Medication info

Amive Tablet 10/40 mg

Prescription medicationTabletExpired
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)휴온스생명과학
Appearance
White to off-white, oval, biconvex, film-coated tablet
Packaging
30 tablets/box - 10 tablets/plate [X3]
Approval status
Expired

MFDS item code 202101616 · Approved 2021.02.18

This product's status changed to Expired on 2026.02.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg daily is recommended. In patients requiring a more significant reduction in LDL cholesterol (over 55%), an initial dose of 10/40 mg daily is recommended. Dose adjustments should be made after evaluating blood lipid levels at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)휴온스생명과학

Efficacy & effects

Improvement of lipids by reducing cholesterol and increasing HDL in hypercholesterolemia and dyslipidemia

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

This medicine is used as an adjunct to diet to lower cholesterol levels, Apo B, triglycerides, etc., in patients with primary hypercholesterolemia and mixed dyslipidemia and to increase good HDL cholesterol. It can also be administered in patients with homozygous familial hypercholesterolemia alongside other lipid-lowering treatments or when other treatments are ineffective. This medication helps reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia and works best when used in conjunction with an appropriate diet. It is important to check for other causes of dyslipidemia such as diabetes and hypothyroidism before administration, and to treat those underlying causes if necessary. Treatment efficacy should be monitored through blood lipid testing, and in patients with acute coronary events, lipid levels should be measured upon admission or within 24 hours following admission. This medication is used for the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day. An initial dose of 10/10 mg or 10/20 mg daily is recommended. In patients requiring a more significant reduction in LDL cholesterol (over 55%), an initial dose of 10/40 mg daily is recommended. Dose adjustments should be made after evaluating blood lipid levels at intervals of more than 2 weeks.

Precautions

This medication has been reported to cause a serious side effect known as rhabdomyolysis, which can lead to acute kidney failure due to rare damage to muscle tissue. Therefore, in patients who exhibit severe myopathy symptoms or those at high risk for kidney failure such as those with severe infections, hypotension, or after major surgeries, this medication should be temporarily discontinued or stopped. This medication should not be used by individuals with allergies to the active ingredient or its components, those with severe liver dysfunction, muscle diseases, pregnant or potentially pregnant women, breastfeeding women, those taking certain antiviral medications, and individuals with lactose intolerance. Caution should be exercised in alcoholics or those with a history of liver disease, patients with severe liver dysfunction, those with impaired kidney function or hypothyroidism, and elderly individuals, who are at higher risk for myopathy; if muscle pain or weakness arises, immediate consultation with a physician is recommended. During treatment with this medication, side effects such as muscle pain, abdominal pain, and increased liver enzyme levels may occur, especially if liver dysfunction or muscle-related symptoms appear, which should be reported to medical personnel. Additionally, this medication can interact with several other drugs, so it is essential to inform your doctor or pharmacist if you are taking other medications. Caution is needed when used in combination with specific antibiotics, antivirals, and immunosuppressants as it may increase the risk of muscle damage. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraception while taking it. The safety and efficacy of this medication in children have not been established and are therefore not recommended. Caution is warranted for elderly patients due to the higher risk of myopathy, though dose adjustment is generally not necessary. Patients with compromised liver or kidney function must consult with medical personnel before taking this medication, and if liver function abnormalities persist, use should be discontinued. In the case of overdose, there is no specific antidote, and treatment should focus on symptomatic support, 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 another container. If symptoms such as dizziness or muscle pain occur during treatment, caution should be exercised when operating vehicles or machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), liver abnormality (jaundice), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, severe skin reactions including erythema multiforme, difficulty breathing, asthma, thrombocytopenia, anaphylaxis, liver failure, severe swelling or urination issues, severe myopathy, rhabdomyolysis, acute kidney failure, intracranial aneurysm, severe neurological symptoms (intracranial)

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • ALT increase
  • AST increase
  • fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress and is best kept in a cool place below 30 degrees Celsius.

Appearance and packaging

Appearance

White to off-white, oval, biconvex, film-coated tablet

Package unit

30 tablets/box - 10 tablets/plate [X3]

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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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.