Sitazid M 50 mg+1000 mg (Tablet)

Indications

• Adjunct to diet and exercise for glycemic control in type 2 diabetes mellitus
• Limitations of use for type 1 diabetes and diabetic ketoacidosis
• Not studied in patients with a history of pancreatitis
• Used in combination with sitagliptin and metformin
• Indicated in adults
• Not effective in certain settings

Pharmacology

• Combines DPP-4 inhibitor and biguanide class antihyperglycemic agents
• Mechanism of action on incretin hormones and insulin regulation
• Slow inactivation of incretin hormones by DPP-4
• Involvement in glucose homeostasis
• Decreases hepatic glucose production
• Increases peripheral glucose uptake
• Utilizes cyclic AMP intracellular signaling pathways

Dosage & Administration

• Individualized dosage based on patient's current regimen
• Maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin
• Twice daily with meals for gradual dose escalation
• Starting dose based on patient's current regimen
• Recommended starting dose for patients not currently treated with metformin
• No studies on prior treatment with other oral antihyperglycemic agents

Interaction

• Use with caution with cationic drugs eliminated by renal tubular secretion
• Potential impact on phenprocoumon anticoagulant effect
• Potential reduction of hypoglycemic effect with levothyroxine

Contraindications

• Renal disease or dysfunction
• Acute or chronic metabolic acidosis, diabetic ketoacidosis
• History of serious hypersensitivity reaction to the product
• Radiologic studies involving intravascular administration of iodinated contrast materials

Side Effects

• Common adverse reactions such as diarrhea, upper respiratory tract infection, and headache
• Hypoglycemia in combination with sulfonylurea and insulin
• Nasopharyngitis with sitagliptin monotherapy
• Adverse reactions due to initiation of metformin therapy such as diarrhea and headache

Pregnancy & Lactation

• Pregnancy category B
• No adequate and well-controlled studies in pregnant women
• Caution advised during administration to nursing women

Precautions & Warnings

• Risk of lactic acidosis with specific conditions
• Symptoms and laboratory abnormalities to monitor
• Caution in patients with hepatic disease
• Assessment of renal function before and during therapy
• Postmarketing reports of acute pancreatitis and renal failure
• Monitoring of vitamin B12 levels
• Patient education on alcohol intake and stress management
• Prompt evaluation of clinical illness for ketoacidosis or lactic acidosis
• Reduced insulin secretagogue or insulin dose when used in combination
• Postmarketing reports of serious allergic and hypersensitivity reactions

Overdose Effects

• Usual supportive measures for sitagliptin overdose
• Modest dialyzable nature of sitagliptin
• Possible usefulness of hemodialysis for metformin overdosage

Therapeutic Class

• Combination oral hypoglycemic preparations

Storage Conditions

• Store below 25°C in a dry place away from light
• Keep out of the reach of children
• Not for use beyond expiry date
• Dispensed only on prescription

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