Medication info
Romijet Tablets 10/5 mg

Romijet Tablets 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
Pink oblong film-coated tablets
Packaging
30 tablets/box[(10 tablets/PTP X 3)], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004592 · Approved 2020.06.23 · Insurance code 670304500

Summary

Main use
LDL-cholesterol reduction and HDL-cholesterol increase effects through treatment of hypercholesterolemia (primary and mixed)
Who takes it
Adults
Adult dose
This medication is taken once daily regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily, with an initial dose of 10/5 mg recommended. For patients requiring greater LDL-cholesterol reduction, the dose may be adjusted. After dosage adjustments, lipid levels should be checked at intervals of at least 4 weeks, and the dose adjusted accordingly, with a maximum of 10/20 mg daily.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

LDL-cholesterol reduction and HDL-cholesterol increase effects through treatment of hypercholesterolemia (primary and mixed)

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

This medicine is used as an adjunct to dietary therapy to lower total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non-HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to raise HDL-cholesterol levels. It is mainly prescribed along with lipid-regulating drugs to patients at high risk of atherosclerotic vascular disease, and proper dietary therapy and non-pharmacological measures must be combined. It is important to identify and treat other causes that may lead to dyslipidemia before treatment. This medication is used when there is insufficient response to dietary therapy, and treatment efficacy is monitored through regular lipid level testing. Customized treatment is performed considering multiple risk factors. Therefore, this medication helps improve hypercholesterolemia and dyslipidemia.

How to take

Adult dose

This medication is taken once daily regardless of meals. The dosage range is 10/5 mg to 10/20 mg daily, with an initial dose of 10/5 mg recommended. For patients requiring greater LDL-cholesterol reduction, the dose may be adjusted. After dosage adjustments, lipid levels should be checked at intervals of at least 4 weeks, and the dose adjusted accordingly, with a maximum of 10/20 mg daily.

Precautions

This medication has been reported to have rare side effects that may lead to serious muscle issues. Patients with an increased risk of impaired renal function due to acute infections, hypotension, major surgery, trauma, etc. should temporarily discontinue this medication. This medication may not be suitable for certain patients. For example, patients allergic to this medication's ingredients, those with severe liver dysfunction, muscle diseases, those taking certain immunosuppressants, patients with significantly impaired renal function, pregnant or potentially pregnant women, nursing mothers, and those with lactose intolerance should not take this medication. Also, individuals with a history of alcoholism or liver disease, those with decreased renal function, patients with hypothyroidism, and the elderly should take special precautions when using this medication, and regular examinations are necessary to minimize the risk of muscle-related side effects. If symptoms such as muscle pain, muscle weakness, fatigue, or fever occur during treatment with this medication, the doctor should be notified immediately, and blood tests may be needed to check for muscle damage. Symptoms of liver dysfunction should also be monitored, and the medication may need to be discontinued if liver enzyme levels become abnormally high. Moreover, this medication can interact with other drugs, so if you are currently taking any other medications, be sure to inform your doctor or pharmacist. Extra caution is needed when taken with anticoagulants, certain antibiotics, immunosuppressants, and fibrate-class medications. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should use appropriate contraception while taking this medication. This medication is not recommended for children as its safety and efficacy have not been established. Elderly patients should take caution due to the risk of muscle-related side effects, although dosage adjustments are generally not necessary. In case of overdose, there is no specific antidote, so treatment should be symptomatic and monitoring of liver function and muscle enzymes should be conducted. Lastly, this medication should be stored out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), profound generalized weakness, sudden and severe headache, thunderclap headache, seizures, confusion in consciousness, visual disturbances, paralysis, significantly reduced urine output.

Mild side effects

Nasopharyngitis, indigestion, muscle pain, headache, dry mouth, elevated liver enzymes, edema, pruritus, dizziness, elevated blood sugar, increased serum lactate dehydrogenase levels, chest discomfort, cough, diarrhea, thrombocytopenia, dermatitis, skin burning sensation, alopecia, oropharyngeal pain, nasal congestion, osteoarthritis, osteoporosis, musculoskeletal stiffness, musculoskeletal discomfort, muscle weakness, skin itching, urticaria, hyperhidrosis, rash, sensory abnormalities, chest discomfort.

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 best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oblong film-coated tablets

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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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.