Medication info

Alfaroastatin Calcium Tablet 5 mg

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
알파제약(주)
Appearance
Yellow round film-coated tablets
Packaging
28 tablets (14 tablets/PTPX2) - 14 tablets/PTP, 28 tablets (14 tablets/PTPX2) - 2 PTP/box
Approval status
Expired

MFDS item code 201903274 · Approved 2019.05.21

This product's status changed to Expired on 2024.05.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for high cholesterol (primary, familial) and to reduce the risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
For adults with primary hypercholesterolemia, this medication can be taken at any time of day regardless of meals. The initial dose is 5 milligrams once daily; if a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted up to 10 milligrams once daily. The maintenance dose should be adjusted depending on the treatment goal and patient response, with a maximum increase up to 20 milligrams once daily at intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), a dose of 5 milligrams to 20 milligrams is administered once daily, and the dosage should be adjusted individually based on treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
알파제약(주)

Efficacy & effects

Treatment for high cholesterol (primary, familial) and to reduce the risk of cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • 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 to treat various forms of hypercholesterolemia and dyslipidemia. It is mainly used as an adjunct to dietary changes and exercise in cases of difficult-to-control primary hypercholesterolemia or mixed hyperlipidemia. In severe cases, it can be used in patients with homozygous familial hypercholesterolemia alongside diet or other treatments to lower cholesterol levels. Additionally, it is administered as an adjunct to diet in children aged 10 to 17 years with familial hypercholesterolemia. It lowers total cholesterol and LDL cholesterol in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis, and is also beneficial for patients with primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in high-risk patients with cardiovascular disease risk factors. Therefore, this medication is used to improve hypercholesterolemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

For adults with primary hypercholesterolemia, this medication can be taken at any time of day regardless of meals. The initial dose is 5 milligrams once daily; if a greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted up to 10 milligrams once daily. The maintenance dose should be adjusted depending on the treatment goal and patient response, with a maximum increase up to 20 milligrams once daily at intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), a dose of 5 milligrams to 20 milligrams is administered once daily, and the dosage should be adjusted individually based on treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients with allergies to this drug, severe liver dysfunction, myopathy, severe kidney dysfunction, or women who are pregnant or breastfeeding. This drug can affect the liver and muscles; therefore, patients with a history of liver disease or those who consume excessive alcohol should undergo liver function tests before administration and be cautious. Additionally, if symptoms of muscle pain or weakness occur, they should immediately consult a doctor. This medication can interact with other drugs, so patients must inform their healthcare provider about any other medications they are taking, especially with fibrate-class medications, which require caution when used in combination. Women who could become pregnant should use appropriate contraception while taking this medication and avoid its use during pregnancy or breastfeeding. Routine liver function and muscle-related tests are recommended while taking this drug, and special caution is warranted for elderly patients or those with decreased kidney function. In the case of overdose, there is no specific antidote, so patients should seek medical help immediately for appropriate treatment and monitoring. Caution is needed while driving or operating machinery, as dizziness may occur. This medication contains lactose, so it is advised that patients with lactose intolerance avoid taking it. Finally, this medication may rarely cause serious skin reactions, liver damage, or neurological abnormalities, and any unusual symptoms should be reported to healthcare staff immediately.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including urticaria and angioedema
  • Stevens-Johnson syndrome
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Chest tightness
  • Difficulty breathing
  • Respiratory abnormalities accompanied by cough and fever
  • Jaundice
  • Hepatitis
  • Severe rash, blistering, skin peeling, pain in oral/ocular mucosa with high fever
  • Abrupt and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis
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  • Myopathy (including myositis)
  • Rhabdomyolysis

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • thrombocytopenia
Show 26 more
  • diarrhea
  • myasthenia
  • hematuria
  • swelling
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive disturbances
  • confusion
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • dysesthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • cough

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best to store it at room temperature, specifically between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTPX2) - 14 tablets/PTP, 28 tablets (14 tablets/PTPX2) - 2 PTP/box

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.