Sitafit 50 mg+500 mg (Tablet)

Indications

• Adjunct to diet and exercise for type 2 diabetes mellitus
• Not indicated for type 1 diabetes or diabetic ketoacidosis
• Not studied in patients with a history of pancreatitis

Pharmacology

• Combines sitagliptin and metformin for glycemic control in type 2 diabetes
• Sitagliptin is a DPP-4 inhibitor
• Mechanism of action involves incretin hormone regulation
• Metformin decreases hepatic glucose production and increases peripheral glucose uptake

Dosage & Administration

• Individualized dosage based on current regimen and tolerability
• Maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin
• Initial combination therapy or maintenance should be individualized

Interaction

• Use with caution with cationic drugs eliminated by renal tubular secretion
• Metformin may decrease the anticoagulant effect of phenprocoumon
• Levothyroxine can reduce the hypoglycemic effect of metformin

Contraindications

• Renal disease or dysfunction
• Acute or chronic metabolic acidosis
• History of serious hypersensitivity reaction to the tablet or sitagliptin
• Contradicted in patients undergoing radiologic studies with iodinated contrast materials

Side Effects

• Common adverse reactions include diarrhea, upper respiratory tract infection, and headache
• Hypoglycemia reported with combination therapy
• Nasopharyngitis reported with sitagliptin monotherapy
• Common adverse reactions of metformin include diarrhea, nausea/vomiting, and headache

Pregnancy & Lactation

• Pregnancy Category B
• Safety during pregnancy not well-known
• Caution advised when administered to nursing women

Precautions & Warnings

• Risk of lactic acidosis with metformin accumulation
• Monitor thyroid-stimulating hormone levels and vitamin B12 serum levels
• Do not use in patients with hepatic disease
• Assess renal function before and during treatment
• Monitor for evidence of ketoacidosis or lactic acidosis
• Consider lower dose with insulin secretagogue or insulin co-administration
• Reports of serious allergic and hypersensitivity reactions
• No clinical studies establishing macrovascular risk reduction

Overdose Effects

• Supportive measures in case of overdose
• Sitagliptin is modestly dialyzable
• Metformin is dialyzable with a clearance of up to 170 mL/min

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

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

Related Brands

• Sitacret-M 50 mg+500 mg (Tablet) - renata-limited