Medication info
Nustatin AL Tablet 20 mg (Rosuvastatin Calcium)

Nustatin AL Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink round film-coated tablet
Packaging
Domestic use - 30 tablets/box [10 tablets/PTP*3], Domestic use - 100 tablets/bottle, Export use - 28 tablets/box [14 tablets/PTP*2]
Approval status
Active

MFDS item code 201401266 · Approved 2014.03.19 · Insurance code 647803960

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Take once daily at any time regardless of meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. Most patients maintain at 10 mg once daily, and adjustments should be made based on LDL-cholesterol levels and patient response at intervals of more than 4 weeks. The maximum dose can be increased to 20 mg once daily.
Child dose
Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should be dosed at 5 mg to 20 mg once daily. The dose should be adjusted according to the individual treatment goals over a period of more than 4 weeks.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dyslipidemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used as an adjunct in cases where hypercholesterolemia and hyperlipidemia are difficult to manage through diet or exercise. It is effective for various types of hyperlipidemia, including primary hypercholesterolemia, familial hypercholesterolemia, and dysbetalipoproteinemia. Specifically, it lowers levels of LDL-cholesterol and total cholesterol, delaying the progression of cardiovascular disease, and is also helpful for pediatric patients with elevated LDL-cholesterol levels. Additionally, this medication improves cardiovascular health by reducing the risk of stroke, myocardial infarction, and vascular revascularization in patients at high risk for coronary artery disease. Overall, it helps to control cholesterol levels and reduce the risk of cardiovascular disease, thus improving the health status of patients.

How to take

Adult dose

Take once daily at any time regardless of meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. Most patients maintain at 10 mg once daily, and adjustments should be made based on LDL-cholesterol levels and patient response at intervals of more than 4 weeks. The maximum dose can be increased to 20 mg once daily.

Child dose

Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should be dosed at 5 mg to 20 mg once daily. The dose should be adjusted according to the individual treatment goals over a period of more than 4 weeks.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any ingredients of this medication, have liver dysfunction, have muscle diseases, severely impaired kidney function, or are pregnant or breastfeeding should not take this medication. Additionally, the high-dose use of this medication is contraindicated in patients at risk for myopathy or rhabdomyolysis. Risk factors include moderate to severe kidney impairment, hypothyroidism, a family history of genetic muscular disorders, and alcoholism. This medication contains lactose, so patients with lactose intolerance should also avoid using it. Before administration, liver function tests and muscle-related tests should be conducted, and regular monitoring should continue during treatment. If symptoms such as muscle pain, weakness, fatigue, or fever occur, notify healthcare personnel immediately. This medication may interact with other drugs, so inform healthcare personnel of any other medications currently being taken, especially in combination with fibrates, cyclosporine, and certain antiviral agents. Women of childbearing potential should use appropriate contraceptive methods and avoid taking this medication while pregnant or breastfeeding. In case of overdose, there is no specific antidote, and treatment should be managed based on symptoms along with liver and muscle function tests. Caution is advised due to the possibility of dizziness when driving or operating machinery. Finally, if severe rash or allergic reactions occur while taking this medication, discontinue immediately and consult healthcare personnel.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including hives and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe myopathy, ocular myopathy, rhabdomyolysis, liver failure, jaundice, acute renal failure, oliguria, difficulty breathing, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe swelling, elevated blood pressure, severe allergic reactions, severe bleeding

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • cough
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  • diarrhea
  • thrombocytopenia
  • jaundice
  • hepatitis
  • increased transaminases
  • lichenoid drug rash
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia

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

Storage

This medication should be stored in a closed container to prevent air and moisture from entering. It should be stored at room temperature, between 1 and 30 degrees Celsius, and not in excessively hot or cold conditions.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Domestic use - 30 tablets/box [10 tablets/PTP*3], Domestic use - 100 tablets/bottle, Export use - 28 tablets/box [14 tablets/PTP*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.

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.