Medication info
Arotin Plus Tablets 10/40 mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Arotin Plus Tablets 10/40 mg (Ezetimibe/Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)씨티씨바이오
Appearance
White or whitish oblong film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202101484 · Approved 2021.02.18 · Insurance code 669502680

Summary

Main use
Reduction of cholesterol and increase of HDL to alleviate the risk of cardiovascular disease in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is between 10/10 mg and 10/80 mg daily, with an initial recommended dose of 10/10 mg or 10/20 mg daily. If a significant reduction in LDL cholesterol is needed, an initial dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dose, lipid levels should be checked after an interval of more than two weeks.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Reduction of cholesterol and increase of HDL to alleviate 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 disease due to hypercholesterolemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medication helps reduce elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels, while also increasing HDL cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia. Additionally, it may be used either as an adjunct to other lipid-lowering therapies or as an alternative treatment when such therapies are insufficient for patients with homozygous familial hypercholesterolemia. It is important that this medication is used in conjunction with dietary changes, and optimal effects are achieved when combined with dietary management and lifestyle improvements rather than used alone. If dyslipidemia is induced by other diseases or medications, it is necessary to first identify and treat the causes. Appropriate testing is essential to accurately ascertain blood lipid levels, and in the event of acute cardiovascular incidents, lipid levels should be promptly assessed to inform appropriate treatment plans. This medication is very effective in the management of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage range is between 10/10 mg and 10/80 mg daily, with an initial recommended dose of 10/10 mg or 10/20 mg daily. If a significant reduction in LDL cholesterol is needed, an initial dose of 10/40 mg daily is recommended. After starting treatment or adjusting the dose, lipid levels should be checked after an interval of more than two weeks.

Precautions

This medication is used to lower blood cholesterol levels. There is a risk of muscle problems, so if you experience severe muscle pain or weakness, you should inform your doctor immediately. Due to the possibility of kidney issues from muscle damage, this medication may be temporarily discontinued if there are pre-existing kidney or liver diseases, or in situations involving serious infections, trauma, or after surgery. Patients with liver dysfunction or persistently elevated liver enzymes should not take this medication. Individuals who are allergic to any of the components of this medication, those with muscle diseases, and women who are pregnant or breastfeeding should not use this medication. This medication should not be taken in conjunction with certain antiviral agents or fibrate medications, so anyone taking other medications should inform their healthcare provider without fail. Patients who consume alcohol excessively, have a history of liver disease, elderly patients, and those with hypothyroidism should use this medication cautiously and may require regular monitoring. Regular liver function tests and muscle-related tests should be conducted during the treatment, and any unusual symptoms must be discussed with healthcare professionals immediately. Caution is advised when driving or operating machinery due to the possibility of dizziness. Women planning to become pregnant should consult healthcare professionals before starting this medication and should use appropriate contraceptive methods during treatment. There are numerous drug interactions, so it is crucial to inform healthcare professionals of any other medications being taken and to consult regarding dosages or alternative medications. There is no specific antidote for overdose, so appropriate treatment and supportive care are necessary based on symptoms, and liver function and muscle conditions should be monitored. This medication has not been established for safety and efficacy in children and is not recommended.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, cholestatic jaundice, jaundice, hepatitis, liver failure, acute renal failure, renal failure, severe edema, hypertension accompanied by

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • dizziness
  • headache
  • hyperkalemia
Show 28 more
  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • chest pain
  • malaise
  • lethargy
  • chest discomfort
  • swelling
  • generalized edema
  • rash
  • urticaria
  • itching
  • hair loss
  • contact dermatitis
  • dry skin
  • sweating
  • acne
  • eczema
  • seborrhea
  • hyperhidrosis
  • thrombocytopenia
  • insomnia
  • nightmares
  • blurred vision
  • tinnitus
  • vomiting
  • constipation

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and humidity, ideally at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness over a longer period.

Appearance and packaging

Appearance

White or whitish oblong film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.