Medication info
Dapaslin Tablet 10mg (Dapagliflozin Propanediol Monohydrate)

Dapaslin Tablet 10mg (Dapagliflozin Propanediol Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
고려제약(주)
Appearance
Yellow, double convex, diamond-shaped film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202300341 · Approved 2023.01.26 · Insurance code 642803440

Summary

Main use
Effectively controls blood sugar in type 2 diabetes and reduces cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10mg once daily. This medication can be administered orally at any time of the day, regardless of meals. Tablets should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There is no relevant data.

Ingredients

Manufacturer
고려제약(주)

Efficacy & effects

Effectively controls blood sugar in type 2 diabetes and reduces cardiovascular risk

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

This medication helps control blood sugar in patients with type 2 diabetes and assists with dietary and exercise regimens. It can be used alone or in combination with other medications. Caution is advised when used in patients with cardiovascular diseases or risk factors, especially if blood sugar is not adequately controlled. Detailed clinical information regarding this medication can be confirmed through a specialist. This medication is effectively used in the management of type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 10mg once daily. This medication can be administered orally at any time of the day, regardless of meals. Tablets should be swallowed whole.

Child dose

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

Precautions

This medication should not be used in certain patients. Patients with allergies to the main ingredients or excipients, those with type 1 diabetes or diabetic ketoacidosis, patients with lactose-related genetic disorders, and patients undergoing dialysis should not receive this medication. Patients with decreased fluid volume or impaired kidney function should use this medication with caution. This drug may lower blood pressure or affect kidney function; thus, these patients should carefully monitor their physical condition before and during treatment. This medication contains specific dyes; patients with allergies or hypersensitivity to these dyes should take precautions. Various side effects may occur during treatment, including genital infections, urinary tract infections, hypoglycemia, fluid depletion, and ketoacidosis; if any unusual symptoms appear, immediate consultation with medical personnel is required. Particularly, symptoms of fluid depletion or low blood pressure may appear, necessitating special caution in patients at high risk of dehydration or hypotension. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, it should be discontinued immediately. The risk of hypoglycemia may increase when taken with other diuretics, insulin, sulfonylureas, etc.; therefore, dosage adjustments may be necessary. There is no specific antidote for overdose, and patients should receive treatment based on their condition; it is unknown whether this drug can be removed through dialysis. Finally, its safety and efficacy in children have not been sufficiently established, so it is advisable not to use it in pediatric patients.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Vulvovaginitis
  • balanitis
  • related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
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  • back pain
  • dysuria
  • polyuria
  • nocturia
  • increased hematocrit
  • elevated serum creatinine
  • elevated blood urea
  • weight loss
  • rash
  • angioedema
  • chest pain
  • weakness
  • pain
  • swelling
  • foreign body sensation
  • facial edema
  • facial pain
  • warmth
  • flu-like symptoms
  • irregular menstruation
  • genital edema
  • discomfort in the vulva
  • itching

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. Additionally, it should be stored at room temperature, preferably between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

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

Package unit

30 tablets/bottle, 300 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.