Medication info
Allstatin Tablet 20 mg (Rosuvastatin Calcium)

Allstatin Tablet 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›20.8mg / 1 tablet
Manufacturer / importer
명인제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201405613 · Approved 2014.11.28 · Insurance code 651904130

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if greater LDL cholesterol reduction is required, the maintenance dose can be adjusted accordingly. Most patients are managed at a maintenance dose of 10 mg once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dose range is 5 mg to 20 mg once daily. The dosage should be adjusted based on individual treatment goals.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and dyslipidemia (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 level
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used as an adjunct when dietary control and exercise are insufficient to manage cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia, lowering the total cholesterol and LDL cholesterol levels, thus delaying the progression of atherosclerosis. Additionally, it serves as an adjunct to dietary therapy in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia if certain criteria are met. It is also used adjunctively in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged adults and older individuals at high risk for cardiovascular disease. Thus, this drug is effectively used for various types of dyslipidemia and reduction of cardiovascular disease risk.

How to take

Adult dose

The initial dose is 5 mg once daily, and if greater LDL cholesterol reduction is required, the maintenance dose can be adjusted accordingly. Most patients are managed at a maintenance dose of 10 mg once daily. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dose range is 5 mg to 20 mg once daily. The dosage should be adjusted based on individual treatment goals.

Precautions

This medicine should not be used in certain patients. For example, patients who are allergic to this medicine or have severely impaired liver function, those with muscle disorders, severe renal impairment, pregnant or breastfeeding women should not take this medicine. Additionally, high-dose administration is prohibited in patients at risk for myopathy. This medicine contains lactose, so patients with lactose intolerance should also avoid this medication. It is important to regularly monitor liver function and muscle status during use of this medicine. Particularly, patients who consume large amounts of alcohol or have a history of liver disease should be more cautious. If muscle pain or weakness occurs, immediate medical attention should be sought, and the drug should be discontinued if necessary. This medicine may interact with other drugs, so patients taking other medications should inform their doctor or pharmacist. In particular, concomitant use with certain antiviral agents, immunosuppressants, antifungals, and antibiotics may increase the risk of muscle damage. Women who are pregnant or may become pregnant should use appropriate contraception, and if pregnancy is confirmed, they must discontinue the medication immediately. It is also recommended that breastfeeding women avoid this medication. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. This medication is known not to significantly impact driving or operating machinery; however, caution is advised as dizziness and similar symptoms may occur. Regular health check-ups and tests as directed by a physician during the use of this medication are important for safe treatment.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, severe muscle weakness, respiratory distress, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms associated with drug reaction (DRESS), immune-mediated necrotizing myopathy, edema, acute renal failure, oliguria, interstitial lung disease, fatal and non-fatal hepatic failure, severe skin reactions, severe allergic reactions.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • hives
  • myalgia
  • weakness
Show 24 more
  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • increased blood creatinine
  • sleep disturbances
  • depression
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medicine should be stored in a tightly sealed container to protect it from air and moisture. The drug should also be stored at room temperature, between 1 to 30 degrees Celsius, avoiding extremes of temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.