Newfarm Dapagliflozin 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage for this medication is 10 mg once a day for monotherapy and adjunct therapy with other antidiabetic agents such as insulin. When this medication is used in combination with insulin or insulin secretagogues such as sulfonylureas, consideration can be given to using a lower dose of insulin or insulin secretagogues to reduce the risk of hypoglycemia. If there is no previous experience with diabetes medication treatment, metformin

Child dose

The efficacy and safety of Dapagliflozin in children under 18 years have not been established. There is no relevant data.

This medication should not be used in certain patients. It is contraindicated in patients with allergies to the active ingredient or excipients, type 1 diabetes, diabetic ketoacidosis, and patients with genetic lactose-related issues. Additionally, patients undergoing dialysis should not use this medication. Patients with reduced fluid volume or renal impairment should use this medication cautiously. This medication may cause blood pressure decrease or renal function deterioration, so it is necessary to closely monitor the patient's fluid status and renal function before and during administration. Caution is particularly required for elderly patients and those taking diuretics. The blood sugar control effect of this medication varies with renal function, and its effectiveness may decrease in patients with moderate or severe renal impairment. The most common side effect when taking this medication is genital infection. It occurs more frequently in women, and patients with a history of infections are at a higher risk of recurrence. Other reported side effects include urinary tract infection, hypoglycemia, decreased fluid volume, dry mouth, constipation, headache, and lumbar pain. Serious side effects include diabetic ketoacidosis, acute kidney injury, necrotizing fasciitis (Fournier's gangrene); if these symptoms are suspected, immediate consultation with a healthcare provider is necessary. When used alongside medications that may induce hypoglycemia, such as insulin or sulfonylureas, the risk of hypoglycemia increases, therefore dosage adjustment may be necessary. Pregnant or breastfeeding women are advised not to use this medication, and it should be discontinued if a pregnancy is confirmed. The safety and efficacy of this medication in children have not been sufficiently established. In case of overdose, there is no specific antidote, and appropriate treatment should be provided according to symptoms. Finally, this medication does not significantly affect ability to drive or operate machinery; however, caution is necessary due to the risk of hypoglycemia when used with other drugs. This medication should be kept out of the reach of children and stored in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), severe systemic drowsiness, sudden and severe headache, thunderclap headache, seizures, consciousness confusion, visual disturbances, paralysis, urination.

Mild side effects

• Vulvovaginitis
• balanitis
• urinary tract infection
• fungal infection
• hypoglycemia
• dry mouth
• constipation
• oral dryness
• dizziness
• lumbar pain

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius, avoiding direct sunlight and storing in a cool location.

Appearance

This medication is a yellow, circular, biconvex, film-coated tablet.

Package unit

PTP - 28 tablets/box [(28 tablets (7 tablets/PTP x 4))]