Diaflozimet 5/1000 mg 30 tablets

Diaflozimet 5/1000 mg 30 tablets

Composition:
Each tablet contains:
Dapagliflozin 5 mg
Metformin hydrochloride (extended release) 1000 mg.
Excipients:
Lactose, magnesium stearate, film coating materials.
Description:
Diaflozimet combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in adults with type 2 diabetes mellitus.
Dapagliflozin is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor that reduces reabsorption of glucose in the kidneys and promotes its excretion in urine, thereby lowering blood glucose levels and reducing cardiovascular and renal risk.
Metformin hydrochloride (extended release) decreases hepatic glucose production, increases insulin sensitivity, and improves peripheral glucose uptake and utilization.
Together, they help maintain stable glucose control with reduced risk of hypoglycemia and additional benefits in weight management and cardiovascular protection.
Indications for Use:
- Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple CV risk factors.
- To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II–IV) with reduced ejection fraction.
- To reduce the risk of kidney disease progression in adults with chronic kidney disease at risk of progression.
Dosage and Method of Administration:
Recommended dose:
One tablet once daily in the morning with food.
- Tablets should be swallowed whole, not crushed or chewed.
- The dosage should be individualized based on current treatment regimen and patient tolerability.
- Do not exceed 10 mg dapagliflozin and 2000 mg metformin hydrochloride daily.
- Adjust or discontinue treatment in patients with renal impairment according to eGFR levels.
Contraindications:
- Hypersensitivity to dapagliflozin, metformin, or any excipients.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, or patients on dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Patients with rare hereditary problems of galactose intolerance or glucose-galactose malabsorption.
Precautions:
- Risk of metformin-associated lactic acidosis, which may be fatal.
- Increased risk of diabetic ketoacidosis, even at moderate blood glucose levels.
- May cause volume depletion and hypotension, particularly in elderly patients or those on diuretics.
- Renal function must be assessed before and during treatment.
- Avoid excessive alcohol consumption.
- Discontinue before major surgery or contrast imaging procedures.
- Risk of genital mycotic infections, urinary tract infections, and necrotizing fasciitis of the perineum.
- Monitor vitamin B12 levels periodically during long-term therapy.
Side Effects:
- Very common: Diarrhea, nausea, genital mycotic infections.
- Common: Urinary tract infections, increased urination, back pain, dizziness, nasopharyngitis, hypoglycemia (with insulin or secretagogues).
- Rare: Ketoacidosis, lactic acidosis, severe skin reactions, hepatic enzyme elevation.
Pregnancy and Lactation:
- Safety during pregnancy has not been established; use only if potential benefit outweighs risk.
- Avoid use during breastfeeding due to possible drug excretion in breast milk.
Storage Conditions:
Store at a temperature not exceeding 30°C, in a dry place, away from light and moisture.
Keep away from reach of children.
Packaging:
Carton box containing 3 strips, each with 10 extended-release film-coated tablets, and a package insert.