Medication info
Atotive Tablet 10/20 mg

Atotive Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202100175 · Approved 2021.01.08 · Insurance code 649105170

Summary

Main use
Treatment of cholesterol and lipid levels improvement in hypercholesterolemia (primary, mixed) and dyslipidemia
Who uses it
Adults
Adult dosage
This medicine is administered once daily, regardless of meals. For patients with primary hypercholesterolemia, the dose is adjusted within the range of 10/10mg to 10/40mg per day, with an initial recommended dose of 10/10mg or 10/20mg per day. If more reduction in LDL cholesterol is needed, the dosage may be adjusted. After starting the treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks and dosages adjusted accordingly.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of cholesterol and lipid levels improvement in hypercholesterolemia (primary, mixed) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medicine is used as an adjunct to improve cholesterol and fat levels in patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia. It helps lower total cholesterol and LDL cholesterol, apo B, triglycerides, and non-HDL cholesterol in the blood, while increasing HDL cholesterol, the good cholesterol, to reduce the risk of cardiovascular diseases. This medicine is prescribed in conjunction with diet and when dietary control alone is insufficient. It is also important to identify and treat secondary causes such as diabetes or hypothyroidism. Treatment effects should be monitored through regular lipid tests and immediate measurements should be taken in the event of acute coronary incidents to initiate appropriate treatment. This medicine improves the risk of vascular diseases associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medicine is administered once daily, regardless of meals. For patients with primary hypercholesterolemia, the dose is adjusted within the range of 10/10mg to 10/40mg per day, with an initial recommended dose of 10/10mg or 10/20mg per day. If more reduction in LDL cholesterol is needed, the dosage may be adjusted. After starting the treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks and dosages adjusted accordingly.

Precautions

This medicine has been reported to have a rare side effect called rhabdomyolysis, which can cause serious muscle abnormalities. Therefore, patients with severe muscle disease symptoms, severe infections, hypotension, major surgery or trauma, metabolic and endocrine disorders should temporarily discontinue or stop taking this medicine. This medicine should not be used by individuals allergic to the active or inactive ingredients, patients with severely impaired liver function, patients with muscle disorders, pregnant women or women who might become pregnant, nursing mothers, individuals taking certain hepatitis treatment medications, or people with lactose intolerance. Caution should be exercised when using this medicine in patients with a history of alcoholism or liver disease, patients with poor kidney function or hypothyroidism, patients with a history of muscle disorders or muscular toxicity from statins or fibrates, elderly patients aged 70 or older, and patients taking fibrate medications. Regular liver function tests and muscle-related tests should be performed during treatment with this medicine, and immediate consultation with a doctor should be sought if symptoms such as muscle pain, muscle cramps, fatigue, or muscle pain accompanied by fever occur. This medicine can cause side effects such as liver dysfunction, digestive disorders, headache, dizziness, hypertension, diabetes, and serious adverse reactions such as severe hepatitis, skin allergic reactions, and muscle rupture have been reported. In particular, this medicine may interact with several other drugs, so if other medications are being taken, this must be communicated to a doctor or pharmacist, and dosing adjustments or caution may be needed when used with certain antibiotics, antivirals, antifungals, or immunosuppressants. Pregnant or nursing women should not use this medicine, and women of childbearing age should use appropriate contraceptive methods while taking this medicine. The safety and efficacy of this medicine in children have not been established, and it should be used cautiously in older adults due to the risk of muscle disorders. It should not be administered to patients with severely impaired liver or kidney function or should be administered cautiously, and in case of overdose, treatment should be based on symptoms, along with liver function and muscle enzyme tests. This medicine should be stored out of reach of children and care should be taken not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities associated with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, decreased urine output

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • fever
  • nasopharyngitis
  • cough
  • itching
  • diarrhea
  • abdominal pain
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  • nausea
  • vomiting
  • belching
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • myalgia
  • arthralgia
  • limb pain
  • muscle cramps
  • back pain
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • hair loss
  • angioedema
  • skin rash
  • hyperhidrosis
  • skin mucous membrane syndrome
  • skin ulcers
  • anemia
  • hernia
  • erectile dysfunction

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

Storage

This medicine should be stored in a tightly sealed container to protect it from air or moisture. The storage temperature should ideally be maintained at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle

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.