Medication info
Pitrovant Tablets 2 mg (Pitavastatin Calcium Hydrate)

Pitrovant Tablets 2 mg (Pitavastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›2.2mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Pale pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201907395 · Approved 2019.10.22 · Insurance code 648104380

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia
Who takes it
Adults
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, the dose can be increased up to a maximum of 4 mg per day. The dosage should be adjusted as needed at intervals of 4 weeks or more, depending on LDL cholesterol levels, treatment goals, and patient response.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo-B protein
  • triglyceride levels
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It also increases HDL cholesterol levels, thereby raising good cholesterol. When used in conjunction with a dietary regimen, it contributes to improving blood lipid levels and reducing the risk of cardiovascular disease. It is used to maintain a healthy blood lipid status.

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, the dose can be increased up to a maximum of 4 mg per day. The dosage should be adjusted as needed at intervals of 4 weeks or more, depending on LDL cholesterol levels, treatment goals, and patient response.

Precautions

This medication should not be used by individuals who have had allergic reactions to certain components. It is not safe to administer to individuals with active liver disease or persistent elevation of liver enzyme levels of unknown origin. Individuals with severe liver dysfunction or bile flow obstruction should not take this medication. This medication should not be used in conjunction with cyclosporine. Patients with a history of myopathy or muscle disease should avoid this drug. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Due to lack of confirmed safety and efficacy, it is not recommended for use in children. Individuals with lactose intolerance or specific genetic metabolic disorders should not take this drug. Patients with renal impairment or a history of liver dysfunction should use this medication with caution, especially when taken with certain lipid-lowering agents or niacin. Excessive alcohol consumption should also be monitored. Patients with hypothyroidism or genetic muscle disorders, or those with a history of adverse reactions related to muscle medication, should exercise caution when using this medication. Elderly patients may require dose adjustments due to a higher risk of adverse reactions. Patients with allergies to the coloring agents in this medication should proceed with caution. Patients with severe muscle weakness or ocular muscle weakness should exercise special caution when using this medication. When taking this medication, symptoms such as muscle pain, weakness, abdominal pain, rash, itching, and abnormal liver function or blood abnormalities may occur. Rhabdomyolysis, a serious muscle-related side effect, can rarely occur, so patients experiencing muscle pain or weakness should consult a physician immediately. Regular liver function tests are required, and if abnormal findings arise, administration should be discontinued. This medication may interact with other drugs, so if you are taking any other medications, inform your healthcare provider, and it is advisable not to take it along with cyclosporine, fibrates, or niacin. Elderly patients or those with reduced renal function are at an increased risk of side effects, requiring careful monitoring and possible dose adjustments. Pregnant or nursing women should not take this medication, and women of childbearing potential should confirm pregnancy before taking it. It is recommended that this medication is not used in children due to lack of confirmed safety and efficacy. This medication should be kept out of the reach of children and stored in its original container to prevent quality degradation or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including increased blood pressure and edema), chest tightness, difficulty in breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, severe skin reactions, asthma attacks, respiratory issues with cough and fever, breathing problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Abdominal pain
  • rash
  • malaise
  • numbness
  • itching
  • dry mouth
  • dyspepsia
  • abdominal distension
  • constipation
  • stomatitis
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  • vomiting
  • loss of appetite
  • glossitis
  • nausea
  • gastrointestinal discomfort
  • diarrhea
  • stiffness
  • drowsiness
  • insomnia
  • headache
  • heaviness in the head
  • dizziness
  • skin tingling
  • insomnia
  • sleep disturbances
  • appetite loss
  • hypertension
  • chest discomfort
  • weakness
  • palpitations
  • fatigue
  • skin pain
  • burning sensation
  • joint pain
  • edema
  • blurred vision
  • photophobia
  • hearing loss
  • hematuria
  • uric acid levels

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

Storage

This medication should be stored in a tightly sealed container that can block light, at temperatures between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and ensures safe use.

Appearance and packaging

Appearance

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

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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.