Medication info
Summito 10 mg (Atorvastatin Calcium)

Summito 10 mg (Atorvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium›10.36mg / 1 tablet
Manufacturer / importer
한국넬슨제약(주)
Appearance
White oval film-coated tablet
Packaging
100 tablets (bottle), 30 tablets (bottle)
Approval status
Active

MFDS item code 201310393 · Approved 2013.11.29 · Insurance code 656701910

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater LDL-cholesterol reduction is required, treatment may start at 20 mg or 40 mg once daily. The dosing range is 10 mg to 80 mg once daily. Dose adjustments should be made according to treatment goals and patient response at intervals of 2-4 weeks. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 mg to 80 mg once daily.
Child dose
For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and a maximum of 20 mg once daily may be used. Dose adjustments should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

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

  • Coronary heart disease
  • multiple risk factors
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
View approved original text

This medicine helps reduce the risk of cardiovascular diseases. It lowers the risk of myocardial infarction and stroke, and is effective in preventing vascular surgeries and chronic stable angina. It is especially used to reduce the occurrence of cardiovascular events in adult patients with diabetes or multiple risk factors. Additionally, it reduces cholesterol and triglyceride levels in patients with hyperlipidemia and increases good cholesterol, HDL-cholesterol. It is also used for treating familial hypercholesterolemia in children and adolescents, improving total cholesterol and LDL-cholesterol levels. Therefore, this medication is used to maintain cardiovascular health and effectively manage related diseases.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater LDL-cholesterol reduction is required, treatment may start at 20 mg or 40 mg once daily. The dosing range is 10 mg to 80 mg once daily. Dose adjustments should be made according to treatment goals and patient response at intervals of 2-4 weeks. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 mg to 80 mg once daily.

Child dose

For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and a maximum of 20 mg once daily may be used. Dose adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication may affect muscles, so if severe muscle pain or weakness occurs, discontinue use immediately and consult a physician. It is particularly important to stop using this medication if there is a significant increase in enzyme levels related to muscle damage or if myopathy is suspected. Do not take this medication if there is an active liver disease or if liver function levels are abnormally high. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not use this medication. Children under 10 years old or patients with certain genetic lactose intolerance should also not take this medication. Individuals with a history of alcohol abuse or liver disease should exercise extra caution when taking this medication and should have regular liver function tests if necessary. Elderly patients and those with impaired kidney function are at a higher risk of muscle-related side effects and should take caution while using this medication. This medication can interact with several drugs, so it is essential to inform your doctor or pharmacist if you are taking other medicines. In particular, the risk of side effects may increase when used in conjunction with certain antibiotics, antifungals, antivirals, and some blood pressure medications. During the use of this medication, if symptoms such as liver dysfunction, muscle pain, fever, or fatigue appear, notify your doctor immediately. Additionally, this medication requires proper storage and should be kept out of reach of children. There is no specific antidote for overdose, so treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored regularly.

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 mouth/eye mucosa, yellowing of the skin or eyes (jaundice), extreme drowsiness, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe swelling throughout the body accompanied by elevated blood pressure, anaphylaxis

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 distension
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory impairment
  • 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 may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness for a long time.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

100 tablets (bottle), 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.