Medication info

Altomiv Tablets 10/40 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
White, oblong, film-coated tablet
Packaging
30 tablets/Alu-Alu[((10 tablets/Alu-Alu) x 3)]
Approval status
Approval withdrawn

MFDS item code 202101595 · Approved 2021.02.18

This product's status changed to Approval withdrawn on 2025.06.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of cholesterol and increase of HDL in dyslipidemia (primary, homozygous familial) to alleviate the risk of vascular disease
Who uses it
Adults
Adult dosage
This medicine is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day. The recommended starting dose is 10/10 mg or 10/20 mg once daily. For patients requiring a greater reduction in LDL cholesterol (greater than 55%), the recommended starting dose is 10/40 mg once daily. Dosage adjustments should be made based on lipid levels confirmed at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Reduction of cholesterol and increase of HDL in dyslipidemia (primary, homozygous familial) to alleviate the risk of vascular disease

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • increased risk of atherosclerotic vascular diseases due to hypercholesterolemia
View approved original text

This medicine helps to lower elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, and raises HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It can be used alone or in conjunction with other treatments for patients with homozygous familial hypercholesterolemia. This medicine helps reduce the risk of atherosclerotic vascular disease in dyslipidemia patients and is most effective when combined with proper dietary management. Additionally, it is essential to check for other health conditions or medications that may affect hypercholesterolemia before use, and to monitor treatment effects with regular lipid tests. Rapid assessment of lipid levels is recommended when experiencing acute coronary events. Overall, this medicine serves as an important adjunct in the treatment of dyslipidemia.

Dosage and Administration

Adult dosage

This medicine is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg per day. The recommended starting dose is 10/10 mg or 10/20 mg once daily. For patients requiring a greater reduction in LDL cholesterol (greater than 55%), the recommended starting dose is 10/40 mg once daily. Dosage adjustments should be made based on lipid levels confirmed at intervals of more than 2 weeks.

Precautions

This medicine may occasionally cause side effects affecting muscles, so if symptoms of muscle pain or weakness occur, it is important to consult a physician immediately. Patients at high risk for severe myopathy or rhabdomyolysis may need to temporarily discontinue or stop this medication. It should not be taken by individuals with allergies to the ingredients or active liver disease, and those with muscle disease are also contraindicated. Pregnant or potentially pregnant women, as well as breastfeeding women, should not take this medication. Patients with liver function problems or a history of severe liver disease should use this medication cautiously and have liver enzyme levels monitored regularly. This medicine may interact with other drugs, especially when taken with medications metabolized in the liver or those affecting muscles. Elderly patients or those with impaired kidney function may also have an increased risk of muscle-related side effects, necessitating physician guidance on usage. Unusual symptoms such as dizziness, muscle pain, or abdominal pain should be reported to healthcare professionals immediately. It is crucial to ensure safety through regular blood tests and liver function tests while on this medication. Caution is advised while driving or operating machinery due to potential dizziness. In the case of overdose, there are no specific antidotes, so appropriate treatment and supportive care should be administered according to symptoms.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe overall lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary symptoms

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevation of liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • malaise
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • paresthesia
  • sensory reduction

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

Storage

This medicine must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, oblong, film-coated tablet

Package unit

30 tablets/Alu-Alu[((10 tablets/Alu-Alu) x 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.