Medication info
Atorcen Tablets 10 mg (Atorvastatin Calcium Hydrate)

Atorcen Tablets 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201206556 · Approved 2012.08.23 · Insurance code 698502310

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of dyslipidemia
Who takes it
Adults · Children
Adult dose
For dyslipidemia, the recommended initial dose is 10 mg of atorvastatin once daily; for patients requiring greater reduction of LDL cholesterol levels, treatment may start with 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2 to 4 weeks to adjust the dose.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, while the recommended maximum dose is 20 mg once daily. Dose adjustments should be made at intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, and improvement of dyslipidemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • increased serum triglycerides
  • familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular disease. Specifically, it lowers the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary heart disease and patients with type 2 diabetes. Additionally, it is effective in reducing the risk of myocardial infarction, stroke, revascularization, hospitalization for congestive heart failure, and angina in adults with coronary heart disease. This drug is used to lower cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol. It can also be used as an adjunct therapy in specific types of dyslipidemia that do not respond adequately to diet. Furthermore, it helps regulate total cholesterol and LDL cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. Therefore, this medication plays an important role in the prevention of cardiovascular disease and the improvement of dyslipidemia.

How to take

Adult dose

For dyslipidemia, the recommended initial dose is 10 mg of atorvastatin once daily; for patients requiring greater reduction of LDL cholesterol levels, treatment may start with 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2 to 4 weeks to adjust the dose.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, while the recommended maximum dose is 20 mg once daily. Dose adjustments should be made at intervals of at least 4 weeks.

Precautions

This medication may cause muscle-related adverse effects, so if you experience muscle pain or weakness that worsens, you should stop treatment immediately and consult your doctor. Especially, if there is a significant increase in muscle enzyme levels, treatment should be discontinued. Patients with impaired kidney function or those who have severe infections, surgery, or trauma need to be cautious. This medication should not be used in patients with poor liver function, active liver disease, pregnant women or women who may become pregnant, and children under 10 years of age. Patients with a history of alcohol abuse or liver disease, elderly patients, and those with hypothyroidism should consult with a physician before use and exercise caution. This medication can interact with various drugs, so you must inform your doctor if you are taking other medications, especially when combined with certain antibiotics, antifungals, or HIV treatments. This medication should not be used during pregnancy, and breastfeeding women should also avoid it. Regular liver function tests are needed as this medication may cause liver dysfunction or hepatitis symptoms, and you should inform your doctor immediately if any adverse effects occur during treatment. If symptoms like muscle pain, fatigue, or fever arise, consult with a healthcare provider immediately, and appropriate contraception should be used during treatment. There is no specific antidote in case of overdose, so treatment should be symptomatic, and it should be stored out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweats, paleness, anaphylaxis, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe cutaneous adverse reactions, asthma attacks, respiratory disturbances accompanied by cough and fever, liver abnormalities (jaundice), yellowing of the skin or eyes, severe lethargy, sudden

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • anorexia
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste changes
  • amnesia
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1°C and 30°C to safely preserve its efficacy.

Appearance and packaging

Appearance

White 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

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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.