Medication info
Atovanjett Tablets 10/40 mg

Atovanjett Tablets 10/40 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White, biconvex, film-coated rectangular tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 202101676 · Approved 2021.02.19 · Insurance code 654005680

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and mitigation of cardiovascular disease risk by increasing HDL
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. The dosage range is 10/10mg to 10/80mg daily. An initial dose of 10/10mg or 10/20mg daily is recommended. For patients requiring a greater reduction in LDL cholesterol (more than 55%), an initial dose of 10/40mg daily is recommended. After initiating therapy or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia, and mitigation of cardiovascular disease risk by increasing HDL

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

This medication is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia to lower total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels and to increase HDL-cholesterol. It is also administered as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia, and in some cases, it may be used alone when other treatments are ineffective. This medication helps reduce the risk of atherosclerotic vascular disease in patients with dyslipidemia. Prior to treatment, secondary causes such as diabetes, hypothyroidism, and liver disease should be evaluated and managed, and treatment effects should be monitored through lipid level testing. It is used in conjunction with an appropriate diet, considering cardiovascular risk factors. In summary, this medication is used to improve hypercholesterolemia and related dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. The dosage range is 10/10mg to 10/80mg daily. An initial dose of 10/10mg or 10/20mg daily is recommended. For patients requiring a greater reduction in LDL cholesterol (more than 55%), an initial dose of 10/40mg daily is recommended. After initiating therapy or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication can cause serious muscle problems; if symptoms such as acute muscle pain or muscle weakness occur, the doctor should be notified immediately. Patients with serious infections, hypotension, major surgery, trauma, severe metabolic abnormalities, etc., may need to temporarily suspend or discontinue this medication. People who are allergic to the active ingredients or excipients, have liver disease or persistently elevated liver enzymes, have muscle disorders, are pregnant or may become pregnant, are nursing mothers, or are taking certain antiviral medications should not take this medication. Additionally, patients with genetic issues such as lactose intolerance should not take this medication. Caution is advised in alcoholics or those with a history of liver disease, individuals with impaired kidney function, those with hypothyroidism, patients with a family history of muscle disorders or a history of taking muscle-toxic medications, seniors over 70 years of age, and those taking certain medications concomitantly. During the use of this medication, side effects such as muscle pain, joint pain, abdominal pain, liver dysfunction, etc., may occur, so they should consult their doctor if they appear. Regular liver function tests should be conducted, and if symptoms of liver damage occur, treatment should be stopped immediately. This medication is not to be used by women who are pregnant or breastfeeding, and appropriate contraception should be used by women of childbearing age. Safety and efficacy have not been established in children, so it is not recommended for them. Older adults are at higher risk for myopathy; therefore, caution is needed, but dosage adjustments are generally not necessary. This medication may interact with other drugs, so any concurrent medications should be reported to a doctor or pharmacist. There is no specific antidote for overdose, so treatment should be based on symptoms and liver function and muscular status should be monitored. This medication should be stored out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough + fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevation of liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 28 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • lethargy
  • weakness
  • chest pain
  • fever
  • nausea
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • sensory disturbances
  • loss of sensation
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • headache
  • tinnitus
  • hearing loss
  • itching
  • rash
  • hair loss

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 important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White, biconvex, film-coated rectangular tablet

Package unit

30 tablets/box [10 tablets/PTP*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.