Medication info
Abajet Tablet 10/10 mg

Abajet Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
A film-coated tablet in a capsule shape, convex on both sides, consisting of white or pale yellow.
Packaging
30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202101394 · Approved 2021.02.18 · Insurance code 660703510

Summary

Main use
Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia and risk mitigation of cardiovascular diseases by increasing HDL.
Who uses it
Adults
Adult dosage
This medication is taken once daily without regard to meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg. The initial recommended dose is either 10/10 mg or 10/20 mg, and for patients requiring a greater reduction in LDL cholesterol (more than 55%), 10/40 mg is recommended. After starting treatment or adjusting the dosage, lipid levels should be rechecked at intervals of at least 2 weeks.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Reduction of cholesterol in hypercholesterolemia (primary, homozygous familial) and dyslipidemia and risk mitigation of cardiovascular diseases by increasing HDL.

  • Primary hypercholesterolemia
  • dyslipidemia
  • homozygous familial hypercholesterolemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol.
View approved original text

This medication helps lower serum total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients suffering from primary hypercholesterolemia, including familial or non-familial hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is particularly used as an adjunctive therapy in patients with homozygous familial hypercholesterolemia or when other treatments are ineffective. Although the drug is expected to reduce the risk of cardiovascular disease, a thorough diagnosis and adherence to dietary therapy prior to use are crucial. Additionally, other secondary causes such as diabetes and hypothyroidism must be confirmed and managed, and lipid levels should be regularly monitored. This medication is utilized to control serum lipid levels and improve cardiovascular risk.

Dosage and Administration

Adult dosage

This medication is taken once daily without regard to meals. For primary hypercholesterolemia, the dosage range is from 10/10 mg to 10/80 mg. The initial recommended dose is either 10/10 mg or 10/20 mg, and for patients requiring a greater reduction in LDL cholesterol (more than 55%), 10/40 mg is recommended. After starting treatment or adjusting the dosage, lipid levels should be rechecked at intervals of at least 2 weeks.

Precautions

This medication has reported rare side effects such as rhabdomyolysis, which can lead to serious muscle issues. Patients with conditions that may pose a high risk for serious muscle problems, such as acute infections, hypotension, major surgery, trauma, metabolic or electrolyte disturbances, or uncontrolled seizures, may need to temporarily cease or discontinue taking this medication. Patients with allergies to any components of this drug, those with active liver disease or persistent unexplained liver enzyme elevation, patients with muscle disorders, pregnant or potentially pregnant women, nursing mothers, patients taking certain antiviral medications, and those with genetic issues such as lactose intolerance should not take this drug. Individuals with a history of alcohol abuse, liver disease, poor kidney function, hypothyroidism, family history of muscle disorders, the elderly, and patients on specific medications should take this drug cautiously and be closely monitored for muscle pain or drug-related side effects. If symptoms such as muscle pain, weakness, fatigue, or fever appear during treatment, the physician should be informed immediately and necessary tests should be conducted. Since liver function abnormalities may occur, liver function testing should be conducted before and during therapy, and if signs of liver damage appear, the medication should be discontinued. This drug is not to be administered to pregnant or breastfeeding women, and women of childbearing potential should use appropriate contraceptive methods during treatment. Its safety in pediatric patients has not been established and is therefore not recommended. In case of overdose, since there is no specific antidote, management should be symptomatic and should include liver function and muscle enzyme tests. This drug may interact with several medications; hence, patients taking other medications must consult a physician or pharmacist, particularly regarding drugs affecting liver metabolism. Caution is advised regarding dizziness when driving or operating machinery. Regular medical exams and necessary tests during treatment are critical, and any unusual symptoms should be reported immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, skin peeling, severe rashes, blisters, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing, shortness of breath or respiratory distress, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound malaise, liver abnormalities (jaundice), sudden and severe headache, thunderclap headaches, seizures, confusion, vision changes.

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
  • increased ALT
  • increased AST
  • malaise
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture, and it is best kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the drug’s effectiveness for a longer period.

Appearance and packaging

Appearance

A film-coated tablet in a capsule shape, convex on both sides, consisting of white or pale yellow.

Package unit

30 tablets/box [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.