Medication info
Atovanjette Tablet 10/20 mg

Atovanjette Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White, bilayer convex film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 202101675 · Approved 2021.02.19 · Insurance code 654005670

Summary

Main use
Improvement of lipid profiles through reduction of cholesterol and increase of HDL in primary hypercholesterolemia (homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day, with a starting dose of 10/10 mg or 10/20 mg recommended. For patients requiring significant LDL-cholesterol reduction, a daily dose of 10/40 mg is advised. After initiating therapy or adjusting dosage, check blood lipid levels at intervals of more than 2 weeks for dosing.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Improvement of lipid profiles through reduction of cholesterol and increase of HDL in primary hypercholesterolemia (homozygous familial) 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 to lower total cholesterol, LDL cholesterol, ApoB, triglycerides, and non-HDL cholesterol levels, and to increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It may also serve as an adjunctive or alternative therapy in patients with homozygous familial hypercholesterolemia. This medication is used in conjunction with dietary therapy, and it is important to implement non-pharmacological measures such as limiting saturated fat and cholesterol intake. Before administering the drug, it is essential to verify and manage secondary causes of dyslipidemia, such as diabetes and hypothyroidism. In patients with acute coronary events, assessing lipid levels upon admission or within 24 hours post-admission is utilized to help determine treatment direction. This medication helps reduce the risk of vascular diseases due to hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day, with a starting dose of 10/10 mg or 10/20 mg recommended. For patients requiring significant LDL-cholesterol reduction, a daily dose of 10/40 mg is advised. After initiating therapy or adjusting dosage, check blood lipid levels at intervals of more than 2 weeks for dosing.

Precautions

This medication has been reported to have a rare side effect of rhabdomyolysis, which may cause severe abnormal muscle conditions. If severe muscle pain or weakness symptoms occur, contact a physician immediately, and if necessary, discontinue the medication. Women who are pregnant or breastfeeding, or those with an allergy to any components of this medication, severe liver dysfunction, or muscle disorders should not take this medication. Patients with specific antiviral drugs or genetic issues like lactose intolerance should also refrain from using this medication. Patients with a history of alcoholism, liver disease, diminished kidney function, hypothyroidism, or elderly patients should take special precautions while using this medication and should be regularly monitored for muscle-related abnormalities. This medication may elevate liver enzyme levels, and liver function tests should be conducted before and during use. If any liver abnormalities occur, discontinue the medication promptly. Blood sugar levels may increase during the course of treatment, so patients at risk of diabetes must manage their blood sugar levels diligently. Combining this medication with certain antibiotics, antifungals, antivirals, or other lipid-lowering agents may increase the risk of muscle damage; consult with a physician or pharmacist regarding any concurrent medications. Women of childbearing potential should ensure adequate contraception while taking this medication and should avoid it if there is a possibility of pregnancy. Symptoms such as dizziness or muscle pain may occur, requiring caution when driving or operating machinery. Safety for pediatric patients has not been established and is therefore not recommended. In case of overdose, there are no specific antidotes, and treatment should be symptomatic, with regular monitoring of liver function and muscle enzyme levels. This medication should be kept out of reach of children and should not be transferred to different containers.

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 fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe drowsiness, sudden and severe headaches, lightning headaches, seizures, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • headache
  • dizziness
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
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  • sinusitis
  • flushing
  • diarrhea
  • fatigue
  • chest pain
  • malaise
  • chest discomfort
  • asthenia
  • generalized edema
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • itching
  • rash
  • hair loss
  • thrombocytopenia
  • hepatitis
  • cholestasis
  • visual impairment
  • hearing loss
  • gynecomastia
  • urinary tract infection
  • hematuria
  • dysuria
  • kidney stones
  • breast.

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. It is advisable to maintain room temperature between 1 to 30 degrees Celsius for storage. Proper storage can safely preserve the medication's efficacy.

Appearance and packaging

Appearance

White, bilayer convex film-coated 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.