Medication info

Poshu Tablet 10 mg (Dapagliflozin)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Dapagliflozin›10mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
Yellow, biconvex, diamond-shaped film-coated tablet
Packaging
100 tablets/bottle, 8 tablets/pouch [8 tablets/Alu-Alu]
Approval status
Approval withdrawn

MFDS item code 202004450 · Approved 2020.06.17

This product's status changed to Approval withdrawn on 2024.01.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improves blood sugar control in type 2 diabetes
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy. In the case of initial combination therapy for patients with no prior experience of diabetes medication, a dose of 5 mg or 10 mg once daily is recommended when used in conjunction with metformin. For special populations, this drug is recommended against for patients with renal impairment at eGFR less than 45 mL/min/1.73 m2, and it should not be administered to patients undergoing dialysis.
Child dose
The efficacy and safety of this medication in pediatric patients under 18 years of age have not been established, and there is no relevant data.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Improves blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty controlling blood sugar
View approved original text

This medication is used to assist in blood sugar control for patients with type 2 diabetes. It can be administered alone along with diet and exercise therapy, or combined with other diabetes medications to enhance blood sugar control if necessary. It is particularly effective when used in conjunction with metformin, sulfonylureas, insulin, and sitagliptin. This drug can also be beneficial for patients who have difficulty controlling their blood sugar with existing treatments. It is used in various ways to improve blood sugar control.

How to take

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy. In the case of initial combination therapy for patients with no prior experience of diabetes medication, a dose of 5 mg or 10 mg once daily is recommended when used in conjunction with metformin. For special populations, this drug is recommended against for patients with renal impairment at eGFR less than 45 mL/min/1.73 m2, and it should not be administered to patients undergoing dialysis.

Child dose

The efficacy and safety of this medication in pediatric patients under 18 years of age have not been established, and there is no relevant data.

Precautions

This medication should not be used in patients with an allergy to the active ingredient or excipients. It must not be administered to patients with type 1 diabetes or those with diabetic ketoacidosis. Since it contains lactose anhydrous, it should not be given to patients with lactose intolerance or genetic related disorders. Patients undergoing dialysis should also avoid this medication. Patients with diminished fluid volume or impaired kidney function should exercise caution when using this drug. This medication can lower blood pressure or impact kidney function, so careful monitoring of fluid status and kidney function is critical. Elderly patients or those who are on diuretics may be at higher risk for hypotension and decreased fluid volume, so caution is warranted. The effectiveness of this drug on blood sugar control may vary depending on kidney function status. Infections of the genital area and urinary tract may occur while taking this medication, so proper hygiene should be maintained, and treatment should be sought immediately if infection symptoms arise. There is a risk of hypoglycemia, so dose adjustments may be necessary when used in conjunction with insulin or sulfonylureas. If symptoms of dehydration or hypotension appear, immediate consultation with medical personnel is required, and discontinuation of medication may be necessary. Diabetic ketoacidosis may occur, so prompt medical attention is required if symptoms such as vomiting, abdominal pain, or breathing difficulties present. This medication is not recommended for patients with severely impaired liver function. Women who are pregnant or breastfeeding should avoid using this medication. Safety and efficacy in pediatric patients have not been established. In cases of overdose, immediate medical intervention is necessary, and as there is no specific antidote, treatment should be symptomatic. Care should be taken while driving or operating machinery during the treatment, and one should be able to recognize and respond to symptoms of hypoglycemia. The medication should be stored in its original container, out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing and fever, yellowing of skin or eyes, severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significant reduction in urine output

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, pruritus vulvae, pruritus genitalis, elevated hematocrit, increased serum creatinine at the beginning of treatment, dyslipidemia, weight loss, thirst, constipation, urinary tract infection, sinusitis, diverticulitis, pelvic inflammatory disease, pneumonia, pulmonary tuberculosis, asthenia,

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

Storage

This medication is susceptible to the effects of air and moisture, so it should be stored in a sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help to preserve the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

100 tablets/bottle, 8 tablets/pouch [8 tablets/Alu-Alu]

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.