LINTRA 5 MG 30 TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults to improve glycemic control as an adjunct to diet and exercise, as monotherapy or in combination with other antidiabetic agents (e.g., metformin, sulfonylurea, pioglitazone, insulin).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): 5 mg orally once daily, as monotherapy or in combination; no renal/hepatic dose adjustment required.

Initial Dose

5 mg once daily

Maintenance Dose

5 mg once daily

Maximum Dose

5mg once daily.

Children's Dosage

Not approved for children. Safety and effectiveness in patients under 18 have not been established.

Dose Adjustment Notes

No dose adjustment is required for renal impairment, hepatic impairment, or older adults; when used with a sulfonylurea or insulin, consider lowering the sulfonylurea/insulin dose to reduce hypoglycemia risk.

How to Take

Swallow 1 film-coated tablet (linagliptin 5 mg) whole once daily, with or without food; take at the same time each day.

Side Effects

Common Side Effects

Nasopharyngitis; cough; diarrhea; hypoglycemia when used with insulin or a sulfonylurea.

Side Effect Frequency

Common (1-10%): nasopharyngitis, cough; hypoglycemia is common mainly when used with insulin or a sulfonylurea; pancreatitis and hypersensitivity reactions are rare; bullous pemphigoid and severe arthralgia are rare/very rare.

Safety & Warnings

Contraindications

Hypersensitivity to linagliptin or any excipient; not indicated for use in type 1 diabetes mellitus or for treatment of diabetic ketoacidosis (DKA).

Warnings & Precautions

Not for type 1 diabetes or DKA; monitor for pancreatitis and discontinue if suspected; increased hypoglycemia risk with insulin or sulfonylureas-consider dose reduction of the concomitant agent; monitor for severe hypersensitivity reactions and discontinue if they occur; consider bullous pemphigoid and discontinue if suspected; severe and disabling arthralgia may occur; consider heart failure risk in patients with existing risk factors and monitor for symptoms.

Age Restriction

Not approved under 18 years

Driving Warning

Safe

Drug Interactions

Drug Interactions

Strong P-glycoprotein and CYP3A4 inducers (e.g., rifampicin/rifampin, carbamazepine, phenytoin, phenobarbital, St John’s wort) can reduce linagliptin exposure and efficacy-avoid or use an alternative antidiabetic; concomitant insulin or sulfonylureas increase hypoglycemia risk-consider lowering the insulin/secretagogue dose; clinically meaningful interactions with P-gp/CYP3A4 inhibitors are generally not expected.

Interaction Severity

MAJOR: Strong P-gp/CYP3A4 inducers (e.g., rifampicin/rifampin, carbamazepine, phenytoin, St John’s wort) may reduce linagliptin exposure and efficacy-avoid or monitor glycemic control closely. MODERATE: Concomitant sulfonylurea or insulin increases hypoglycemia risk-consider dose reduction of the sulfonylurea/insulin. MINOR: Strong P-gp/CYP3A4 inhibitors (e.g., ketoconazole) may increase exposure but is generally not clinically significant at recommended doses.

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children. Safety and effectiveness in patients under 18 have not been established.

Elderly

Standard adult dosing - no dose adjustment required based on age alone

Kidney Impairment

No dose adjustment required at any stage of renal impairment, including end-stage renal disease and patients on dialysis.

Liver Impairment

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

Storage & Patient Advice

Storage Conditions

Do not store above 30°C.

Missed Dose

Take as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular schedule. Do not take two doses at the same time.

Stopping the Medicine

No taper is required; may be stopped if clinically indicated, but advise prescriber review because glycemic control may worsen after discontinuation.

Overdose

Overdose is generally managed with standard supportive care (consider GI decontamination if appropriate, monitor vitals and blood glucose, treat symptomatic hypoglycemia especially if combined with insulin/sulfonylurea); doses up to 600 mg have been tolerated in studies; linagliptin is not expected to be effectively removed by hemodialysis.

Patient Counseling

Take 1 tablet once daily with or without food, ideally at the same time daily; low blood sugar is uncommon alone but risk increases with insulin/sulfonylurea-know symptoms and management; seek urgent care for severe persistent abdominal pain (pancreatitis), new blistering rash (bullous pemphigoid), or severe joint pain; not for type 1 diabetes or diabetic ketoacidosis; continue diet/exercise and follow-up for HbA1c/clinical review.

Monitoring Requirements

Monitor glycemic control (HbA1c about every 3 months until stable, then every 6 months; SMBG as clinically indicated), and monitor for pancreatitis symptoms; monitor renal function periodically as part of routine diabetes care (especially if comorbid CKD or on nephrotoxic agents).

Pharmacology

Mechanism of Action

Selective, reversible DPP-4 inhibition increases endogenous incretins (GLP-1, GIP), enhancing glucose-dependent insulin secretion and reducing glucagon, lowering fasting and postprandial glucose.

Onset of Action

Tmax ~1.5 hours; glucose-lowering effect begins early after initiation (within days) with full assessment by HbA1c over ~3 months.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Terminal half-life >100 hours; effective (accumulation) half-life ~12 hours.

Bioavailability

Approximately 30%.

Metabolism

Minimal metabolism; the majority is eliminated unchanged (predominantly via biliary/fecal excretion), with only a small fraction renally excreted; CYP involvement is not clinically significant.

Excretion

Predominantly fecal/biliary excretion (~80-85%); minimal renal excretion (~5%).

Protein Binding

Concentration-dependent, saturable binding: very high at low concentrations (~99%) and decreases at higher concentrations (approximately 75-89%) due to DPP-4 binding saturation.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5 mg linagliptin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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