Medication info
Amplin 10 mg (Empagliflozin)

Amplin 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Light yellow, double convex, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102580 · Approved 2021.03.24 · Insurance code 653405970

Summary

Main use
Effective for blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose for this medication is 10 mg once daily for monotherapy or additional combination therapy with insulin and other antihyperglycemic agents. If additional blood sugar control is needed with good tolerance, the dose can be increased to 25 mg once daily. It can be taken without regard to meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses in one day.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Effective for blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used alongside dietary and exercise therapy to help control blood sugar levels in adults with type 2 diabetes. It can be used alone or in combination with other diabetes medications such as Metformin, Pioglitazone, Sulfonylureas, Insulin, DPP-4 inhibitors for patients who have difficulty controlling their blood sugar or are already taking other diabetes medications. It is particularly effective in patients whose blood sugar is poorly controlled, and special care is required for patients with concomitant cardiovascular disease. This medication effectively improves blood glucose levels and aids in diabetes treatment.

How to take

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy or additional combination therapy with insulin and other antihyperglycemic agents. If additional blood sugar control is needed with good tolerance, the dose can be increased to 25 mg once daily. It can be taken without regard to meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses in one day.

Precautions

This medication should not be administered to certain patients. Firstly, patients who are allergic to the active ingredient or any component of this medication should not take it. Secondly, it should not be used in patients with type 1 diabetes or diabetic ketoacidosis. Thirdly, it is not administered to patients with severely impaired kidney function or end-stage renal disease, and those undergoing dialysis. Fourthly, since it contains lactose, patients with lactose intolerance or galactose intolerance, as well as those with glucose-galactose malabsorption syndrome should not take this medication. Caution is required when administering this medication to patients with decreased kidney function. If kidney function falls below a certain level, dosage adjustments may be necessary or treatment may need to be stopped. It is not used in patients with end-stage renal disease or those on dialysis as its effectiveness cannot be expected. Regular monitoring of kidney function is essential to observe any changes. In patients with mild to moderate heart failure, caution is advised, and it is not recommended for patients with severe heart failure. There is a risk of hypoglycemia when used in conjunction with insulin or medications that promote insulin secretion, and dosage adjustments of insulin may be necessary when used with these medications. Various adverse reactions may occur during the use of this medication. The most common adverse reactions include hypoglycemia, genital infections, urinary tract infections, increased urination, and decreased fluid volume. Particularly, hypoglycemia can occur more frequently when combined with insulin or sulfonylureas. Additionally, severe metabolic acidosis such as ketoacidosis can rarely occur, in which case treatment should be stopped immediately, and evaluation and treatment by medical personnel are required. This medication is not used for the treatment of type 1 diabetes. Elderly patients, especially those over 75 years of age, are at a higher risk for fluid volume loss complications such as dehydration or hypotension and require caution. This medication may increase the risk of genital fungal infections, so patients with a history of fungal infections should be particularly cautious. Caution is advised when driving or operating machinery due to the risk of hypoglycemia. Particularly, if used in conjunction with insulin or sulfonylureas, extra care should be taken. Women who are pregnant or planning to become pregnant should not take this medication, and treatment should be stopped immediately upon confirmation of pregnancy. It is also recommended for breastfeeding women to stop breastfeeding while taking this medication. The safety and efficacy of this medication in patients who are children or adolescents, specifically those under 18 years of age, have not been established, and it should not be used in this population. In cases of overdose, no specific toxicity symptoms have been reported; however, appropriate treatment should be provided based on clinical condition. This medication should be kept out of reach of children, and transferring it to other containers should be avoided to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, liver damage (liver abnormalities), heart failure, hypoglycemia (significant hypoglycemia when used with sulfonylureas or insulin), severe edema or urinary abnormalities, severe allergic reactions, severe skin abnormal reactions, respiratory problems

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • balanitis
  • other genital infections
  • rash
  • skin itching
  • increased urination
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
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  • abnormalities in diagnostic tests
  • constipation
  • diarrhea
  • indigestion
  • abdominal pain
  • nausea
  • gastritis
  • weight loss
  • dizziness
  • headache
  • fatigue
  • facial swelling
  • edema
  • cough
  • epistaxis
  • allergic rhinitis
  • anxiety
  • insomnia
  • drowsiness
  • muscle pain
  • musculoskeletal pain

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

Storage

This medication may be sensitive to air and moisture, so it should be kept in a tightly closed container. It is best stored at room temperature between 1 and 30 degrees Celsius. This will help maintain its effectiveness safely.

Appearance and packaging

Appearance

Light yellow, double convex, round film-coated tablet

Package unit

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.