Ardance-L Tablet
Empagliflozin + Linagliptin
25 mg+5 mg
Pharmacil Ltd.
| Pack size | |
|---|---|
| Unite Price | 40.00 BDT |
Indications
Ardance-L Tablet is used for:
Type 2 Diabetes Mellitus
Adult Dose
Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments.
10 mg/5 mg once daily in the morning.
Dose may be increased to 25 mg/5 mg once daily if needed and tolerated.
Hepatic impairment: No dose adjustment required
Child Dose
Renal Dose
Renal impairment
eGFR >45 mL/min/1.73 m2: No dose adjustment required
eGFR 30-45 mL/min/1.73 m2: Do not initiate drug
eGFR < 30 mL/min/1.73 m2, end-stage renal disease (ESRD), or dialysis: Contraindicated
Discontinued if eGFR is persistently drops to <45 mL/min/1.73 m2
Administration
May be taken with or without food
Contra Indications
Severe renal impairment, end-stage renal disease, or dialysis
Hypersensitivity to empagliflozin, linagliptin, or excipients (eg, anaphylaxis, angioedema, exfoliative skin conditions, urticaria, bronchial hyperreactivity)
Precautions
Not to be used in patients w/ type 1 diabetes. Immediately assess for ketoacidosis if symptoms eg, nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness occur. Discontinue treatment if ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene), pancreatitis, bullous pemphigoid is suspected or in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery).
Higher risk of ketoacidosis in patients on a very low carbohydrate diet, w/ an acute illness, pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol abuse, severe dehydration & history of ketoacidosis.
Evaluate for necrotizing fasciitis in patients who present w/ pain or tenderness, erythema, swelling in the genital or perineal area, fever, malaise. Combination w/ sulphonylurea or insulin.
Patients for whom an empagliflozin-induced decrease in BP could pose a risk eg, patients w/ known CV disease, on antihypertensive therapy w/ history of hypotension or patients ≥75 yr. Monitor carefully vol status (eg, physical exam, BP measurements, laboratory tests including haematocrit) & electrolytes in conditions that may lead to fluid loss (eg, GI illness).
Complicated UTI including pyelonephritis & urosepsis. Cardiac failure (NYHA class I-IV). Positive test result for glucose in urine.
Not to be used in patients w/ eGFR <60 mL/min/1.73 m2 or CrCl <60 mL/min. Assess renal function prior to treatment initiation & periodically during treatment; & prior to initiation of any concomitant medicines that may have negative impact on renal function.
Avoid use during pregnancy. Discontinue breast feeding during treatment.
Not recommended for use in childn <18 yr. Not recommended in elderly >85 yr.
Pregnancy-Lactation
Pregnancy
Based on animal data showing adverse renal effects from empagliflozin, it is not recommended during the second and third trimesters of pregnancy
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy; an alternate diabetic therapy appropriate for pregnant women should be initiated
Animal data
In animal studies, empagliflozin, a component of the drug combination, resulted in adverse renal changes in rats when administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy
Doses approximately 13-times maximum clinical dose caused renal pelvic and tubule dilatations that were reversible
No adverse developmental effects were observed when the combination of linagliptin and empagliflozin was administered to pregnant rats
Lactation
There is no information regarding presence in human milk, effects on breastfed infant, or effects on milk production; since potential for serious adverse reactions, including potential for empagliflozin to affect postnatal renal development, in a breastfed infant, advise patients that therapy is not recommended while breastfeeding; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother should be initiated
Interactions
May increase risk of hypoglycemia w/ insulin & sulphonylureas. Interference w/ 1,5-anhydroglucitol (1,5-AG) assay.
Empagliflozin: May add to the diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension.
Risk of decreased efficacy w/ UGT enzyme inducers.
Linagliptin: Decreased exposure w/ rifampicin & reduced efficacy w/ strong P-gp or CYP450 isozyme CYP3A4 inducer.
Side Effects
Side effects of Empagliflozin + Linagliptin :
>10%
Urinary tract infection (11.4-12.5%)
1-10%
Upper respiratory tract infection (7%)
Nasopharyngitis (5.9-6.6%)
Increased LDL-C (4.6-6.5%)
Hypoglycemia (2.2-3.6%)
Increased hematocrit (2.8%)
Mode of Action
First combination approved by the FDA of a sodium glucose cotransporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor
Empagliflozin: SGLT2 inhibitor; SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen; SGLT2 inhibitors reduce glucose reabsorption and lower the renal threshold for glucose, thereby increasing urinary glucose excretion
Linagliptin: DPP-4 inhibitor; increases and prolongs incretin hormone activity, which is inactivated by DPP-4 enzyme; incretins regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic beta cells and reducing glucagon secretion from pancreatic alpha cells
Note
Ardance-L 25 mg+5 mg Tablet generic name is Empagliflozin + Linagliptin. Ardance-L 25 mg+5 mg Tablet is manufactured by Pharmacil Ltd.Ardance-L is availble in all over Bangladesh.
Mes BD drug index information on Ardance-L Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.