Medication info
Spitin Tablet 80 mg (Atorvastatin Calcium Trihydrate)

Spitin Tablet 80 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›86.8mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
White, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202101463 · Approved 2021.02.18 · Insurance code 641607510

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults
Adult dosage
Atorvastatin is initiated with a dose of 10 mg once daily at any time regardless of meals, and for those requiring more significant LDL cholesterol reduction, can start at 20 mg or 40 mg. The prescribed dose should be individualized within the range of 10 to 80 mg once daily according to treatment goals and patient response, and lipid levels should be evaluated 2 to 4 weeks after starting the medication to adjust dosage.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • angioplasty
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication helps reduce the risk of various cardiovascular diseases. In particular, it decreases the risk of myocardial infarction and stroke in individuals with risk factors such as hypertension, smoking, and high cholesterol, and it also reduces the need for angioplasty and the occurrence of stable angina. It is effective in reducing the risk of cardiovascular complications in patients with Type 2 diabetes who have risk factors. For patients already with coronary heart disease, it lowers the risk of non-fatal myocardial infarction, stroke, angina, and hospitalization due to congestive heart failure. Additionally, this medication is used to treat hyperlipidemia, particularly effective in lowering total cholesterol, LDL cholesterol, and triglycerides, while increasing HDL cholesterol levels in patients with primary hypercholesterolemia and dyslipidemia. It is used to improve cardiovascular health due to these effects.

Dosage and Administration

Adult dosage

Atorvastatin is initiated with a dose of 10 mg once daily at any time regardless of meals, and for those requiring more significant LDL cholesterol reduction, can start at 20 mg or 40 mg. The prescribed dose should be individualized within the range of 10 to 80 mg once daily according to treatment goals and patient response, and lipid levels should be evaluated 2 to 4 weeks after starting the medication to adjust dosage.

Precautions

This medication may cause muscle issues, so if symptoms such as muscle pain or weakness occur, stop taking it immediately and consult a doctor. Do not take this medication if you have allergic reactions, severe liver disease, or muscle disease. Women who are pregnant, may become pregnant, or are breastfeeding, as well as children under 10 years old, should not use this medication. Individuals with liver function issues or those who consume alcohol excessively should use this medication cautiously and require regular liver function tests. While taking this medication, if you experience unusual symptoms such as muscle pain, weakness, fever, or fatigue, inform your doctor immediately. The risk of muscle damage may increase when used in combination with certain antibiotics, antifungals, and antivirals, so inform your doctor of any other medications you are taking. Grapefruit juice can raise the blood levels of this medication and increase the risk of side effects, so avoid excessive consumption. This medication may elevate blood sugar levels, so people at risk of diabetes should carefully manage their blood sugar. Elderly patients or those with decreased kidney function have a higher risk of muscle-related side effects, so more caution is needed during administration. Regular blood tests and liver function tests should be conducted while taking this medication, and usage should be stopped immediately if any abnormalities are found. The safety of this medication for long-term use in children and adolescents has not been sufficiently confirmed, so caution is advised. Pregnant or breastfeeding women should not use this medication, and appropriate contraception should be used if planning a pregnancy. There is no specific antidote for overdose, so treatment should be symptomatic, and close monitoring of liver function and muscle condition should be conducted according to a doctor's instructions. Keep out of reach of children, and store in the original container to prevent misuse or quality deterioration.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, 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
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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. The storage temperature should be maintained between 1°C and 30°C at room temperature to ensure the effectiveness of the medication.

Appearance and packaging

Appearance

White, round film-coated tablet

Package unit

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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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.