Daprotab
Generic Name
Dapagliflozin
Manufacturer
Hypothetical Manufacturer
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
daprotab 2 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Dapagliflozin is an SGLT2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus, and also indicated for heart failure and chronic kidney disease.
Uses & Indications
Dosage
Adults
The usual starting dose is 5 mg once daily, which can be increased to 10 mg once daily if needed. For patients requiring a lower initial dose or with specific comorbidities, 2 mg orally once daily might be considered. Max dose is 10 mg daily.
Elderly
No dosage adjustment is required based on age alone. However, renal function should be assessed before initiation and periodically thereafter.
Renal_impairment
No dosage adjustment is needed for mild to moderate renal impairment (eGFR ≥ 25 mL/min/1.73 m²). Initiation is not recommended in patients with eGFR < 25 mL/min/1.73 m².
How to Take
Take orally once daily, preferably in the morning, with or without food.
Mechanism of Action
Dapagliflozin blocks the sodium-glucose cotransporter 2 (SGLT2) in the renal tubules, reducing glucose reabsorption and increasing glucose excretion in the urine, thereby lowering blood glucose levels. It also has diuretic effects and cardiovascular and renal benefits independent of glycemic control.
Pharmacokinetics
Onset
Glucose-lowering effect typically begins within 30 minutes to 1 hour.
Excretion
Excreted primarily via urine (approximately 75%) and feces (approximately 21%), mainly as metabolites.
Half life
The mean plasma terminal half-life is approximately 12.9 hours.
Absorption
Rapidly and well absorbed after oral administration. Peak plasma concentration (Tmax) is reached approximately 0.5-2 hours post-dose.
Metabolism
Primarily metabolized via O-deglucosidation to an inactive metabolite (dapagliflozin 3-O-glucuronide).
Side Effects
Contraindications
- Hypersensitivity to dapagliflozin or any excipients of the tablet.
- Severe renal impairment (eGFR < 25 mL/min/1.73 m²) or end-stage renal disease (ESRD), or patients on dialysis.
Drug Interactions
Digoxin
May increase digoxin exposure; monitor digoxin levels.
Diuretics
Concomitant use with loop or thiazide diuretics may increase the risk of dehydration and hypotension.
Insulin and Insulin Secretagogues
Increased risk of hypoglycemia when co-administered. A lower dose of insulin or insulin secretagogue may be required.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, initiate appropriate supportive treatment based on the patient's clinical presentation. Dapagliflozin is not significantly removed by hemodialysis.
Pregnancy & Lactation
Not recommended during the second and third trimesters of pregnancy (Category C) due to potential for adverse renal development in the fetus. Discontinue if pregnancy occurs. Avoid use during lactation as dapagliflozin is excreted in animal milk; it is unknown if it is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, specific to product labeling.
Availability
Pharmacies, Hospitals
Approval Status
FDA approved
Patent Status
Off-patent in many countries, but may vary by formulation/region
Clinical Trials
Extensive clinical trials, including DECLARE-TIMI 58, DAPA-HF, and DAPA-CKD, have demonstrated the efficacy and safety of dapagliflozin across its approved indications for type 2 diabetes, heart failure, and chronic kidney disease.
Lab Monitoring
- Renal function (eGFR) should be assessed before initiation and periodically thereafter.
- Blood glucose and HbA1c levels should be monitored regularly.
- Monitor for signs and symptoms of volume depletion (e.g., changes in blood pressure, electrolyte imbalance).
Doctor Notes
- Educate patients on the importance of hydration and recognition of symptoms of dehydration, DKA, and UTIs/genital infections.
- Monitor renal function (eGFR) at baseline and periodically, especially in elderly or vulnerable patients.
- Consider temporary discontinuation in situations of acute illness, surgery, or prolonged fasting due to increased risk of DKA.
Patient Guidelines
- Take Daprotab exactly as prescribed by your doctor.
- Stay well hydrated, especially during illness, strenuous activity, or in hot weather.
- Be aware of symptoms of genital or urinary tract infections and report them to your doctor.
- Recognize and report symptoms of diabetic ketoacidosis (DKA), such as nausea, vomiting, abdominal pain, excessive thirst, and unusual fatigue.
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to compensate for a missed dose.
Driving Precautions
Dapagliflozin itself is not expected to affect the ability to drive or operate machinery. However, dizziness or symptomatic hypotension may occur, especially in dehydrated patients or during concomitant use with diuretics. Caution is advised.
Lifestyle Advice
- Maintain a healthy and balanced diet along with a regular exercise regimen.
- Regularly monitor your blood glucose levels as advised by your healthcare provider.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.