Sitagil 50 mg (Tablet)

Indications

• Adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus
• Not indicated for patients with type 1 diabetes
• Not indicated for the treatment of diabetic ketoacidosis

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 in a glucose-dependent manner

Dosage & Administration

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

Interaction

• Did not meaningfully alter the pharmacokinetics of specific drugs
• Slightly increases the mean concentration of Digoxin
• No dose adjustment of Digoxin required

Contraindications

• History of serious hypersensitivity reaction to sitagliptin (e.g., anaphylaxis or angioedema)

Side Effects

• Common adverse reactions: headache, upper respiratory tract infection, nasopharyngitis
• Hypoglycemia may occur in patients treated with the combination of Sitagil and sulfonylurea, and as an add-on to insulin

Pregnancy & Lactation

• Pregnancy Category B
• Should be used during pregnancy only if clearly needed
• Secreted in the milk of lactating rats at a ratio of 4:1
• Unknown excretion in human milk
• Caution should be exercised when administered to a nursing woman

Precautions & Warnings

• Prompt discontinuation if pancreatitis is suspected
• Dosage adjustment recommended in patients with renal insufficiency or ESRD
• Careful dose selection in elderly patients with decreased renal function
• Assessment of renal function in elderly patients prior to initiating dosing
• Assessment of renal function in patients with mild, moderate, or severe renal insufficiency
• Alternate treatment for diabetes if hypersensitivity reaction is suspected

Use in Special Populations

• Safety and effectiveness not established in pediatric patients under 18 years of age
• Careful dose selection in elderly patients
• No dosage adjustment required for mild renal insufficiency
• 50 mg once daily for moderate renal insufficiency
• 25 mg once daily for severe renal insufficiency or ESRD
• Administration without regard to the timing of hemodialysis

Overdose Effects

• Maximal mean increases in QTc of 8.0 msec observed at high doses
• Supportive measures in case of overdose
• Modestly dialyzable
• Approximately 13.5% removed over a 3- to 4-hour hemodialysis session

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 after the expiry date
• To be dispensed only on the prescription of a registered physician

Related Brands

• Sitagil 100 mg (Tablet) - incepta-pharmaceuticals-ltd
• Sliptin 25 mg (Tablet) - drug-international-ltd
• Sliptin 50 mg (Tablet) - drug-international-ltd
• Sliptin 100 mg (Tablet) - drug-international-ltd
• Incrit 50 mg (Tablet) - synovia-pharma-plc