TRAJENTA 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; may be used as monotherapy or in combination with other glucose-lowering agents (e.g., metformin, sulfonylurea, pioglitazone, insulin).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): 5 mg orally once daily, with or without food; when combined with insulin or a sulfonylurea, consider reducing the insulin/sulfonylurea dose to reduce hypoglycemia risk.

Initial Dose

5mg once daily.

Maintenance Dose

5mg once daily.

Maximum Dose

5mg once daily.

Children's Dosage

Not recommended for use in children and adolescents under 18 years of age.

Dose Adjustment Notes

No dose adjustment is required for renal or hepatic impairment; no titration is needed. If used with insulin or a sulfonylurea, consider lowering the insulin/sulfonylurea dose to reduce hypoglycemia risk.

How to Take

Swallow tablet whole with water, with or without food, at any time of the day but at the same time each day.

Side Effects

Common Side Effects

Nasopharyngitis; cough; diarrhea; and hypoglycemia when used with insulin or a sulfonylurea (also reported: headache).

Side Effect Frequency

Common (≥5%): Nasopharyngitis. Hypoglycemia: not increased with linagliptin monotherapy, but risk increases when used with insulin or a sulfonylurea. Post-marketing/rare: pancreatitis, hypersensitivity reactions (e.g., angioedema, urticaria, rash), severe arthralgia, bullous pemphigoid.

Safety & Warnings

Contraindications

Hypersensitivity to linagliptin or to any excipient (including a history of serious hypersensitivity reactions such as anaphylaxis, angioedema, exfoliative skin reactions, urticaria, or bronchial hyperreactivity) to linagliptin.

Warnings & Precautions

Not indicated for type 1 diabetes or diabetic ketoacidosis; monitor for pancreatitis and discontinue if suspected; increased hypoglycemia risk when combined with insulin or sulfonylureas (consider dose reduction); discontinue if bullous pemphigoid suspected; discontinue if severe arthralgia occurs; use caution in patients with prior angioedema to another DPP-4 inhibitor; routine “heart failure risk” monitoring is not a standard linagliptin-specific precaution.

Age Restriction

Not approved under 18 years

Driving Warning

Safe

Drug Interactions

Interaction Severity

MAJOR: Strong P-gp/CYP3A4 inducers (e.g., rifampicin/rifampin, carbamazepine, phenytoin, phenobarbital, St John’s wort) may markedly reduce linagliptin exposure/efficacy-avoid or use alternative. MODERATE: Insulin or sulfonylureas-additive hypoglycemia risk; consider dose reduction of insulin/SU. MINOR/none clinically meaningful: Strong P-gp/CYP3A4 inhibitors (e.g., ketoconazole) generally do not require adjustment.

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not recommended for use in children and adolescents under 18 years of age.

Elderly

Standard adult dosing - no dose adjustment required based on age alone; caution regarding hypoglycemia risk when combined with sulfonylurea or insulin

Kidney Impairment

No dose adjustment is required at any stage of renal impairment, including end-stage renal disease.

Liver Impairment

No dose adjustment is required in hepatic impairment (mild, moderate, or severe).

Storage & Patient Advice

Stopping the Medicine

Do not stop without consulting the prescriber; discontinue immediately and seek urgent medical care if pancreatitis is suspected or if a serious hypersensitivity reaction occurs.

Overdose

In overdose, provide supportive care and contact emergency services/poison center; monitor glucose and clinical status; consider GI decontamination if appropriate; linagliptin is not expected to be significantly removed by hemodialysis.

Patient Counseling

Take 5 mg once daily at the same time each day, with or without food; if a dose is missed, take it when remembered but do not take two doses in one day. Continue diet/exercise. Low blood sugar is uncommon alone but can occur with insulin/sulfonylurea-know symptoms and monitor as advised. Seek urgent care for severe/persistent abdominal pain (pancreatitis), facial/throat swelling or rash (allergy), severe joint pain, or blistering skin reactions; report new/worsening shortness of breath or edema if they occur.

Pharmacology

Mechanism of Action

Selective, reversible inhibition of DPP-4 increases endogenous incretin hormones (GLP-1, GIP), leading to glucose-dependent increased insulin secretion and decreased glucagon secretion.

Onset of Action

Pharmacodynamic DPP-4 inhibition occurs within hours (Tmax ~1.5 hours), with glucose-lowering evident within the first days to week; full HbA1c effect is assessed over ~12 weeks.

Duration of Effect

24 hours

Half-Life

Long terminal half-life >100 hours due to saturable DPP-4 binding; effective accumulation half-life is ~12 hours (supporting once-daily dosing).

Bioavailability

Approximately 30%.

Metabolism

Minimal metabolism; most of the drug is excreted unchanged, with a minor inactive metabolite formed (primarily via CYP3A4).

Excretion

Predominantly fecal/biliary excretion (about 80-85%); minimal renal excretion (about 5%), largely unchanged.

Protein Binding

Concentration-dependent binding: ~99% at low concentrations, decreasing to ~70-80% at higher concentrations (saturable, related to DPP-4 binding).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5mg linagliptin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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