Medication info
Uniloba Tablet 20mg (Rosuvastatin Calcium)

Uniloba Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Pink round film-coated tablet
Packaging
Domestic use - 30 tablets/box [10 tablets/PTP x 3], Domestic use - 30 tablets/bottle, Export use - 30 tablets/box [10 tablets/PTP x 3], Export use - 100 tablets/box [10 tablets/PTP x 10], Export use - 30 tablets/bottle
Approval status
Active

MFDS item code 201601638 · Approved 2016.03.28 · Insurance code 669804720

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 milligrams once daily, and if more reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose for most patients is 10 milligrams once daily. The maintenance dose should be adjusted regularly based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase to 20 milligrams once daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the typical dosage range is 5 milligrams to 20 milligrams once daily. The dose must be adjusted individually based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atherosclerosis
  • dyslipidemia
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
  • vascular reoperation risk
View approved original text

This medication is primarily used for patients with hypercholesterolemia and hyperlipidemia. It is used as an adjunct when dietary changes and exercise are insufficient to control primary hypercholesterolemia, particularly familial hypercholesterolemia and mixed hyperlipidemia. It is also helpful for patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. This medication is particularly used to lower total cholesterol, LDL cholesterol, and Apo-B levels in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years. It lowers total cholesterol and LDL cholesterol, thereby delaying the progression of atherosclerosis and effectively reducing the risk of cardiovascular disease, stroke, and myocardial infarction. Hence, it is used for hyperlipidemia and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily, and if more reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose for most patients is 10 milligrams once daily. The maintenance dose should be adjusted regularly based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or more, with a maximum increase to 20 milligrams once daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the typical dosage range is 5 milligrams to 20 milligrams once daily. The dose must be adjusted individually based on the recommended treatment goals for each patient.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to this medication, those with severely impaired liver function, those with muscle diseases, and women who are pregnant or breastfeeding should not take this medication. Additionally, care is needed for patients with severely impaired kidney function or those taking certain medications simultaneously. In particular, patients at high risk for muscle-related side effects should carefully consider dose adjustments or the necessity of administration. This medication may affect liver function; thus, patients with a history of liver disease or those who consume excessive alcohol should undergo regular liver function tests before and during treatment. If symptoms such as myalgia or muscle weakness occur, they should immediately inform their physician, and the administration of this medication may be stopped if necessary. These symptoms can rarely progress to serious muscle damage. This medication contains lactose, so patients with lactose intolerance are advised not to take it. There may be interactions with other medications during treatment, so all medications being taken should be disclosed to healthcare providers, particularly when taken with certain antivirals, antibiotics, immunosuppressants, or fibrate class medications. Women who could become pregnant should use appropriate contraception to avoid pregnancy, and if pregnancy is confirmed, they should immediately discontinue the medication. In case of overdose, there is no specific antidote, and treatment should be symptomatic along with monitoring of liver function and muscle enzyme levels. Lastly, this medication may show higher blood concentrations in Asians, so dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, respiratory distress, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal liver failure, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, myopathy (including myositis), rhabdomyolysis, acute renal failure, oliguria, edema, severe muscle weakness

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • cough
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  • diarrhea
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • increased transaminases
  • elevated ALT
  • elevated AST

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help ensure the medication's effectiveness for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Domestic use - 30 tablets/box [10 tablets/PTP x 3], Domestic use - 30 tablets/bottle, Export use - 30 tablets/box [10 tablets/PTP x 3], Export use - 100 tablets/box [10 tablets/PTP x 10], Export use - 30 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.