MedPath logo

Trajenta Film-Coated Tablets 5mg

Prescription Only
Drug type: Therapeutic
ATC code: A10BH05
Dosage form: TABLET, FILM COATED
Route of administration: ORAL
Active ingredient: Linagliptin; LINAGLIPTIN

Indications

TRAJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Dosage and Administration

Adults

The recommended dose is 5 mg once daily. TRAJENTA can be taken with or without a meal at any time of the day.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Hepatic Impairment

No dose adjustment is required for patients with hepatic impairment.

Elderly

No dose adjustment is necessary. Experience in patients older than > 75 years of age is limited.

Children and adolescents

TRAJENTA is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Missed dose

If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken at the same day.

Registrant
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Approval Date
2012-02-08
Approval Number
SIN14101P
Manufacturer
West-Ward Columbus Inc. Dragenopharm Apotheker Püschl GmbH
Licence Holder
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.