JULEEN 100 MG 30 TAB

Indications

Approved Uses

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; can be used as monotherapy or in combination with other antidiabetic agents.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: 100 mg orally once daily. Renal adjustment: eGFR/CrCl 30-<45 mL/min: 50 mg once daily; eGFR/CrCl <30 mL/min or ESRD (including dialysis): 25 mg once daily.

Initial Dose

100 mg once daily.

Maintenance Dose

100 mg once daily.

Maximum Dose

100 mg once daily.

Children's Dosage

Not approved for children under 18 years.

Dose Adjustment Notes

Assess renal function before initiation and periodically; reduce dose in moderate to severe renal impairment/ESRD. When used with insulin or a sulfonylurea, consider lowering the insulin/sulfonylurea dose to reduce hypoglycemia risk.

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food, preferably at the same time each day.

Side Effects

Common Side Effects

Nasopharyngitis/upper respiratory tract infection, headache; gastrointestinal upset (nausea, diarrhea); hypoglycemia mainly when combined with insulin or a sulfonylurea.

Safety & Warnings

Contraindications

History of a serious hypersensitivity reaction to sitagliptin (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) or to any excipient.

Warnings & Precautions

Assess renal function before initiation and periodically and adjust dose for renal impairment; discontinue if pancreatitis is suspected; discontinue for serious hypersensitivity reactions; consider discontinuation if severe arthralgia occurs; discontinue if bullous pemphigoid is suspected; monitor for heart failure signs in at-risk patients; not indicated for type 1 diabetes or diabetic ketoacidosis.

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

Insulin and insulin secretagogues (e.g., sulfonylureas): increased hypoglycemia risk-consider lowering the insulin/secretagogue dose; Digoxin: small increase in digoxin exposure-clinical monitoring is prudent.

Interaction Severity

Insulin/sulfonylureas: clinically significant increased hypoglycemia risk-consider dose reduction and monitor (commonly managed as moderate/clinically significant). Digoxin: minor increase in digoxin exposure-monitor as appropriate. Strong P-gp/CYP3A4 inducers (e.g., rifampin): may reduce sitagliptin exposure-monitor glycemic control.

Food Interaction

No restriction

Special Populations

Children

Not approved for children under 18 years.

Elderly

Standard adult dosing; however, renal function should be assessed before initiation and monitored periodically as renal function declines with age. Dose adjustment based on renal function, not age alone.

Kidney Impairment

eGFR ≥45 mL/min/1.73 m²: 100 mg once daily; eGFR ≥30 to <45 mL/min/1.73 m²: 50 mg once daily; eGFR <30 mL/min/1.73 m² (including ESRD on dialysis): 25 mg once daily (may be administered without regard to the timing of dialysis).

Liver Impairment

No dose adjustment is needed in mild to moderate hepatic impairment; severe hepatic impairment has not been studied-use with caution.

Storage & Patient Advice

Stopping the Medicine

Do not stop sitagliptin without prescriber advice; if discontinued, monitor blood glucose and adjust the diabetes regimen as glycemic control may worsen (no taper is required).

Overdose

Overdose is generally unlikely to cause hypoglycemia unless combined with insulin or a sulfonylurea; manage with supportive care, consider GI decontamination if appropriate, and monitor clinically-hemodialysis removes only a small/modest amount of sitagliptin.

Patient Counseling

Take once daily with or without food, swallow whole, and take consistently each day; continue diet/exercise. Low blood sugar is uncommon alone but can occur with insulin/sulfonylureas-know symptoms. Seek urgent care for severe persistent abdominal pain (possible pancreatitis) or signs of serious allergy; report severe joint pain. Inform clinicians about kidney disease and attend periodic glucose and renal monitoring.

Monitoring Requirements

Glycemic control (HbA1c about every 3 months until stable then every 6 months; SMBG/fasting glucose as clinically indicated), renal function (SCr/eGFR) at baseline and periodically, and clinical monitoring for pancreatitis and hypersensitivity reactions; monitor for hypoglycemia when combined with insulin/sulfonylurea.

Pharmacology

Mechanism of Action

Selective DPP-4 inhibition increases endogenous incretins (GLP-1, GIP), enhancing glucose-dependent insulin secretion and suppressing glucagon, lowering blood glucose with low intrinsic hypoglycemia risk.

Duration of Effect

24 hours

Half-Life

Approximately 12.4 hours

Bioavailability

Approximately 87%.

Metabolism

Sitagliptin is minimally metabolized; the majority is eliminated unchanged in urine (about 79%), with minor metabolism mainly via CYP3A4 and to a lesser extent CYP2C8 to inactive metabolites.

Excretion

Primarily renal elimination: ~79% excreted unchanged in urine; total urinary recovery ~87%, with ~13% in feces.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 100 mg sitagliptin as sitagliptin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative (prescription-only antidiabetic therapy).

Diabetes Type

Type 2

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