Medication info
Spitin Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Spitin Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.35mg / 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 200807683 · Notified 2008.07.10 · Insurance code 641602890

Summary

Main use
Reduction of risk for myocardial infarction and stroke, improvement of hypercholesterolemia
Who takes it
Adults · Children
Adult dose
For hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily, but if a greater reduction of LDL-cholesterol is required, 20 mg or 40 mg can be initiated once daily. This medication is dosed in the range of 10 to 80 mg once daily. The initial and maintenance doses of this medication should be individualized based on treatment goals and responses, and lipid levels should be evaluated 2 to 4 weeks after initiation and/or dose adjustment. The goal of treatment is to lower LDL-cholesterol, so using LDL-cholesterol levels during treatment initiation and evaluation is recommended. If LDL-cholesterol levels cannot be used, total cholesterol can be utilized to monitor treatment response. In patients with homozygous familial hypercholesterolemia, this medication is administered at a dose of 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies or when such therapies are not feasible.
Child dose
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage can be adjusted based on individual patient treatment goals.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Reduction of risk for myocardial infarction and stroke, improvement of hypercholesterolemia

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

This medication helps reduce the risk of cardiovascular diseases. It particularly decreases the risk of myocardial infarction, stroke, vascular procedures, hospitalization due to congestive heart failure, angina, and various cardiovascular diseases. It lowers total cholesterol, LDL-cholesterol, Apo-B protein, and triglyceride levels in patients with hyperlipidemia while increasing HDL-cholesterol levels to improve blood lipid status. It is effectively used to manage cholesterol levels in patients with familial hypercholesterolemia, especially in children and adolescents aged 10 to 17 years who find it difficult to control with diet alone. Overall, this drug helps manage several risk factors for cardiovascular diseases and improve dyslipidemia to maintain cardiovascular health. Therefore, it is used for reducing the risk of cardiovascular disease and treating hyperlipidemia.

How to take

Adult dose

For hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily, but if a greater reduction of LDL-cholesterol is required, 20 mg or 40 mg can be initiated once daily. This medication is dosed in the range of 10 to 80 mg once daily. The initial and maintenance doses of this medication should be individualized based on treatment goals and responses, and lipid levels should be evaluated 2 to 4 weeks after initiation and/or dose adjustment. The goal of treatment is to lower LDL-cholesterol, so using LDL-cholesterol levels during treatment initiation and evaluation is recommended. If LDL-cholesterol levels cannot be used, total cholesterol can be utilized to monitor treatment response. In patients with homozygous familial hypercholesterolemia, this medication is administered at a dose of 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies or when such therapies are not feasible.

Child dose

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage can be adjusted based on individual patient treatment goals.

Precautions

This medication should be discontinued immediately and a doctor consulted if any unusual symptoms occur in the muscles. There is a risk of developing serious muscle diseases such as myopathy or rhabdomyolysis, so caution is needed, especially for patients with renal or liver function issues. It should not be used by those allergic to this medication or who have liver or muscle diseases, by pregnant or breastfeeding women, children under 10 years of age, or patients taking certain medications. Patients with a history of alcoholism or liver disease, hypothyroidism, and the elderly should be more cautious and report any muscle-related symptoms to healthcare providers immediately. Regular liver function tests and blood tests should be performed while on this medication, and if symptoms of hepatitis, muscle pain, fatigue, or fever occur, consult a doctor immediately. Co-administration with certain antibiotics, antifungals, antivirals, etc., may increase the blood concentration of this medication, raising the risk of side effects, so inform healthcare providers about all medications taken. Women of childbearing age taking this medication should use appropriate contraception and discontinue the medication immediately if pregnancy is confirmed. Breastfeeding women should not take this medication, and children and the elderly should be carefully observed due to the potential for side effects.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities with cough and fever, yellowing of skin or eyes (jaundice), generalized weakness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine changes

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pharyngitis/laryngitis
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste alteration
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint swelling
  • back pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius.

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.