Medication info
Atovastatin 10 mg Tablets (Atorvastatin Calcium Hydrate)

Atovastatin 10 mg Tablets (Atorvastatin Calcium Hydrate)

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

MFDS item code 201309774 · Approved 2013.10.16 · Insurance code 679801360

Summary

Main use
Reduction of risk for myocardial infarction and stroke, improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater reductions in LDL cholesterol are required, treatment may start at 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. Both the initial and maintenance doses should be individualized based on treatment goals and responses, with lipid levels analyzed and adjusted 2 to 4 weeks after starting treatment. For homozygous familial hypercholesterolemia, the dosage is 10 to 80 mg once daily, used in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible. Pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia have a recommended initial dose of 10 mg once daily, with a recommended maximum dose of 20 mg (there is no clinical data for doses higher than 20 mg in this population). The dosage should be adjusted appropriately based on individual treatment goals, with adjustments made at intervals of 4 weeks or more. Patients with renal impairment: Renal conditions do not affect the plasma concentration of atorvastatin or the LDL cholesterol-lowering effect, so there is no need to adjust the dose. Elderly patients: The efficacy and safety in patients over 70 years of age are similar to those in the general adult population.
Child dose
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a recommended maximum dose of 20 mg once daily. The dosage should be adjusted appropriately according to treatment goals.

Ingredients

Manufacturer
(주)티디에스팜

Efficacy & effects

Reduction of risk for myocardial infarction and stroke, improvement of hyperlipidemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular intervention
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
  • angina
View approved original text

This medication helps to reduce the risks of cardiovascular diseases. It decreases the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary heart disease and in patients with type 2 diabetes. It is also used to lower the risk of non-fatal myocardial infarction, stroke, and angina in patients who already have heart disease. It is effective in treating hyperlipidemia by controlling cholesterol and triglyceride levels and increasing HDL cholesterol levels. It is used as an adjunct therapy for various types of dyslipidemia that are not controlled by diet. It also aids in treating pediatric patients with familial hypercholesterolemia under certain conditions. This medication is used to reduce the risk of cardiovascular diseases and improve blood lipid levels.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater reductions in LDL cholesterol are required, treatment may start at 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. Both the initial and maintenance doses should be individualized based on treatment goals and responses, with lipid levels analyzed and adjusted 2 to 4 weeks after starting treatment. For homozygous familial hypercholesterolemia, the dosage is 10 to 80 mg once daily, used in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible. Pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia have a recommended initial dose of 10 mg once daily, with a recommended maximum dose of 20 mg (there is no clinical data for doses higher than 20 mg in this population). The dosage should be adjusted appropriately based on individual treatment goals, with adjustments made at intervals of 4 weeks or more. Patients with renal impairment: Renal conditions do not affect the plasma concentration of atorvastatin or the LDL cholesterol-lowering effect, so there is no need to adjust the dose. Elderly patients: The efficacy and safety in patients over 70 years of age are similar to those in the general adult population.

Child dose

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a recommended maximum dose of 20 mg once daily. The dosage should be adjusted appropriately according to treatment goals.

Precautions

This medication may pose a risk of muscle problems, so if severe muscle pain or weakness occurs, stop taking it immediately and consult a doctor. This medication should not be used by individuals with specific liver diseases, those with muscle disorders, pregnant women, or women who may become pregnant, and children under the age of 10. Individuals with liver function issues, those who consume alcohol heavily, elderly patients, and those with impaired kidney function need to exercise caution when using this medication, and regular tests should be performed to monitor liver and muscle status. If symptoms of liver dysfunction or hepatitis (nausea, vomiting, fatigue, etc.) occur while taking this medication, inform a doctor immediately. This medication has many interactions with other drugs, so inform your doctor or pharmacist of any medications you are currently taking, especially when used with certain antibiotics, antifungals, antivirals, and some cardiovascular drugs. If symptoms such as muscle pain, cramps, weakness, or other muscle-related issues occur during treatment, inform your doctor immediately, and conduct blood tests to check for muscle damage if necessary. Women of childbearing age should use appropriate contraception while on this medication, and if pregnancy is confirmed, they should stop taking it immediately. Breastfeeding women should not take this medication as it can pass into breast milk and cause side effects in the baby. The safety and efficacy of this medication in children and adolescents over the long term have not been sufficiently studied, so caution is advised in its use. There are no specific antidotes for overdose, so treatment should be administered according to symptoms, and regular checks on liver function and muscle status should be performed. This medication should be stored out of reach of children and kept in its original container, as transferring it to another container may pose risks of misuse or deterioration in quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever-related respiratory issues, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision disturbances, paralysis, urination issues.

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorder
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to keep the medication effective and safe over time.

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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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.