Brand Name: Empacoza Plus.
Composition:
Each Empacoza plus 10/5 mg tablet contains:
empagliflozin ........................................................ 10 mg
linagliptin ………………………………………………………. 5 mg
Each Empacoza 25/5 mg tablet contains:
empagliflozin ........................................................ 25 mg
Linagliptin ……………………………………………………. 5 mg
Therapeutic Indications
- fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:
○ to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of ُEmpacoza Plus do not provide adequate glycaemic control
- when already being treated with the free combination of empagliflozin and linagliptin.
Dosage and Administration:
- The recommended starting dose is one film-coated tablet of Empacoza Plus 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily excipients
Warnings and precautions:
- Diabetic ketoacidosis
- Renal impairment
- Monitoring of renal function
- Hepatic injury
- Elevated haematocrit
- Chronic kidney disease
- Risk for volume depletion
- Elderly
- Urinary tract infections
- Necrotising fasciitis of the perineum (Fournier’s gangrene)
- Lower limb amputations
- Cardiac failure
Undesirable Effects:
- Urinary tract infection (7.6-9.3%)
- Female genital mycotic infections (5.4-6.4%)
- Upper respiratory tract infection (3.1-4%)
- Increased urination (3.2-3.4%)
- Dyslipidemia (2.9-3.9%)
- Male genital mycotic infections (1.6-3.1%)
- Arthralgia (2.3-2.4%)
- Nausea (1.1-2.3%)
- Polydipsia (1.5-1.7%)
- the dose can be increased to one film-coated tablet of Empacoza Plus 25 mg/5 mg (25 mg empagliflozin plus 5 mg linagliptin) once daily
Contraindications:
- Hypersensitivity to the active substances, to any other Sodium-Glucose-Co-Transporter-2 (SGLT2) inhibitor, to any other Dipeptidyl-Peptidase-4 (DPP-4) inhibitor, or to any of the
Pharmacological Properties:
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus
Linagliptin is an inhibitor of DPP-4 an enzyme which is involved in the inactivation of the incretin
hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide).
These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Packaging:
Empacoza plus 10/5 mg Tablets: Box containing 3 blisters of 10 tablets each.
Empacoza plus 25/5 mg Tablets: Box containing 3 blisters of 10 tablets each.
