Medication info

Rostatin Tablets (Rosuvastatin)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Lovastatin›20mg / 1 tablet
Manufacturer / importer
Ildong Pharmaceutical Co., Ltd.
Appearance
Light blue round tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 199700558 · Notified 1997.12.11

This product's status changed to Approval withdrawn on 2024.05.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of primary hyperlipidemia and prevention of coronary heart disease caused by hyperlipidemia
Who takes it
Adults
Adult dose
Adults: Administer lovastatin 20-80㎎ orally per day in 1 or several divided doses, together with dietary therapy. The initial dose is 20㎎ once daily with the evening meal. For patients with markedly elevated serum cholesterol [i.e., > 300㎎/㎗(7.8mmol/ℓ) despite diet], administer 40㎎ per day. The maximum daily dose is 80㎎. The dose may be increased or decreased as appropriate according to age and symptoms.

Ingredients

Manufacturer
Ildong Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of primary hyperlipidemia and prevention of coronary heart disease caused by hyperlipidemia

  • Hypercholesterolemia
  • hypertriglyceridemia
View approved original text

This medication is used to treat primary hyperlipidemia, specifically hypercholesterolemia (type IIa) and the combined form of hypercholesterolemia and hypertriglyceridemia (type IIb). It also has the effect of reducing the risk of coronary heart disease caused by hyperlipidemia. By taking this medication, you can control blood lipid levels and lower the risk of cardiovascular disease. Therefore, it is a medication that helps improve and prevent these conditions.

How to take

Adult dose

Adults: Administer lovastatin 20-80㎎ orally per day in 1 or several divided doses, together with dietary therapy. The initial dose is 20㎎ once daily with the evening meal. For patients with markedly elevated serum cholesterol [i.e., > 300㎎/㎗(7.8mmol/ℓ) despite diet], administer 40㎎ per day. The maximum daily dose is 80㎎. The dose may be increased or decreased as appropriate according to age and symptoms.

Precautions

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis, so it's important to inform your doctor immediately if you experience muscle pain or weakness symptoms. In particular, there are several medications that may interact with this drug, so if you are taking other medications, be sure to inform your doctor or pharmacist. This medication may affect liver function, so patients with liver disease or abnormally high liver enzyme levels should undergo careful examination before using this drug. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should only take it when the possibility of pregnancy is low. Elderly patients, patients with renal impairment, excessive alcohol consumers, and others should exercise extra caution when taking this drug, and regular blood tests and physician monitoring are necessary. During the period of taking this medication, it is advised to avoid drinking a lot of grapefruit juice and to be cautious not to use it in combination with certain antibiotics or antifungal medications. If muscle-related symptoms or symptoms of liver dysfunction appear, stop taking the medication immediately and consult medical personnel. This medication is not recommended for use in children, as safety and efficacy have not been established. While taking this medication, it is important to recognize the possibility of side effects and to consult a specialist immediately if unusual symptoms occur.

Side effects

  • Myopathy
  • rhabdomyolysis
  • myalgia
  • tenderness
  • muscle weakness
  • myoglobinuria
  • acute renal failure
  • elevated serum aminotransferase levels
  • jaundice
  • chest pain
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  • gastroesophageal reflux
  • dry mouth
  • vomiting
  • leg pain
  • shoulder pain
  • arthralgia
  • insomnia
  • sensory disturbances
  • alopecia
  • pruritus
  • eye irritation
  • muscle cramps
  • immune-mediated necrotizing myopathy
  • specific cranial nerve dysfunction
  • tremors
  • dizziness
  • vertigo
  • amnesia
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disorders
  • depression
  • cognitive disorders
  • interstitial lung disease
  • anaphylaxis
  • angioedema
  • lupus-like syndrome
  • polymyalgia rheumatica
  • dermatomyositis
  • vasculitis
  • purpura
  • thrombocytopenia
  • leukopenia
  • hemolytic anemia
  • positive antinuclear antibody
  • increased erythrocyte sedimentation rate
  • eosinophilia
  • arthritis
  • urticaria
  • myasthenia
  • photosensitivity
  • fever
  • chills
  • flushing
  • malaise
  • dyspnea
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • pancreatitis
  • hepatitis
  • cholestatic jaundice
  • hepatic steatosis
  • cirrhosis
  • fulminant hepatic necrosis
  • liver cancer
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • progression of cataracts
  • ocular muscle paralysis
  • elevated aminotransferase levels
  • elevated ALP
  • elevated γ-GT
  • elevated bilirubin levels
  • thyroid dysfunction
  • anemia
  • myositis
  • hyperkalemia
  • immune-mediated necrotizing myopathy

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

Storage

This medication may be sensitive to light, so it should be stored in a container that blocks light. Additionally, for safe storage, it is recommended to keep it at room temperature, which should not be too hot or too cold.

Appearance and packaging

Appearance

Light blue round tablets

Package unit

30 tablets/bottle, 300 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.