Medication info
Febaro Tablet 1mg (Pitavastatin Calcium Hydrate)

Febaro Tablet 1mg (Pitavastatin Calcium Hydrate)

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

MFDS item code 202102808 · Approved 2021.03.31 · Insurance code 650205780

Summary

Main use
Improvement of cardiovascular disease risk through reduction of cholesterol in hypercholesterolemia (primary, familial) and dyslipidemia, as well as increase in HDL.
Who takes it
Adults · Children
Adult dose
For adults, the usual initial dose is 1 to 2 mg of Pitavastatin Calcium taken once daily. If the LDL-cholesterol lowering effect is not sufficient, it may be increased 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 the patient's response. The treatment effect of this medication is maintained with continuous administration.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 16 years), 1mg of Pitavastatin Calcium is taken once daily. If the LDL-cholesterol lowering effect is insufficient, the maximum daily dosage may be increased to 2mg.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Improvement of cardiovascular disease risk through reduction of cholesterol in hypercholesterolemia (primary, familial) and dyslipidemia, as well as increase in HDL.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo-B protein
  • elevated triglycerides
  • LDL-cholesterol over 190 mg/dL
  • LDL-cholesterol over 160 mg/dL
  • family history of early cardiovascular disease
  • risk factors for cardiovascular disease.
View approved original text

This medication helps to lower total cholesterol, LDL-cholesterol, Apo-B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing levels of HDL-cholesterol, known as 'good cholesterol'. It is particularly aimed at controlling blood cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 16 years, thereby reducing the risk of cardiovascular diseases. This medication supports dietary effects, so maintaining a healthy diet along with consistent usage is essential. It is strongly recommended for young patients showing high LDL-cholesterol levels, especially those with familial history or other cardiovascular risk factors. Overall, this medication is used to improve blood lipid levels and protect cardiovascular health.

How to take

Adult dose

For adults, the usual initial dose is 1 to 2 mg of Pitavastatin Calcium taken once daily. If the LDL-cholesterol lowering effect is not sufficient, it may be increased 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 the patient's response. The treatment effect of this medication is maintained with continuous administration.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 16 years), 1mg of Pitavastatin Calcium is taken once daily. If the LDL-cholesterol lowering effect is insufficient, the maximum daily dosage may be increased to 2mg.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to the components of this medication, those with seriously impaired liver function, and women who are pregnant or breastfeeding should not take this medication. Additionally, patients with muscle disorders or specific genetic lactose metabolism disorders should also not be treated with this medication. Particular caution should be taken when using this medication in patients with kidney or liver issues, elderly patients, children, or those with hypothyroidism. Co-administration of this medication with certain other medications can lead to muscle damage or worsening of kidney function, therefore, consultation with a physician or pharmacist is necessary. During the use of this medication, unusual symptoms such as muscle pain, weakness, indigestion, or skin rash may occur, and patients should promptly inform their healthcare provider if these symptoms arise. Regular liver function tests should be conducted, and blood lipid levels should be monitored to evaluate the treatment effect and side effects. Pregnant women or women who may become pregnant should avoid using this medication, and if pregnancy is confirmed during treatment, it should be discontinued immediately and a physician consulted. This medication should only be carefully administered to children under the guidance of a physician, and its safety has not been established for children under 10 years of age. This medication should be stored out of reach of children, and must be kept in the original packaging to ensure safe usage. Lastly, since this medication is a treatment for hyperlipidemia, adequate testing should be conducted prior to administration, and it is important to combine its use with dietary and exercise interventions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, abnormal respiratory signs accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, markedly decreased urine output.

Mild side effects

  • Abdominal pain
  • fatigue
  • paresthesia
  • itching
  • headache
  • myalgia
  • skin rash
  • thrombocytopenia
  • dry mouth
  • dyspepsia
Show 22 more
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastric discomfort
  • diarrhea
  • decrease in platelet count
  • granulocytopenia
  • leukopenia
  • eosinophilia
  • leukocytosis
  • increase in globulin
  • anemia
  • polyuria
  • decrease in aldosterone
  • increase in aldosterone
  • increase in adrenocorticotropic hormone
  • increase in cortisol
  • increase in testosterone.

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

Storage

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, to maintain the efficacy of the medication, it should be kept in a cool room temperature, specifically between 1 and 30 degrees Celsius.

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.

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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.