Diaflozimet 5/500 mg 30 tablets

Diaflozimet 5/500 mg 30 tablets

Composition:
Each extended-release film-coated tablet contains:
Active ingredients:
Dapagliflozin propanediol monohydrate 6.15 mg (equivalent to 5 mg dapagliflozin) and Metformin hydrochloride 500 mg.
Inactive ingredients:
Lactose anhydrous, Microcrystalline cellulose, Crospovidone, Colloidal silicon dioxide, Magnesium stearate, Ethanol 96%, Carboxymethylcellulose sodium, Hypromellose, Opadry II Orange.
Description:
Diaflozimet is a fixed-dose combination of dapagliflozin, an SGLT2 inhibitor, and metformin, a biguanide antihyperglycemic agent.
The drug lowers blood glucose through complementary mechanisms: increasing urinary glucose excretion and reducing hepatic glucose production.
Indications for Use:
- Diaflozimet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when both dapagliflozin and metformin are appropriate.
- Not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Dosage and Method of Administration:
- Take one tablet once daily in the morning with food. Swallow whole without crushing or chewing.
- The dosage should be individualized based on effectiveness and tolerability, not exceeding the maximum dose of 10 mg dapagliflozin and 2000 mg metformin daily.
- Assess renal function prior to initiation and periodically thereafter.
Contraindications:
- Moderate to severe renal impairment (eGFR < 60 mL/min/1.73 m²)
- Diabetic ketoacidosis
- Severe hepatic impairment
- Hypersensitivity to active substances or excipients
- Pregnancy and lactation.
Precautions:
- Risk of lactic acidosis, particularly in patients with renal or hepatic dysfunction or alcohol abuse.
- Avoid use during acute conditions causing hypoxia.
- Ensure adequate hydration and monitor renal function.
- Discontinue prior to iodinated contrast imaging procedures.
Side Effects:
- Common: genital mycotic infections, urinary tract infections, diarrhea, nausea, headache, dizziness.
- Less common: hypotension, hypoglycemia (with other agents), rash, vitamin B12 deficiency.
Pregnancy and Lactation:
Not recommended during pregnancy or breastfeeding due to insufficient safety data.
Storage Conditions:
Store in a dry place at a temperature not exceeding 30°C.
Keep out of reach of children.
Packaging:
Carton box containing 3 strips, each with 10 tablets, and an insert leaflet.