GLIPTEN 100MG 28TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults as an adjunct to diet and exercise to improve glycemic control, used as monotherapy or in combination with other glucose‑lowering agents (e.g., metformin, sulfonylurea, thiazolidinedione, insulin) when appropriate.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: 100 mg orally once daily (normal renal function or mild renal impairment). Renal dosing: eGFR ≥45 mL/min/1.73 m²: 100 mg daily; eGFR 30-<45: 50 mg daily; eGFR <30 or ESRD (including dialysis): 25 mg daily. If combined with sulfonylurea or insulin, consider reducing the sulfonylurea/insulin dose.

Initial Dose

100 mg once daily.

Maintenance Dose

100 mg once daily.

Maximum Dose

100 mg once daily.

Children's Dosage

Not approved for use in pediatric patients under 18 years.

Dose Adjustment Notes

Renal impairment: dose reduction is required in moderate to severe renal impairment and ESRD; assess renal function before initiation and periodically. Hepatic impairment: no adjustment needed in mild to moderate hepatic impairment (data limited in severe). When used with a sulfonylurea or insulin, consider lowering the sulfonylurea/insulin dose to reduce hypoglycemia risk.

Side Effects

Common Side Effects

Nasopharyngitis, upper respiratory tract infection, headache, hypoglycemia (when used with sulfonylurea or insulin), nausea, diarrhea, constipation

Side Effect Frequency

Common (1-10%): hypoglycaemia when used with a sulfonylurea or insulin; nasopharyngitis; upper respiratory tract infection; headache. Uncommon/rare: pancreatitis; hypersensitivity reactions (including anaphylaxis/angioedema/serious skin reactions); severe arthralgia; bullous pemphigoid; renal impairment (frequency not known in some labels).

Safety & Warnings

Warnings & Precautions

Not indicated for type 1 diabetes or diabetic ketoacidosis; pancreatitis risk-stop if suspected and do not restart if confirmed; assess renal function before initiation and periodically and adjust dose for renal impairment (worsening renal function/acute renal failure reported); serious hypersensitivity reactions-stop immediately if suspected; severe disabling arthralgia-consider discontinuation; bullous pemphigoid-stop if suspected; heart failure risk-monitor for signs/symptoms especially in at-risk patients.

Age Restriction

Not approved under 18 years.

Drug Interactions

Interaction Severity

Sulfonylureas/insulin: increased hypoglycemia risk (clinically important-consider dose reduction of sulfonylurea/insulin). Digoxin: small increase in digoxin exposure-monitor clinically/levels if needed. Strong P‑gp/CYP3A4 inhibitors (e.g., cyclosporine): may increase sitagliptin exposure-generally monitor; usually not requiring routine dose change.

Food Interaction

No restriction.

Special Populations

Children

Not approved for use in pediatric patients under 18 years.

Storage & Patient Advice

Stopping the Medicine

Do not stop sitagliptin without consulting the prescriber; stopping may worsen glycemic control.

Overdose

Manage with standard supportive measures (remove unabsorbed drug if appropriate, clinical monitoring, supportive treatment); hypoglycemia is mainly a risk when combined with insulin/secretagogues; sitagliptin is modestly removed by hemodialysis (limited removal).

Patient Counseling

Take once daily with or without food and try to take it at the same time each day; if a dose is missed, do not double. Know and manage hypoglycemia risk if also using insulin or a sulfonylurea. Seek urgent care for severe/persistent abdominal pain (possible pancreatitis) and report severe joint pain or blistering rash. Not for type 1 diabetes or DKA. Store below 30°C in original blister packaging.

Pharmacology

Mechanism of Action

Selective DPP‑4 inhibition increases endogenous incretin (GLP‑1, GIP) activity, leading to glucose‑dependent increased insulin secretion and decreased glucagon secretion, lowering fasting and post‑prandial glucose.

Duration of Effect

Approximately 24 hours (supports once‑daily dosing).

Half-Life

Approximately 12 hours (reported range about 8-14 hours).

Bioavailability

Approximately 87%.

Metabolism

Minimal metabolism; most is excreted unchanged. Minor oxidative metabolism via CYP3A4 and CYP2C8 to inactive metabolites.

Protein Binding

Approximately 38%

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 100mg sitagliptin as sitagliptin phosphate monohydrate (equivalent to 128.5mg sitagliptin phosphate monohydrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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