Medication info
Rochta Tablet 20 mg (Rosuvastatin Calcium)

Rochta Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
Pink, round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201000999 · Approved 2010.01.28

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) 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 starting dose is 5 mg once daily, and the maintenance dose is generally 10 mg once daily, which most patients are adjusted to. The maintenance dose should be adjusted according to LDL-cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 mg daily if necessary.
Children's dosage
The typical dosage range is 5 mg to 20 mg once daily. The administered dose should be individually adjusted according to the recommended therapeutic target for each patient. Dosing should be adjusted every 4 weeks or more if necessary.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

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

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

This medication is primarily used as an adjunct when diet and exercise are not sufficient to control primary hypercholesterolemia and mixed dyslipidemia. It helps to lower cholesterol levels in patients with familial hypercholesterolemia, both homozygous and heterozygous, and delays the progression of atherosclerosis. It is also employed as an adjunct in diet therapy when hypercholesterolemia persists in adolescents over 10 years old, and it applies to patients with primary dysbetalipoproteinemia. Moreover, this drug assists in reducing the risks of stroke, myocardial infarction, and arterial revascularization in adults at high risk for cardiovascular disease. Overall, it is effective in lowering cholesterol levels and decreasing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day, regardless of meals. The starting dose is 5 mg once daily, and the maintenance dose is generally 10 mg once daily, which most patients are adjusted to. The maintenance dose should be adjusted according to LDL-cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 mg daily if necessary.

Children's dosage

The typical dosage range is 5 mg to 20 mg once daily. The administered dose should be individually adjusted according to the recommended therapeutic target for each patient. Dosing should be adjusted every 4 weeks or more if necessary.

Precautions

This medication should not be administered to certain patients. For example, it should not be used by patients who are allergic to this medication, those with severely impaired liver function, patients with muscle diseases, those taking certain immunosuppressants, patients with severely impaired kidney function, women who are pregnant or breastfeeding, and patients with genetic issues such as lactose intolerance. Additionally, this medication should be used with caution in patients who consume excessive alcohol or have a history of liver disease, and regular liver function tests should be conducted. If symptoms of muscle pain or weakness occur, immediate consultation with medical personnel is necessary, and if needed, blood tests should be performed to check for muscle damage. During the use of this medication, if symptoms such as severe muscle pain, weakness, or fever occur, it is important to stop taking the medication immediately and consult a physician. Furthermore, concurrent use with certain medications may increase the blood concentration of this drug and elevate the risk of side effects, so it is crucial to inform healthcare providers about other medications being taken. Women who are pregnant or may become pregnant should use appropriate contraception before taking this medication and should discontinue use immediately if pregnancy occurs. It is also safest for breastfeeding women to avoid using this medication. In the case of overdose, there is no specific antidote, and appropriate treatment should be provided based on symptoms while monitoring liver function and muscle enzyme levels. Lastly, this medication can cause dizziness, requiring caution while driving or operating machinery. It is important to consult medical personnel immediately if adverse reactions occur during use.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, severe muscle weakness, ocular myasthenia, jaundice, hepatitis, acute renal failure, oliguria, rhabdomyolysis, severe edema, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe neurologic symptoms (e.g., headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis), increase in serum creatinine.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, hematuria, diarrhea, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, body pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, peripheral neuropathy, thrombocytopenia, hepatitis, increased transaminases, eosinophilia, and drug reaction with eosinophilia and systemic symptoms syndrome, lupus-like syndrome, immune-mediated necrotizing myopathy.

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. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. This will help maintain the efficacy of the drug.

Appearance and packaging

Appearance

Pink, round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)

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.

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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.