Medication info
Artech Tablet 10 mg (Atorvastatin Calcium Hydrate)

Artech Tablet 10 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201800795 · Approved 2018.02.09 · Insurance code 689000300

Summary

Main use
Reduction of risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg once daily; if more LDL cholesterol reduction is needed, it can be started at 20 mg or 40 mg once daily. This medication can be administered in a dosage range of 10 to 80 mg once daily. Initial and maintenance dosages should be individualized based on treatment goals and response, and lipid levels should be analyzed within 2 to 4 weeks after starting therapy or adjusting dosages.
Children's dosage
For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum dose is 20 mg once daily. Dosage adjustments should be made at intervals of 4 weeks or more based on treatment goals.

Ingredients

Manufacturer
(주)시어스제약

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
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hyperlipidemia
View approved original text

This medication helps to reduce the risk of cardiovascular diseases. High-risk individuals may lower their risks of myocardial infarction, stroke, vascular surgery, and angina. It is also effective in reducing the risk of myocardial infarction and stroke for diabetic patients. Adults diagnosed with heart disease can experience a reduced risk of myocardial infarction, stroke, congestive heart failure hospitalization, and angina. Moreover, individuals with hyperlipidemia can benefit from this medication to lower LDL cholesterol and total cholesterol levels and increase HDL cholesterol levels. In pediatric patients with severe hypercholesterolemia, this medication is used as a dietary aid to improve cholesterol levels.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg once daily; if more LDL cholesterol reduction is needed, it can be started at 20 mg or 40 mg once daily. This medication can be administered in a dosage range of 10 to 80 mg once daily. Initial and maintenance dosages should be individualized based on treatment goals and response, and lipid levels should be analyzed within 2 to 4 weeks after starting therapy or adjusting dosages.

Children's dosage

For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum dose is 20 mg once daily. Dosage adjustments should be made at intervals of 4 weeks or more based on treatment goals.

Precautions

This medication may present muscle-related symptoms, so if any muscle pain or weakness occurs, it must be reported to a physician immediately. In particular, if there is an increase in creatine kinase levels or muscle disease is suspected, the medication should be discontinued. Patients with liver dysfunction should not use this medication and must have regular liver function tests. Pregnant women or those who could become pregnant should not take this medication and should ensure effective contraception during treatment. Nursing mothers should also not take this medication. Children under 10 years of age and patients with certain hereditary diseases should not use this medication. Patients with a history of liver disease or alcohol addiction should take this medication with caution. Elderly individuals or those with impaired kidney function are at increased risk for muscle disease, hence caution is needed. This medication may interact with other drugs, particularly certain antibiotics, antifungals, antivirals, and some lipid-lowering agents, so caution is necessary when used concurrently. Consumption of grapefruit juice may increase the blood concentration of this medication, so excessive intake should be avoided. If symptoms such as muscle pain, cramps, fatigue, or fever appear, immediate medical attention is required. Regular monitoring of liver function and muscle conditions during the intake of this medication is important. In case of overdose, there are no specific antidotes, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels. Keep out of reach of children and store in the original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, pallor, anaphylaxis, high fever with severe rash, blisters, peeling skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, mucocutaneous syndrome), pain in oral/eye mucosa, severe skin adverse reactions, asthma attack, respiratory issues accompanying cough and fever, jaundice (yellowing of skin or eyes), severe systemic reactions

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • amnesia
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • 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. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

White round film-coated tablets

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.