DAFA-M-H Tablets

DAFA-M-H Tablets
Generic Name:
Dapagliflozin 10 mg + Metformin Hydrochloride 500 mg
Therapeutic Group:
Antidiabetic Agents
Drug Category:
SGLT2 Inhibitor + Biguanide Combination
Content / Composition:
Each film-coated tablet contains:
Dapagliflozin …………………………… 10 mg
Metformin Hydrochloride ………… 500 mg
Excipients ……………………………… q.s.
Indications:
DAFA-M-H is indicated for:
Type 2 Diabetes Mellitus
Patients inadequately controlled on metformin alone
Combination therapy to improve glycemic control
Reduction of cardiovascular risk in diabetic patients
Renal protection in diabetic nephropathy
Dosage:
Usual dose: One tablet once or twice daily
Recommended to be taken with meals (to reduce GI side effects of metformin)
Dose adjustment based on patient condition and renal function
As directed by the physician
Contraindications:
Hypersensitivity to dapagliflozin or metformin
Type 1 Diabetes Mellitus
Diabetic ketoacidosis
Severe renal impairment (eGFR <30 mL/min/1.73 m²)
Severe hepatic impairment
Conditions predisposing to lactic acidosis
Pregnancy and lactation
Administration:
Oral administration with meals
Swallow whole with water
Do not crush or chew
Maintain proper hydration
Drug Interactions:
Insulin / Sulfonylureas → Increased risk of hypoglycemia
Diuretics → Increased dehydration risk
Alcohol → Increased risk of lactic acidosis
Cationic drugs (e.g., cimetidine) → May affect metformin elimination
Nephrotoxic drugs → Monitor renal function
Compatibility:
Compatible with insulin, DPP-4 inhibitors, GLP-1 analogs
Suitable for combination diabetes therapy
Effective dual mechanism (renal glucose excretion + reduced hepatic glucose production)
Stability / Storage:
Store below 25°C
Protect from moisture, light, and heat
Keep out of reach of children
Precautions:
Monitor renal function regularly
Risk of lactic acidosis (metformin component)
Risk of dehydration and hypotension (dapagliflozin)
Increased risk of urinary/genital infections
Temporarily discontinue before major surgery or contrast imaging
Use cautiously in elderly patients
Side Effects:
Common:
Gastrointestinal upset (nausea, diarrhea)
Increased urination
Genital infections
Headache
Uncommon:
Dizziness
Hypotension
Vitamin B12 deficiency (long-term metformin use)
Serious (Rare):
Lactic acidosis
Diabetic ketoacidosis
Acute kidney injury
Clinical Note:
DAFA-M-H provides a dual mechanism of action by combining dapagliflozin (renal glucose excretion) and metformin (hepatic glucose suppression), offering superior glycemic control along with cardiovascular and renal benefits. It is widely used in modern diabetes management protocols.