Medication info
Hutex Atorvastatin Tablets 10 mg (Atorvastatin Calcium Trihydrate)

Hutex Atorvastatin Tablets 10 mg (Atorvastatin Calcium Trihydrate)

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

MFDS item code 200705818 · Notified 2007.05.21 · Insurance code 649101310

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended starting dose for the treatment of hyperlipidemia is 10 mg of atorvastatin once daily; for those requiring a greater decrease in LDL-cholesterol, therapy may begin with 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. Lipid levels should be analyzed and the dose adjusted within 2 to 4 weeks of starting treatment. Patients with homozygous familial hypercholesterolemia should receive a dosage of 10 to 80 mg once daily.
Child dose
The recommended starting dose for pediatric patients (ages 10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosage should be adjusted according to the treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

  • Coronary artery 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 lower the risk of cardiovascular diseases such as myocardial infarction, stroke, and angina in adults with multiple risk factors for cardiovascular disease and in patients with type 2 diabetes. It is also used to improve blood lipid levels by reducing total cholesterol and LDL-cholesterol, apo-B protein, and triglyceride levels in patients with hyperlipidemia, while raising HDL-cholesterol levels. It is effective for controlling cholesterol levels in pediatric and adolescent patients with familial hypercholesterolemia who have high levels of LDL-cholesterol. This medication is used as an adjunct when diet alone is insufficient to maintain cardiovascular health and reduce the risk of disease occurrences. Thus, it is used for reducing the risk of cardiovascular diseases and treating hyperlipidemia.

How to take

Adult dose

The recommended starting dose for the treatment of hyperlipidemia is 10 mg of atorvastatin once daily; for those requiring a greater decrease in LDL-cholesterol, therapy may begin with 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. Lipid levels should be analyzed and the dose adjusted within 2 to 4 weeks of starting treatment. Patients with homozygous familial hypercholesterolemia should receive a dosage of 10 to 80 mg once daily.

Child dose

The recommended starting dose for pediatric patients (ages 10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosage should be adjusted according to the treatment goals at intervals of 4 weeks or more.

Precautions

This medication may cause muscle-related symptoms; therefore, if severe muscle pain or weakness is experienced, notify a doctor immediately. This medication can affect liver function; hence, it should not be administered if there is liver disease or elevated liver function test results, and regular liver function tests should be conducted during treatment. Women who are pregnant or may become pregnant, and nursing mothers should not use this medication. It should not be administered to children under 10 years of age, and the safety and efficacy in children aged 10 to under 18 years have not been sufficiently studied. This medication may interact with certain drugs, so inform your doctor or pharmacist if other medications are being taken. Patients with excessive alcohol intake or a history of liver disease should exercise special caution when using this medication. Elderly patients have a higher risk of side effects such as muscle abnormalities or liver function degradation, thus careful monitoring is required during treatment. This medication may increase blood concentration when taken with grapefruit juice; therefore, excessive consumption of grapefruit juice should be avoided. Severe muscle abnormalities, such as myopathy or rhabdomyolysis, may occur; if symptoms such as muscle pain, cramps, or weakness surface, consult a doctor immediately. Regular blood tests and liver function tests during treatment are important to monitor any abnormalities. This medication may cause allergic reactions or skin rashes, itching, so if these symptoms occur, discontinue use and consult a doctor. There is no specific antidote for overdose; appropriate treatment should be initiated based on symptoms, and periodic liver and muscle-related tests should be conducted. Keep out of reach of children and store in the 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 rash with fever, blisters, skin peeling, painful mucous membranes in the mouth/eyes, severe allergic reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme fatigue, liver abnormalities (jaundice), sudden and unexpected reactions

Mild side effects

  • Weakness
  • fatigue
  • 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 and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • tingling sensations
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the efficacy of the medication.

Appearance and packaging

Appearance

White oval 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.