Medication info
Atorvastatin Calcium Hydrate 10 mg Tablet

Atorvastatin Calcium Hydrate 10 mg Tablet

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

MFDS item code 201307559 · Approved 2013.05.30 · Insurance code 650303020

Summary

Main use
Reduction of risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended starting dose for the treatment of hyperlipidemia is 10 mg once daily, and if greater LDL cholesterol reduction is needed, it may be started at 20 mg or 40 mg once daily. The dosing can be individualized within the range of 10 to 80 mg once daily based on treatment goals and response, and dosage adjustments should be made at intervals of 2 to 4 weeks. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 to 80 mg once daily.
Child dose
The recommended starting dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the maximum dose is 20 mg per day. Dose adjustments should be made based on treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It particularly decreases the risk of myocardial infarction and stroke, as well as the risk of vascular surgery and angina. Additionally, it is effective in lowering total cholesterol and LDL cholesterol while increasing good HDL cholesterol in patients with hyperlipidemia. This drug is also used for patients with familial hypercholesterolemia that are not controlled through diet and specific dyslipidemias. It assists in lowering cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia. Overall, this medication is used to improve cardiovascular health and reduce related risks.

How to take

Adult dose

The recommended starting dose for the treatment of hyperlipidemia is 10 mg once daily, and if greater LDL cholesterol reduction is needed, it may be started at 20 mg or 40 mg once daily. The dosing can be individualized within the range of 10 to 80 mg once daily based on treatment goals and response, and dosage adjustments should be made at intervals of 2 to 4 weeks. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 to 80 mg once daily.

Child dose

The recommended starting dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the maximum dose is 20 mg per day. Dose adjustments should be made based on treatment goals at intervals of 4 weeks or more.

Precautions

This medication may cause muscle-related abnormalities; therefore, if muscle pain or weakness worsens, or if creatine kinase levels significantly increase, treatment should be stopped immediately. This drug should not be used in women who are pregnant or have certain diseases, in children under the age of 10, or in patients with severely impaired liver function. Individuals with a history of alcohol abuse or liver disease, those with poor kidney function, and patients with hypothyroidism should use this medication cautiously, and muscle-related tests are recommended beforehand. While taking this medication, side effects such as muscle pain, fatigue, indigestion, headaches, and skin rashes may occur, and patients should consult with their doctor if these symptoms arise. As this medication can affect liver function, regular liver function tests should be performed, and if symptoms of hepatitis or jaundice appear, treatment should be stopped immediately. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use adequate contraception while taking it. This drug has numerous interactions with other medications; caution is needed when taking together with certain antibiotics, antifungal agents, antivirals, some lipid-lowering agents, and grapefruit juice. Elderly patients or those with impaired kidney function are at increased risk of muscle-related side effects, so careful monitoring is required during administration. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored continuously as needed. This medication should be stored out of the reach of children and kept securely in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, mucous membrane syndrome, severe allergic reactions, severe skin reactions, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, shortness of breath, liver abnormalities (jaundice), yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, seizures, confusion of consciousness.

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal distension
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory disturbances
  • loss of sensation
  • taste abnormalities
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and the temperature should be between 1 to 30 degrees Celsius, ideally at room temperature. Storing it this way helps maintain the drug's effectiveness and prevents deterioration.

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.