Trajenta® Abridged Prescribing Information
For the use only of Registered Medical Practitioner or a Hospital or a Laboratory only
Composition:1 film-coated tablet contains linagliptin 5 mg Indication: Monotherapy and Combination Therapy: Trajenta® tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Trajenta® should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.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. 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. Contraindications: Hypersensitivity to the active ingredient or any of the excipients. Special warnings and precautions: General: Trajenta® should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Pancreatitis: Acute pancreatitis has been observed in patients taking linagliptin. If pancreatitis is suspected, Trajenta® should be discontinued. Hypoglycaemia: Linagliptin alone showed a comparable incidence of hypoglycaemia to placebo and lower hypoglycaemic events compared to Glimiperide. Sulphonylureas are known to cause hypoglycaemia. Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea. A dose reduction of the sulphonylurea may be considered. Bullous Pemphigoid : Bullous pemphigoid has been observed in patients taking linagliptin. If bullous pemphigoid is suspected, Trajenta® should be discontinued. Heart Failure: An association between DPP-4 inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. Consider the risks and benefits of Trajenta® prior to initiating treatment in patients at risk for heart failure. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of Trajenta®. Severe and Disabling Arthralgia: There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate. Side effects: Nasopharyngitis, cough. Hypoglycaemias in the placebo controlled studies (10.9 %; N=471) were mild (80% %; N=384) or moderate (16.6 %; N=78) or severe (1.9%; N=9) in intensity. Post –marketing side effects include angioedema, urticaria, rash, bullous pemphigoid, mouth ulceration, severe & disabling arthralgia and rhabdomyolysis. Shelf Life: 36 Months.Storage: Store in a safe place out of the reach of children. Do not store above 30o C.[API dated 11 January 2021 [Source: Trajenta® PI Version version 09 April 2020] This is abridged prescribing information for Trajenta®. It is recommended to refer to the full prescribing information before prescribing.