Medication info
Arojet Tablets 10/10 mg

Arojet Tablets 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
White oblong film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202101483 · Approved 2021.02.18 · Insurance code 648604200

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medicine is administered once daily, without regard to meals. For primary hypercholesterolemia, the dosing range is 10/10 mg to 10/80 mg daily. The recommended starting dose is 10/10 mg or 10/20 mg daily. For patients requiring greater reductions in LDL cholesterol (more than 55%), a starting dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dose, lipid levels should be monitored at intervals of more than 2 weeks.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
View approved original text

This medicine is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol levels. It is also administered as an adjunct in patients with homozygous familial hypercholesterolemia when other lipid-lowering therapies are not effective. This medicine is particularly beneficial for those at high risk of atherosclerotic vascular disease due to dyslipidemia and should be used in conjunction with dietary measures such as restriction of saturated fats and cholesterol intake for effectiveness. It is important to identify and treat secondary causes of dyslipidemia such as diabetes and hypothyroidism before use. Regular monitoring of total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels is recommended during therapy, and timely testing and treatment is advised in the event of cardiovascular events requiring hospitalization. This medicine is used to improve lipid levels in patients and assist in managing cardiovascular health.

Dosage and Administration

Adult dosage

This medicine is administered once daily, without regard to meals. For primary hypercholesterolemia, the dosing range is 10/10 mg to 10/80 mg daily. The recommended starting dose is 10/10 mg or 10/20 mg daily. For patients requiring greater reductions in LDL cholesterol (more than 55%), a starting dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dose, lipid levels should be monitored at intervals of more than 2 weeks.

Precautions

This medication carries a risk of serious muscle problems; therefore, if symptoms such as muscle pain or weakness occur, the doctor should be notified immediately. Especially in cases of serious infections, hypotension, major surgery, trauma, or severe metabolic disturbances, administration of this medication should be temporarily suspended or discontinued. This medicine should not be used in patients with allergies to the active ingredient or its components, liver function impairment, muscle diseases, or in women who are pregnant or breastfeeding. Additionally, co-administration with certain antiviral medications is prohibited. Caution is advised for patients with a history of alcohol dependency or liver disease, poor kidney function, hypothyroidism, and the elderly. This medication may cause rare side effects such as myopathy and rhabdomyolysis; if muscle-related symptoms are severe or CPK levels rise significantly, treatment should be discontinued. Liver function abnormalities may occur, so liver tests should be performed before and during treatment, and treatment should be stopped immediately if signs of liver damage appear. This medicine may increase blood glucose levels; however, the risk of diabetes should be regularly monitored in patients at risk while recognizing that its cardiovascular disease prevention benefits outweigh this risk. Women who are pregnant or may become pregnant should not take this medication and should use appropriate contraception during treatment. Nursing mothers are also advised against using this medication. The safety and efficacy of this medication have not been established in pediatric patients, and it is not recommended for such use. Precaution is needed when prescribing to the elderly due to a heightened risk of muscle issues. This medication may interact with other drugs; patients should inform their doctor or pharmacist of any concomitant medications. There is no specific antidote for overdose; treatment should be symptomatic, along with monitoring liver function and muscle-related tests. Keep this medication out of reach of children and avoid transferring it to different containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pale skin, severe rash with high fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination abnormalities

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 28 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • headache
  • fatigue
  • constipation
  • bloating
  • vomiting
  • pharyngitis
  • sinusitis
  • upper respiratory infections
  • muscle cramps
  • neck pain
  • muscle fatigue
  • itching
  • rash
  • hair loss
  • dry skin
  • sweating
  • acne
  • eczema
  • seborrheic dermatitis
  • thrombocytopenia
  • blurred vision
  • tinnitus
  • vomiting
  • abdominal pain

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

Storage

This medicine may be sensitive to air or moisture, so it should be kept in a tightly closed container. The storage temperature should ideally be maintained between 1 and 30 degrees Celsius to preserve its effectiveness for a longer period.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

30 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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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.