Medication info
Allstatin 5 mg (Rosuvastatin Calcium)

Allstatin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
명인제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201402893 · Approved 2014.06.30 · Insurance code 651904020

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily as the initial dose, at any time of day regardless of meals. If necessary, the maintenance dose may be adjusted to up to 10 mg once daily at intervals of 4 weeks or longer, and may be increased to a maximum of 20 mg once daily.
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the typical dose is between 5 mg and 20 mg once daily, with treatment tailored to individual patients' needs at intervals of 4 weeks or longer.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Treatment of 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
  • elevated 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 when dietary management and exercise are insufficient to control primary hypercholesterolemia and mixed dyslipidemia patients. It is also used with diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels, thus delaying the progression of atherosclerosis. It serves as an adjunct therapy in children aged 10 to 17 years with heterozygous familial hypercholesterolemia who meet certain criteria. Additionally, it is used to support dietary management in patients with primary dysbetalipoproteinemia. Furthermore, it aids in reducing the risk of stroke, myocardial infarction, and revascularization in patients with certain age and cardiovascular risk factors. Thus, this drug is effectively used for various dyslipidemias and reducing cardiovascular disease risks.

How to take

Adult dose

Administer 5 mg once daily as the initial dose, at any time of day regardless of meals. If necessary, the maintenance dose may be adjusted to up to 10 mg once daily at intervals of 4 weeks or longer, and may be increased to a maximum of 20 mg once daily.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the typical dose is between 5 mg and 20 mg once daily, with treatment tailored to individual patients' needs at intervals of 4 weeks or longer.

Precautions

This medication should not be used in individuals with certain allergic reactions or severe liver dysfunction. Those with muscle issues or taking certain medications, and individuals with severe renal impairment should also avoid this medication. Pregnant or breastfeeding women, as well as women who may become pregnant, must consult a physician before taking this medication and use appropriate contraceptive methods. Since this medication may cause muscle-related side effects, patients should immediately inform healthcare providers if symptoms such as myalgia or muscle weakness occur. Regular liver function tests and blood glucose monitoring are necessary as side effects may include liver dysfunction or elevated blood sugar. Individuals who consume alcohol excessively or have a history of liver disease should exercise caution when taking this medication and undergo frequent liver enzyme tests. This medication can increase drug concentration and risk of side effects when taken with certain other medications, so patients must inform their healthcare provider about any concurrent medications. Special precautions are necessary for children and adolescents, and their growth and development should be monitored regularly. Patients should be cautious when driving or operating machinery as dizziness may occur. In cases of overdose, as there are no specific antidotes, the patient should immediately visit a hospital for appropriate treatment. If severe rashes or allergic reactions occur during the course of this medication, the use should be immediately discontinued, and healthcare providers should be consulted.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including hives, angioedema, tightness in the chest, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome (DRESS), jaundice, hepatitis, acute renal failure, oliguria, severe swelling, severe allergic reactions, severe skin reactions, respiratory problems, liver impairment (jaundice), severe neurological symptoms, severe swelling or urination abnormalities, myopathy, rhabdomyolysis, multiple

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • asthenia
  • thrombocytopenia
  • cough
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  • diarrhea
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • joint pain
  • memory loss
  • sleep disorders
  • depression
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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. It is recommended to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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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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.