JANUVIA 100MG TAB

Indications

Approved Uses

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 antihyperglycemic agents (e.g., metformin, sulfonylurea, TZD, insulin).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: 100 mg orally once daily (with or without food) as monotherapy or combination therapy; renal impairment: reduce dose based on eGFR (e.g., 50 mg daily for moderate impairment; 25 mg daily for severe impairment/ESRD).

Initial Dose

100 mg orally once daily.

Maintenance Dose

100 mg orally once daily.

Maximum Dose

100 mg orally once daily.

Children's Dosage

Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Dose Adjustment Notes

Renal dose adjustment is required in moderate to severe renal impairment and ESRD; no routine titration is needed; when used with a sulfonylurea or insulin, consider lowering the sulfonylurea/insulin dose to reduce hypoglycemia risk.

How to Take

Swallow the tablet whole (do not split/crush/chew); take orally once daily with or without food; take at the same time each day; may be taken with water.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

History of a serious hypersensitivity reaction to sitagliptin (e.g., anaphylaxis, angioedema, or severe cutaneous adverse reactions such as Stevens-Johnson syndrome).

Warnings & Precautions

Warn/monitor for acute pancreatitis (stop if suspected), serious hypersensitivity reactions (stop immediately if suspected), severe and disabling arthralgia (consider discontinuation), bullous pemphigoid (stop if suspected), heart failure risk (use caution/monitor in at-risk patients), and renal impairment/acute kidney injury risk-assess renal function before initiation and periodically and adjust dose by eGFR; not indicated for type 1 diabetes or diabetic ketoacidosis.

Age Restriction

Not approved under 18 years of age.

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-monitor clinically (and levels if indicated).

Interaction Severity

Insulin/sulfonylureas: clinically significant increased hypoglycemia risk-manage by reducing the insulin or sulfonylurea dose (commonly treated as moderate/clinically important rather than a direct pharmacokinetic interaction). Digoxin: slight increase in digoxin concentrations-monitor as appropriate. Strong P-gp/CYP3A4 inhibitors (e.g., cyclosporine): may increase sitagliptin exposure-generally monitor/clinical judgment; routine dose change usually not required.

Food Interaction

No restriction.

Special Populations

Children

Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Elderly

Standard adult dosing (100mg once daily); no dose adjustment based on age alone, but renal function should be assessed as elderly patients are more likely to have reduced renal function

Kidney Impairment

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

Liver Impairment

Mild to moderate hepatic impairment: no dose adjustment; severe hepatic impairment: not studied/limited data-use with caution.

Storage & Patient Advice

Stopping the Medicine

Do not stop taking sitagliptin without speaking to the prescriber; stopping may worsen glycemic control and requires a plan for alternative therapy/monitoring.

Overdose

If overdose is suspected, seek urgent medical advice/poison center; provide supportive care and monitor glucose and vital signs; hypoglycemia is more likely when combined with insulin/secretagogues; sitagliptin is modestly removed by hemodialysis (limited removal).

Patient Counseling

Take once daily with or without food at a consistent time; low blood sugar is uncommon alone but can occur with insulin/sulfonylureas-know symptoms and management; seek urgent care for severe persistent abdominal pain (possible pancreatitis) or serious allergic reactions; report severe joint pain; inform clinician of kidney disease and ensure periodic renal tests; not for type 1 diabetes or diabetic ketoacidosis.

Monitoring Requirements

Monitor glycemic control (HbA1c about every 3 months until stable, then at least every 6 months; SMBG as clinically indicated) and renal function (eGFR/serum creatinine) before initiation and periodically; monitor for pancreatitis symptoms and hypersensitivity reactions; monitor for hypoglycemia when used with insulin or sulfonylurea.

Pharmacology

Mechanism of Action

Selective DPP-4 inhibition increases endogenous incretin (GLP-1, GIP) activity, enhancing glucose-dependent insulin secretion and decreasing glucagon secretion, thereby lowering blood glucose.

Half-Life

Approximately 12.4 hours.

Bioavailability

Approximately 87%

Metabolism

Minimal metabolism; most is excreted unchanged, with a small fraction metabolized mainly via CYP3A4 and CYP2C8 to inactive metabolites.

Excretion

Primarily renal elimination with most of the dose excreted unchanged in urine (approximately ~80%); a smaller fraction is recovered in feces (approximately ~10-15%).

Product Information

Available Dosage Forms

Film-coated tablets.

Composition per Dose

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

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.