Medication info
Rostojeng 10 mg (Rosuvastatin Calcium)

Rostojeng 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201405051 · Approved 2014.10.30 · Insurance code 657805470

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer the initial dose of 5 mg once daily at any time of the day regardless of meals. If a greater reduction in LDL cholesterol is needed, the maintenance dose may be adjusted to 10 mg once daily. The maintenance dose can be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg per day.
Child dose
The usual dosage range for pediatric patients aged 10 to 17 years is once daily between 5 mg and 20 mg. The dose should be adjusted according to individual treatment goals with intervals of 4 weeks or more.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia
  • 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 in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise are inadequate. It also helps reduce blood cholesterol levels in patients with homozygous familial hypercholesterolemia when used in conjunction with other lipid-lowering therapies. It lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia to delay the progression of atherosclerosis and can also be used as an adjunct in children with heterozygous familial hypercholesterolemia who meet certain criteria. It is also used in conjunction with diet in patients with primary dysbetalipoproteinemia. Additionally, it contributes to the reduction of the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years and women over 60 years who have high cardiovascular risk factors. It is thus widely used in the prevention and treatment of cardiovascular diseases.

How to take

Adult dose

Administer the initial dose of 5 mg once daily at any time of the day regardless of meals. If a greater reduction in LDL cholesterol is needed, the maintenance dose may be adjusted to 10 mg once daily. The maintenance dose can be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase to 20 mg per day.

Child dose

The usual dosage range for pediatric patients aged 10 to 17 years is once daily between 5 mg and 20 mg. The dose should be adjusted according to individual treatment goals with intervals of 4 weeks or more.

Precautions

This medicine should not be administered to certain patients. For instance, patients who are allergic to this medication, those with severely impaired liver function, patients with muscle diseases, those with certain renal impairments, as well as pregnant or nursing women should not use this drug. While using this medication, liver function and muscle health should be monitored periodically. Patients who consume a lot of alcohol or have a history of liver disease should be especially cautious and should inform their doctor immediately if they experience symptoms like muscle pain or weakness. This medication can affect muscles, potentially causing muscle pain or, rarely, muscle destruction, so use should be discontinued if severe muscle-related symptoms occur. Furthermore, this medication can interact with certain drugs; therefore, if taking other medications, patients must inform their healthcare provider. Special caution is needed when used with certain antibiotics, antifungals, immunosuppressants, etc. Women of childbearing potential should confirm that they are not pregnant and use appropriate contraception before taking this medicine. During pregnancy, this medication should not be taken, and it should be discontinued if pregnancy occurs. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored. Caution is also required when driving or operating machinery, as dizziness may occur. Finally, this medication contains lactose, so patients with lactose intolerance should be careful when taking it.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscular weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, chest tightness, difficulty breathing, severe headache, confusion, visual disturbances, paralysis, severe swelling accompanied by elevated blood pressure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • fatigue
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  • numbness
  • paraesthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • ocular muscle weakness
  • lupus-like syndrome
  • arthralgia
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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 closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius to effectively preserve the drug's efficacy and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

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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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.