Medication info

Rosunex Tablets 20mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Pink round film-coated tablets
Packaging
28 tablets/PTP
Approval status
Expired

MFDS item code 201400353 · Approved 2014.01.27

This product's status changed to Expired on 2024.01.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for improvement of hypercholesterolemia (primary, mixed) and dyslipidemia as well as reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
The initial dose of this medication is 5 milligrams once daily, and it may be adjusted to 10 milligrams or a maximum of 20 milligrams at intervals of 4 weeks or more as needed. It can be taken at any time of the day, regardless of meals. Dosage adjustment is not necessary for elderly patients and those with mild to moderate renal impairment. The recommended starting dose for Asian patients and those susceptible to myopathy is 5 milligrams.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Treatment for improvement of hypercholesterolemia (primary, mixed) and dyslipidemia as well as reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct when dietary changes and exercise are insufficient for controlling patients with primary hypercholesterolemia and mixed dyslipidemia. It is also utilized as an adjunct to diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. Additionally, it effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Furthermore, in patients over 50 years old for men and over 60 years old for women with risk factors for cardiovascular disease, it reduces the risk of complications after stroke, myocardial infarction, and arterial revascularization. This drug effectively improves hyperlipidemia and cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose of this medication is 5 milligrams once daily, and it may be adjusted to 10 milligrams or a maximum of 20 milligrams at intervals of 4 weeks or more as needed. It can be taken at any time of the day, regardless of meals. Dosage adjustment is not necessary for elderly patients and those with mild to moderate renal impairment. The recommended starting dose for Asian patients and those susceptible to myopathy is 5 milligrams.

Precautions

This drug should not be used in certain patients. For instance, it should not be administered to those who are allergic to any of the components of this drug, have active liver disease, or have muscular diseases. Additionally, it should be avoided in women who are severely renal impaired, pregnant, or breastfeeding, as well as in fertile women who do not use appropriate contraception. High doses are prohibited for patients at high risk for muscle diseases. This drug should be used with caution in patients who consume large amounts of alcohol or have a history of liver disease, and liver function tests should be conducted regularly before and during treatment. Muscle pain, myopathy, and occasionally serious muscle damage such as rhabdomyolysis can occur, so patients should immediately inform their healthcare provider if they experience any unusual muscle symptoms. Particularly in cases with risk factors for muscle damage such as renal impairment, hypothyroidism, family history of genetic muscle diseases, elderly patients, and alcohol abuse, more caution is needed. This drug can also affect liver function, so it should be stopped immediately if symptoms of liver damage or abnormal blood tests appear. It contains lactose, so patients with genetic issues such as lactose intolerance should not use this medication. There may be interactions with other medications, so it is crucial to inform healthcare providers about any current medications. When combined with certain medications, the blood concentration of this drug may increase, raising the risk of side effects. It should not be used during pregnancy or breastfeeding, and women of childbearing age should ensure proper contraception is utilized. In case of overdose, there is no specific antidote, and treatment should be based on symptoms, along with monitoring liver function and muscle enzyme levels. Caution is needed when driving or operating machinery as dizziness may occur. During the course of taking this drug, adverse reactions may include headache, dizziness, dyspepsia, muscle pain, and liver function abnormalities; these symptoms should be discussed with a healthcare provider if they persist or worsen.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) with eosinophilia, rhabdomyolysis, myopathy, immune-mediated myopathy, acute renal failure, oliguria, headache (in cases of severe headache), chest tightness, difficulty breathing, respiratory distress, jaundice, liver failure, fatal liver failure, disorientation, visual disturbances, paralysis, extreme edema associated with increased blood pressure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • diarrhea
Show 24 more
  • thrombocytopenia
  • jaundice
  • hepatitis
  • increase in transaminases
  • lupus-like syndrome
  • arthralgia
  • immune-mediated necrotizing myopathy
  • hematuria
  • edema
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive decline
  • forgetfulness
  • amnesia
  • cognitive impairment
  • confusion
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture exposure, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/PTP

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.