Medication info
Poglin 10 mg (Dapagliflozin Propanediol Hydrate)

Poglin 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Yellow, biconvex, diamond-shaped film-coated tablet
Packaging
PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202202271 · Approved 2022.05.30 · Insurance code 657807800

Summary

Main use
Effect on blood sugar control in type 2 diabetes and reduction of cardiovascular risk.
Who takes it
Adults · Children
Adult dose
The recommended dose of this drug is 10 mg taken once daily for monotherapy and additional combination therapy with other antidiabetic medications such as insulin. In initial combination therapy with metformin, it can be given as 5 mg once daily or 10 mg once daily. This drug can be taken orally at any time of the day, regardless of food intake. The tablet should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and reduction of cardiovascular risk.

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

This drug plays a complementary role in improving blood sugar control in patients with type 2 diabetes by supplementing dietary and exercise therapies. It can be used alone or in combination with other medications. It should be used cautiously in patients with cardiovascular disease or risk factors among those whose blood sugar is not adequately controlled. It is important to manage it safely with reference to expert clinical trial information when taking it. Overall, this drug is effective in the treatment of type 2 diabetes and improves blood sugar control.

How to take

Adult dose

The recommended dose of this drug is 10 mg taken once daily for monotherapy and additional combination therapy with other antidiabetic medications such as insulin. In initial combination therapy with metformin, it can be given as 5 mg once daily or 10 mg once daily. This drug can be taken orally at any time of the day, regardless of food intake. The tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established.

Precautions

This drug should not be used in patients with allergies to the main ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It is also not suitable for patients with lactose intolerance or certain genetic metabolic disorders. It should not be used in patients receiving dialysis. Use with caution in patients with volume depletion or renal function problems. This drug may lower blood pressure or cause temporary changes in renal function, necessitating caution. Patients with impaired renal function, the elderly, and those taking diuretics should closely monitor their fluid status and renal function. During treatment with this drug, there may be occurrences of genital infections and urinary tract infections, so if related symptoms appear, immediate consultation with healthcare professionals is necessary. There is a risk of hypoglycemia, so dosage adjustments may be needed when used with insulin or sulfonylureas. If dehydration or hypotension symptoms occur, it is advisable to temporarily stop taking this drug and consult a healthcare professional. Severe metabolic abnormalities known as diabetic ketoacidosis may occur, so immediate examination is needed if symptoms such as vomiting, abdominal pain, or difficulty breathing arise. It is safest for women who are pregnant or breastfeeding not to use this drug, and if pregnancy is confirmed, it should be discontinued. Elderly patients have a higher risk of decreased renal function and reduced fluid volume, so caution should be exercised. This drug may increase urination, so patients with bladder-related diseases should consider the possibility of condition worsening when using it. In case of overdose, as there are no specific antidotes, appropriate treatment should be undertaken based on symptoms, and attention should be paid to dehydration or hypotension symptoms. During treatment with this drug, caution should be exercised for hypoglycemia symptoms while driving or operating machinery, especially when taken with insulin or sulfonylureas. The safety and efficacy of this drug have not been established in children, so it is not used in that population. When storing the drug, keep it out of the reach of children and store it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • Severe swelling (edema)
  • Chest tightness
  • Difficulty breathing
  • Cold sweat
  • Paleness
  • Severe rash with fever
  • Blisters
  • Skin peeling
  • Pain in oral/ocular mucosa
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  • Shortness of breath or difficulty breathing
  • Asthma attack
  • Respiratory abnormalities with cough and fever
  • Yellowing of skin or eyes (jaundice)
  • Systemic extreme lethargy
  • Sudden and severe headache
  • Thunderclap headache
  • Seizure
  • Confusion of consciousness
  • Visual disturbances
  • Paralysis
  • Significant reduction in urine output
  • Severe systemic edema

Mild side effects

  • Vulvovaginitis, balanitis, and related genital infections
  • Urinary tract infections
  • Hypoglycemia
  • Reduced fluid volume (including dehydration, hypovolemia, hypotension)
  • Dizziness
  • Constipation
  • Dry mouth
  • Low back pain
  • Dysuria
  • Polyuria
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  • Nocturia
  • Interstitial nephritis
  • Increase in hematocrit
  • Elevation of blood creatinine at the beginning of treatment
  • Increase in blood urea
  • Weight loss
  • Itching
  • Urticaria
  • Cold sweat
  • Cough
  • Difficulty breathing
  • Palpitations
  • Insomnia
  • Tinnitus
  • Chest pain
  • Weakness
  • Fatigue
  • Pain
  • Edema
  • Foreign body sensation
  • Hunger
  • Vaginal discharge

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This way, the drug's efficacy can be preserved for a long time.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

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

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.