Medication info
Atorvaeb Tablet 10/20 Milligrams

Atorvaeb Tablet 10/20 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
익수제약(주)
Appearance
White, biconvex, rectangular film-coated tablet
Packaging
30 tablets/PTP
Approval status
Active

MFDS item code 202101508 · Approved 2021.02.18

Summary

Main use
Lipid improvement through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, without regards to meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily. A starting dose of 10/10mg or 10/20mg daily is recommended. For patients requiring greater reduction in LDL cholesterol, a starting dose of 10/40mg daily is recommended. After dosing adjustment, lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

Lipid improvement through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia

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

This medication is used as an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol. Particularly, it is administered as an add-on or alternative therapy in patients with homozygous familial hypercholesterolemia. The drug has not been studied in certain types of dyslipidemia and secondary causes such as diabetes or hypothyroidism should be verified before treatment. Lipid control should be conducted in conjunction with an appropriate diet and should be initiated only if treatment response is insufficient. This medication effectively helps control cholesterol levels in patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily, without regards to meals. For primary hypercholesterolemia, the dosage range is 10/10mg to 10/80mg daily. A starting dose of 10/10mg or 10/20mg daily is recommended. For patients requiring greater reduction in LDL cholesterol, a starting dose of 10/40mg daily is recommended. After dosing adjustment, lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication carries a risk of inducing rhabdomyolysis, a rare side effect that can cause severe muscle damage. Patients with severe infections, surgery, trauma, or kidney problems should temporarily suspend or discontinue this medication. Patients allergic to any components of this drug, those with liver disease, muscle disease, pregnant or nursing women, and patients taking certain antiviral agents should not use this medication. Patients with specific genetic disorders such as lactose intolerance should also avoid it. Caution is advised for those with a history of liver disease, alcohol abuse, elderly patients, and patients with impaired renal function, as they are at higher risk for muscle-related side effects. Care is also needed when taken with fibrate-class drugs. This medication may cause adverse reactions such as muscle pain, abdominal pain, elevated liver enzymes, dizziness, cough, nausea, diarrhea, joint pain, muscle weakness, musculoskeletal pain, hyperkalemia, bronchitis, sinusitis, flushing, fatigue, malaise, headache, vomiting, dry mouth, insomnia, nightmares, blurry vision, tinnitus, itching, rash, hair loss, thrombocytopenia, visual impairment, hearing loss, erectile dysfunction, urinary tract infection, frequent urination, cystitis, hematuria, dysuria, kidney stones, nocturia. Liver function may be compromised, so regular liver function tests should be performed before and during treatment. This medication should not be administered to pregnant women or those who may become pregnant, and women of childbearing age should use appropriate contraception. Dizziness may occur, so caution is warranted when driving or operating machinery. Since this medication can interact with other drugs, consult a doctor or pharmacist if taking any other medications. There is no specific antidote for overdose, so treatment is symptomatic and liver function and muscle enzyme levels should be monitored. It is not recommended for children due to the lack of established safety and efficacy. Elderly patients should use caution due to the higher risk of muscle side effects. Patients with impaired liver or kidney function should consult medical professionals before use.

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, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 27 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • headache
  • vomiting
  • dry mouth
  • insomnia
  • nightmares
  • blurry vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • visual impairment
  • hearing loss
  • erectile dysfunction
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. This will help to preserve the effectiveness of the medication over time.

Appearance and packaging

Appearance

White, biconvex, rectangular film-coated tablet

Package unit

30 tablets/PTP

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.