Medication info
Jovatorin Tablets 10/10 mg (Ezetimibe/Simvastatin)

Jovatorin Tablets 10/10 mg (Ezetimibe/Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
White to off-white, biconvex, rectangular tablets
Packaging
30 Tablets (10 Tablets/Blister Package X 3)
Approval status
Active

MFDS item code 201602085 · Approved 2016.04.12 · Insurance code 693202710

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This drug is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day, with a generally recommended starting dose of 10/20 mg per day. Patients with less need for LDL cholesterol reduction may start at 10/10 mg per day. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of more than four weeks.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apolipoprotein B
  • elevated triglycerides
  • increased risk of atherosclerotic cardiovascular diseases due to hypercholesterolemia.
View approved original text

This medication is used as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia and mixed hyperlipidemia, and to increase HDL cholesterol. Especially in patients with homozygous familial hypercholesterolemia, it may be administered when other lipid-lowering therapies are ineffective or as an adjunctive therapy. This drug should be used together with an appropriate diet, including restrictions on saturated fat and cholesterol, and is used when there is insufficient response to non-drug measures. Additionally, it is important to confirm and treat secondary causes such as diabetes and hypothyroidism before administration. This drug helps improve blood lipid levels in patients, reducing the risk of atherosclerotic cardiovascular diseases caused by hypercholesterolemia.

How to take

Adult dose

This drug is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day, with a generally recommended starting dose of 10/20 mg per day. Patients with less need for LDL cholesterol reduction may start at 10/10 mg per day. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of more than four weeks.

Precautions

This drug is used to lower blood cholesterol levels. Symptoms such as muscle pain or weakness may occur during treatment, so if these symptoms appear, you must inform your doctor immediately. Particularly, the risk of muscle-related side effects may increase when taken at high doses or with certain other medications. This drug may affect liver function, so it should not be taken by individuals with liver disease or abnormal liver function test results. Women who are pregnant or breastfeeding should not take this drug, and women who may become pregnant must confirm their pregnancy status before taking it. Additionally, the risk of side effects may increase when taken with certain enzyme-inhibiting drugs, so you should inform your doctor or pharmacist of any medications you are taking. Caution is needed for elderly patients and children, especially those under 10 years old, as safety has not been fully established. Regular blood tests to check liver function and muscle enzyme levels are recommended during treatment. In case of overdose, general treatment for symptoms will be provided as there is no specific antidote. During treatment with this medication, grapefruit juice and certain drug combinations should be avoided, and healthcare professionals should be informed of this medication when starting new drugs.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, severe allergic reactions, severe skin adverse reactions (including rash, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, erythema multiforme), myopathy, rhabdomyolysis, liver abnormalities (hepatitis, liver dysfunction, jaundice, acute liver necrosis, liver failure), respiratory issues (dyspnea, interstitial lung disease).

Mild side effects

Headache, diarrhea, myalgia, limb pain, influenza, upper respiratory infection, fatigue, abdominal pain, nausea, constipation, dyspepsia, flatulence, itching, rash, elevated creatine phosphokinase (CPK) levels, weight loss, edema, thirst, facial swelling, syncope, paresthesia, insomnia, gastritis, atrophic gastritis, mucus stools, irritable bowel syndrome, sore throat, nocturia, hematuria, alopecia, gynecomastia, decreased libido, sexual dysfunction, cataracts.

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 closed container. Additionally, it is recommended to store the medication at room temperature, between 1 to 30 degrees Celsius, avoiding excessively high or low temperatures.

Appearance and packaging

Appearance

White to off-white, biconvex, rectangular tablets

Package unit

30 Tablets (10 Tablets/Blister Package X 3)

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.