Posiro Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and add-on therapy with other blood glucose-lowering agents such as insulin. For initial combination therapy, the dose is 5 mg or 10 mg once daily. In patients with chronic heart failure and chronic kidney disease, the dose is 10 mg once daily. For patients with severe liver impairment, a starting dose of 5 mg is recommended, and if tolerated well, it may be increased to 10 mg. Once daily throughout the day.

Child dose

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

This medication should not be used in patients who have had allergic reactions to the active ingredients or excipients, in patients with type 1 diabetes, those with diabetic ketoacidosis, and patients undergoing dialysis. It should be used with caution in patients with decreased fluid volume or renal impairment, and fluid status and renal function should be carefully assessed before administration. After administration, symptoms of hypotension and renal function should be continuously monitored. The blood sugar control effect of this medication varies with renal function, and caution is necessary as its effectiveness may be reduced in patients with moderate to severe renal impairment. The most common side effect noted in clinical trials and post-marketing studies was genital infections, which may occur more frequently in women or in patients with a history of infections. Hypoglycemia may occur when used in conjunction with insulin or sulfonylureas, so insulin or sulfonylurea doses should be adjusted to reduce the risk of hypoglycemia when co-administered with this medication. Dehydration or hypotension due to decreased fluid volume may occur, especially in elderly patients or those taking diuretics, so fluid status must be closely monitored. Serious metabolic complications such as diabetic ketoacidosis may rarely occur in patients taking this medication, so immediate consultation with healthcare providers and appropriate testing is required if symptoms or signs appear. There is an increased risk of urinary tract infections and pyelonephritis, so prompt treatment is necessary if infection symptoms present. Rare but serious cases of skin infections such as perineal necrosis have been reported; if pain, swelling, or redness occurs around the perineum, immediate medical attention is required. Women who are pregnant or planning to become pregnant should avoid taking this medication, and it is also advised against for breastfeeding women. Safety and efficacy in children and adolescents have not been established, thus it is not used in this age group. In cases of overdose, there is no specific antidote, and symptomatic treatment should be provided based on symptoms. This medication does not significantly affect driving or operating machinery, but caution is advised due to the risk of hypoglycemia when taken with insulin or sulfonylureas. Finally, this medication should be stored out of reach of children and kept in the original container to maintain its quality.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme malaise, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis,

Mild side effects

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

This medication should be stored in an airtight container to prevent air and moisture from penetrating. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

28 tablets/box [(7 tablets/Alu-Alu x 4)], 30 tablets/bottle, 28 tablets/bottle