proteins in the kidneys and intestines. These proteins are responsible for reabsorbing glucose from the urine and gastrointestinal tract. By blocking these transporters, sotagliflozin promotes glucose excretion in the urine and reduces glucose absorption from the intestines. This mechanism helps to lower blood glucose levels and improve glycemic control in individuals with diabetes.  

Spectrum:

sotagliflozin’s effect includes: sotagliflozin lowers blood glucose levels by increasing the removal of urinary glucose and reducing glucose absorption from the intestines. This helps to improve glycemic control in patients with diabetes. 

• Weight management: sotagliflozin has been associated with modest weight loss in some individuals. The increased urinary excretion of glucose leads to a loss of calories, which can contribute to weight reduction. 
• Blood pressure: sotagliflozin may benefit blood pressure by promoting diuresis (increased urine production) and reducing fluid volume. This can lead to a modest reduction in blood pressure levels. 
• Cardiovascular benefits: Clinical trials have shown that sotagliflozin may benefit type 2 diabetic patients. 
• Renal protection: sotagliflozin has shown potential renal protective effects by reducing the progression of kidney disease in patients with type 2 diabetes. It may help to preserve kidney function and reduce the risk of diabetic kidney disease development. 

Drug Interaction

Adverse Reaction

Black Box Warning

Black Box Warning: 

None  

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Type 1 diabetes 
• Severe renal impairment 

Cautions 

• Genital mycotic infections 
• UTI 
• Hypotension 
• Dehydration 
• Hypoglycemia 
• Volume depletion 
• Electrolyte depletion 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the risk due to drugs in pregnant females. Though administering the drug  

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

sotagliflozin is a dual inhibitor of SGLT2 and SGLT1 proteins. SGLT2, primarily expressed in the kidneys, reabsorbs glucose from the urine back into the bloodstream. SGLT1 is expressed in the intestines, facilitating glucose absorption from the GI tract into the bloodstream. 

By inhibiting SGLT2 and SGLT1, sotagliflozin reduces glucose reabsorption in the kidneys and decreases glucose absorption from the intestines. This results in increased urinary glucose excretion and reduced postprandial glucose levels. 

Pharmacodynamics: 

The primary pharmacodynamic effect of sotagliflozin is the reduction of renal glucose reabsorption, leading to increased urinary glucose excretion. This results in lowering blood glucose levels, both fasting and postprandial. 

Pharmacokinetics: 

Absorption 

sotagliflozin is orally administered and is rapidly absorbed after ingestion. The time to achieve peak plasma concentration (Tmax) is approximately 1-2 hours. It has good bioavailability, with about 90% of the drug reaching the systemic circulation. 

Distribution 

Protein-bound is 99% 

The volume of distribution of lurbinectedin at steady state is 504 L 

Metabolism 

The liver metabolizes sotagliflozin through the cytochrome P450 enzyme system, mainly CYP3A4. The metabolites formed are pharmacologically inactive. The elimination half-life of sotagliflozin is approximately 12-14 hours, allowing for once-daily dosing. 

Elimination and Excretion 

The drug and its metabolites are primarily eliminated through the feces (approximately 75%) and, to a lesser extent, in the urine (approximately 20%). 

Adminstartion

Administration: 

sotagliflozin can be taken with or without food. Taking the medication simultaneously each day is generally recommended to establish a consistent routine. 

To ensure the effectiveness of sotagliflozin therapy, it is essential to take the medication as the healthcare professional prescribes. Missing doses or inconsistent use may result in suboptimal glycemic control and reduced benefits. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: sotagliflozin 

Pronounced: soe-ta-gli-floe-zin 

Why do we use sotagliflozin? 

sotagliflozin is primarily used in the management of type 1 diabetes mellitus. It also helps in weight management & cardiovascular benefits.