Medication info
Pitasin Tablet 1 mg (Pitavastatin Calcium)

Pitasin Tablet 1 mg (Pitavastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium›1mg / 1 tablet
Manufacturer / importer
알리코제약(주)
Appearance
White round film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 202003706 · Approved 2020.05.21 · Insurance code 656005150

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL cholesterol, etc.)
Who takes it
Adults · Children
Adult dose
For adults, the usual starting dose is to take 1-2 mg of pitavastatin calcium once daily. If the LDL cholesterol lowering effect is insufficient, the dose can be increased to a maximum of 4 mg per day. Dosing should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, therapeutic goals, and patient responses.
Child dose
For pediatric patients (ages 10 to 16) with heterozygous familial hypercholesterolemia, take 1 mg of pitavastatin calcium once daily. If the LDL cholesterol lowering effect is insufficient, the maximum can be raised to 2 mg per day.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL cholesterol, etc.)

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo-B protein
  • elevated triglyceride levels
  • abnormal LDL cholesterol levels
  • family history of early cardiovascular disease
  • risk factors for cardiovascular disease
View approved original text

This medication primarily helps lower cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It reduces total cholesterol, LDL cholesterol, and Apo-B protein levels while increasing HDL cholesterol levels, improving cardiovascular health. It is also used in patients aged 10 to 16 years with heterozygous familial hypercholesterolemia, especially in cases where LDL cholesterol levels are high, or there is a family history and other cardiovascular risk factors, in conjunction with a dietary plan. This medication aids in managing cholesterol levels as an adjunct to dietary control. It plays an important role in maintaining a healthy cardiovascular system.

How to take

Adult dose

For adults, the usual starting dose is to take 1-2 mg of pitavastatin calcium once daily. If the LDL cholesterol lowering effect is insufficient, the dose can be increased to a maximum of 4 mg per day. Dosing should be appropriately adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, therapeutic goals, and patient responses.

Child dose

For pediatric patients (ages 10 to 16) with heterozygous familial hypercholesterolemia, take 1 mg of pitavastatin calcium once daily. If the LDL cholesterol lowering effect is insufficient, the maximum can be raised to 2 mg per day.

Precautions

This medication should not be used in certain patients. For example, those who have had an allergic reaction to this medication, have liver issues, or have persistently elevated liver enzyme levels should not be administered this drug. Additionally, patients with severe liver impairment, bile flow disorders, and those taking cyclosporine should not use this medication. Individuals with myopathy, pregnant or potentially pregnant women, and breastfeeding women should also avoid taking this medication. Because this medication contains lactose, individuals with lactose intolerance or related genetic diseases should exercise caution. Patients with impaired kidney function or a history of liver impairment and those who excessively consume alcohol should use this medication with caution. Furthermore, care should be taken when co-administering fibrates or niacin, as the risk of muscle damage may increase. Patients with hypothyroidism or genetic muscle diseases, as well as the elderly, children, and patients with severe myasthenia gravis, should also be cautious when using this medication. This medication may cause side effects such as abdominal pain, rash, fatigue, myalgia, and it may lead to abnormalities in liver function or changes in blood test values, so regular monitoring is necessary. If muscle pain or weakness occurs, consultation with a healthcare provider should be sought immediately, and in severe cases, discontinuation of use is advised. Rarely, hepatic dysfunction, thrombocytopenia, allergic reactions, and neurological symptoms may occur. This medication is used in the treatment of hypercholesterolemia, so it is advisable to undergo thorough examinations and to combine it with dietary and exercise therapies before administration. Regular liver function tests should be conducted, and immediate action should be taken in case of side effects. The risk of muscle-related side effects increases with higher doses of this medication, so caution is necessary when increasing the dosage. This medication can interact with certain drugs, especially when co-administered with cyclosporine, fibrates, niacin, erythromycin, etc., as this may increase the risk of kidney dysfunction or muscle damage, necessitating avoidance of co-administration or careful observation. Elderly individuals may experience side effects more easily due to decreased physical function, thus requiring dosage adjustments and caution. Pregnant or breastfeeding women should avoid this medication as it may pose risks to the fetus and infant. In children, it should only be administered under the careful guidance of an experienced physician when treating familial hypercholesterolemia, and caution should be taken in cases of intense or vigorous activity due to the risk of muscle damage. Safety in children under 10 years old has not been established. This medication should be kept out of reach of children and stored in its original container to prevent deterioration or misuse. In animal studies, some instances of cataracts have been reported, so caution is advised with long-term use.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • rhabdomyolysis
  • acute renal failure
  • hepatic dysfunction
  • jaundice
  • thrombocytopenia
  • severe allergic reactions
  • serious skin reactions
  • respiratory issues
Show 3 more
  • hepatic abnormalities (jaundice)
  • serious neurological symptoms
  • severe edema or urinary issues

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • numbness
  • itching
  • headache
  • myalgia
  • stiffness
  • drowsiness
  • insomnia
Show 25 more
  • heaviness in the head
  • dizziness
  • thirst
  • indigestion
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • thrombocytopenia
  • agranulocytosis
  • leukopenia
  • eosinophilia
  • leukocytosis
  • increased globulins
  • positive Coombs test
  • anemia
  • frequent urination
  • elevated BUN
  • elevated serum creatinine
  • reduced aldosterone

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

Storage

This medication may be sensitive to light, so it should be stored in a tightly sealed container that blocks light. It is also important to store it at room temperature, between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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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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.