Medication info
Atorjet Tablets 10/20 Milligrams

Atorjet Tablets 10/20 Milligrams

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)한국피엠지제약
Appearance
White oblong film-coated tablets
Packaging
30 tablets/box[(10 tablets/PTP packaging (Alu-Alu) x 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202101543 · Approved 2021.02.18 · Insurance code 697101030

Summary

Main use
Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This drug is taken once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily, with a recommended starting dose of either 10/10 mg or 10/20 mg daily. For patients requiring a significant reduction in LDL-cholesterol, a starting dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels should be checked at least two weeks apart.

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia

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

This drug is used as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and for the increase of HDL-cholesterol levels. It may also be used in patients with homozygous familial hypercholesterolemia either alone or together with other lipid-lowering therapies (e.g., LDL-Apheresis) when those treatments are not effective. It should be administered with appropriate dietary measures, including limitation of saturated fats and cholesterol, and any secondary causes of dyslipidemia should be investigated and treated. Since this drug has not established a clear benefit in reducing cardiovascular morbidity and mortality, it should be administered while considering the patient's risk factors. Lipid testing, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides, is important, and in patients with an acute coronary event, lipid levels should be measured at admission or within 24 hours. Thus, this drug improves lipid levels in managing hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This drug is taken once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is 10/10 mg to 10/80 mg daily, with a recommended starting dose of either 10/10 mg or 10/20 mg daily. For patients requiring a significant reduction in LDL-cholesterol, a starting dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dosage, lipid levels should be checked at least two weeks apart.

Precautions

This drug may rarely cause muscle damage, so if symptoms of severe muscle pain or muscle weakness occur, the doctor should be notified immediately. In patients at high risk for muscle damage, for example after severe infections, hypotension, major surgery, or trauma, the use of this drug should be temporarily stopped or discontinued. Patients allergic to any components of this drug, those with active liver disease or persistent unexplained increases in liver enzymes, or patients with muscle disorders should not use this drug. Women who are pregnant or may become pregnant, as well as nursing women, should not use this drug. Moreover, patients taking certain antiviral drugs or fibrate-class medications should not take this drug concurrently. Patients with a history of alcohol abuse or liver disease, those with severe liver dysfunction, or patients with kidney impairment or hypothyroidism should use this drug cautiously. This drug contains yellow pigment, so individuals with allergies to it should take care. Patients taking this drug should regularly undergo liver function tests, and if any symptoms of liver dysfunction (e.g., nausea, vomiting, fatigue, etc.) occur, they should consult a doctor immediately. This drug has many interactions with other medications, so if patients are taking other medications, they must inform their doctor or pharmacist, especially if combined with drugs that affect liver metabolism. While taking this drug, dizziness or muscle pain may occur, so caution should be exercised when driving or operating machinery. There are no specific antidotes for overdose, so patients should visit a medical institution immediately for appropriate treatment and monitoring. Safety and efficacy in children have not been established, so it is not recommended for use in this population. Elderly patients are at higher risk of muscle damage, so they should be observed carefully without dose adjustments. This drug should be kept out of the reach of children and should not be transferred to another container.

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 fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision changes, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • dizziness
  • diarrhea
  • nausea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
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  • sinusitis
  • flushing
  • fatigue
  • headache
  • constipation
  • hyperglycemia
  • hypoglycemia
  • loss of appetite
  • dyspepsia
  • vomiting
  • belching
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • taste disturbance
  • amnesia
  • peripheral neuropathy
  • itching
  • skin rash
  • hair loss
  • thrombocytopenia
  • hepatitis
  • blurred vision

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

Storage

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

30 tablets/box[(10 tablets/PTP packaging (Alu-Alu) x 3)], 30 tablets/bottle, 100 tablets/bottle

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.