Medication info
Robo One Tablet 10 Milligrams (Rosuvastatin Calcium)

Robo One Tablet 10 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
원광제약(주)
Appearance
Pink round film-coated tablet
Packaging
PTP packaging - 28 tablets/PTP [(14 tablets/PTP × 2)]
Approval status
Active

MFDS item code 202000554 · Approved 2020.02.03 · Insurance code 662600860

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the medication can be taken once daily at any time regardless of meals. The initial dose is 5 milligrams once daily, adjustable to a maintenance dose of 10 milligrams once daily if necessary. Maintenance dose adjustments should occur at intervals of 4 weeks or more based on LDL cholesterol levels and patient response.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage may range from 5 milligrams to 20 milligrams once daily, with the dose adjusted individually according to treatment goals.

Ingredients

Manufacturer
원광제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, reduction of cardiovascular disease risk

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

This medication is used as an adjunct to dietary changes for patients with primary hypercholesterolemia or mixed dyslipidemia that cannot be controlled with diet and exercise alone. It can also be used in conjunction with dietary changes or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia to enhance efficacy. It is utilized to lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. Especially, it is also used as an adjunct to dietary changes in pediatric patients with heterozygous familial hypercholesterolemia aged between 10 and 17 years who meet certain criteria. It is also beneficial for patients with primary dysbetalipoproteinemia. Finally, in men over 50 years and women over 60 years with elevated high-sensitivity C-reactive protein levels and additional risk factors for cardiovascular disease, it contributes to reducing the risk of stroke, myocardial infarction, and revascularization procedures, thereby lowering cardiovascular disease risk. This medication effectively improves cholesterol and cardiovascular risk factors.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the medication can be taken once daily at any time regardless of meals. The initial dose is 5 milligrams once daily, adjustable to a maintenance dose of 10 milligrams once daily if necessary. Maintenance dose adjustments should occur at intervals of 4 weeks or more based on LDL cholesterol levels and patient response.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage may range from 5 milligrams to 20 milligrams once daily, with the dose adjusted individually according to treatment goals.

Precautions

This medication should not be administered to specific patients. For example, patients allergic to any component of this medication, those with severely impaired liver function, patients with muscle disorders, and certain patients with decreased renal function should not use this medication. Furthermore, pregnant or breastfeeding women, and women of childbearing potential should refrain from taking this medication unless appropriate contraception is used. This medication may affect liver function, so individuals with a history of liver disease or those consuming alcohol heavily should undergo liver function tests before taking the medication and should continue regular testing during treatment. If symptoms such as muscle pain or weakness occur, medical attention should be sought immediately, and in severe cases, discontinuation of the medication may be necessary. The use of this medication in conjunction with certain drugs may elevate blood concentrations, increasing the risk of muscle-related side effects, so it is crucial to consult with a healthcare professional before taking any other medications. If pregnant or breastfeeding, this medication may pose risks to the fetus or infant, so it should not be used, and women of childbearing potential should use appropriate contraception before use. In case of overdose, there is no specific antidote, and treatment should be based on symptoms, along with liver function and muscle enzyme testing. This medication may cause side effects such as dizziness or headaches, so caution is necessary when driving or operating machinery. Finally, this medication may rarely cause severe skin reactions, liver damage, or kidney problems in some individuals, so if new symptoms arise, immediate consultation with a healthcare provider is advised.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, severe muscle weakness, respiratory distress, ocular muscle weakness, Stevens-Johnson syndrome, jaundice, acute renal failure, oliguria, severe skin reactions (Stevens-Johnson syndrome, DRESS), severe allergic reactions, severe edema, serious liver damage, and hyperbilirubinemia.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, urticaria, muscle pain, weakness, diarrhea, hematuria, chest discomfort, loss of appetite, abdominal distension, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, fatigue, numbness, sensory abnormalities, joint pain, cough, memory loss, peripheral neuropathy, thrombocytopenia, increased transaminases, hepatitis, eosinophilia, and generalized symptoms accompanying drug reaction syndrome

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 sealed container. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help preserve the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

PTP packaging - 28 tablets/PTP [(14 tablets/PTP × 2)]

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.