Medication info

Altomib Tablets 10/10 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
White rectangular film-coated tablets
Packaging
30 tablets/Alu-Alu[((10 tablets/Alu-Alu) x 3)]
Approval status
Approval withdrawn

MFDS item code 202101593 · 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This product's status changed to Approval withdrawn on 2025.06.23.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 to suppress the risk of cardiovascular disease in hypercholesterolemia (primary, homozygous familial) 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. The recommended starting dose is 10/10 mg or 10/20 mg per day. For patients requiring significant LDL cholesterol reduction, a starting dose of 10/40 mg per day is recommended. After initiating therapy or adjusting the dose, lipid levels should be checked at an interval of more than 2 weeks.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Reduction of cholesterol and increase of HDL to suppress the risk of cardiovascular disease in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular diseases due to hypercholesterolemia.
View approved original text

This medication is used to assist dietary regimen in patients with primary hypercholesterolemia and mixed dyslipidemia to reduce total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels and to increase HDL cholesterol levels. It is also used as an adjunct therapy for patients with homozygous familial hypercholesterolemia or in cases where other treatments are ineffective. This medication is recommended when dietary and non-drug therapies are insufficient and is prescribed based on the results of lipid tests to treat secondary causes of dyslipidemia. This helps to reduce the risk of vascular diseases and maintain healthy blood lipid levels.

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. The recommended starting dose is 10/10 mg or 10/20 mg per day. For patients requiring significant LDL cholesterol reduction, a starting dose of 10/40 mg per day is recommended. After initiating therapy or adjusting the dose, lipid levels should be checked at an interval of more than 2 weeks.

Precautions

This medication has rare side effects such as rhabdomyolysis which can cause serious muscle damage; therefore, patients showing severe symptoms of myopathy or those with impaired renal function should stop or temporarily cease using this medication. Patients who have allergies to the active ingredients or excipients of this medication, have severely impaired liver function, have muscle diseases, are pregnant or may become pregnant, are breastfeeding, are taking certain antiviral medications, or have genetic conditions like lactose intolerance should not take this medication. Patients at high risk of myopathy, including alcoholics, those with a history of liver disease, those with impaired renal function or hypothyroidism, and the elderly should use this medication with caution, and when taking with certain drugs, the risk of muscle-related side effects may increase, thus careful monitoring is required. During the use of this medication, side effects such as muscle pain, weakness, abdominal pain, and elevated liver enzyme levels may occur, and if such symptoms manifest, the patient must inform a doctor and undergo evaluation immediately. In case symptoms indicating liver dysfunction appear, such as nausea, vomiting, or fatigue, medication should be discontinued and medical consultation sought, and regular liver function tests are recommended. This medication should not be used during pregnancy or breastfeeding, and women of childbearing potential should use proper contraception while taking this medication. The safety and efficacy of this medication in children have not been established, and it is not recommended due to the risk of myopathy in the elderly, requiring careful administration. When used in conjunction with other drugs, interactions may affect the blood concentration of this medication; thus, especially when taken with certain antibiotics, antivirals, antifungals, or fibrates, it is critical to follow a doctor's instructions. Dizziness may occur while driving or operating machinery, requiring caution. In case of overdose, there is no specific antidote; therefore, symptomatic treatment and supportive care should be received, and regular monitoring of liver function and muscle enzyme levels should be conducted.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (including angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, painful mucosal lesions in the mouth/eyes, severe skin adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by coughing and fever, yellowing of the skin or eyes.

Mild side effects

  • Muscle pain
  • abdominal pain
  • hyperkalemia
  • cough
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • nausea
  • diarrhea
  • vomiting
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  • headache
  • dizziness
  • fatigue
  • malaise
  • chest pain
  • fever
  • flushing
  • back pain
  • constipation
  • pharyngitis
  • sinusitis
  • upper respiratory tract infection
  • rash
  • skin eruptions
  • itching
  • hair loss
  • thrombocytopenia
  • abnormal liver function tests
  • increased serum creatine kinase
  • xerostomia
  • discomfort in the epigastric region
  • belching
  • gastrointestinal discomfort
  • loss of appetite
  • alopecia.

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, and it is advisable to maintain a storage temperature between 1°C and 30°C room temperature. This storage method helps to preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White rectangular film-coated tablets

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.

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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.