Siglimet 50 mg+1000 mg (Tablet)

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Store below 25°C in a dry place away from light
• Keep the medicines in a safe place, 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

Indications

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Pharmacology

• Combines two antihyperglycemic agents with complementary mechanisms of action
• Slows the inactivation of incretin hormones in patients with type 2 diabetes
• Increases insulin release and decreases glucagon levels in a glucose-dependent manner
• Decreases hepatic glucose production
• Decreases intestinal absorption of glucose
• Increases peripheral glucose uptake and utilization

Dosage & Administration

• Individualized dosage based on the patient's current regimen, effectiveness, and tolerability
• Maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin
• Twice daily with meals
• Gradual dose escalation to reduce gastrointestinal side effects
• Dose based on current regimen for patients not currently treated with metformin
• Starting dose providing sitagliptin dosed as 50 mg twice daily and the dose of metformin already being taken for patients already treated with metformin
• Administer extended-release tablet once daily with a meal preferably in the evening
• Adjust dosing based on effectiveness and tolerability
• Co-administration with insulin secretagogue or insulin may require lower doses to reduce the risk of hypoglycemia

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 renal dysfunction
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
• History of a serious hypersensitivity reaction to this tablet or sitagliptin
• Use caution in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials

Side Effects

• Diarrhea
• Upper respiratory tract infection
• Headache
• Hypoglycemia
• Nasopharyngitis
• Nausea/vomiting
• Flatulence
• Abdominal discomfort
• Indigestion
• Asthenia

Pregnancy & Lactation

• Pregnancy Category B
• Safety in pregnant women not known, should be used during pregnancy only if clearly needed
• Caution should be exercised when administered to a nursing woman

Precautions & Warnings

• Lactic acidosis can occur due to metformin accumulation
• Regular monitoring of thyroid-stimulating hormone (TSH) levels is recommended in patients with hypothyroidism
• Long-term treatment associated with a decrease in vitamin B12 serum levels
• Monitoring of the vitamin B12 level is recommended
• Do not use in patients with hepatic disease
• Assess renal function before initiating and at least annually thereafter
• Promptly discontinue if pancreatitis is suspected
• Monitor hematologic parameters annually
• Warn against excessive alcohol intake
• May need to discontinue temporarily during periods of stress and decreased intake of fluids and food
• Evaluate patients previously controlled on this tablet who develop laboratory abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis
• May need lower dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia
• There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin
• No clinical studies establishing conclusive evidence of macrovascular risk reduction

Overdose Effects

• Supportive measures in the event of an overdose
• Employ clinical monitoring and institute supportive therapy as indicated by the patient's clinical status
• Sitagliptin is modestly dialyzable
• Hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected
• Pancreatitis may occur in the context of a metformin overdose

Related Brands

• Sitagil M 50 mg+500 mg (Tablet (Extended Release)) - incepta-pharmaceuticals-ltd
• Sliptin-M 50 mg+500 mg (Tablet) - drug-international-ltd
• 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