Medication info
Atorine Tablets 10 mg (Atorvastatin Calcium Trihydrate)

Atorine Tablets 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)옵투스제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201601007 · Approved 2016.02.23 · Insurance code 674101390

Summary

Main use
Reduction of risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily. For patients requiring more significant reductions in LDL cholesterol levels, the starting dose can be 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. After initiating treatment and adjusting the dosage, lipid levels should be analyzed within 2-4 weeks for further dosage adjustments. The goal of treatment is to lower LDL cholesterol levels; therefore, LDL cholesterol is recommended for assessing treatment initiation and response. If LDL cholesterol levels cannot be used, total cholesterol levels should be monitored to gauge treatment response. For patients with homozygous familial hypercholesterolemia, the treatment dosage is 10 to 80 mg once daily, given in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.
Children's dosage
The recommended starting dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage should be adjusted at intervals of four weeks or more.

Ingredients

Manufacturer
(주)옵투스제약

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • dysbeta-lipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
View approved original text

This medication reduces the risks of myocardial infarction, stroke, the need for vascular revascularization, angina, and hospitalization for congestive heart failure in adults with multiple risk factors related to cardiovascular disease and patients with type 2 diabetes. It also lowers total cholesterol, LDL cholesterol, and triglyceride levels, while raising HDL cholesterol levels in patients with primary hypercholesterolemia and dyslipidemia, thereby supporting cardiovascular health. It is also used to decrease total cholesterol and LDL cholesterol levels in certain pediatric patients aged 10 to 17. Overall, this medication helps to reduce the risk of cardiovascular disease and improve dyslipidemia.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily. For patients requiring more significant reductions in LDL cholesterol levels, the starting dose can be 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. After initiating treatment and adjusting the dosage, lipid levels should be analyzed within 2-4 weeks for further dosage adjustments. The goal of treatment is to lower LDL cholesterol levels; therefore, LDL cholesterol is recommended for assessing treatment initiation and response. If LDL cholesterol levels cannot be used, total cholesterol levels should be monitored to gauge treatment response. For patients with homozygous familial hypercholesterolemia, the treatment dosage is 10 to 80 mg once daily, given in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.

Children's dosage

The recommended starting dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage should be adjusted at intervals of four weeks or more.

Precautions

This medication may pose a risk of muscle problems; therefore, if symptoms of muscle pain or weakness occur, immediate discontinuation and consultation with a physician are required. This medication should not be used in women with certain conditions, during pregnancy, during breastfeeding, or in children under 10 years of age. Patients with liver or kidney function issues should use this medication with caution, and regular monitoring of liver function and muscle condition is important. Interactions may occur when taken with other medications, so patients should inform their doctor or pharmacist of any medications they are currently taking. It is recommended to avoid or limit alcohol intake during the medication course, and excessive grapefruit juice should also be avoided. Women who may become pregnant should use appropriate contraceptive methods while taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. Women who are breastfeeding should not take this medication, and special caution is needed for children and older adults when using this medication. There is no specific antidote for overdose, so in case of overdosage, it is essential to visit a medical institution immediately for treatment based on symptoms. Keep this medication out of reach of children, and it is safest to store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a temperature range of 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

White oval film-coated 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

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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.