Medication info

Posalin Tablets 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Yellow round film-coated tablets
Packaging
Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [7 tablets/Alu-Alu x 4]
Approval status
Active

MFDS item code 202201074 · Approved 2022.03.15

Summary

Main use
Effective for controlling blood sugar in type 2 diabetes and reducing cardiovascular risk
Who takes it
Adults
Adult dose
The recommended dose of this medication is once daily at 10 mg for monotherapy and add-on therapy with insulin and other glucose-lowering agents. When used in combination with insulin or insulin secretagogues such as sulfonylureas, consideration should be given to using lower doses of insulin or insulin secretagogues to reduce the risk of hypoglycemia. Initial combination therapy may be considered when there has been no prior experience with diabetes medication.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Effective for controlling blood sugar in type 2 diabetes and reducing cardiovascular risk

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication helps patients with type 2 diabetes effectively control their blood sugar. It is used as an adjunct to diet and exercise, and can be administered alone or in combination with other medications. It is particularly useful for patients with type 2 diabetes who have cardiovascular diseases or risk factors. This medication can improve blood sugar levels, aiding in diabetes management, and may contribute to reducing the risk of cardiovascular events. Please refer to professional information for detailed descriptions. This medication is effectively used in the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is once daily at 10 mg for monotherapy and add-on therapy with insulin and other glucose-lowering agents. When used in combination with insulin or insulin secretagogues such as sulfonylureas, consideration should be given to using lower doses of insulin or insulin secretagogues to reduce the risk of hypoglycemia. Initial combination therapy may be considered when there has been no prior experience with diabetes medication.

Precautions

This medication should not be used in patients who are allergic to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. Caution should be exercised in patients with reduced fluid volume or impaired kidney function, as blood pressure may drop or kidney function may rapidly change. Elderly patients or those taking diuretics may require additional precautions due to higher risks of hypotension and decreased blood volume. Blood sugar control effects may vary based on kidney function, and this medication is not recommended for patients with severely impaired renal function. The most commonly occurring side effect in clinical trials is genital infections, which may occur more frequently in women or patients with a history of infections. Hypoglycemia may occur more frequently when used with insulin or sulfonylureas, potentially necessitating dose adjustments. Symptoms of dehydration or hypotension may occur due to reduced fluid volume, so symptoms should be monitored closely. Serious metabolic disturbances such as diabetic ketoacidosis may arise, thus immediate consultation with medical personnel is necessary if symptoms such as vomiting, abdominal pain, or breathing difficulties occur. Risk of urinary tract infections, such as pyelonephritis, may also increase, so prompt treatment is required if relevant symptoms arise. This medication may temporarily worsen kidney function, necessitating regular kidney function tests. Rare but serious infections such as Fournier's gangrene can occur, so immediate medical attention is necessary if pain, swelling, or fever around the genital area arises. It is advisable not to use this medication during pregnancy, and it should also be avoided in breastfeeding cases. Elderly patients require closer monitoring due to higher risks of decreased kidney function and fluid volume reduction. Dose adjustments may be necessary when taking with insulin, sulfonylureas, or diuretics to mitigate the risks of hypotension or hypoglycemia. There is no specific antidote in cases of overdose, so appropriate treatment based on symptoms is essential. During the medication period, regular blood sugar monitoring should be conducted, with particular attention to hypoglycemia symptoms. The safety and efficacy of this medication in pediatric patients have yet to be established, so its use is discouraged. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty or shortness of breath, asthma attacks, cough with accompanying fever affecting breathing, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, vision 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, increased hematocrit, elevated blood creatinine, elevated blood urea, weight loss, gastrointestinal disturbances (gastroesophageal reflux disease, upper abdominal pain, diverticulitis, chronic pancreatitis, etc.), hyperglycemia, sensory disturbances, cerebral infarction, nerve compression, weakness, pain, keratitis, chronic obstruction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [7 tablets/Alu-Alu x 4]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.