Medication info

Atorvastatin 10 mg Tablets (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White circular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201701343 · Approved 2017.03.20 · Insurance code 657203250

Summary

Main use
Reduction of risks of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended starting dose for hyperlipidemia treatment is 10 mg of atorvastatin once a day. For patients requiring a more significant reduction in LDL cholesterol, it can be initiated at 20 mg or 40 mg once a day. The dosing range is 10 to 80 mg once a day. The initiation and maintenance doses should be individualized based on treatment goals and response, and lipid levels should be analyzed to adjust dosing within 2 to 4 weeks.
Children's dosage
The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once a day, with a recommended maximum dose of 20 mg per day. The dosing should be adjusted according to treatment goals.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

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

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • vascular interventions
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hypercholesterolemia
View approved original text

This medication is used to reduce the risk of cardiovascular diseases. In particular, it lowers the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary heart disease and those with type 2 diabetes, and it is also effective in vascular interventions and chronic stable angina. Furthermore, it lowers the risk of non-fatal myocardial infarction, stroke, hospitalizations for congestive heart failure, and angina in patients with clinical evidence. This drug helps improve cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases HDL cholesterol. It is also used in patients with dysbetalipoproteinemia, elevated triglycerides, and familial hypercholesterolemia who do not respond to other therapies. Among pediatric patients, it is effective in controlling cholesterol levels in patients with heterozygous familial hypercholesterolemia who meet specific criteria. Therefore, this medication is used to improve patients' health by reducing the risk of cardiovascular diseases and improving dyslipidemia.

Dosage and Administration

Adult dosage

The recommended starting dose for hyperlipidemia treatment is 10 mg of atorvastatin once a day. For patients requiring a more significant reduction in LDL cholesterol, it can be initiated at 20 mg or 40 mg once a day. The dosing range is 10 to 80 mg once a day. The initiation and maintenance doses should be individualized based on treatment goals and response, and lipid levels should be analyzed to adjust dosing within 2 to 4 weeks.

Children's dosage

The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once a day, with a recommended maximum dose of 20 mg per day. The dosing should be adjusted according to treatment goals.

Precautions

This medication should be discontinued immediately if there are unusual symptoms in the muscles or if muscle enzyme levels rise significantly. Special caution is required, especially when serious myopathy or rhabdomyolysis is suspected, as there is a risk of kidney function deterioration. This drug should not be used in patients with certain diseases or allergic reactions, pregnant or nursing women, children under 10 years of age, and those taking some other medications. It should be used cautiously in cases of liver or kidney problems, alcohol addiction, hypothyroidism, and a history of muscle diseases. Elderly patients also require caution due to a higher risk of muscle-related side effects. During treatment, if symptoms such as fatigue, muscle pain, muscle weakness, or fever occur, you must inform healthcare professionals immediately, and regular blood tests to check liver function and muscle enzyme levels are important. This medication can interact with various drugs, so if you are taking other medications, you must inform your doctor or pharmacist, especially if used in conjunction with certain antibiotics, antifungals, antivirals, blood pressure medications, hypoglycemic agents, oral contraceptives, etc. Women who are pregnant or of childbearing potential must use adequate contraception, and if pregnancy is confirmed, they should stop taking it immediately. Nursing mothers should not take this medication. There is no specific antidote in case of overdose, so treatment should be symptomatic based on symptoms while closely monitoring liver function and muscle enzyme levels. Keep this medication out of the reach of children, and store it in its original container to prevent misuse or deterioration of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, peeling skin, oral/ocular mucous membrane pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, respiratory problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver issues (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • rhinopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
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  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • and joint

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

Storage

This medication should be stored in a tightly sealed container as it may be sensitive to light and air. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

White circular 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.