Medication info

Entiruvatine Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/PTP [(15 tablets/PTP x 2 pieces)]
Approval status
Expired

MFDS item code 201908118 · Approved 2019.11.27

This product's status changed to Expired on 2024.11.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of cholesterol improvement in hypercholesterolemia and familial hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of the day regardless of meals. The initial dosage is 5mg once daily, and if more significant LDL-cholesterol reduction is needed, the maintenance dosage may be adjusted accordingly. The maintenance dose is typically 10mg once daily, which is the adjusted dose for most patients. The maintenance dosage should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Children's dosage
The usual dosage range is 5mg to 20mg once daily. The dosing regimen should be individually adjusted according to the recommended treatment goal for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment of cholesterol improvement in hypercholesterolemia and familial hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used as an adjunctive treatment for patients with primary hypercholesterolemia and mixed dyslipidemia that is not controlled by dietary changes and exercise. It is also used in conjunction with diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia, helping to lower total cholesterol and LDL-cholesterol levels, thereby delaying the progression of atherosclerosis. Particularly, it reduces total cholesterol and LDL-cholesterol levels as an adjunctive treatment to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia and contributes to reducing the risks associated with stroke, myocardial infarction, and arterial revascularization in adults at high risk of cardiovascular disease. Thus, it is effectively used in various types of dyslipidemia and for risk reduction of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day regardless of meals. The initial dosage is 5mg once daily, and if more significant LDL-cholesterol reduction is needed, the maintenance dosage may be adjusted accordingly. The maintenance dose is typically 10mg once daily, which is the adjusted dose for most patients. The maintenance dosage should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Children's dosage

The usual dosage range is 5mg to 20mg once daily. The dosing regimen should be individually adjusted according to the recommended treatment goal for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in patients with known allergies to specific ingredients. Patients with severe liver dysfunction or elevated liver enzymes of unknown cause should avoid this medication. Patients with muscle disorders or problems with muscle should not take this medication. Those taking certain immunosuppressants, and patients with severe renal impairment should also avoid this medication. Pregnant or breastfeeding women, and fertile women not using proper contraception should not take this medication. Patients at risk of muscle disorders should avoid high doses and should be cautious if they have renal impairment, hypothyroidism, or a history of genetic muscle diseases. Patients with genetic metabolic disorders such as lactose intolerance should also not take this medication. Patients who consume large amounts of alcohol or have a history of liver disease should undergo frequent liver function tests, and other conditions such as hypothyroidism should be treated first. If symptoms like muscle pain, weakness, or cramps occur, the doctor should be informed immediately, and blood tests may be required to check for muscle damage. Patients at risk of severe muscle damage should check their muscle enzyme levels before starting treatment and should not take the medication if levels are elevated. This medication may rarely cause severe skin reactions or liver dysfunction; therefore, if symptoms such as skin rash or jaundice appear, use should be stopped immediately. This medication may interact with other drugs; thus, any medications being taken should be reported to a doctor or pharmacist. In the case of overdose, there is no specific antidote, so treatment should be symptomatic and liver function and muscle enzyme tests are necessary. Caution is advised when driving or operating machinery as dizziness may occur. During pregnancy, this medication may be harmful to the fetus, so it should not be taken if planning to become pregnant or if already pregnant. It is important to regularly check blood tests and liver function tests during the use of this medication for any abnormalities.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, chest tightness, difficulty breathing, respiratory distress, asthma attacks, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ophthalmoplegia, immune-mediated necrotizing myopathy, rhabdomyolysis, acute kidney injury, oliguria, severe edema, severe allergic reactions, severe skin abnormal reactions, respiratory issues

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
Show 21 more
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • abnormal liver function tests

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is safe to keep it at room temperature between 1 degree and 30 degrees Celsius. Therefore, avoid excessively cold or hot places, and it is advisable to keep it in a cool place away from direct sunlight.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/PTP [(15 tablets/PTP x 2 pieces)]

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.