Medication info
Monorova Tablet 10mg (Rosuvastatin Calcium)

Monorova Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 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 201400102 · Approved 2014.01.10 · Insurance code 642104410

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for each individual patient.

Ingredients

Manufacturer
(주)유한양행

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
View approved original text

This medication is primarily used for various conditions related to hypercholesterolemia. It is used as an adjunct therapy in cases of primary hypercholesterolemia or mixed dyslipidemia that are not controlled by diet and exercise. It is also used in conjunction with existing treatments for patients with homozygous familial hypercholesterolemia to lower blood cholesterol levels. This drug effectively reduces total cholesterol and LDL-cholesterol to slow the progression of atherosclerosis. It is particularly suitable for pediatric patients aged 10-17 with heterozygous familial hypercholesterolemia. It is also utilized as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia. In high-risk patients with elevated high-sensitivity C-reactive protein levels and additional cardiovascular disease risk factors, it is expected to reduce the risk of myocardial infarction, stroke, and vascular revascularization. Therefore, this medication is used to improve the risks associated with dyslipidemia and cardiovascular diseases.

How to take

Adult dose

The initial dose is 5 mg once daily, and if a greater reduction in LDL-cholesterol is needed, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily, with most patients being managed at this dose. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to the recommended treatment goals for each individual patient.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to this drug's ingredients, patients with severely impaired liver function, those with muscular disorders, patients with severe renal impairment, and women who are pregnant or breastfeeding should not take this medication. Additionally, liver function tests should be conducted before and during this medication. Caution is advised for those with liver disease or hypothyroidism. If symptoms of myalgia or muscle weakness occur, notify medical personnel immediately, and in severe cases, discontinue use of the drug. This medication can interact with some other drugs, so if you are currently taking any other medications, you must inform your doctor or pharmacist. In particular, there may be an increased risk of muscle-related side effects when used in combination with certain antiviral medications, immunosuppressants, or fibrates. Women who are pregnant or planning to become pregnant should use appropriate contraception and should discontinue this medication immediately if pregnancy is confirmed. It is also advisable for breastfeeding women to avoid taking this medication. In case of overdose, there is no specific antidote, and treatment should be symptom-based, monitoring liver function and muscle enzyme levels. This medication can rarely cause side effects such as skin rash, abnormal liver function, neurological issues, and muscle damage, so consult medical personnel immediately if any symptoms arise. Caution is advised when driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, mouth/eye mucosal pain, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme general lethargy, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • body aches
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • amnesia
  • memory impairment
  • confusion

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature of 1 to 30 degrees Celsius. This helps to ensure that the medication remains effective and safe to use.

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.