Description
Glaptivia Plus 50/1000 mg 30 Film-coated tablets
Composition
Each tablet contains:
Sitagliptin 50 mg
Metformin hydrochloride 1000 mg
Description
Glaptivia Plus is a fixed-dose combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide. This oral antidiabetic agent is used to improve glycemic control in adults with type 2 diabetes mellitus.
Indications for Use
Glaptivia Plus is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of use:
Not for use in patients with type 1 diabetes mellitus.
Not studied in patients with a history of pancreatitis.
Dosage and Method of Administration
-Recommended dose: orally twice daily with meals.
-Max daily dose: 100 mg sitagliptin + 2000 mg metformin HCl.
-Do not split or crush tablets.
-Initial dose for metformin-naïve patients: 50 mg sitagliptin / 500 mg metformin twice daily.
-Renal function should be assessed before and during treatment.
-Contraindicated if eGFR < 30 mL/min/1.73 m².
-Not recommended if eGFR is 30–45 mL/min/1.73 m².
-Temporarily discontinue before iodinated contrast imaging in at-risk patients.
Contraindications
-Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
-Acute or chronic metabolic acidosis, including diabetic ketoacidosis
-History of serious hypersensitivity to sitagliptin, metformin, or Glaptivia Plus
Precautions
-Lactic acidosis: Rare but serious; monitor renal function. Educate patients on symptoms: malaise, myalgia, abdominal pain, somnolence, respiratory distress.
-Use with caution in elderly, alcoholics, or those undergoing surgery or radiological contrast imaging.
-Temporarily discontinue before surgeries or imaging with iodinated contrast in at-risk individuals.
-Avoid in hypoxic conditions or with excessive alcohol use.
-Not recommended with drugs that may impair renal function or increase metformin levels.
Side Effects
-Gastrointestinal: nausea, vomiting, diarrhea
-Risk of lactic acidosis
-Hypoglycemia (especially with insulin or sulfonylureas)
-Hypersensitivity: rash, urticaria, angioedema, anaphylaxis
-Rare risk of pancreatitis
Pregnancy and Breastfeeding
Limited data; use only if potential benefit justifies potential risk.
Not recommended during breastfeeding.
Storage Conditions
Store below 30°C. Protect from moisture.
Packaging
A carton box containing 3 blisters 10 tablets each and insert leaflet.
