Medication info
Atorvastatin-Ezetimibe Tablet 10/40 Milligrams

Atorvastatin-Ezetimibe Tablet 10/40 Milligrams

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
제일헬스사이언스(주)
Appearance
White to off-white, bilaterally convex oval film-coated tablets
Packaging
30 tablets/box[(10 tablets/PTP x3)]
Approval status
Active

MFDS item code 202101437 · Approved 2021.02.18

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. The dosage should be adjusted based on the patient’s LDL-cholesterol baseline, treatment goals, and their response. For primary hypercholesterolemia, the daily dosage range is 10/10mg to 10/80mg, with an initial recommended dose of 10/10mg or 10/20mg per day. For patients requiring significant LDL-cholesterol reduction, an initial dose of 10/40mg per day is recommended.

Ingredients

Manufacturer
제일헬스사이언스(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL-cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL-cholesterol
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps lower elevated total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and raises good cholesterol HDL cholesterol levels. It is particularly used when other treatments are difficult to combine with or substitute in patients with homozygous familial hypercholesterolemia. This medication should be used in conjunction with appropriate dietary control, and it is important to first identify and manage other causes of dyslipidemia, such as diabetes and thyroid disorders. Blood lipid levels should be consistently monitored before and during treatment to assess efficacy. This contributes to reducing the risk of vascular disease and improving health.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. The dosage should be adjusted based on the patient’s LDL-cholesterol baseline, treatment goals, and their response. For primary hypercholesterolemia, the daily dosage range is 10/10mg to 10/80mg, with an initial recommended dose of 10/10mg or 10/20mg per day. For patients requiring significant LDL-cholesterol reduction, an initial dose of 10/40mg per day is recommended.

Precautions

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to serious muscle damage. Therefore, if symptoms such as severe muscle pain or muscle weakness occur, it is important to consult a physician immediately. This medication should not be used in patients with allergies to the ingredients, active liver disease, muscle disorders, women who are pregnant or breastfeeding, and those taking certain hepatitis treatment medications. Patients with lactose intolerance should also not take this medication. Patients with a history of alcohol addiction, impaired liver function, reduced kidney function, hypothyroidism, a history of muscle disorders, or elderly patients who are at a higher risk of muscle damage should use this medication with caution. Because this medication can burden the liver, liver function tests should be performed before administration, and if any symptoms of liver dysfunction occur during treatment, the physician should be notified immediately. If symptoms such as nausea, vomiting, fatigue, or jaundice occur, administration should be discontinued. During the use of this medication, if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, healthcare providers should be informed immediately, and blood tests may need to be performed to check for muscle damage. This medication may interact with other drugs, so it is essential to inform the physician or pharmacist if taking other medications. The risk of muscle damage may increase particularly when used in conjunction with certain antibiotics, antiviral medications, antifungal agents, immunosuppressants, and some lipid-lowering agents. Women of childbearing age should use adequate contraceptive methods to avoid pregnancy while taking this medication and should discontinue use immediately upon confirmation of pregnancy. Women who are breastfeeding are also advised not to take this medication. The safety of this medication in children and adolescents has not been established and use is not recommended. Caution is also required for elderly patients who may be at risk of muscle damage. In the case of an overdose of this medication, there is no specific antidote, so appropriate treatment and supportive care should be provided according to symptoms, and monitoring of liver function and muscle damage should be done. This medication should be stored out of reach of children, and it is advisable not to transfer it 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 high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • joint pain
  • muscle weakness
  • hyperkalemia
  • bronchitis
Show 26 more
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • diarrhea
  • constipation
  • vomiting
  • sore throat
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • paresthesia
  • sensory loss
  • taste distortion
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • itching
  • hair loss
  • skin rash
  • angioedema
  • gynecomastia

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 should be kept in a cool place at a temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White to off-white, bilaterally convex oval film-coated tablets

Package unit

30 tablets/box[(10 tablets/PTP x3)]

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.