Medication info

Entirobatin Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/PTP [15 tablets/PTP x 2 packs], 30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201907227 · Approved 2019.10.15

This product's status changed to Expired on 2024.10.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of LDL-cholesterol in hypercholesterolemia and familial hypercholesterolemia and treatment of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be administered at any time of day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is typically 10 mg once daily for most patients. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily increase to 20 mg.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual treatment goals of each patient.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Reduction of LDL-cholesterol in hypercholesterolemia and familial hypercholesterolemia and treatment of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • 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 adjunct when dietary changes and exercise alone are insufficient to control conditions associated with hypercholesterolemia. It is particularly effective in patients with primary hypercholesterolemia, mixed hyperlipidemia, and familial hypercholesterolemia, lowering total cholesterol and LDL-cholesterol levels to delay the progression of atherosclerosis. Additionally, it is also used as an adjunct in dietary management for children with heterozygous familial hypercholesterolemia to improve cholesterol and related markers. It also aids in primary dysbetalipoproteinemia and contributes to reducing the risk of stroke, myocardial infarction, and vascular reintervention in middle-aged or older patients with high sensitivity C-reactive protein levels and cardiovascular risk factors. In summary, this medication is effectively used to reduce cardiovascular risks associated with various forms of hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication can be administered at any time of day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is typically 10 mg once daily for most patients. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily increase to 20 mg.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual treatment goals of each patient.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to any ingredient in this medication, patients with severely impaired liver function, patients with muscle diseases, and patients with severe renal impairment should not take this medication. Furthermore, women who are pregnant or breastfeeding, and women of childbearing potential should avoid using this medication without proper contraception. This medication can pose a risk of muscle issues, so patients with a history of muscle disease or a family history of such conditions, as well as those with hypothyroidism or alcoholism, should be particularly cautious. This medication contains lactose, and should not be administered to patients with genetic issues like lactose intolerance. Patients who consume excessive alcohol or have liver disease should undergo liver function tests before taking this medication and should continue regular checks during treatment. If symptoms of muscle pain or weakness occur, patients should inform their physician immediately, and stop using the medication if necessary. High doses of this medication may affect kidney function, so kidney function tests may also be needed. Asian patients may exhibit higher bodily concentrations of this medication, indicating a need for dosage adjustment. This medication can interact with other drugs, so patients taking other medications should consult their physician or pharmacist. It should not be used during pregnancy or breastfeeding, and women planning to become pregnant must ensure contraception. In case of overdose, there is no specific antidote, so treatment should be symptomatic and liver function and muscle enzyme levels should be monitored. Dizziness may occur when taking this medication, so caution is needed while driving or operating machinery. This medication can rarely cause serious skin reactions or liver damage, so if skin rashes or jaundice symptoms occur, the medication should be stopped immediately and medical advice sought. Overall, this medication requires regular monitoring of liver and muscle health and should be taken carefully according to a physician's instructions.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, memory loss, peripheral neuropathy, severe muscle weakness, respiratory distress, ocular muscle weakness, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fatigue
  • numbness
  • sensory changes
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hives.

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 stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius. This helps maintain the medication's efficacy and safety for an extended period.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/PTP [15 tablets/PTP x 2 packs], 30 tablets/bottle, 100 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.