Medication info
Robat 20mg (Rosuvastatin Calcium)

Robat 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201904552 · Approved 2019.07.04 · Insurance code 658106560

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular risks
Who uses it
Adults · Children
Adult dosage
Administer 5 milligrams as the initial dose once daily at any time, regardless of meals. If necessary, adjust to a maintenance dose of 10 milligrams once daily, based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or more. The maximum dose is 20 milligrams once daily.
Children's dosage
For pediatric patients aged 10 to 17 years, the dosage is 5 milligrams to 20 milligrams once daily. The dose should be adjusted every 4 weeks or more, according to the treatment goals of individual patients.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular risks

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

This medication is used as an adjunct when diet and exercise alone do not control primary hypercholesterolemia and mixed dyslipidemia patients. It is especially applicable to patients with familial hypercholesterolemia and lowers total cholesterol and LDL cholesterol levels to the target range, thereby delaying the progression of atherosclerosis. It is also suitable for specific pediatric patients aged 10 to 17 years and serves as an adjunct to diet for patients with mixed dyslipidemia. Additionally, while there is no clinical evidence of coronary heart disease, it may help reduce the risk of stroke, myocardial infarction, and vascular reconstruction in patients of certain ages and risk factors. In summary, this medication is used to reduce the risk of hypercholesterolemia and related cardiovascular diseases.

Dosage and Administration

Adult dosage

Administer 5 milligrams as the initial dose once daily at any time, regardless of meals. If necessary, adjust to a maintenance dose of 10 milligrams once daily, based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or more. The maximum dose is 20 milligrams once daily.

Children's dosage

For pediatric patients aged 10 to 17 years, the dosage is 5 milligrams to 20 milligrams once daily. The dose should be adjusted every 4 weeks or more, according to the treatment goals of individual patients.

Precautions

This medication should not be administered to specific patients. For example, individuals allergic to any component of this drug, those with severe liver impairment, or those with muscle diseases should not use it. Moreover, patients with severely impaired kidney function or women who are pregnant or breastfeeding, as well as women of childbearing potential, should consult their doctor before taking this medication. This medication may cause muscle-related side effects; therefore, immediate medical attention should be sought if symptoms such as muscle pain, weakness, or cramps occur. Special caution is needed for those with reduced kidney function, hypothyroidism, alcohol abuse, and elderly patients. Regular liver function tests should be conducted, and if any abnormalities arise, medication should be discontinued immediately. During the course of this medication, there is a potential for drug interactions; therefore, it is essential to inform the healthcare provider of all medications being taken. The blood concentration of this drug may increase when taken with certain medicines, raising the risk of side effects. Women who are pregnant or plan to become pregnant must use effective contraception, and if pregnancy is confirmed, they should stop taking this medication. In the case of overdose, there are no specific antidotes, and treatment based on symptoms along with liver function and muscle enzyme tests are required. This medication is not known to have major impacts on driving or operating machinery, but caution is advised due to possible dizziness. Lastly, this medication contains lactose, so individuals with lactose intolerance should avoid taking it.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, chest tightness, difficulty breathing, severe rash with fever, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, thrombocytopenia, severe edema accompanied by elevated blood pressure, acute renal failure, oliguria, severe muscle weakness, ocular muscle weakness, immune-mediated myopathy

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • arthralgia

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

Storage

This medication may be sensitive to air and light, so it should be stored in a tightly closed container. It is best to maintain room temperature between 1 degree and 30 degrees Celsius for storage. Proper storage will help ensure the safety and effectiveness of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

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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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.