Medication info
Spitin Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Spitin Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›20.7mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200807684 · Notified 2008.07.10 · Insurance code 641602880

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
Hyperlipidemia The recommended initial dose is 10 mg of atorvastatin once daily, but for patients requiring a greater reduction in LDL cholesterol, it may start at 20 mg or 40 mg once daily. This medication is administered at a dosage range of 10 to 80 mg once daily. After initiating treatment and adjusting the dose, lipid levels should be analyzed within 2 to 4 weeks to adjust the dose accordingly. For homozygous familial hypercholesterolemia patients, the dosage is administered at 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when those therapies are not possible.
Child dose
Heterozygous familial hypercholesterolemia pediatric patients (ages 10 to 17) The recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosage may be adjusted according to therapeutic goals.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

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

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

This medication helps reduce the risk of cardiovascular diseases. It is particularly effective in reducing the risk of myocardial infarction and stroke, as well as lowering the risk of angioplasty and angina. It plays a role in treating hyperlipidemia by lowering major cholesterol levels and increasing good HDL cholesterol. Additionally, it is used for treating dyslipidemia in pediatric patients aged 10 to 17 years with a familial predisposition or many risk factors for cardiovascular diseases. This medication is effective in protecting heart health and improving vascular-related issues.

How to take

Adult dose

Hyperlipidemia The recommended initial dose is 10 mg of atorvastatin once daily, but for patients requiring a greater reduction in LDL cholesterol, it may start at 20 mg or 40 mg once daily. This medication is administered at a dosage range of 10 to 80 mg once daily. After initiating treatment and adjusting the dose, lipid levels should be analyzed within 2 to 4 weeks to adjust the dose accordingly. For homozygous familial hypercholesterolemia patients, the dosage is administered at 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when those therapies are not possible.

Child dose

Heterozygous familial hypercholesterolemia pediatric patients (ages 10 to 17) The recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosage may be adjusted according to therapeutic goals.

Precautions

This medication may cause unusual muscle reactions, so if muscle pain or weakness worsens, you should immediately stop taking it and consult your doctor. In particular, if there is a significant increase in muscle enzyme levels or suspicion of serious myopathy, the medication should be discontinued. It should not be used in patients with liver function problems or liver disease, and regular liver function tests are required. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and fertile women should use appropriate contraception while on this medication. Children or pediatric patients under 10 years old should not take this medication. Caution is needed for patients with a history of alcoholism or liver disease, elderly patients, and patients with decreased kidney function, and they should carefully monitor for side effects. It may interact with other medications, especially when combined with certain antibiotics, antifungals, antivirals, immunosuppressants, and some lipid-lowering agents. This medication contains lactose, so patients with lactose intolerance should not take it. If symptoms of liver and muscle dysfunction appear during treatment, you should promptly inform your doctor and regular blood tests and liver function tests will be necessary. There is no specific antidote for overdose, and treatment should be based on symptoms while monitoring liver function and muscle enzyme levels. Store out of reach of children, keep in the original container, and avoid transferring to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe allergic reaction, severe rash with high fever, blisters, skin peeling, oral/eye mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver problems (jaundice), sudden onset

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paraesthesia
  • loss of sensation
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. A storage temperature between 1 degree and 30 degrees Celsius is recommended.

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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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.