Radiglip-M 50 mg+1000 mg (Tablet (Extended Release))

Indications

• Improvement of glycemic control in adults with type 2 diabetes mellitus
• Adjunct to diet and exercise
• Limitations of use in patients with type 1 diabetes or diabetic ketoacidosis
• Limitations of use in patients with a history of pancreatitis

Pharmacology

• Combines two antihyperglycemic agents with complementary mechanisms of action
• Dipeptidyl peptidase-4 (DPP-4) inhibitor (Sitagliptin)
• Slows inactivation of incretin hormones
• Increases insulin release and decreases glucagon levels
• Increases insulin synthesis and release from pancreatic beta cells
• Decreases hepatic glucose production
• Decreases intestinal absorption of glucose
• Increases peripheral glucose uptake and utilization

Dosage & Administration

• Individualized dosage based on patient's current regimen, effectiveness, and tolerability
• Maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin
• Twice daily administration with meals
• Gradual dose escalation to reduce gastrointestinal side effects due to metformin
• Starting dose based on patient's current regimen
• Administered once daily with a meal for extended-release tablet

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, including diabetic ketoacidosis
• History of serious hypersensitivity reaction to the product
• 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
• Caution advised in nursing women

Precautions & Warnings

• Risk of lactic acidosis
• Regular monitoring of thyroid-stimulating hormone (TSH) levels
• Long-term treatment associated with decrease in vitamin B12 serum levels
• Postmarketing reports of acute renal failure and acute pancreatitis
• Hematologic parameter monitoring recommended
• Warn against excessive alcohol intake
• Potential need for insulin during periods of stress and decreased intake of fluids and food
• Evaluation for evidence of ketoacidosis or lactic acidosis
• Potential serious allergic and hypersensitivity reactions reported in patients

Overdose Effects

• Usual supportive measures for overdose
• Modest dialyzability of sitagliptin
• Hemodialysis may be useful for removal of 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
• Do not use after the date of expiry
• To be dispensed only on the prescription of a registered physician

Related Brands

• Sitacret-M 50 mg+500 mg (Tablet) - renata-limited
• Sitafit 50 mg+500 mg (Tablet) - team-pharmaceuticals-ltd
• Janmet XR 50 mg+500 mg (Tablet (Extended Release)) - acme-laboratories-ltd