Ardance-M
Generic Name
Dapagliflozin and Metformin Hydrochloride
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ardance m 5 mg tablet | ৳ 23.00 | ৳ 230.00 |
Description
Overview of the medicine
Ardance-M 5 mg/500 mg Tablet is a combination medicine used to lower blood glucose levels in adults with type 2 diabetes mellitus when diet and exercise alone do not provide adequate control. It contains Dapagliflozin (an SGLT2 inhibitor) and Metformin Hydrochloride (a biguanide).
Uses & Indications
Dosage
Adults
Individualized. Typically, one tablet (Dapagliflozin 5 mg/Metformin 500 mg) orally twice daily with meals. Dosage may be titrated based on efficacy and tolerability, up to a maximum of Dapagliflozin 10 mg/Metformin 2000 mg daily.
Elderly
No specific dosage adjustment based solely on age, but renal function should be monitored due to increased risk of renal impairment in older patients.
Renal_impairment
Contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73m²). Dose adjustment may be needed for moderate impairment; careful monitoring is required.
How to Take
Take orally, twice daily with meals to reduce gastrointestinal side effects associated with Metformin. Swallow the tablet whole with water; do not crush, cut, or chew.
Mechanism of Action
Dapagliflozin selectively inhibits sodium-glucose cotransporter 2 (SGLT2) in the renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Glycemic lowering effects typically begin within a few hours for metformin and within the first week for dapagliflozin.
Excretion
Dapagliflozin is primarily excreted renally, with a small portion via feces. Metformin is predominantly excreted unchanged in the urine.
Half life
Dapagliflozin: approximately 10-12 hours. Metformin: approximately 6.2 hours (plasma), 17.6 hours (blood).
Absorption
Dapagliflozin is rapidly absorbed with peak plasma concentrations occurring within 2 hours. Metformin is slowly and incompletely absorbed from the gastrointestinal tract, with peak plasma concentrations reached in 2-3 hours.
Metabolism
Dapagliflozin is metabolized primarily by UGT1A9 to an inactive glucuronide. Metformin is not metabolized and is excreted unchanged.
Side Effects
Contraindications
- •Hypersensitivity to Dapagliflozin, Metformin, or any component of the tablet.
- •Severe renal impairment (eGFR <30 mL/min/1.73m²), end-stage renal disease, or patients on dialysis.
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis (DKA), with or without coma.
- •Acute conditions with potential for renal impairment (e.g., dehydration, severe infection, shock).
Drug Interactions
Cimetidine
May increase Metformin plasma concentrations.
Loop Diuretics
May increase the risk of dehydration and hypotension, and potentially affect renal function.
Topiramate, Zonisamide
May increase the risk of lactic acidosis.
Insulin and Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia, dosage adjustment may be needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to hypoglycemia, lactic acidosis, gastrointestinal disturbances (nausea, vomiting, diarrhea), and dehydration. Management is supportive and symptomatic; hemodialysis can be used to remove metformin.
Pregnancy & Lactation
Not recommended during pregnancy, especially during the second and third trimesters, due to potential adverse effects on renal development. Avoid during lactation as it is unknown if dapagliflozin is excreted in human milk, and metformin is known to be present in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patented for Dapagliflozin component, Metformin is off-patent
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Global Brand Names
International brand names for this medicine
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