Sliptin-M 50 mg+500 mg (Tablet)

Indications

• Adjunct to diet and exercise for glycemic control in type 2 diabetes mellitus
• Not for type 1 diabetes or diabetic ketoacidosis treatment
• 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
• Metformin HCl decreases hepatic glucose production and increases peripheral glucose uptake

Dosage & Administration

• Individualized dosage based on patient's regimen and tolerability
• Starting dose for patients not on metformin: 50 mg sitagliptin/500 mg metformin twice daily
• Starting dose for patients on metformin: 50 mg sitagliptin/1000 mg metformin twice daily
• Extended-release tablet administered once daily with a meal

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
• Use with iodinated contrast materials

Side Effects

• Common adverse reactions: diarrhea, upper respiratory tract infection, headache
• Hypoglycemia reported with sitagliptin in combination with sulfonylurea and insulin
• Common adverse reactions due to metformin: diarrhea, nausea/vomiting, headache

Pregnancy & Lactation

• Pregnancy Category B
• Use during pregnancy only if clearly needed
• Caution advised when administered to nursing women

Precautions & Warnings

• Lactic acidosis risk with metformin accumulation
• Regular monitoring of TSH levels recommended in patients with hypothyroidism
• Long-term treatment may decrease vitamin B12 levels
• No clinical studies establishing macrovascular risk reduction
• Warn against excessive alcohol intake
• Promptly evaluate patients for evidence of ketoacidosis or lactic acidosis
• Consider lower dose of insulin secretagogue or insulin when used in combination

Overdose Effects

• Usual supportive measures for sitagliptin overdose
• Metformin is dialyzable with hemodialysis being useful for removal

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

Related Brands

• Sliptin-M 50 mg+1000 mg (Tablet) - drug-international-ltd
• Incrit-M 50 mg+500 mg (Tablet) - synovia-pharma-plc
• Incrit-M 50 mg+1000 mg (Tablet) - synovia-pharma-plc
• Siglimet XR 50 mg+500 mg (Tablet (Extended Release)) - square-pharmaceuticals-plc
• Siglimet XR 50 mg+1000 mg (Tablet (Extended Release)) - square-pharmaceuticals-plc