Janvia 100 mg (Tablet)

Indications

• Adjunct to diet and exercise for type 2 diabetes mellitus
• Monotherapy and combination therapy
• Improves glycemic control in adults
• Not for use in patients with type 1 diabetes
• Not for treatment of diabetic ketoacidosis
• Not studied in patients with history of pancreatitis

Pharmacology

• DPP-4 inhibitor
• Slows inactivation of incretin hormones
• Increases and prolongs action of incretin hormones
• Regulates glucose homeostasis
• Increases insulin release and decreases glucagon levels
• Selective for DPP-4
• Does not inhibit DPP-8 or DPP-9 activity

Dosage & Administration

• Recommended dose: 50mg twice a day or 100mg once daily
• Can be taken with or without food

Interaction

• No meaningful alteration of pharmacokinetics with metformin
• No meaningful alteration of pharmacokinetics with glyburide
• No meaningful alteration of pharmacokinetics with simvastatin
• No meaningful alteration of pharmacokinetics with rosiglitazone
• No meaningful alteration of pharmacokinetics with warfarin
• No meaningful alteration of pharmacokinetics with oral contraceptives
• Slightly increases mean Digoxin concentration

Contraindications

• History of serious hypersensitivity reaction to sitagliptin

Side Effects

• Common adverse reactions: headache, upper respiratory tract infection, nasopharyngitis
• Hypoglycemia may occur in combination with sulfonylurea or add on to insulin

Pregnancy & Lactation

• Pregnancy Category B
• Use during pregnancy only if clearly needed
• Secreted in the milk of lactating rats
• Excretion in human milk unknown, caution during lactation

Precautions & Warnings

• Prompt discontinuation if pancreatitis is suspected
• Dosage adjustment in patients with renal insufficiency
• Careful dose selection in elderly patients with decreased renal function
• Use with caution in patients with mild, moderate, or severe renal insufficiency
• Post-marketing reports of serious hypersensitivity reactions
• Safety and effectiveness not established in pediatric patients under 18 years

Use in Special Populations

• Safety and effectiveness not established in pediatric patients under 18 years
• Dose adjustment recommended in patients with moderate or severe renal insufficiency
• Different doses recommended based on renal insufficiency levels or ESRD

Overdose Effects

• Maximal mean QTc increase observed at high doses
• No experience with doses above 800mg in clinical studies
• Reasonable to employ usual supportive measures in event of overdose
• Modestly dialyzable, approximately 13.5% removal in hemodialysis

Therapeutic Class

• Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Storage Conditions

• Store below 25°C in a dry place away from light
• Keep out of the reach of children
• Do not use later than the date of expiry
• To be dispensed only on the prescription of a registered physician

Related Brands

• Janvia 50 mg (Tablet) - acme-laboratories-ltd
• Glipita 100 mg (Tablet) - beximco-pharmaceuticals-ltd
• Glipita 50 mg (Tablet) - beximco-pharmaceuticals-ltd