Glyxambi Drug Interactions

No interactions between the two components of this fixed-dose combination have been observed in clinical studies.
No drug interaction studies have been performed with GLYXAMBI and other medicinal products, however, such studies have been conducted with the individual active substances.
No clinically meaningful pharmacokinetic interactions were observed when empagliflozin or linagliptin were co-administered with other commonly used medicinal products. Based on results of pharmacokinetic studies, no dose adjustment of GLYXAMBI is recommended when co-administered with commonly prescribed medicinal products (see Pharmacology: Pharmacodynamics under Actions), except those mentioned as follows.
Insulin and sulfonylureas: Insulin and sulfonylureas may increase the risk of hypoglycaemia. Therefore, a lower dose of insulin or sulfonylureas may be required to reduce the risk of hypoglycaemia when used in combination with GLYXAMBI (see Dosage & Administration, Precautions, and Adverse Reactions).
Diuretics: Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see Precautions).
Lithium: Empagliflozin may increase renal lithium excretion and the blood lithium levels may be decreased. Serum concentration of lithium should be monitored more frequently after empagliflozin initiation and dose changes. Refer the patient to the lithium prescribing doctor in order to monitor serum concentration of lithium.
UGT inhibitors and inducers: Empagliflozin is primarily metabolised via UGT (see Pharmacology: Pharmacokinetics under Actions); however, a clinically relevant effect of UGT inhibitors on empagliflozin is not expected.
Rifampicin: A study was conducted to assess the effect of rifampicin, a potent inductor of P-glycoprotein and CYP3A4, on the pharmacokinetics of 5 mg linagliptin. Multiple co-administration of linagliptin with rifampicin, resulted in a 39.6% and 43.8% decreased linagliptin steady-state AUC and C_max and about 30% decreased DPP-4 inhibition at trough. Thus linagliptin in combination with strong P-glycoprotein inducers is expected to be clinically efficacious, although full efficacy might not be achieved.
Ritonavir: A study was conducted to assess the effect of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, on the pharmacokinetics of linagliptin. Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir increased the AUC and C_max of linagliptin approximately two-fold and three-fold, respectively. Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will not be associated with an increased accumulation. These changes in linagliptin pharmacokinetics were not considered to be clinically relevant. Therefore, clinically relevant interactions would not be expected with other P-glycoprotein or CYP3A4 inhibitors and dose adjustment is not required.