Medication info
Empacombi Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Empacombi Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Yellow, brownish, bilayer, biconvex, film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201335 · Approved 2022.04.04 · Insurance code 645211000

Summary

Main use
Control of blood sugar in Type 2 Diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet at a time, twice a day. The maximum recommended daily doses for Empagliflozin and Metformin are 25 mg and 2000 mg, respectively. For patients who do not achieve sufficient blood sugar control with Metformin alone or in combination with insulin or other medications, it is recommended to take 5 mg of Empagliflozin twice a day (total daily amount of 10 mg) along with the existing Metformin dosage. If further blood sugar control is needed,

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Control of blood sugar in Type 2 Diabetes and prevention of cardiovascular events

  • Difficulty in controlling blood sugar
  • Type 2 diabetes
  • cardiovascular disease
View approved original text

This medication effectively enhances blood sugar control in adult patients with Type 2 diabetes when combined with dietary management and exercise. It is particularly suitable for patients whose blood sugar levels are not adequately controlled, and additional information from a specialist is recommended for patients with a history of cardiovascular disease. This medication improves blood sugar control, aiding in the management of diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet at a time, twice a day. The maximum recommended daily doses for Empagliflozin and Metformin are 25 mg and 2000 mg, respectively. For patients who do not achieve sufficient blood sugar control with Metformin alone or in combination with insulin or other medications, it is recommended to take 5 mg of Empagliflozin twice a day (total daily amount of 10 mg) along with the existing Metformin dosage. If further blood sugar control is needed,

Precautions

This medication helps control blood sugar levels. While taking this medication, there is a risk of a rare side effect called lactic acidosis, so caution is advised. When used in conjunction with other diabetes medications, hypoglycemic symptoms may occur, so care must be taken. Patients with moderate to severe renal impairment, acute kidney issues, severe infections, heart problems, etc., should not take this medication. Pregnant or breastfeeding women are also advised not to take this medication. During treatment, regular monitoring of kidney function is necessary to ensure there are no abnormalities, and if dehydration, severe vomiting, diarrhea occurs, cessation of the medication should be discussed with a doctor. Additionally, this medication should be discontinued at least 48 hours prior to surgery and resumed only after kidney function has returned to normal post-surgery. This medication may increase the risk of urinary or genital infections, so immediate treatment is necessary if infection symptoms appear. During treatment, be alert for hypoglycemic symptoms, especially if using insulin or other hypoglycemic agents, as dose adjustment may be needed to reduce the risk of hypoglycemia. Vitamin B12 levels may decrease, so regular testing is required for long-term use. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. Patients taking this medication should be cautious of symptoms related to fluid volume depletion, especially elderly patients or those with cardiovascular diseases. In case of overdose, immediate hospital treatment should be sought, and dialysis may be required. This medication is not recommended for children, and elderly patients should start with the minimum dose while frequently monitoring kidney function. Finally, this medication should be stored out of reach of children, and it should be kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction
  • Severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, severe skin abnormal reactions
  • Shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever
  • Yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headache,

Mild side effects

Hypoglycemia, urinary tract infection, genital infection, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, altered taste, itching, rash, hives, angioedema, urinary difficulty, interstitial nephritis, thirst, increased serum lipids, increased blood creatinine/reduced glomerular filtration rate, increased hematocrit, decreased and deficiency of Vitamin B12, decreased fluid volume, headache, dizziness, insomnia, weakness

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is important to maintain room temperature between 1 and 30 degrees Celsius to ensure the efficacy and safety of the medication over time.

Appearance and packaging

Appearance

Yellow, brownish, bilayer, biconvex, film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 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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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.