Medication info
Atoriv Tablet 10/10 mg

Atoriv Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202100227 · Approved 2021.01.08 · Insurance code 684502040

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, it is administered in a range of 10/10 mg to 10/40 mg per day. The recommended initial dosage is 10/10 mg or 10/20 mg once daily. Patients requiring greater reductions in LDL cholesterol may have their dosages adjusted. After starting treatment or adjusting dosages, lipid levels should be checked after an interval of more than 2 weeks.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • elevated apolipoprotein B
  • increased triglycerides
  • and increased non-HDL cholesterol.
View approved original text

This medication is used in patients with primary hypercholesterolemia, particularly in patients with heterozygous familial and non-familial hypercholesterolemia. It also helps to reduce total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides in patients with mixed dyslipidemia, while increasing HDL cholesterol, the good cholesterol. This medication is used in conjunction with an appropriate diet and is adjunctively administered when diet alone is inadequate. Before taking, secondary causes such as diabetes or hypothyroidism should be identified and treated if necessary. After administration, total cholesterol and LDL, HDL, and triglyceride levels should be regularly monitored to evaluate treatment progress. This medication is used to maintain vascular health and improve risks associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, it is administered in a range of 10/10 mg to 10/40 mg per day. The recommended initial dosage is 10/10 mg or 10/20 mg once daily. Patients requiring greater reductions in LDL cholesterol may have their dosages adjusted. After starting treatment or adjusting dosages, lipid levels should be checked after an interval of more than 2 weeks.

Precautions

This medication has been reported to cause rare but severe muscle problems. Particularly in cases of acute infection, hypotension, major surgery, trauma, or uncontrolled seizures, it is necessary to temporarily discontinue or stop this medication. This medication should not be given to patients with allergies to the active ingredient or components, patients with severe liver disease or persistent unexplained elevation of liver enzymes, muscle disease patients, pregnant or potentially pregnant women, nursing mothers, patients taking certain antiviral agents, and patients with genetic issues such as lactose intolerance. Patients with alcohol addiction, impaired liver function, poor kidney function or hypothyroidism, those at high risk for myopathy, elderly individuals over the age of 70, and patients taking specific medications must use this medication cautiously. While on this medication, if symptoms such as muscle pain, muscle weakness, fatigue, or muscle pain accompanied by fever occur, the physician should be notified immediately, and muscle enzyme tests should be performed if necessary. If muscle enzyme levels significantly increase or symptoms worsen, this medication should be discontinued. As liver function could be affected, liver function tests should be performed before and during treatment. If liver damage symptoms such as nausea, vomiting, or fatigue appear, the physician should be notified immediately. This medication may raise blood sugar levels. Therefore, patients at risk for diabetes should regularly check their blood sugar. Additionally, serious skin reactions or allergic reactions may rarely occur, so if skin rashes, itching, swelling of lips or face appear, immediate medical attention is necessary. This medication interacts with many other drugs, especially those that inhibit or activate enzymes that metabolize drugs in the liver. Caution is warranted when combined with specific antibiotics, antivirals, antifungals, immunosuppressants, and some lipid-lowering agents, as dosage adjustments or discontinuation may be necessary. Women of childbearing age should use appropriate contraceptive methods to avoid pregnancy while on this medication, and it should not be taken during pregnancy or breastfeeding. The safety and efficacy of this medication in children have not been established, so it is not recommended. Elderly patients are at higher risk of muscle problems, so caution is advised, and special care is needed for patients with poor liver or kidney function. In cases of overdose, there is no specific antidote, so treatment is symptomatic based on manifestations, and liver function and muscle enzyme levels should be monitored. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucous membranes, shortness of breath or breathing difficulty, asthma attack, respiratory distress associated with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urinary symptoms.

Mild side effects

  • Decreased sensation
  • sensory abnormalities
  • hypertension
  • elevated ALT
  • elevated GGT
  • nasopharyngitis
  • cough
  • itching
  • dizziness
  • diabetes
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  • headache
  • abdominal pain
  • diarrhea
  • fatigue
  • constipation
  • nausea
  • pharyngitis
  • sinusitis
  • upper respiratory tract infection
  • muscle pain
  • joint pain
  • back pain
  • chest pain
  • chest discomfort
  • edema
  • weakness
  • generalized edema
  • palpitations
  • congestive heart failure
  • myocardial ischemia
  • flushing
  • cough
  • sputum
  • runny nose
  • limb pain
  • hypoglycemia
  • anemia
  • splenomegaly.

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is best to store at room temperature, between 1 to 30 degrees Celsius. This way, the efficacy of the medication can be safely maintained.

Appearance and packaging

Appearance

White oval 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.