Medication info
Pitavastatin Calcium Hydrate 1mg

Pitavastatin Calcium Hydrate 1mg

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›1.102mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
White, round, film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202102639 · Approved 2021.03.25 · Insurance code 073000150

Summary

Main use
Reduction of cholesterol and improvement of HDL in hypercholesterolemia (primary, heterozygous familial) and dyslipidemia
Who takes it
Adults · Children
Adult dose
In adults, the usual initial dose is 1 to 2 mg of pitavastatin calcium once daily. If the reduction effect of LDL cholesterol is insufficient, the dose may be increased up to a maximum of 4 mg per day. The dosage should be adjusted appropriately at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response. The therapeutic effect of this medication is maintained with continuous administration.
Child dose
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10-16) should take 1 mg of pitavastatin calcium once a day. If the reduction effect of LDL cholesterol is insufficient, the maximum daily dose may be increased.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Reduction of cholesterol and improvement of HDL in hypercholesterolemia (primary, heterozygous familial) and dyslipidemia

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

This medication lowers total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It also helps to increase HDL cholesterol, known as 'good cholesterol.' It is used as an adjunctive treatment to effectively reduce total cholesterol and LDL cholesterol levels in pediatric patients aged 10 to 16 with heterozygous familial hypercholesterolemia. It is particularly recommended for those with an LDL cholesterol level of 190 mg/dL or greater or those with levels of 160 mg/dL or greater with a family history of cardiovascular disease or other risk factors. This drug is an effective treatment method for improving blood lipid levels in conjunction with dietary management.

How to take

Adult dose

In adults, the usual initial dose is 1 to 2 mg of pitavastatin calcium once daily. If the reduction effect of LDL cholesterol is insufficient, the dose may be increased up to a maximum of 4 mg per day. The dosage should be adjusted appropriately at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response. The therapeutic effect of this medication is maintained with continuous administration.

Child dose

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10-16) should take 1 mg of pitavastatin calcium once a day. If the reduction effect of LDL cholesterol is insufficient, the maximum daily dose may be increased.

Precautions

This medication should not be given to certain patients. For instance, those who are allergic to this medication, have active liver disease, or have severely impaired liver function should not use it. Additionally, patients taking this medication should not use it alongside cyclosporine due to potential risks. Pregnant women, women who may become pregnant, and nursing mothers should also avoid this medication. Genetic conditions such as lactose intolerance should also avoid this medication. Caution is required when using this medication in patients with kidney or liver dysfunction, those who consume alcohol excessively, older adults, and children. Particularly, when taken with other specific medications, there is a risk of muscle damage and deterioration of kidney function, so caution is necessary. Regular blood tests and liver function tests should be conducted to ensure no abnormalities occur during treatment. Side effects such as muscle pain, weakness, abdominal pain, rash, headaches, and dyspepsia may occur during the course of taking this medication. If severe muscle pain or loss of strength occurs, consult a physician immediately. Abnormal liver function, thrombocytopenia, allergic reactions, and other side effects have been reported; if any abnormal symptoms occur, discontinue use and consult a specialist. This medication may interact with specific drugs, so inform your doctor or pharmacist if you are taking other medications. In particular, co-administration with cyclosporine, fibrates, niacin, erythromycin, etc., increases the risk of kidney dysfunction and muscle damage. Older adults and children may be more sensitive to side effects of this medication; therefore, dosage adjustments and careful observation are necessary. Pregnant or nursing women must avoid this medication as it can harm the fetus or infant. This medication should be stored out of reach of children and kept in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest discomfort, difficulty breathing, jaundice, sudden and severe headache, numbness, thrombocytopenia, rhabdomyolysis (muscle pain, weakness, increased CPK, elevated myoglobin), acute kidney failure, liver dysfunction, elevated blood pressure, severe edema, severe allergic reactions, severe skin reactions, respiratory issues, liver issues (jaundice), severe neurological symptoms, severe edema, or urinary abnormalities

Mild side effects

Abdominal pain, rash, fatigue, numbness, itching, headache, muscle pain, stiffness, drowsiness, insomnia, thirst, dyspepsia, abdominal bloating, constipation, stomatitis, vomiting, loss of appetite, glossitis, nausea, gastrointestinal discomfort, diarrhea, palpitations, fatigue, skin pain, burning sensation, joint pain, swelling, blurred vision, photophobia, hearing loss, hematuria, elevated uric acid levels, elevated serum potassium and phosphate levels, altered taste, discoloration of urine, fatigue, positive antinuclear antibody

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

Storage

This medication is sensitive to light, so it should be stored in a light-resistant container. Additionally, it is important to store it at temperatures between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White, round, 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.