Posidapa Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this medicine is 10 mg once daily for monotherapy and additional combination therapy with insulin or other antihyperglycemic agents. For initial combination therapy, when there is no prior experience of treatment with diabetic medication, the recommended starting dosage with metformin is 5 mg or 10 mg once daily. For chronic heart failure and chronic kidney disease, the dosage is 10 mg once daily. Dosage adjustment may be necessary for patients with renal impairment and hepatic impairment.

Child dose

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

This medicine should not be used in patients who have had allergic reactions to the active ingredient or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis, and to those undergoing dialysis. This medicine contains lactose hydrate, hence it should not be administered to patients with lactose intolerance or specific genetic disorders. Care should be taken when using this medicine in patients with reduced fluid volume or kidney dysfunction, and blood pressure, fluid status, and kidney function should be carefully monitored before and after administration. The blood sugar control effect of this medicine may vary based on kidney function, so it is not recommended for patients with severe kidney impairment. While using this medicine, side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur, so symptoms should be closely monitored. Genital infections are particularly more common in women, and if there is a history of infections, the risk of recurrence may be higher, so caution is advised. There is a risk of hypoglycemia, so dosages of insulin or sulfonylureas may need to be adjusted if taken together. This medicine may cause a reduction in fluid volume, leading to hypotension or dehydration, so elderly patients or those taking diuretics should be particularly careful. In severe cases, rare complications such as perineal necrosis may occur, so if symptoms like pain, swelling, or redness appear in the genital area or perineum, medical assistance should be sought immediately. Pregnant or breastfeeding women are advised not to use this medicine, and it should be discontinued if pregnancy is confirmed. The safety and efficacy of this medicine for children has not been established, hence it should not be used in pediatric populations. There is no specific antidote in case of overdose, so appropriate treatment should be conducted according to symptoms, and hospitalization may be required for monitoring and treatment. Generally, it is safe to drive or operate machinery while taking this medicine, but caution should be exercised for hypoglycemic symptoms if used with insulin or sulfonylureas. Lastly, it is important to keep this medicine in its original container and store it out of reach of children.

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, elevated hematocrit, increased serum creatinine during early treatment, dyslipidemia, weight loss, rash, cold sweat, itching, vasogenic headache, orthostatic hypotension, palpitations, insomnia, tinnitus, dyspepsia, nausea, diarrhea, vomiting, weakness, hunger, vaginal discharge

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

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

Package unit

30 tablets/bottle, 100 tablets/bottle