Medication info
Zadiplogin M Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Zadiplogin M Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
Orange-yellow, biconvex, oval 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 202201356 · Approved 2022.04.04 · Insurance code 661905720

Summary

Main use
Efficacy in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is one tablet twice a day. The dosage should be determined based on each patient's treatment regimen, efficacy, and tolerability within the maximum recommended daily dosage of 25 mg for empagliflozin and 2000 mg for metformin. For patients unable to maintain adequate blood glucose control with metformin alone or in combination with other medications like insulin, the dose of empagliflozin can be 5 mg taken twice daily (total of 10 mg).

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Efficacy in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
  • cardiovascular events
View approved original text

This medication is used to assist in blood sugar control for adults with type 2 diabetes alongside dietary and exercise therapy. It is especially effective for patients whose blood sugar levels are not adequately controlled and can be administered to patients with cardiovascular disease. However, precautions related to cardiovascular events should be referred to professional guidelines. This improves blood sugar control and aids in diabetes management.

How to take

Adult dose

The recommended dose of this medication is one tablet twice a day. The dosage should be determined based on each patient's treatment regimen, efficacy, and tolerability within the maximum recommended daily dosage of 25 mg for empagliflozin and 2000 mg for metformin. For patients unable to maintain adequate blood glucose control with metformin alone or in combination with other medications like insulin, the dose of empagliflozin can be 5 mg taken twice daily (total of 10 mg).

Precautions

This medication is primarily used for treating diabetes. Rare side effects such as severe lactic acidosis can occur during administration, so particular caution is needed for patients with impaired kidney function or liver issues. Also, when taken with other diabetes medications such as insulin or sulfonylureas, hypoglycemic symptoms may appear, so blood sugar levels should be monitored closely. This medication should not be used in patients with moderate to severe renal impairment, acute infections, dehydration, heart failure, or acute myocardial infarction. It is necessary to stop taking this medication for a certain period before and after surgeries or tests using iodine contrast agents and resume after kidney function has returned to normal. It is safest for pregnant or breastfeeding women to avoid this medication. During use, symptoms such as urinary tract infections, genital infections, and increased urination may occur, and any irregular symptoms should be immediately reported to a physician. Additionally, this medication can cause reduced fluid volume and lower blood pressure; therefore, elderly individuals or those with hypotension need to be cautious during use. Long-term use can lead to decreased vitamin B12, so it's advisable to check vitamin B12 status. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. Patients should be well-informed about the symptoms of hypoglycemia, lactic acidosis, and ketoacidosis while on this medication and should inform medical staff immediately if symptoms occur. Finally, this medication is not recommended for children under 18 and should be administered to elderly patients at the minimum dose while regularly monitoring kidney function.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, perineal necrosis, lactic acidosis, ketoacidosis, urosepsis, pyelonephritis, severe allergic reactions, myocardial infarction, cerebral infarction, concussion, cerebral ischemia, kidney damage, acute kidney injury, acute cholecystitis, autoimmune hepatitis, hepatitis, severe skin reactions, severe edema or urination abnormalities, severe neurological symptoms (severe headache, seizures, altered consciousness, visual disturbances, paralysis),

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • hives
  • erythema
  • angioedema
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • decreased and deficient vitamin B12
  • reduced fluid volume
  • weight loss
  • dizziness
  • headache
  • fatigue

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is crucial to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will ensure the medication's efficacy.

Appearance and packaging

Appearance

Orange-yellow, biconvex, oval 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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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.