Medication info
Monorova Tablet 20 Milligrams (Rosuvastatin Calcium)

Monorova Tablet 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)유한양행
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201400111 · Approved 2014.01.10 · Insurance code 642104420

Summary

Main use
Treatment for hypercholesterolemia and reduced risk of cardiovascular disease
Who takes it
Adults · Children
Adult dose
The medication is taken once daily at any time regardless of meals. The initial dose is 5 milligrams, and adjustments can be made at intervals of 4 weeks or more according to treatment goals. Generally, the maintenance dose is 10 milligrams, with a maximum increase to 20 milligrams.
Child dose
For pediatric patients aged 10 to 17 years, the dosage is 5 to 20 milligrams once daily. The dosage should be adjusted individually according to the treatment goals, and adjustments should be made at intervals of 4 weeks or more. For children under 10 years old, safety and efficacy have not been established.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Treatment for hypercholesterolemia and reduced risk of cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
  • arterial revascularization risk
View approved original text

This medication is used as an adjunct when dietary measures and exercise are insufficient for controlling primary hypercholesterolemia and mixed dyslipidemia. It is particularly beneficial for patients with heterozygous familial hypercholesterolemia or dysbetalipoproteinemia. It lowers total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis and reducing the risk of cardiovascular disease. Additionally, it is suitable for some pediatric patients aged 10 to 17 years and serves as a safe dietary supplement. It reduces the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged and elderly patients with high hypersensitive C-reactive protein levels and additional cardiovascular risk factors. Overall, this medication is used to improve the risk of various cardiovascular diseases associated with dyslipidemia.

How to take

Adult dose

The medication is taken once daily at any time regardless of meals. The initial dose is 5 milligrams, and adjustments can be made at intervals of 4 weeks or more according to treatment goals. Generally, the maintenance dose is 10 milligrams, with a maximum increase to 20 milligrams.

Child dose

For pediatric patients aged 10 to 17 years, the dosage is 5 to 20 milligrams once daily. The dosage should be adjusted individually according to the treatment goals, and adjustments should be made at intervals of 4 weeks or more. For children under 10 years old, safety and efficacy have not been established.

Precautions

This medication should not be used in certain patients. First, it should not be administered to patients with a known allergy to this medication, those with severely impaired liver function, patients with muscle disorders, and those with significantly reduced kidney function. Additionally, it should not be used by pregnant or nursing women, or women of childbearing age who are not using effective contraception. The 40 milligrams dosage is contraindicated for patients at high risk for muscle disorders. Caution should be exercised in patients who consume large amounts of alcohol or have a history of liver disease. Liver function tests should be repeated before and during administration, and any thyroid dysfunction or nephrotic syndrome should be treated prior. If symptoms such as myalgia, muscle weakness, or cramps occur during treatment, immediate medical attention should be sought. In particular, if there is a significant increase in muscle enzyme levels, the medication should be discontinued, and it can be restarted at a lower dose once symptoms improve. This medication may interact with certain drugs, so it is essential to consult a healthcare provider about any medications being taken concurrently. Particularly, concomitant use with certain antiviral agents, immunosuppressants, some antibiotics, and fibrate class drugs may increase the risk of muscle-related side effects. This medication should be avoided during pregnancy due to potential risks to the fetus, and it is also advisable to avoid use during lactation. In cases of overdose, there are no specific antidotes, so treatment should be symptomatic, and liver and muscle function tests are required. Patients may experience dizziness while on this medication; therefore, caution is advised when driving or operating machinery. Finally, this medication can rarely cause severe skin reactions, liver dysfunction, or muscle damage, so any abnormal symptoms should be reported to healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, breathing difficulties, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) with elevated eosinophils and generalized symptoms, jaundice, hepatitis, severe liver failure, severe allergic reaction, severe skin reaction, rhabdomyolysis, immune-mediated necrotizing myopathy, ocular myasthenia gravis, severe muscle weakness, acute renal failure, oliguria, increased serum creatinine, and elevated blood pressure.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • hives
  • myalgia
  • malaise
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  • chest discomfort
  • cough
  • diarrhea
  • thrombocytopenia
  • increased transaminases
  • elevated ALT
  • elevated AST
  • increased CK
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal distension
  • hematuria
  • arthralgia
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory loss
  • speech difficulties

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Pink 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.