Medication info
Monoroba Tablet 5 Milligrams (Rosuvastatin Calcium)

Monoroba Tablet 5 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201400112 · Approved 2014.01.10 · Insurance code 642104430

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For primary hypercholesterolemia and other indications, the medication can be administered at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily; if needed, the maintenance dose can be adjusted to 10 milligrams once daily. Dosage adjustments should be made at intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dose of 20 milligrams.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), a dose of 5 to 20 milligrams is administered once daily. The dosage should be adjusted based on individual treatment goals.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • familial heterozygous 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 primarily used as an adjunct in patients with hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise alone are inadequate. It is particularly useful in patients with familial hypercholesterolemia, as it lowers total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. Additionally, it serves as an adjunct in dietary therapy for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used as an adjunct in the treatment of primary dysbetalipoproteinemia, helping to reduce the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged and older individuals at high risk for cardiovascular diseases. Therefore, this medication is utilized to improve cardiovascular health by regulating cholesterol and cardiovascular risk factors.

How to take

Adult dose

For primary hypercholesterolemia and other indications, the medication can be administered at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily; if needed, the maintenance dose can be adjusted to 10 milligrams once daily. Dosage adjustments should be made at intervals of 4 weeks or longer based on LDL cholesterol levels, treatment goals, and patient response, with a maximum dose of 20 milligrams.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), a dose of 5 to 20 milligrams is administered once daily. The dosage should be adjusted based on individual treatment goals.

Precautions

This medication should not be used in certain patients. For example, it must not be administered to patients with an allergy to any component of this medication, patients with severe liver dysfunction, those with muscle disorders, and those with severe renal impairment. Special caution is necessary for pregnant or nursing women and for women of childbearing age who do not use adequate contraception. This medication contains lactose; therefore, patients with lactose intolerance should not use it. It is important to periodically test liver function and muscle status while taking this medication. Patients who consume a large amount of alcohol or who have a history of liver disease should use it with greater caution, and those with hypothyroidism or nephrotic syndrome should treat the underlying condition first. If symptoms such as muscle pain, muscle weakness, or cramps occur, the doctor should be notified immediately for evaluation. This medication may interact with other drugs; thus, it is essential to inform your doctor or pharmacist about any medications being taken together. The risk of muscle-related side effects may increase, especially when used in combination with certain antiviral agents, immunosuppressants, or fibrates. If pregnant or nursing, it is safest not to use this medication, and women planning to become pregnant should utilize adequate contraception. In cases of overdose, there is no specific antidote; thus, treatment should be supportive and liver function and muscle enzyme levels should be monitored. Rarely, side effects such as skin rash, liver dysfunction, muscle problems, or neurological symptoms may occur; if any unusual symptoms arise, immediate consultation with medical staff is advised. Caution is needed as dizziness may occur when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, ocular muscle weakness, jaundice, hepatitis, acute kidney failure, oliguric condition, severe edema, severe allergic reactions, severe skin reactions, respiratory issues, hepatic abnormalities (jaundice), serious neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramp
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air or moisture; thus, it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to preserve its effectiveness and safety for an extended period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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.