Medication info

Arotatin Tablets 20 Milligrams (Atorvastatin Calcium Hydrate)

Prescription medicationExpired
Ingredient · strength
Atorvastatin Calcium Hydrate›Strength being verified
Manufacturer / importer
(주)유앤생명과학
Appearance
White film-coated round tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201801460 · Approved 2018.04.02

This product's status changed to Expired on 2023.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
It can be administered at any time of the day, regardless of food. The recommended initial dose for hyperlipidemia is 10 mg once daily, but for patients requiring more significant reductions in LDL cholesterol levels, treatment can be started at 20 mg or 40 mg once daily. It can be administered in a range of 10 mg to 80 mg once daily. Dosage should be personalized based on therapeutic goals and response, with lipid levels analyzed for adjustment within 2 to 4 weeks.
Children's dosage
The recommended initial dose for pediatric patients (10 - 17 years old) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosage adjustments should be made according to therapeutic goals, and re-evaluated every 4 weeks.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

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

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • vascular surgeries
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hyperlipidemia
View approved original text

This medication helps to reduce the risk of cardiovascular diseases. Specifically, it decreases the risk of myocardial infarction, stroke, vascular surgeries, and angina in adults with risk factors for coronary artery disease and patients with type 2 diabetes. It also reduces the risk of non-fatal myocardial infarction and stroke in adults who already have coronary artery disease, and lowers the risk of hospitalization due to congestive heart failure. In patients with hyperlipidemia, it is used to lower total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels while increasing HDL cholesterol levels. It is especially beneficial in managing cholesterol levels in pediatric patients with familial hypercholesterolemia. Overall, this drug is used to improve cardiovascular health.

Dosage and Administration

Adult dosage

It can be administered at any time of the day, regardless of food. The recommended initial dose for hyperlipidemia is 10 mg once daily, but for patients requiring more significant reductions in LDL cholesterol levels, treatment can be started at 20 mg or 40 mg once daily. It can be administered in a range of 10 mg to 80 mg once daily. Dosage should be personalized based on therapeutic goals and response, with lipid levels analyzed for adjustment within 2 to 4 weeks.

Children's dosage

The recommended initial dose for pediatric patients (10 - 17 years old) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosage adjustments should be made according to therapeutic goals, and re-evaluated every 4 weeks.

Precautions

This medication carries a risk of muscle issues; therefore, if symptoms such as muscle pain or weakness occur, you must inform your doctor immediately. This drug should not be used in patients with certain liver diseases or severely impaired liver function. Pregnant or potentially pregnant women, as well as breastfeeding mothers, should not take this medication. Children, particularly those under 10 years of age, should not be administered this drug. Regular liver function tests are important as there may be liver function abnormalities or symptoms of hepatitis. This medication can interact with other drugs, so it is imperative to inform your doctor or pharmacist about any other medications you are taking. Particular caution is required when taken with certain antibiotics, antifungals, antivirals, and some cardiovascular medications. Grapefruit juice can increase the blood concentration of this medication, so it is advisable to avoid grapefruit juice during treatment. Alcohol consumption can burden the liver, so it should be limited as much as possible. Elderly patients are at a higher risk of muscle-related issues and should exercise greater caution when taking this medication. In case of overdose, since there are no specific antidotes, it is important to receive appropriate treatment according to symptoms. This medication should be kept out of reach of children and stored in its original container for safety.

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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory distress, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • loss of appetite
  • constipation
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • amnesia
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, the drug should be kept at room temperature between 1°C to 30°C. This way of storage helps maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

White film-coated round tablet

Package unit

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

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.