Medication info
Nerostin Tablet (Rosuvastatin Calcium)

Nerostin Tablet (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
에스에스팜(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets/PTP packaging, 30 tablets/PTP packaging
Approval status
Active

MFDS item code 201603999 · Approved 2016.06.27 · Insurance code 663300850

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Regardless of meals, administer 5 milligrams once daily as the initial dose. If a greater reduction in LDL cholesterol levels is needed, adjust to a maintenance dose of 10 milligrams once daily. Dosing adjustments should be made at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17 years), administer a daily dose of 5 to 20 milligrams. The dosage should be adjusted according to individual treatment goals.

Ingredients

Manufacturer
에스에스팜(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial 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 to diet for patients with primary hypercholesterolemia and mixed hyperlipidemia who are difficult to control with diet and exercise. It can also be used in conjunction with other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also used as a dietary supplement in some pediatric patients with high LDL cholesterol levels and cardiovascular disease risk factors. It also applies to the treatment of primary dysbetalipoproteinemia. Lastly, it is useful for middle-aged patients with high sensitivity C-reactive protein levels and additional cardiovascular disease risk factors in reducing the risks of stroke, myocardial infarction, and arterial revascularization procedures. This medication is effectively used in reducing hyperlipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

Regardless of meals, administer 5 milligrams once daily as the initial dose. If a greater reduction in LDL cholesterol levels is needed, adjust to a maintenance dose of 10 milligrams once daily. Dosing adjustments should be made at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17 years), administer a daily dose of 5 to 20 milligrams. The dosage should be adjusted according to individual treatment goals.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to patients who are allergic to any component of this drug, patients with severely impaired liver function, patients with muscle diseases, and patients with severe kidney dysfunction. It should also not be given to pregnant or nursing women, or to women of childbearing age who do not use appropriate contraception. For women of childbearing age, it should only be used if the pregnancy possibility is low and after adequately explaining the risk to the fetus. This drug is contraindicated in patients with a high risk of muscle-related side effects. For example, patients with moderate to severe renal impairment, hypothyroidism, a family history of muscle diseases, alcohol dependence, and those receiving certain drug combinations should avoid high doses. It contains lactose, so patients with lactose intolerance or related genetic disorders should not use it. This drug can affect liver function, so patients with a history of excessive drinking or liver disease must undergo regular liver function tests before and during administration. If symptoms such as muscle pain, weakness, or cramps occur, notify healthcare professionals immediately, and if needed, conduct blood tests to check for muscle damage. If muscle enzyme levels significantly increase, the use of the drug should be discontinued. This drug can rarely cause serious skin reactions, liver damage, kidney issues, and neurological abnormalities. If such symptoms occur, discontinue the drug immediately and consult a doctor. There may be interactions when combined with other medications, so it is essential to inform about any medications currently being taken, especially when taking specific antivirals, immunosuppressants, antibiotics, or fibric acid derivatives. Women who are pregnant or planning to become pregnant should not take this drug, and nursing mothers should avoid its use. In the case of overdose, there is no specific antidote, and treatment based on symptoms and liver and muscle function tests is necessary. Dizziness may occur when driving or operating machinery, so caution is advised. Finally, this drug may present higher blood concentration levels in Asians, requiring dose adjustments. Therefore, it is crucial to take it exactly as directed by a physician and to consult immediately if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, jaundice, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, significant decrease in urine output, severe swelling of the entire body with accompanying high blood pressure, severe allergic reactions, severe skin reactions, respiratory problems, liver issues (jaundice), severe neurological symptoms, severe edema or urination difficulties, rhabdomyolysis, severe muscle weakness

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • hives
  • myalgia
  • weakness
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  • hematuria
  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory disturbances
  • joint pain
  • amnesia
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lupus-like syndrome
  • muscle rupture
  • thrombocytopenia
  • depression

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

Storage

Store this drug in a closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/PTP packaging, 30 tablets/PTP packaging

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.