Medication info
Posalin Tablet 10 mg (Dapagliflozin Propanediol Monohydrate)

Posalin Tablet 10 mg (Dapagliflozin Propanediol Monohydrate)

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

MFDS item code 202200440 · Approved 2022.01.27 · Insurance code 657203950

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other glucose-lowering agents. In initial combination therapy with metformin, the recommended starting dose is 5 mg or 10 mg once daily. This medication can be taken orally at any time of day, regardless of meals. The tablet must be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There are no relevant data.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used along with diet and exercise therapy to help control blood sugar in patients with type 2 diabetes. It can be administered alone or in combination with other medications. It may be used particularly in patients with cardiovascular disease or risk factors who have not achieved adequate blood sugar control. This drug effectively improves patients' blood sugar levels and aids in the management of cardiovascular risk, playing an important role in the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other glucose-lowering agents. In initial combination therapy with metformin, the recommended starting dose is 5 mg or 10 mg once daily. This medication can be taken orally at any time of day, regardless of meals. The tablet must be swallowed whole.

Child dose

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

Precautions

This medication should not be used in patients with allergies to the active ingredient or excipients, patients with type 1 diabetes, diabetic ketoacidosis, and those undergoing dialysis. Use with caution in patients with reduced fluid volume or impaired kidney function. This medication may lower blood pressure or affect kidney function, so it's important to closely monitor fluid status and kidney function before and after administration. The blood sugar control effectiveness of this medication may vary depending on kidney function, and it is not recommended for patients with moderate to severe renal impairment. This medication may cause side effects such as genital infections, urinary tract infections, hypoglycemia, dehydration, and ketoacidosis, so if any unusual symptoms occur, immediate consultation with healthcare professionals is necessary. Particularly, genital infections may occur more frequently in women, so attention to hygiene is important, and appropriate treatment is necessary if infection symptoms develop. When used with insulin or sulfonylureas, which may cause hypoglycemia, there may be an increased risk of hypoglycemia, so dose adjustments may be necessary. Women who are pregnant or breastfeeding should avoid using this medication, and if pregnancy is confirmed, discontinuation should occur immediately. Elderly patients or those with impaired kidney function should use this medication with caution, and signs of reduced fluid volume and low blood pressure should be closely monitored. This medication does not significantly affect the ability to drive or operate machinery, but caution is required due to the risk of hypoglycemia. In the case of overdose, there are no specific antidotes, so prompt treatment based on symptoms should be sought, and appropriate management should follow the physician's instructions. Regular consultations with healthcare professionals to monitor kidney function, blood pressure, blood sugar, and signs of infection during the use of this medication are important.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat (severe allergic reactions), skin rash, blisters, skin peeling, pain in the oral/ocular mucosa (severe skin reactions), shortness of breath or difficulty breathing, asthma attack, cough with fever, respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy (liver abnormalities), sudden and severe headache, thunderclap headache, seizures, altered consciousness

Mild side effects

  • Vulvitis
  • balanitis
  • genital infection
  • urinary tract infection
  • hypoglycemia
  • dizziness
  • constipation
  • dry mouth
  • low back pain
  • dysuria
Show 25 more
  • polyuria
  • nocturia
  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • weakness
  • itching
  • rash
  • cold sweat
  • chest pain
  • fatigue
  • pain
  • peripheral edema
  • generalized edema
  • hunger
  • vaginal discharge
  • menstrual irregularities
  • vertigo
  • palpitations
  • insomnia
  • tinnitus

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

Storage

This medication should be stored tightly sealed to prevent exposure to air or moisture. Additionally, it is safest to store the medication at room temperature, which is not too cold or too hot, specifically between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

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

Package unit

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