Samsung Dapagliflozin (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dose for this medication is 10mg once daily for monotherapy and combination therapy. In initial combination therapy with metformin, the recommended initial dosing is either 5mg or 10mg once daily. Dosing guidelines exist for renal impairment, liver impairment, and elderly patients, but the basic dose remains the same. This medication can be taken orally once daily at any time of the day, regardless of food intake, and should be swallowed whole.

Child dose

The efficacy and safety for children under 18 years have not been established, so it is not recommended.

This medication should not be used in certain patients. For example, people who are allergic to the active ingredient or excipients of this medication, type 1 diabetes patients, patients with diabetic ketoacidosis, and those with hereditary lactose intolerance should not take this medication. Additionally, patients undergoing hemodialysis should not use this medication. Patients with low fluid volume or renal function issues should use this medication cautiously. This medicine may lower blood pressure or affect renal function, so fluid status and renal function should be thoroughly assessed before administration, and during treatment, blood pressure symptoms or renal function changes should be monitored regularly. Special caution is particularly needed for elderly patients or those taking diuretics. This medication contains colorants such as Yellow No. 4 and Yellow No. 5, so patients who are allergic to these substances or have had hypersensitivity reactions should be careful. While taking this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, volume depletion, and diabetic ketoacidosis may occur. Genital infections may occur more commonly in women and patients with a history of infections, so treatment should be sought immediately if infection symptoms appear. Hypoglycemia may occur more frequently when used with medications such as insulin or sulfonylureas, so blood sugar changes should be carefully monitored. This medication should be used cautiously in patients with poor liver function, and elderly patients are at higher risk for volume depletion, so caution is required. Additionally, this medication may result in positive urine glucose tests, which should be noted. Pregnant women are advised not to use this medication, and it should be discontinued immediately if pregnancy is confirmed. Nursing mothers should also not use this medication. This medication may interact with other drugs, so patients taking diuretics, insulin, or sulfonylureas should consult healthcare providers for potential dose adjustments. It may also affect serum lithium levels, so patients undergoing lithium treatment should monitor serum levels frequently. Currently, there are no specific antidotes in cases of overdose, so it is important to receive appropriate treatment based on symptoms. Finally, this medication does not significantly affect driving or machinery operation abilities, but there is a risk of hypoglycemia when taken in combination with other diabetes medications. Medicines should be stored out of reach of children and kept in their original containers.

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, cough+fever accompanied respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, vision abnormalities, paralysis, urine retention

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• thirst
• dizziness
• constipation
• dry mouth
• low back pain

This medication may be sensitive to air or moisture, so it must be kept in a closed container. Additionally, to maintain the effectiveness of the medicine, it is important to store it at room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

Yellow, double convex, diamond-shaped film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle