Medication info
Newbaro Tablets 2mg (Pitavastatin Calcium Hydrate)

Newbaro Tablets 2mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›2mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Very pale yellowish-red round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201507597 · Approved 2015.11.05 · Insurance code 669906460

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
Adult dose
In adults, the initial dose is 1 to 2 mg of pitavastatin calcium taken once daily. If LDL cholesterol levels are not adequately lowered, the dose may be increased to a maximum of 4 mg daily. Dosage may be adjusted appropriately at intervals of 4 weeks or more.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • apolipoprotein B
  • triglyceride levels
View approved original text

This medication helps to control blood lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Specifically, it lowers levels of total cholesterol, LDL cholesterol (known as bad cholesterol), apolipoprotein B, and triglycerides. At the same time, it contributes to improving cardiovascular health by increasing the level of HDL cholesterol (good cholesterol). These effects primarily occur in conjunction with dietary measures and play an important role in correcting lipid balance in the body. Ultimately, it is used to reduce the risk of cardiovascular disease and maintain a healthy blood lipid status.

How to take

Adult dose

In adults, the initial dose is 1 to 2 mg of pitavastatin calcium taken once daily. If LDL cholesterol levels are not adequately lowered, the dose may be increased to a maximum of 4 mg daily. Dosage may be adjusted appropriately at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, it is not to be used in individuals who have had allergic reactions to this medication, those with severely impaired liver function, pregnant or nursing women, and children, as there is no experience of use in these groups. Additionally, patients with renal or liver impairment, myopathy, and those taking certain medications (such as cyclosporine, fibrate-containing drugs, etc.) must exercise extreme caution when using this medication, as serious side effects such as muscle pain or worsening renal function may occur. During the course of treatment with this medication, side effects such as muscle pain, weakness, rash, dyspepsia, and liver function abnormalities may occur; if these symptoms appear, patients should consult their healthcare provider immediately. Regular liver function tests should be performed, and if abnormalities are found, the medication should be discontinued, and appropriate treatment should be taken. It's also crucial to check for muscle damage via blood tests. This medication may interact with other drugs; therefore, patients should inform their healthcare provider about any other medications they are taking. Serious side effects may occur if taken with certain drugs, so caution is necessary. Elderly patients have a higher risk of side effects due to decreased physical function and should be more cautious while using this medication. Pregnant women or women who may become pregnant should avoid this medication as it may harm the fetus, and if pregnancy is confirmed, they should discontinue use immediately. Finally, this medication has not been proven safe for use in children, so it is advised not to use it in this population. This medication should be stored in its original container and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), rhabdomyolysis (muscle pain, weakness, elevated CPK levels, rise in myoglobin in blood and urine), acute renal failure, severe liver dysfunction, jaundice, sudden and severe headache, paralysis, thrombocytopenia, elevated blood pressure, chest discomfort, difficulty breathing, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms,

Mild side effects

  • Abdominal pain
  • rash
  • fatigue
  • numbness
  • itching
  • stiffness
  • drowsiness
  • insomnia
  • headache
  • feeling of heaviness
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  • dizziness
  • thirst
  • dyspepsia
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • thrombocytopenia
  • agranulocytosis
  • leukopenia
  • eosinophilia
  • leukocytosis
  • globulin elevation
  • positive Coombs test
  • anemia
  • polyuria
  • increased BUN
  • elevated serum creatinine

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

Storage

This medication may be sensitive to light, hence it should be stored in a tightly sealed container that does not allow light to pass through. Additionally, it is best to store the medication at room temperature between 1 to 30 degrees Celsius. This helps maintain its effectiveness and ensures safe use.

Appearance and packaging

Appearance

Very pale yellowish-red round film-coated tablets

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

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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.