Medication info
Atovazine Plus Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Atovazine Plus Tablet 10/10 mg (Ezetimibe, Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
영진약품(주)
Appearance
White or off-white oblong film-coated tablet
Packaging
30 tablets/box [(10 tablets/Alu-Alu × 3)]
Approval status
Active

MFDS item code 202101620 · Approved 2021.02.18 · Insurance code 642405210

Summary

Main use
Lipid improvement through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is suggested. If more LDL cholesterol reduction is needed, an initial dose of 10/40 mg per day is advised. After starting the medication or adjusting the dose, monitor blood lipid levels at intervals of more than 2 weeks before adjusting the dosage.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

Lipid improvement through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) 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 dietary therapy to reduce total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels and to increase HDL cholesterol in patients with primary hypercholesterolemia, particularly in patients with familial hypercholesterolemia and mixed dyslipidemia. It is also administered to patients with homozygous familial hypercholesterolemia in conjunction with other lipid-lowering therapies or as an alternative to lower total cholesterol and LDL cholesterol levels. This medication is given concurrently with appropriate dietary management and lifestyle changes and is considered when evaluation and treatment of other secondary causes are necessary. It should be administered cautiously to patients with increased cardiovascular risk to aid in dyslipidemia treatment. Therefore, this medication is used to regulate lipid levels associated with hypercholesterolemia and improve cardiovascular health.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg per day is suggested. If more LDL cholesterol reduction is needed, an initial dose of 10/40 mg per day is advised. After starting the medication or adjusting the dose, monitor blood lipid levels at intervals of more than 2 weeks before adjusting the dosage.

Precautions

This medication may cause a rare side effect called rhabdomyolysis, which can affect muscles. There is a risk of kidney problems due to this; therefore, the medication should be temporarily suspended or discontinued, especially in cases of acute infection, hypotension, or after major surgery where there are risk factors. This medication should not be administered to specific patients, such as those allergic to the drug's components, those with severely impaired liver function, patients with muscle disorders, pregnant or nursing women, individuals currently taking certain antiviral medications, and patients with lactose intolerance. In patients with liver or muscle issues, elderly patients, and those taking certain other medications, this drug should be used with caution. Particularly, patients with decreased liver function should have their liver enzyme levels frequently monitored. If symptoms such as muscle pain, muscle weakness, fatigue, or fever occur while taking this medication, the doctor should be notified immediately, and blood tests should be performed as needed to check for muscle damage. If muscle damage is significant, the medication may be discontinued. Women who are pregnant or may become pregnant should not take this medication, and women of childbearing age should use appropriate contraception while taking it. It is also advised that nursing women refrain from taking this medication. This medication is not recommended for children as safety and efficacy have not been established. Elderly individuals are at a higher risk of muscle-related issues, so caution is necessary, although dosage adjustments are generally not required. In case of overdose, there are no specific antidotes, and treatment should focus on symptom management, alongside testing for liver function and muscle damage. This medication may interact with various drugs; therefore, individuals taking other medications should inform their doctor or pharmacist. Caution is particularly important when taken with drugs that inhibit or induce enzymes that metabolize medications in the liver. Lastly, regular monitoring of liver function and muscle status is essential while taking this medication, and any unusual symptoms should be reported to healthcare providers immediately.

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, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Muscle pain
  • abdominal pain
  • increased liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 26 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • vomiting
  • constipation
  • pharyngitis
  • sinusitis
  • upper respiratory infection
  • low back pain
  • muscle cramps
  • itching
  • rash
  • hair loss
  • anemia
  • headache
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • sore throat
  • muscle fatigue
  • myositis
  • thrombocytopenia
  • increased serum creatine kinase.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. Therefore, avoid storing it in excessively hot or cold locations.

Appearance and packaging

Appearance

White or off-white oblong film-coated tablet

Package unit

30 tablets/box [(10 tablets/Alu-Alu × 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.