Medication info
Unilova Tablet 5 mg (Rosuvastatin Calcium)

Unilova Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Yellow round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP x 3)], For export - 100 tablets/box [(10 tablets/PTP x 10)]
Approval status
Active

MFDS item code 201605331 · Approved 2016.08.31 · Insurance code 669804830

Summary

Main use
Treatment for hypercholesterolemia (primary and familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication is administered once daily at an initial dose of 5 milligrams, regardless of meals, any time during the day. For more substantial LDL cholesterol reduction, the maintenance dose can be adjusted to 10 milligrams once daily, and can be increased up to a maximum of 20 milligrams per day based on LDL cholesterol levels and patient response, with intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily at doses ranging from 5 milligrams to 20 milligrams. The dose should be adjusted individually according to treatment goals with intervals of 4 weeks or more.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Treatment for hypercholesterolemia (primary and familial) and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
View approved original text

This medication is an adjunct used in patients with primary hypercholesterolemia and mixed dyslipidemia when not controlled by diet alone and exercise. It also effectively lowers serum cholesterol levels when administered in conjunction with diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it plays a role in delaying the progression of atherosclerosis by lowering total cholesterol and LDL cholesterol to target levels. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, reducing total cholesterol and LDL cholesterol levels. Additionally, it is used as an adjunct to diet for patients with primary dysbetalipoproteinemia. Most importantly, this medication helps reduce the risk of stroke, myocardial infarction, and vascular revascularization in middle-aged patients with high-sensitivity C-reactive protein levels and cardiovascular disease risk factors. Overall, this medication is effectively used for the prevention and treatment of hypercholesterolemia and related cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication is administered once daily at an initial dose of 5 milligrams, regardless of meals, any time during the day. For more substantial LDL cholesterol reduction, the maintenance dose can be adjusted to 10 milligrams once daily, and can be increased up to a maximum of 20 milligrams per day based on LDL cholesterol levels and patient response, with intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is administered once daily at doses ranging from 5 milligrams to 20 milligrams. The dose should be adjusted individually according to treatment goals with intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients allergic to any ingredient of this medication, those with severe liver function problems, patients with muscle-related disorders, and those taking specific medications. Women who are pregnant, breastfeeding, or of childbearing potential should have a thorough consultation regarding the risk of pregnancy and effects on the fetus before taking this medication. It is important to regularly check liver function and muscle condition while taking this medication. Patients with a history of liver disease, those who consume excessive alcohol, have hypothyroidism, or have impaired kidney function should be especially cautious. If symptoms such as muscle pain, weakness, or cramps occur, medical personnel should be notified immediately, and this medication can be discontinued if necessary. Additionally, after intense exercise, muscle enzyme test results may be affected, so caution is required during testing. This medication can raise blood sugar levels in some patients; therefore, those at risk for diabetes should undergo regular testing related to blood sugar. There may be interactions with other medications; therefore, current medications should be disclosed to medical personnel, especially when combined with specific antiviral drugs, immunosuppressants, antifungals, and fibrate-type medications. The use of this medication is not recommended during pregnancy or breastfeeding, and women planning to become pregnant should use appropriate contraceptive methods. In case of overdose, since no specific antidote exists, treatment should follow the symptoms while monitoring liver function and muscle enzyme levels. This medication may cause symptoms such as dizziness, so caution is needed when driving or operating machinery. Finally, if severe skin rashes, fever, or systemic symptoms indicating severe skin reactions occur while taking this medication, use should be discontinued immediately, and consultation with medical personnel is required.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, severe muscle weakness, difficulty breathing, ophthalmoplegia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, chest discomfort

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • myalgia
  • weakness
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • dysesthesia
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • hematuria
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • memory impairment

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. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP x 3)], For export - 100 tablets/box [(10 tablets/PTP x 10)]

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.