Medication info
Newstatin Tablet 2.5 mg (Rosuvastatin Calcium)

Newstatin Tablet 2.5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›2.6mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP * 3], 100 tablets/bottle
Approval status
Active

MFDS item code 202300974 · Approved 2023.03.21 · Insurance code 647805560

Summary

Main use
Improvement of hypercholesterolemia and hyperlipidemia
Who uses it
Adults
Adult dosage
This medication can be taken at any time during the day, regardless of meals. The initial dose is 2.5 or 5 milligrams once daily, while the maintenance dose is 10 milligrams once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase up to 20 milligrams daily if needed.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and hyperlipidemia

  • Hypercholesterolemia
  • familial hypercholesterolemia
  • hyperlipidemia
View approved original text

This medication is used for primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and mixed hyperlipidemia. It is primarily prescribed as an adjunct when diet and exercise alone are not sufficient, helping to lower blood cholesterol levels and reduce the risk of cardiovascular diseases. It also plays a role in supporting patients to maintain a healthy lifestyle along with continuous treatment.

Dosage and Administration

Adult dosage

This medication can be taken at any time during the day, regardless of meals. The initial dose is 2.5 or 5 milligrams once daily, while the maintenance dose is 10 milligrams once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase up to 20 milligrams daily if needed.

Precautions

This medication should not be used in certain patients. For example, it should not be given to individuals allergic to any component of this medication, those with active liver disease, myopathy patients, those taking cyclosporine, patients with severe kidney dysfunction, pregnant or breastfeeding women, and patients at high risk for muscle-related disorders. Additionally, this medication contains lactose and should not be used by individuals with lactose intolerance or related genetic disorders. Patients taking this medication should be closely monitored for symptoms such as liver dysfunction, muscle pain, or muscle weakness. In particular, if there are signs of elevated liver enzyme levels or muscle-related abnormal symptoms, medical staff should be notified immediately, and the medication may need to be discontinued if necessary. Caution is needed when administering this medication to patients with a history of excessive alcohol consumption or liver disease. Moreover, in cases of hypothyroidism or nephrotic syndrome, treatment of the underlying condition should be completed before administration of this drug. Patients at high risk for myopathy or rhabdomyolysis require careful evaluation and continuous monitoring before administering this medication. If symptoms such as muscle pain, muscle weakness, or cramping occur, medical staff should be informed immediately, and blood tests should be conducted to assess muscle damage. Furthermore, this medication may interact with various drugs, so patients should inform healthcare professionals if they are taking other medications, as certain drug combinations may increase the concentration of this medication and heighten the risk of side effects. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraceptive methods. Taking this medication during pregnancy can pose risks to the fetus, so caution is necessary. In cases of overdose, there are no specific antidotes, and treatment should focus on symptom management and monitoring liver function and muscle enzyme levels as needed. Finally, while this medication is unlikely to significantly affect driving or machine operation abilities, patients should be aware that dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or breathing difficulty, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Dyspepsia
  • pruritus
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
Show 23 more
  • thrombocytopenia
  • diarrhea
  • facial swelling
  • shingles
  • vulvar pruritus
  • rash
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and the storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Storing it this way helps preserve the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP * 3], 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.