Medication info
Spitin Tablets 40 mg (Atorvastatin Calcium Trihydrate)

Spitin Tablets 40 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200809440 · Notified 2008.09.11 · Insurance code 641604610

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who takes it
Adults
Adult dose
For hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily, and for patients requiring greater LDL cholesterol reduction, it may start with 20 mg or 40 mg once daily. The dosing range is from 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment and dose adjustments.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • symptoms related to angioplasty
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • beta-lipoproteinemia
  • elevated serum triglycerides
View approved original text

This medication is effective in reducing the risk of cardiovascular diseases. It lowers the risk of myocardial infarction and stroke in patients with multiple risk factors for coronary heart disease (e.g., hypertension, smoking, diabetes, etc.), and it reduces the need for angioplasty as well as symptoms of angina. Furthermore, in patients already diagnosed with coronary artery disease, it also decreases the risk of myocardial infarction, stroke, and hospitalization for congestive heart failure. Additionally, it helps lower LDL cholesterol and total cholesterol levels while increasing HDL cholesterol levels in patients with hyperlipidemia. It is particularly used for treating various forms of hyperlipidemia and dyslipidemia that are not controlled by dietary regulation. Overall, it is widely utilized for the prevention and management of cardiovascular diseases.

How to take

Adult dose

For hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily, and for patients requiring greater LDL cholesterol reduction, it may start with 20 mg or 40 mg once daily. The dosing range is from 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment and dose adjustments.

Precautions

This medication may cause unusual symptoms in muscles; hence, if there are severe or persistent symptoms of muscle pain or weakness, it is essential to consult a doctor immediately. Particularly, if there is a significant increase in muscle enzyme levels or if muscle disease is suspected, the medication should be discontinued. Patients with liver problems or those with significantly elevated liver enzyme levels should not use this medication. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Children under 10 years of age should also refrain from using this medication. This drug contains lactose, so patients with lactose intolerance should avoid use. Patients who consume alcohol heavily or have a history of liver disease should use this medication with caution and undergo regular liver function tests. Elderly patients are at a higher risk for muscle disease and rhabdomyolysis, so they must take the medication with increased caution. Interactions may occur when taken with other medications; therefore, it is crucial to inform the physician or pharmacist of any other medications being taken. Caution is especially required when taken alongside specific antibiotics, antifungal drugs, antiviral medications, and certain antihypertensives. Regular monitoring of liver function and muscle status during the use of this medication is crucial. There are no specific antidotes for overdose; hence, appropriate treatment should be provided based on symptoms. Keep out of reach of children and store in the original container. If allergic reactions such as skin rash, itching, or breathing difficulties occur, discontinuation of the medication is essential, and healthcare professionals should be informed. Adequate contraception should be enforced during the use of this medication, and if pregnancy is confirmed, immediate discontinuation is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rashes, blisters, peeling skin, pain in mucous membranes of mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe reactions

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngitis
  • laryngitis
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorder
  • amnesia
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramping
  • joint pain

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

Storage

This medication must be stored in a tightly sealed container to protect it from air or moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. This helps to preserve the medication's efficacy and safety.

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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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.