Description
Diaflozimet 10 mg/1000 mg 30 tablets
Composition:
Active Ingredients:
– Dapagliflozin Propanediol Monohydrate (D90 < 750 μm) 12.3 mg equivalent to Dapagliflozin 10 mg.
– Metformin Hydrochloride 1000 mg.
Inactive Ingredients:
Lactose anhydrous, Microcrystalline cellulose (PH 302), Crospovidone, Colloidal silicon dioxide (Aerosil 200), Magnesium stearate, Carboxymethylcellulose sodium, Hypromellose (Methocel K100M), and film coating Opadry AMB Pink 80W240011 (partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, iron oxide red and yellow, FD&C Blue No.2).
Description:
Diaflozimet is a fixed-dose combination of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a biguanide. Dapagliflozin reduces renal glucose reabsorption, promoting urinary glucose excretion, while metformin decreases hepatic glucose production and improves insulin sensitivity. Diaflozimet is indicated to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalization for heart failure and progression of chronic kidney disease.
Indications for Use:
– As an 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 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 sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease.
Dosage and Method of Administration:
Administer orally once daily in the morning with food. Swallow tablets whole; do not crush, split, or chew.
Recommended dose: Dapagliflozin 10 mg + Metformin HCl 1000 mg once daily.
Maximum daily dose: Dapagliflozin 10 mg / Metformin HCl 2000 mg.
Assess renal function before initiation and periodically thereafter.
Contraindicated in patients with eGFR < 30 mL/min/1.73 m².
Contraindications:
– Hypersensitivity to dapagliflozin, metformin, or any excipient.
– Severe renal impairment (eGFR < 30 mL/min/1.73 m²), end-stage renal disease, or dialysis.
– Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
– Severe hepatic impairment.
– Hypoxic conditions (cardiac or respiratory failure, shock).
– Pregnancy and breastfeeding.
Precautions:
– Lactic Acidosis:Metformin-associated lactic acidosis has been reported, sometimes fatal. Symptoms include malaise, myalgia, abdominal pain, respiratory distress, hypothermia, hypotension, and bradycardia.
Risk factors: renal impairment, alcohol abuse, age >65 years, hepatic impairment, hypoxic states, radiological studies with contrast, and surgery.
Discontinue Diaflozimet immediately if suspected and initiate supportive measures in hospital.
– Ketoacidosis: Dapagliflozin increases the risk of diabetic ketoacidosis, which may occur even with moderate hyperglycemia. Discontinue the drug if suspected.
– Hypoglycemia: Concomitant use with insulin or sulfonylureas may increase hypoglycemia risk – dose adjustment required.
– Volume Depletion and Hypotension: Osmotic diuresis due to dapagliflozin may lead to reduced intravascular volume. Caution in elderly or those on diuretics.
– Genital and Urinary Tract Infections: Increased risk of genital mycotic and urinary infections (vulvovaginitis, balanitis, cystitis).
– Vitamin B12 Deficiency: Long-term metformin use may decrease vitamin B12 levels – periodic monitoring is recommended.
– Additional warnings: Avoid excessive alcohol intake. Withhold during major surgery or radiological procedures involving contrast media. Use cautiously in hepatic impairment.
Side Effects:
– Common: Urinary tract infections, genital mycotic infections, diarrhea, nausea, headache, dizziness, polyuria.
– Occasional: Back pain, constipation, pharyngitis, hypoglycemia (with insulin).
– Rare: Lactic acidosis, diabetic ketoacidosis, Fournier’s gangrene, allergic reactions, hyponatremia.
Pregnancy and Breastfeeding:
Diaflozimet is contraindicated during pregnancy.
Dapagliflozin may adversely affect fetal renal development.
Metformin is excreted in human milk – not recommended during lactation.
Storage Conditions:
Store in a dry place below 30°C.
Protect from moisture and direct sunlight.
Keep out of reach of children.
Packaging:
Carton box containing 3 blister strips, each with 10 extended-release film-coated tablets, and an enclosed package insert.
