Medication info
Romijet Tablet 10/10 mg

Romijet Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
Yellow oblong film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP X 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004590 · Approved 2020.06.23 · Insurance code 670304520

Summary

Main use
Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and reduction of the risk of atherosclerotic vascular diseases.
Who takes it
Adults
Adult dose
This medication is taken once daily regardless of meals. The dosage range is from 10/5 mg to 10/20 mg per day. The initial recommended dosage is 10/5 mg once daily. For patients requiring more significant LDL-cholesterol reduction, the dosage can be adjusted. After initiation of therapy or dosage adjustment, lipid levels should be checked at intervals of more than 4 weeks to adjust the dosage, with a maximum of 10/20mg per day.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Improvement of lipid levels in hypercholesterolemia (primary, mixed type) and reduction of the risk of atherosclerotic vascular diseases.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • elevated Apo B protein
  • increased triglycerides
  • raised non-HDL cholesterol
  • decreased HDL cholesterol
  • increased risk of atherosclerotic vascular diseases due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to diet to lower elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia or mixed dyslipidemia, and to raise levels of HDL cholesterol. In particular, when administering lipid-modifying drugs to patients at high risk of atherosclerotic vascular diseases due to hypercholesterolemia, multiple risk factors should be taken into account. This medication should be used in conjunction with an appropriate dietary regimen, including restriction of saturated fats and cholesterol, and is recommended when there is insufficient response to non-pharmacological treatment. If there is a secondary cause of dyslipidemia, it is important to identify and treat this first, and initial tests should include lipid tests measuring total cholesterol, LDL, HDL, triglycerides. Additionally, patients with acute coronary events should verify their lipid levels upon hospitalization or within 24 hours to guide treatment. This medication helps to improve lipid levels associated with dyslipidemia.

How to take

Adult dose

This medication is taken once daily regardless of meals. The dosage range is from 10/5 mg to 10/20 mg per day. The initial recommended dosage is 10/5 mg once daily. For patients requiring more significant LDL-cholesterol reduction, the dosage can be adjusted. After initiation of therapy or dosage adjustment, lipid levels should be checked at intervals of more than 4 weeks to adjust the dosage, with a maximum of 10/20mg per day.

Precautions

This medication has been reported to rarely cause rhabdomyolysis, which may lead to serious kidney problems. Therefore, if severe muscle pain or muscle weakness occurs, it is important to consult a physician immediately. Those with hypersensitivity to this medication, liver disease, muscle disease, severe renal impairment, pregnant or breastfeeding women should not take this medication. Additionally, when taken with certain medications, the risk of muscle damage may increase; therefore, inform your doctor if you are taking other medications. It is important to regularly check liver function and blood tests before treatment and during treatment to monitor liver enzyme levels and markers for muscle damage. Caution is required when used by the elderly, alcoholics, and those with hypothyroidism, and it is advisable to inform healthcare personnel immediately if muscle pain or adverse drug reactions occur. Women of childbearing potential should use appropriate contraception while taking this medication, and discontinue it immediately upon confirmation of pregnancy. The safety and effectiveness of this medication have not been sufficiently established in children and adolescents, hence it is not recommended for this population. This medication contains lactose, so those with lactose intolerance should not take it, and in case of overdose, consult healthcare personnel immediately for appropriate care. Lastly, dizziness and similar symptoms may occur while taking this medication, requiring caution during driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or trouble breathing, asthma attacks, abnormal respiratory symptoms with cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination problems.

Mild side effects

  • Nasopharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • increased blood sugar
  • pruritus
Show 25 more
  • myalgia
  • arthralgia
  • weakness
  • fatigue
  • paresthesia
  • itching
  • diarrhea
  • vomiting
  • chest discomfort
  • cough
  • drowsiness
  • thrombocytopenia
  • dermatitis
  • skin burning sensation
  • alopecia
  • nasal congestion
  • eyelid drooping
  • diabetes
  • diabetic neuropathy
  • tremor
  • depression
  • neurodegenerative disorders
  • postural dizziness
  • migraine
  • epigastric discomfort.

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. Additionally, it is best to keep the medication at room temperature between 1°C and 30°C. This will help to maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP X 3)], 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.