Trajenta Tablets / Film-coated
Linagliptin
5mg
BOEHRINGER INGELHEIM ROXANE INC.
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | GULF DRUG EST. |
| Retail Price | 186.00 AED |
Indications
Trajenta Tablets / Film-coated is used for:
Type 2 Diabetes Mellitus
Adult Dose
Oral
Type 2 diabetes mellitus
Adult: 5 mg once daily.
Indicated for adults with diabetes mellitus type II along with diet and exercise to lower blood sugar; may be used as monotherapy or in combination with other common antidiabetic medications including metformin, sulfonylurea, pioglitazone, or insulin.
Elderly: No dose adjustment is necessary based on age.
Hepatic or renal impairment: No dosage adjustment required.
Child Dose
Safety and efficacy not established
Renal Dose
Renal Impairment: No dose adjustment.
Administration
May administer with or without food
Contra Indications
Patients with a history of a hypersensitivity reaction to linagliptin, such as urticaria, angioedema, or bronchial hyperreactivity. Type 1 DM. Treatment of diabetic ketoacidosis.
Precautions
Concomitant use w/ sulphonylureas which are known to cause hypoglycemia; dose reduction of sulphonylureas may be considered. May affect ability to drive or operate machinery. Childn. Elderly >75 yr. Pregnancy & lactation.
Lactation: Unknown whether distributed in breast milk; caution advised
Pregnancy-Lactation
Pregnancy
The limited data in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
In animal reproduction studies, no adverse developmental effects were observed when linagliptin was administered to pregnant rats during period of organogenesis at doses similar to maximum recommended clinical dose, based on exposure
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity
Lactation
There is no information regarding presence of linagliptin in human milk, the effects on breastfed infant, or effects on milk production; however, linagliptin is present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
Increased risk of hypoglycaemia when used w/ an insulin secretagogue (e.g. sulfonylurea) or insulin. Plasma concentration of linagliptin may be decreased by strong inducers of P-glycoprotein (e.g. rifampicin) and may be increased by strong P-glycoprotein inhibitors (e.g. ritonavir).
Adverse Effects
Side effects of Linagliptin :
1-10%
Nasopharyngitis (4.3%), Hyperlipidemia (2.8%; with pioglitazone), Cough (2.4%; with metformin and sulfonylurea), Hypertriglyceridemia (2.4%; with sulfonylurea), Weight gain (2.3%; with pioglitazone),
Hypoglycemia 7.6% overall incidence, 22.9% incidence compared with placebo plus metformin and a sulfonylurea
Incidence similar to placebo with monotherapy or combined with metformin or pioglitazone
Mechanism of Action
Dipeptidyl peptidase 4 (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
Trajenta 5mg Tablets / Film-coated manufactured by BOEHRINGER INGELHEIM ROXANE INC.. Its generic name is Linagliptin. Trajenta is availble in United Arab Emirates.
Farmaco UAE drug index information on Trajenta Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.