Medication info
Atom Tablet 10/40 mg

Atom Tablet 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
White or whitish rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101523 · Approved 2021.02.18 · Insurance code 647304010

Summary

Main use
Lipid control effect through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. Primary hypercholesterolemia: the dosage range is 10/10 mg to 10/80 mg per day, with an initial recommended dose of 10/10 mg or 10/20 mg daily. For patients requiring a greater reduction in LDL-cholesterol (more than 55%), an initial dose of 10/40 mg daily is recommended. After administration begins or dosage adjustments, serum lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Lipid control effect through cholesterol reduction and HDL increase in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to dietary therapy to lower elevated total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia, while increasing HDL-cholesterol. Additionally, it can be administered as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia or when other therapies are ineffective. This medication is applied in conjunction with a diet that includes restrictions on saturated fat and cholesterol, specifically when there is insufficient response to appropriate non-pharmacologic measures. It is essential to identify and treat other secondary causes (e.g., diabetes, hypothyroidism) beforehand. In patients with acute coronary events, lipid testing should be performed upon admission or within 24 hours of admission, and LDL-lowering therapy can be initiated upon discharge. This medication aids in improving dyslipidemia and associated cardiovascular risks.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. Primary hypercholesterolemia: the dosage range is 10/10 mg to 10/80 mg per day, with an initial recommended dose of 10/10 mg or 10/20 mg daily. For patients requiring a greater reduction in LDL-cholesterol (more than 55%), an initial dose of 10/40 mg daily is recommended. After administration begins or dosage adjustments, serum lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication can rarely cause a serious side effect known as rhabdomyolysis, which can damage muscles. Particularly, patients with risk factors such as acute infections, hypotension, major surgery or trauma, severe metabolic disorders should temporarily discontinue or use this medication cautiously. Patients allergic to the active ingredient or any components, those with liver disease or persistently elevated liver enzyme levels, those with muscle diseases, pregnant or nursing women, patients taking certain antiviral medications, and those with lactose intolerance should not be administered this medication. Patients with a history of alcohol abuse, liver dysfunction, impaired kidney function, hypothyroidism, muscle disease, or elderly patients at high risk of muscle damage should use this medication with caution. Patients experiencing symptoms such as muscle pain, muscle weakness, malaise, and muscle pain accompanied by fever while taking this medication should inform their doctor immediately and undergo examination. In cases of severe muscle damage, the medication should be discontinued, and upon re-administration, it should begin with a lower dosage and be closely monitored. Liver dysfunction can also occur, so liver enzyme tests should be performed before and during treatment, and if symptoms of liver damage (nausea, vomiting, fatigue, etc.) arise, the doctor should be informed immediately. Use of this medication during pregnancy is prohibited, and women of childbearing age should use appropriate contraceptive methods. Nursing mothers should also avoid taking this medication. This medication may cause dizziness or fatigue; therefore, caution is advised when driving or operating machinery. When taken with other drugs, interactions may increase the concentration of this medication in the blood or raise the risk of side effects, thus dosage adjustments and monitoring are necessary per doctor’s direction, especially when combined with certain antibiotics, antiviral drugs, immunosuppressants, or fibrates. Safety in children has not been established, thus it is not recommended, and elderly patients are at higher risk of muscle damage and should exercise caution. There is no specific antidote for overdose, so treatment should be symptomatic along with appropriate supportive therapy, and liver function and muscle enzyme levels should be monitored. This medication should be kept out of reach of children, and transferring it to another container is not recommended for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevation of liver enzymes
  • dizziness
  • cough
  • nausea
  • constipation
  • diarrhea
  • hyperkalemia
  • bronchitis
Show 27 more
  • sinusitis
  • flushing
  • fatigue
  • weakness
  • malaise
  • chest pain
  • headache
  • rash
  • itching
  • alopecia
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • blurred vision
  • visual disturbances
  • tinnitus
  • hearing loss
  • erectile dysfunction
  • urinary tract infections
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • urinary incontinence
  • hypoglycemia
  • hyperglycemia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

White or whitish rectangular film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu x 3]

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.