Medication info
PARMA EMPAGLOW DUO Tablets 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

PARMA EMPAGLOW DUO Tablets 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)한국파마
Appearance
Biconvex, oval film-coated tablet that is dark brownish-purple
Packaging
60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202302642 · Approved 2023.09.05 · Insurance code 653007060

Summary

Main use
Efficacy in controlling blood sugar in Type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet once, twice a day. This should be determined considering the therapy, efficacy, and tolerability of each patient, ensuring not to exceed 25 mg of empagliflozin and 2000 mg of metformin. If using metformin alone or in combination with insulin or other medications and sufficient blood sugar control is not achieved, it is recommended to take 5 mg of empagliflozin twice a day (total daily dose of 10 mg) with the existing dose of metformin. If tolerability is excellent and additional blood sugar control is needed, empagliflozin can be increased to 25 mg (total daily dose). Patients switching to this medication from a combination of empagliflozin (total daily dose of either 10 mg or 25 mg) and metformin should use their prior doses.

Ingredients

Manufacturer
(주)한국파마

Efficacy & effects

Efficacy in controlling blood sugar in Type 2 diabetes and preventing cardiovascular events

  • Blood sugar control disorders
  • Type 2 diabetes
  • cardiovascular diseases
View approved original text

This medication is used to assist dietary and exercise therapy in effectively regulating blood sugar levels in adult patients with Type 2 diabetes. It particularly enhances blood sugar management by using empagliflozin and metformin together. In patients with diabetes who have insufficient blood sugar control and have cardiovascular diseases, caution should be exercised regarding the occurrence of cardiovascular events when using this drug, so please consult expert guidance. This drug is used to improve blood sugar control in patients with Type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once, twice a day. This should be determined considering the therapy, efficacy, and tolerability of each patient, ensuring not to exceed 25 mg of empagliflozin and 2000 mg of metformin. If using metformin alone or in combination with insulin or other medications and sufficient blood sugar control is not achieved, it is recommended to take 5 mg of empagliflozin twice a day (total daily dose of 10 mg) with the existing dose of metformin. If tolerability is excellent and additional blood sugar control is needed, empagliflozin can be increased to 25 mg (total daily dose). Patients switching to this medication from a combination of empagliflozin (total daily dose of either 10 mg or 25 mg) and metformin should use their prior doses.

Precautions

This medication is used to lower blood sugar and should not be administered to patients with impaired kidney function or certain diseases. There may be a rare side effect of severe lactic acidosis, so if symptoms such as muscle pain, breathlessness, weakness, or abdominal pain occur, immediate medical attention is required. When used in conjunction with insulin or other diabetes medications, hypoglycemia may occur, so careful monitoring of blood sugar levels is necessary. Patients with reduced kidney function or conditions that can cause acute kidney injury should not take this medication or should temporarily discontinue it, and regular kidney function tests should be conducted. Urinary infections or genital infections may occur; hence, immediate treatment is required when there are signs of infection. Women who are pregnant or breastfeeding should not take this medication for safety reasons, especially breastfeeding should be discontinued. In elderly patients, there is a higher risk of fluid loss, so fluid status should be managed properly, and kidney function should be monitored frequently. Before surgery or radiographic examinations involving contrast agents, this medication should be discontinued, and it can be resumed once kidney function returns to normal after the examination. It is recommended to avoid alcohol consumption while taking this medication, and if any abnormal reactions occur, consult a doctor or pharmacist. Regular blood tests and symptom observation should be conducted to ensure the safe use of the medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, peeling skin, pain in mouth/eye mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbance
  • itching
  • rash
  • hives
  • erythema multiforme
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • hypotension
  • hypoglycemia
  • reduced appetite
  • nausea
  • vomiting

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Biconvex, oval film-coated tablet that is dark brownish-purple

Package unit

60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 60 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.