Medication info
Uniloba Tablet 10mg (Rosuvastatin Calcium)

Uniloba Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Pink 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 201602318 · Approved 2016.04.26 · Insurance code 669804810

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Without regard to meals, administer 5 milligrams once daily as the initial dose. The maintenance dose is 10 milligrams once daily; it may be increased up to a maximum of 20 milligrams once daily according to the patient's response at intervals of at least 4 weeks.
Children's dosage
Children aged 10 to 17 years with heterozygous familial hypercholesterolemia are administered 5 milligrams up to 20 milligrams once daily. The dose should be adjusted according to individual treatment targets at intervals of at least 4 weeks.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Treatment for hypercholesterolemia (primary, 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 early coronary heart disease
View approved original text

This medication is used as an adjunct when diet and exercise alone cannot control primary hypercholesterolemia and mixed dyslipidemia patients. It is especially used in conjunction with other treatments for patients with homozygous familial hypercholesterolemia, lowering total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It is also used as an adjunct in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia when certain criteria are met. Additionally, it is used adjunctively in the treatment of primary dysbetalipoproteinemia. This drug is effective in reducing the risk of stroke, myocardial infarction, and vascular reintervention in middle-aged patients with elevated high-sensitivity C-reactive protein and cardiovascular risk factors. Overall, this medication is used to improve blood cholesterol levels and reduce cardiovascular risks.

Dosage and Administration

Adult dosage

Without regard to meals, administer 5 milligrams once daily as the initial dose. The maintenance dose is 10 milligrams once daily; it may be increased up to a maximum of 20 milligrams once daily according to the patient's response at intervals of at least 4 weeks.

Children's dosage

Children aged 10 to 17 years with heterozygous familial hypercholesterolemia are administered 5 milligrams up to 20 milligrams once daily. The dose should be adjusted according to individual treatment targets at intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any component of this drug, those with severe liver dysfunction, patients with muscle disorders, and those who are taking specific medications should avoid treatment. Additionally, women who are pregnant or breastfeeding, as well as women of childbearing potential, must consider pregnancy planning and fetal risks, and should use appropriate contraceptive methods. This medication can affect the liver and muscles, so patients with a history of liver disease, excessive alcohol consumption, and risk factors for myopathy must consult with a physician before use and be monitored carefully. During treatment, if symptoms such as muscle pain, weakness, or fever occur, inform medical personnel immediately, and if necessary, a blood test should be conducted to check for muscle damage. This drug may increase blood sugar levels in some patients; individuals at risk for diabetes should have regular blood glucose checks. Furthermore, this drug can interact with several other medications, so it is essential to inform healthcare providers about any concurrent medications, especially caution is advised when combined with specific antiviral agents, immunosuppressants, antibiotics, and fibrates. Side effects reported in clinical trials and post-marketing studies include headaches, dizziness, dyspepsia, skin rash, muscle pain, and rarely severe side effects such as liver damage or muscle rupture may occur. In case of overdose, as there is no specific antidote, immediate medical attention should be sought for treatment based on symptoms, and monitoring of liver function and muscle enzyme levels should be conducted. Finally, while this medication is unlikely to affect driving or operating machinery, caution is advised as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, thrombocytopenia, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), jaundice, hepatitis, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, oliguria, severe edema, severe allergic reactions, severe skin reactions, respiratory issues, liver abnormalities (jaundice), serious

Mild side effects

  • Headaches
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rashes
  • muscle pain
  • weakness
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • hematuria

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

Storage

Store this medication in a tightly closed container to protect from air and moisture. It is best to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink 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.