Medication info

Altomib Tablets 10/20 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 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Approval withdrawn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 202101594 · 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This product's status changed to Approval withdrawn on 2025.06.23.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 in hypercholesterolemia (primary, homozygous familial) and improvement of lipids through cholesterol reduction and HDL increase in dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg once a day is recommended. For patients requiring greater LDL cholesterol reduction, an initial dose of 10/40 mg once a day is recommended. After initiation of treatment or dosage adjustment, lipid levels should be checked at least every two weeks, and the dosage should be adjusted accordingly. Homozygous familial hypercholesterolemia

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and improvement of lipids through cholesterol reduction and HDL increase in dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • increased risk of atherosclerotic vascular diseases caused by hypercholesterolemia
View approved original text

This medication is primarily used to control cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It effectively lowers total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol while raising HDL cholesterol. Additionally, it can be used alone or in conjunction with other therapies in patients with homozygous familial hypercholesterolemia. This medication is used as an adjunct treatment when non-pharmacological therapies such as dietary measures are insufficient, and it is important to identify and treat other secondary causes before use. It helps improve health status through cholesterol control in patients at high risk for cardiovascular diseases. This way, it is used to treat dyslipidemia by keeping blood lipid levels balanced.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg once a day is recommended. For patients requiring greater LDL cholesterol reduction, an initial dose of 10/40 mg once a day is recommended. After initiation of treatment or dosage adjustment, lipid levels should be checked at least every two weeks, and the dosage should be adjusted accordingly. Homozygous familial hypercholesterolemia

Precautions

This medication can cause a rare side effect called rhabdomyolysis, which can lead to serious muscle issues. Immediate medical attention is required if symptoms of severe muscle pain or weakness occur. Patients who are allergic to the active ingredient or components, those with severe liver dysfunction, those with muscle diseases, women who are pregnant or may become pregnant, nursing mothers, individuals taking specific hepatitis medications, and those with lactose intolerance should not take this medication. Patients with a history of alcohol dependence or liver disease, those with reduced kidney function, those with hypothyroidism, individuals with a family history of muscle diseases or previous experiences of muscle toxicity from similar medications, and those aged 70 years or older should use this medication with caution. Regular monitoring of liver function and muscle status is necessary during treatment, and any symptoms such as liver dysfunction, muscle pain, muscle weakness, severe fatigue, or fever should prompt immediate consultation with healthcare professionals. Furthermore, this medication may interact with several other drugs, so patients must inform healthcare professionals of any medicines currently being taken, particularly when used with certain antibiotics, antivirals, antifungals, immunosuppressants, and fibrate medications. Women who are pregnant or nursing should not use this medication, and women of childbearing potential should use appropriate contraception during treatment. Care is needed while driving or operating machinery, as dizziness may occur. Finally, this medication is not recommended for children as its safety and efficacy have not been established. The elderly should also exercise caution due to the increased risk of muscle problems.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), high fever with severe rash, blisters, skin peeling, pain of oral/ocular mucosa (severe skin adverse reaction), shortness of breath or difficulty breathing, asthma attacks, cough with fever-related respiratory abnormalities (respiratory issues), yellowing of skin or eyes (jaundice), severe lethargy (liver abnormalities), sudden and severe

Mild side effects

  • Muscle pain
  • abdominal pain
  • hyperkalemia
  • headache
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 23 more
  • fatigue
  • dizziness
  • pharyngitis
  • sinusitis
  • flushing
  • bronchiolitis
  • dental abscess
  • vestibular neuritis
  • bradycardia
  • anemia
  • hernia
  • vitamin D deficiency
  • gastric polyps
  • duodenal polyps
  • duodenitis
  • erectile dysfunction
  • breast lump
  • skin lump
  • ingrown toenails
  • thyroid adenoma
  • depression
  • upper respiratory infection
  • conjunctival hyperemia

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

Storage

Store this medication in a tightly closed container to prevent air or moisture ingress, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain 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.

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.