Medication info
Arovant 20 mg (Atorvastatin Calcium Trihydrate)

Arovant 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
영일제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201603076 · Approved 2016.05.30 · Insurance code 649404880

Summary

Main use
Reduction of risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dose for hyperlipidemia treatment is 10 mg of atorvastatin taken once daily, and if more LDL cholesterol reduction is needed, it can be started at 20 mg or 40 mg once daily. Generally, the drug is administered once daily within a range of 10 to 80 mg. Lipid levels should be analyzed and the dose adjusted every 2 to 4 weeks after starting treatment. For patients with homozygous familial hypercholesterolemia, the dose is 10 to 80 mg once daily.
Children's dosage
The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. Dosing adjustments should be made individually according to therapeutic goals.

Ingredients

Manufacturer
영일제약(주)

Efficacy & effects

Reduction of risk of myocardial infarction and stroke, and improvement of hyperlipidemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hyperlipidemia
  • primary hypercholesterolemia
View approved original text

This medication is used to reduce the risk of various cardiovascular diseases. It decreases the risk of myocardial infarction, stroke, vascular surgery, chronic stable angina, congestive heart failure, and angina, among others. It is especially effective for adults with risk factors such as hypertension, smoking, and family history, as well as for patients with type 2 diabetes. Additionally, it helps treat hyperlipidemia by lowering total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels, while increasing HDL cholesterol. It is also used as an adjunct therapy in the treatment of pediatric patients aged 10 to 17 years with familial hypercholesterolemia. This drug is used to reduce the risk of cardiovascular disease and improve hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended initial dose for hyperlipidemia treatment is 10 mg of atorvastatin taken once daily, and if more LDL cholesterol reduction is needed, it can be started at 20 mg or 40 mg once daily. Generally, the drug is administered once daily within a range of 10 to 80 mg. Lipid levels should be analyzed and the dose adjusted every 2 to 4 weeks after starting treatment. For patients with homozygous familial hypercholesterolemia, the dose is 10 to 80 mg once daily.

Children's dosage

The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. Dosing adjustments should be made individually according to therapeutic goals.

Precautions

This medication should be discontinued immediately if muscle-related abnormalities occur. Especially if muscle pain, muscle weakness, or muscle cramps occur along with a significant increase in creatine kinase levels, medical attention should be sought. This drug should not be used in patients with specific liver diseases or in those with severely impaired liver function. If liver function test results are significantly abnormal, the medication should be discontinued. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, as it may be harmful to the fetus or nursing infant. This medication should not be administered to children, especially those under 10 years of age, as safety and efficacy have not been established. Care should be taken when using this medication in patients with certain conditions such as liver disease, renal impairment, hypothyroidism, or alcoholism, and regular monitoring should be conducted to assess their status. There may be interactions with other medications, so if the patient is currently taking any other medications, it is essential to inform the physician or pharmacist. Caution is especially needed when combining with certain antibiotics, antifungals, HIV treatments, and other lipid-lowering agents. During treatment with this medication, if symptoms such as liver function abnormalities, muscle pain, fatigue, or fever occur, the physician should be consulted immediately, and blood tests may be necessary to monitor liver and muscle status. This medication poses a higher risk of myopathy in alcohol abusers or the elderly, so these patients should be observed more closely. Appropriate contraceptive measures should be used during treatment, and if pregnancy is confirmed, the medication should be discontinued immediately and the healthcare provider should be consulted. When storing this medication, keep it out of reach of children, and it should be stored in the original container; it is safest not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • anorexia
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should maintain room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.

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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.