Elpida 200 Tablet
Sotagliflozin
200 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 10's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 150.00 AED |
Indications
Elpida 200 Tablet is used for:
Diabetes Mellitus, Type 1, Adjunct to insulin therapy
Adult Dose
Oral
Tablet
As an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes mellitus with a body mass index > 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day.
After at least three months, if additional glycaemic control is needed, in patients tolerating sotagliflozin 200 mg, the dose may be increased to 400 mg once daily.
Hepatic impairment
No dose adjustment is recommended in patients with mild hepatic impairment. Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment.
Child Dose
Renal Dose
Renal impairment
Assessment of renal function is recommended prior to initiation of sotagliflozin and periodically thereafter.
Initiation of sotagliflozin is not recommended when eGFR is less than 60 ml/min/1.73 m2 and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2.
Sotagliflozin should not be used in patients with severe renal impairment, end stage renal disease (ESRD) or in patients on dialysis as it has not been studied in these patients.
Administration
Oral use. Sotagliflozin should be taken once daily before the first meal of the day.
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.
Precautions
Diabetic ketoacidosis
Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with an increased risk of DKA.
Hypotension:
Before initiating Sotagliflozin, volume status should be assessed and correction on hypovolemia should be made in the elderly, in patients with renal impairment, in patients with low systolic blood pressure and in patients on diuretics since Sotagliflozin causes intravascular volume contraction.
Impairment in Renal Function:
Renal function should be evaluated prior to initiating Sotagliflozin and periodically. Initiation of sotagliflozin is not recommended when eGFR is less than 60 ml/min/1.73 m2 and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2
Hepatic impairment:
Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment, as sotagliflozin exposure is increased in these patients.
Genital mycotic infections:
Monitoring and treatment should be done as appropriate.
Urinary tract infections:
Temporary interruption of Sotagliflozin should be considered when treating pyelonephritis and urosepsis.
Insulin
Insulin may increase the risk of hypoglycaemia. A lower dose of insulin may be required to minimise the risk of hypoglycaemia when used in combination with sotagliflozin.
Pregnancy-Lactation
Pregnancy
There are no data from the use of sotagliflozin in pregnant women.
Animal studies have shown that sotagliflozin crosses the placenta.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility and pregnancy. Pharmacologically-related reversible renal changes were observed in a rat postnatal study, corresponding to the second and third trimesters of human pregnancy.
Therefore, sotagliflozin is not recommended during the second and third trimesters of pregnancy.
As a precautionary measure, when pregnancy is detected, treatment with sotagliflozin should be discontinued.
Breast-feeding
No data in humans are available on excretion of sotagliflozin into milk.
Available toxicological data in animals have shown excretion of sotagliflozin into milk.
A risk to the newborns/infants cannot be excluded.
Sotagliflozin should not be used during breast-feeding.
Fertility
No studies on the effect on human fertility have been conducted for sotagliflozin. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Interactions
Adverse Effects
Side effects of Sotagliflozin :
The most frequently reported adverse reactions were genital mycotic infections, diabetic ketoacidosis and diarrhoea.
The following adverse reactions have been identified:
Hypotension, renal impairment, hepatic impairment, genital mycotic infections, urinary tract infections, nausea, vomiting, or abdominal pain, excessive thirst, constantly feeling tired, high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests, difficulty breathing/rapid, deep breathing, difficulty paying attention, or confusion, rapid weight loss.
Mechanism of Action
Sotagliflozin is a dual inhibitor of sodium glucose cotransporter type 1 (SGLT1) and SGLT2. Local intestinal inhibition of SGLT1, the major transporter for glucose absorption, delays and reduces glucose absorption in the proximal intestine, resulting in a blunting and delay of postprandial hyperglycaemia.
SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, sotagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Note
Elpida 200 200 mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Sotagliflozin. Elpida 200 is availble in Bangladesh.
Farmaco BD drug index information on Elpida 200 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.